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Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance)Text with EEA relevance
Consolidated text: Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance)Text with EEA relevance
合并文本：2017 年 4 月 5 日欧洲议会和理事会关于医疗器械的法规 （EU） 2017/745，修订指令 2001/83/EC、法规 （EC） No 178/2002 和法规 （EC） No 1223/2009 并废除理事会指令 90/385/EEC 和 93/42/EEC（与 EEA 相关的文本）与 EEA 相关的文本
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance)Text with EEA relevance
ELI: http://data.europa.eu/eli/reg/2017/745/2023-03-20
IE：http://data.europa.eu/eli/reg/2017/745/2023-03-20
This consolidated text may not include the following amendments:
本合并案文可能不包括以下修正案：
| Amending act 修正法案 | Amendment type 修正类型 | Subdivision concerned 相关细分 | Date of effect 生效日期 |
|---|---|---|---|
| 32023R2197 | Modified by 修改者 | annex VI part C section 6.6 附件六 C 部分 第 6.6 节 |
09/11/2025 |
| 32024R0568 | Modified by 修改者 | article 106 paragraph 14 第106条第14款 |
01/01/2025 |
02017R0745 — EN — 20.03.2023 — 003.001
This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document
本文仅供参考，不具有法律效力。国际电联的机构对其内容不承担任何责任。相关法案的真实版本，包括其序言，是在欧洲联盟官方公报上公布的，并以EUR-Lex形式提供。这些正式文本可通过本文件所载的链接直接查阅
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REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
(Text with EEA relevance) (OJ L 117 5.5.2017, p. 1) |
Amended by: 修订者：
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Official Journal 官方日志 |
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No 不 |
page 页 |
date 日期 |
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L 130 L 130型 |
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24.4.2020 |
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COMMISSION DELEGATED REGULATION (EU) 2023/502 of 1 December 2022 |
L 70 长 70 |
1 |
8.3.2023 |
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L 80 长 80 |
24 |
20.3.2023 |
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Corrected by: 更正者：
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Corrigendum, OJ L 117, 3.5.2019, p. 9 (2017/745) |
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Corrigendum, OJ L 334, 27.12.2019, p. 165 (2017/745) |
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
欧洲议会和理事会条例 （EU） 2017/745
of 5 April 2017
2017年4月5日
on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
关于医疗器械，修订指令 2001/83/EC、法规 （EC） No 178/2002 和法规 （EC） No 1223/2009，并废除理事会指令 90/385/EEC 和 93/42/EEC
(Text with EEA relevance)
（与欧洲经济区相关的文本）
CHAPTER I 第一章
SCOPE AND DEFINITIONS 范围和定义
Article 1 第1条
Subject matter and scope
主题和范围
1. 本条例规定了有关在欧盟投放、提供或投入使用供人使用的医疗器械及其器械配件的规则。本法规也适用于在欧盟进行的有关此类医疗器械和配件的临床研究。
二、本规章亦应自根据第9条通过的通用规范适用之日起，适用于附件十六所列的无预期医疗用途的产品组，同时考虑到现有技术水平，特别是具有医疗用途的类似器械的现有协调标准， 基于类似的技术。附件十六所列每组产品的通用规格应至少涉及附件一中规定的对有关产品组的风险管理的应用，并在必要时进行有关安全性的临床评估。
The necessary common specifications shall be adopted by
►M1
26 May 2021 ◄ . They shall apply as from six months after the date of their entry into force or from
►M1
26 May 2021 ◄ , whichever is the latest.
必要的通用规范应在 ►M1 2021 年 5 月 26 日 ◄ 之前采用。它们应自生效之日起六个月或自 2021 年 5 月 26 日 ◄ M1 起适用，以最晚者为准。
Notwithstanding Article 122, Member States' measures regarding the qualification of the products covered by Annex XVI as medical devices pursuant to Directive 93/42/EEC shall remain valid until the date of application, as referred to in the first subparagraph, of the relevant common specifications for that group of products.
尽管有第122条的规定，成员国根据指令93/42/EEC对附件十六所涵盖的产品进行医疗器械资格的措施应有效，直至该类产品的相关通用规范的适用之日（如第1项所述）。
This Regulation also applies to clinical investigations conducted in the Union concerning the products referred to in the first subparagraph.
本条例也适用于在欧盟进行的有关第1项所述产品的临床研究。
3. 同时具有医疗和非医疗目的的器械应累计满足适用于具有预期医疗目的的器械和适用于非预期医疗目的的器械的要求。
4. 就本条例而言，本条例根据第2款适用的医疗器械、医疗器械配件和附件十六所列产品在下文中称为“器械”。
5. 如果由于投放市场的具有预期医疗目的的器械与没有预期医疗目的的产品在特性和风险方面的相似性而有理由，委员会有权根据第115条通过授权法案，通过增加新的产品组来修订附件十六中的清单， 为了保护用户或其他人的健康和安全或公共卫生的其他方面。
This Regulation does not apply to:
in vitro diagnostic medical devices covered by Regulation (EU) 2017/746;
法规 （EU） 2017/746 涵盖的体外诊断医疗器械;
medicinal products as defined in point 2 of Article 1 of Directive 2001/83/EC. In deciding whether a product falls under Directive 2001/83/EC or under this Regulation, particular account shall be taken of the principal mode of action of the product;
第2001/83/EC号指令第1条第2点中定义的医药产品。在决定产品是否属于指令 2001/83/EC 或本法规时，应特别考虑产品的主要作用方式;
advanced therapy medicinal products covered by Regulation (EC) No 1394/2007;
法规 （EC） No 1394/2007 涵盖的先进治疗医药产品;
human blood, blood products, plasma or blood cells of human origin or devices which incorporate, when placed on the market or put into service, such blood products, plasma or cells, except for devices referred to in paragraph 8 of this Article;
人血、血液制品、人源血浆或血细胞，或在投放市场或投入使用时含有此类血液制品、血浆或细胞的器械，但本条第8款所述器械除外;
cosmetic products covered by Regulation (EC) No 1223/2009;
法规 （EC） No 1223/2009 涵盖的化妆品;
transplants, tissues or cells of animal origin, or their derivatives, or products containing or consisting of them; however this Regulation does apply to devices manufactured utilising tissues or cells of animal origin, or their derivatives, which are non-viable or are rendered non-viable;
移植物、动物源性组织或细胞，或其衍生物，或含有或由它们组成的产品;但是，本法规确实适用于使用动物源性组织或细胞或其衍生物制造的器械，这些器械不可行或无法存活;
transplants, tissues or cells of human origin, or their derivatives, covered by Directive 2004/23/EC, or products containing or consisting of them; however this Regulation does apply to devices manufactured utilising derivatives of tissues or cells of human origin which are non-viable or are rendered non-viable;
指令 2004/23/EC 涵盖的人类来源的移植物、组织或细胞或其衍生物，或包含或组成的产品;但是，本法规确实适用于使用人类来源的组织或细胞衍生物制造的不可行或无法存活的器械;
products, other than those referred to in points (d), (f) and (g), that contain or consist of viable biological material or viable organisms, including living micro-organisms, bacteria, fungi or viruses in order to achieve or support the intended purpose of the product;
除（d）、（f）和（g）点所述的产品外，含有或由活的生物材料或活生物体组成，包括活的微生物、细菌、真菌或病毒，以实现或支持产品的预期目的;
food covered by Regulation (EC) No 178/2002.
第178/2002号条例（EC）涵盖的食品。
6. 本条例不适用于：
7. 任何器械在投放市场或投入使用时，将法规 （EU） 2017/746 第 2 条第 2 点中定义的体外诊断医疗器械作为组成部分，应受本法规管辖。法规 （EU） 2017/746 的要求应适用于器械的体外诊断医疗器械部分。
8. 任何器械在投放市场或投入使用时，将一种物质作为不可分割的一部分，如果单独使用，将被视为第2001/83/EC号指令第1条第2款所定义的医药产品，包括该指令第1条第10款所定义的源自人血或人血浆的医药产品， 并且具有设备辅助作用的，应根据本规则进行评估和授权。
However, if the action of that substance is principal and not ancillary to that of the device, the integral product shall be governed by Directive 2001/83/EC or Regulation (EC) No 726/2004 of the European Parliament and of the Council (
1
), as applicable. In that case, the relevant general safety and performance requirements set out in Annex I to this Regulation shall apply as far as the safety and performance of the device part are concerned.
但是，如果该物质的作用是主要作用而不是设备作用的辅助作用，则整体产品应受欧洲议会和理事会 （1） 指令 2001/83/EC 或法规 （EC） 第 726/2004 号（如适用）的约束。在这种情况下，本法规附件 I 中规定的相关一般安全和性能要求应适用于设备部件的安全和性能。
9. 任何用于管理第2001/83/EC号指令第1条第2款所定义的医药产品的器械均应受本条例管辖，但不影响该指令和第726/2004号条例（EC）关于医药产品的规定。
However, if the device intended to administer a medicinal product and the medicinal product are placed on the market in such a way that they form a single integral product which is intended exclusively for use in the given combination and which is not reusable, that single integral product shall be governed by Directive 2001/83/EC or Regulation (EC) No 726/2004, as applicable. In that case, the relevant general safety and performance requirements set out in Annex I to this Regulation shall apply as far as the safety and performance of the device part of the single integral product are concerned.
但是，如果用于管理医药产品的器械和医药产品以形成单一整体产品的方式投放市场，该整体产品专门用于给定组合且不可重复使用，则该单一整体产品应受指令 2001/83/EC 或法规 （EC） No 726/2004 的约束， 如适用。在这种情况下，本法规附件 I 中规定的相关一般安全和性能要求应适用于单个整体产品的设备部分的安全性和性能。
10. 任何器械在投放市场或投入使用时，将人源性非活组织或细胞或其衍生物作为不可分割的一部分，其作用与器械的作用相辅相成，应根据本条例进行评估和授权。在这种情况下，应适用指令 2004/23/EC 中规定的捐赠、采购和测试规定。
However, if the action of those tissues or cells or their derivatives is principal and not ancillary to that of the device and the product is not governed by Regulation (EC) No 1394/2007, the product shall be governed by Directive 2004/23/EC. In that case, the relevant general safety and performance requirements set out in Annex I to this Regulation shall apply as far as the safety and performance of the device part are concerned.
但是，如果这些组织或细胞或其衍生物的作用是主要的，而不是设备的作用，并且产品不受法规 （EC） No 1394/2007 的约束，则该产品应受指令 2004/23/EC 的约束。在这种情况下，本法规附件 I 中规定的相关一般安全和性能要求应适用于设备部件的安全和性能。
11. 本法规是指令 2014/30/EU 第 2（3） 条所指的特定联盟立法。
12. 欧洲议会和理事会第2006/42/EC号指令第2条第（a）款第（a）点所指的机械设备，如果存在该指令规定的相关危险，也应满足该指令附件I中规定的基本健康和安全要求，但这些要求比设定的一般安全和性能要求更具体见本条例附件一第二章。
13. 本法规不影响指令 2013/59/Euratom 的适用。
14. 本条例不影响成员国在本条例未涵盖的方面限制使用任何特定类型设备的权利。
15. 本条例不应影响有关卫生服务和医疗保健的组织、提供或资助的国家法律，例如要求某些设备只能根据医疗处方提供，要求只有某些卫生专业人员或保健机构才能配发或使用某些设备，或者它们的使用必须伴随着特定的专业咨询。
16. 本条例的任何规定均不得限制新闻自由或媒体言论自由，只要这些自由在欧盟和成员国得到保障，特别是根据《欧洲联盟基本权利宪章》第11条。
Article 2 第2条
Definitions 定义
For the purposes of this Regulation, the following definitions apply:
就本法规而言，以下定义适用：
‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
“医疗器械”是指制造商打算单独或组合用于人类用于以下一项或多项特定医疗目的的任何仪器、仪器、器具、软件、植入物、试剂、材料或其他物品：
疾病的诊断、预防、监测、预测、预后、治疗或缓解，
伤害或残疾的诊断、监测、治疗、缓解或赔偿，
调查、替换或修改解剖结构或生理或病理过程或状态，
通过对来自人体的标本进行体外检查来提供信息，包括器官、血液和组织捐献，
and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
并且不能通过药理学、免疫学或代谢手段在人体内或人体上实现其主要预期作用，但可以通过这些手段辅助其功能。
The following products shall also be deemed to be medical devices:
下列产品也应视为医疗器械：
用于控制或支持受孕的设备;
专门用于清洁、消毒或灭菌第1条第（4）款所述设备以及本条第1款所述设备的产品。
‘accessory for a medical device’ means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s);
“医疗器械配件”是指虽然其本身不是医疗器械，但其制造商打算与一种或多种特定医疗器械一起使用的物品，以专门使医疗器械能够按照其预期用途使用，或就其预期用途而言，具体和直接地协助医疗器械的医疗功能;
‘custom-made device’ means any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person's professional qualifications which gives, under that person's responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs.
“定制设备”是指根据国家法律授权的任何人的书面规定专门制造的任何设备，该设备具有特定的设计特征，由该人负责，仅供特定患者使用，以满足其个人条件和需求。
However, mass-produced devices which need to be adapted to meet the specific requirements of any professional user and devices which are mass-produced by means of industrial manufacturing processes in accordance with the written prescriptions of any authorised person shall not be considered to be custom-made devices;
但是，需要根据任何专业用户的特定要求进行改装的批量生产设备，以及根据任何授权人员的书面规定通过工业制造工艺批量生产的设备，不应被视为定制设备;
‘active device’ means any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy. Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be deemed to be active devices.
“有源装置”是指任何装置，其操作依赖于人体为此目的产生的能量或重力以外的能量来源，并且通过改变该能量的密度或转换该能量来起作用。用于在有源设备和患者之间传输能量、物质或其他元素的设备，没有任何重大变化，不应被视为有源设备。
Software shall also be deemed to be an active device;
软件也应被视为有源设备;
‘implantable device’ means any device, including those that are partially or wholly absorbed, which is intended:
“植入式器械”是指任何器械，包括部分或全部被吸收的器械，其目的是：
完全引入人体，或
替换上皮表面或眼睛表面，
by clinical intervention and which is intended to remain in place after the procedure.
通过临床干预，并打算在手术后保持原位。
Any device intended to be partially introduced into the human body by clinical intervention and intended to remain in place after the procedure for at least 30 days shall also be deemed to be an implantable device;
任何打算通过临床干预部分引入人体并打算在手术后保持至少 30 天的装置也应被视为植入式装置;
‘invasive device’ means any device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body;
“侵入性装置”是指全部或部分通过体孔或体表穿透体内的任何装置;
‘generic device group’ means a set of devices having the same or similar intended purposes or a commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics;
“通用器械组”是指具有相同或相似的预期用途或技术通用性的一组器械，允许它们以通用方式进行分类，而不反映特定特性;
‘single-use device’ means a device that is intended to be used on one individual during a single procedure;
“一次性设备”是指在单个程序中打算在一个人身上使用的设备;
‘falsified device’ means any device with a false presentation of its identity and/or of its source and/or its CE marking certificates or documents relating to CE marking procedures. This definition does not include unintentional non-compliance and is without prejudice to infringements of intellectual property rights;
“伪造器械”是指任何虚假展示其身份和/或来源和/或其CE标志证书或与CE标志程序有关的文件的器械。该定义不包括无意的不遵守，也不妨碍侵犯知识产权;
‘procedure pack’ means a combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose;
“程序包”是指包装在一起并投放市场的产品组合，目的是用于特定的医疗目的;
‘system’ means a combination of products, either packaged together or not, which are intended to be inter-connected or combined to achieve a specific medical purpose;
“系统”是指旨在相互连接或组合以实现特定医疗目的的产品组合，无论是否包装在一起;
‘intended purpose’ means the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation;
“预期用途”是指根据制造商在标签、使用说明或促销或销售材料或声明中提供的数据以及制造商在临床评估中指定的设备的用途;
‘label’ means the written, printed or graphic information appearing either on the device itself, or on the packaging of each unit or on the packaging of multiple devices;
“标签”是指出现在设备本身、每个单元的包装上或多个设备的包装上的书面、印刷或图形信息;
‘instructions for use’ means the information provided by the manufacturer to inform the user of a device's intended purpose and proper use and of any precautions to be taken;
“使用说明”是指制造商提供的信息，用于告知用户设备的预期用途和正确使用以及应采取的任何预防措施;
‘Unique Device Identifier’ (‘UDI’) means a series of numeric or alphanumeric characters that is created through internationally accepted device identification and coding standards and that allows unambiguous identification of specific devices on the market;
“唯一设备标识符”（“UDI”）是指通过国际公认的设备标识和编码标准创建的一系列数字或字母数字字符，可以明确识别市场上的特定设备;
‘non-viable’ means having no potential for metabolism or multiplication;
“不可行”意味着没有新陈代谢或繁殖的潜力;
‘derivative’ means a ‘non-cellular substance’ extracted from human or animal tissue or cells through a manufacturing process. The final substance used for manufacturing of the device in this case does not contain any cells or tissues;
“衍生物”是指通过制造过程从人类或动物组织或细胞中提取的“非细胞物质”。在这种情况下，用于制造设备的最终物质不包含任何细胞或组织;
‘nanomaterial’ means a natural, incidental or manufactured material containing particles in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1-100 nm;
“纳米材料”是指含有未结合状态或聚集体或团聚体的颗粒的天然、偶然或人造材料，其中，对于数量尺寸分布中50%或更多颗粒，一个或多个外部尺寸在1-100纳米的尺寸范围内;
Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions below 1 nm shall also be deemed to be nanomaterials;
富勒烯、石墨烯薄片和一个或多个外形尺寸小于1nm的单壁碳纳米管也应视为纳米材料;
‘particle’, for the purposes of the definition of nanomaterial in point (18), means a minute piece of matter with defined physical boundaries;
就第（18）点中纳米材料的定义而言，“粒子”是指具有定义物理边界的微小物质;
‘agglomerate’, for the purposes of the definition of nanomaterial in point (18), means a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components;
就第（18）点中纳米材料的定义而言，“团聚体”是指弱结合颗粒或聚集体的集合，其中产生的外表面积与各个组分的表面积之和相似;
‘aggregate’, for the purposes of the definition of nanomaterial in point (18), means a particle comprising of strongly bound or fused particles;
就第（18）点中纳米材料的定义而言，“聚集体”是指由强结合或融合的颗粒组成的颗粒;
‘performance’ means the ability of a device to achieve its intended purpose as stated by the manufacturer;
“性能”是指设备实现制造商所述预期目的的能力;
‘risk’ means the combination of the probability of occurrence of harm and the severity of that harm;
“风险”是指伤害发生的可能性和伤害的严重程度的组合;
‘benefit-risk determination’ means the analysis of all assessments of benefit and risk of possible relevance for the use of the device for the intended purpose, when used in accordance with the intended purpose given by the manufacturer;
“效益-风险确定”是指在按照制造商给出的预期目的使用时，对可能与将设备用于预期目的相关的所有益处和风险评估进行分析;
‘compatibility’ is the ability of a device, including software, when used together with one or more other devices in accordance with its intended purpose, to:
“兼容性”是指设备（包括软件）根据其预期用途与一个或多个其他设备一起使用时，能够：
perform without losing or compromising the ability to perform as intended, and/or
在不损失或损害按预期执行的能力的情况下执行，和/或
integrate and/or operate without the need for modification or adaption of any part of the combined devices, and/or
集成和/或操作，无需修改或调整组合设备的任何部分，和/或
be used together without conflict/interference or adverse reaction.
一起使用，没有冲突/干扰或不良反应。
‘interoperability’ is the ability of two or more devices, including software, from the same manufacturer or from different manufacturers, to:
“互操作性”是指来自同一制造商或不同制造商的两个或多个设备（包括软件）能够：
exchange information and use the information that has been exchanged for the correct execution of a specified function without changing the content of the data, and/or
交换信息，并使用已交换的信息来正确执行指定功能，而不改变数据的内容，和/或
communicate with each other, and/or
相互通信，和/或
work together as intended.
按预期协同工作。
‘making available on the market’ means any supply of a device, other than an investigational device, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;
“在市场上提供”是指在商业活动过程中为在欧盟市场上分销、消费或使用而供应的设备（研究设备除外），无论是作为有偿回报还是免费;
‘placing on the market’ means the first making available of a device, other than an investigational device, on the Union market;
“投放市场”是指在欧盟市场上首次提供除研究设备以外的设备;
‘putting into service’ means the stage at which a device, other than an investigational device, has been made available to the final user as being ready for use on the Union market for the first time for its intended purpose;
“投入使用”是指除研究设备外的设备已提供给最终用户，作为其预期目的首次准备在欧盟市场上使用的阶段;
‘manufacturer’ means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trade mark;
“制造商”是指制造或完全翻新设备或设计、制造或完全翻新设备并以其名称或商标销售该设备的自然人或法人;
‘fully refurbishing’, for the purposes of the definition of manufacturer, means the complete rebuilding of a device already placed on the market or put into service, or the making of a new device from used devices, to bring it into conformity with this Regulation, combined with the assignment of a new lifetime to the refurbished device;
就制造商的定义而言，“完全翻新”是指对已经投放市场或投入使用的设备进行全面重建，或从旧设备中制造新设备，以使其符合本法规，并为翻新设备分配新的使用寿命;
‘authorised representative’ means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under this Regulation;
“授权代表”是指在欧盟内设立的任何自然人或法人，他们已收到并接受位于欧盟以外的制造商的书面授权，代表制造商就与后者在本条例下的义务有关的特定任务行事;
‘importer’ means any natural or legal person established within the Union that places a device from a third country on the Union market;
“进口商”是指在欧盟内设立的任何自然人或法人，将来自第三国的设备投放到欧盟市场;
‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service;
“分销商”是指供应链中除制造商或进口商外，在市场上提供设备直至投入使用的任何自然人或法人;
‘economic operator’ means a manufacturer, an authorised representative, an importer, a distributor or the person referred to in Article 22(1) and 22(3);
“经济经营者”是指制造商、授权代表、进口商、分销商或第22条第（1）款和第22条第（3）款所指的人;
‘health institution’ means an organisation the primary purpose of which is the care or treatment of patients or the promotion of public health;
“卫生机构”是指以照顾或治疗患者或促进公共卫生为主要目的的组织;
‘user’ means any healthcare professional or lay person who uses a device;
“用户”是指使用设备的任何医疗保健专业人员或非专业人士;
‘lay person’ means an individual who does not have formal education in a relevant field of healthcare or medical discipline;
“非专业人士”是指在医疗保健或医学学科的相关领域没有接受过正规教育的个人;
‘reprocessing’ means a process carried out on a used device in order to allow its safe reuse including cleaning, disinfection, sterilisation and related procedures, as well as testing and restoring the technical and functional safety of the used device;
“再处理”是指对使用过的器械进行的过程，以便其安全再利用，包括清洁、消毒、灭菌和相关程序，以及测试和恢复使用过的器械的技术和功能安全性;
‘conformity assessment’ means the process demonstrating whether the requirements of this Regulation relating to a device have been fulfilled;
“合格评定”是指证明是否满足本法规中有关器械的要求的过程;
‘conformity assessment body’ means a body that performs third-party conformity assessment activities including calibration, testing, certification and inspection;
“合格评定机构”是指执行第三方合格评定活动（包括校准、测试、认证和检验）的机构;
‘notified body’ means a conformity assessment body designated in accordance with this Regulation;
“公告机构”是指根据本法规指定的合格评定机构;
‘CE marking of conformity’ or ‘CE marking’ means a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in this Regulation and other applicable Union harmonisation legislation providing for its affixing;
“符合性CE标志”或“CE标志”是指制造商表明设备符合本法规和其他适用的欧盟协调立法中规定的适用要求的标记;
‘clinical evaluation’ means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;
“临床评估”是指持续生成、收集、分析和评估与器械有关的临床数据的系统和有计划的过程，以验证器械在按照制造商预期使用时的安全性和性能，包括临床益处;
‘clinical investigation’ means any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device;
“临床研究”是指为评估设备的安全性或性能而进行的涉及一名或多名人类受试者的任何系统调查;
‘investigational device’ means a device that is assessed in a clinical investigation;
“研究设备”是指在临床研究中评估的设备;
‘clinical investigation plan’ means a document that describes the rationale, objectives, design, methodology, monitoring, statistical considerations, organisation and conduct of a clinical investigation;
“临床研究计划”是指描述临床研究的基本原理、目标、设计、方法、监测、统计考虑、组织和实施的文件;
‘clinical data’ means information concerning safety or performance that is generated from the use of a device and is sourced from the following:
“临床数据”是指在使用设备时产生的有关安全性或性能的信息，其来源如下：
有关器械的临床研究，
科学文献中报道的临床调查或其他研究，可以证明与相关设备等效的设备，
发表在同行评审的科学文献中的报告，内容涉及相关设备的其他临床经验或可以证明与相关设备等效的设备，
来自上市后监测的临床相关信息，特别是上市后的临床随访;
‘sponsor’ means any individual, company, institution or organisation which takes responsibility for the initiation, for the management and setting up of the financing of the clinical investigation;
“申办者”是指负责启动、管理和建立临床研究融资的任何个人、公司、机构或组织;
‘subject’ means an individual who participates in a clinical investigation;
“受试者”是指参与临床研究的个人;
‘clinical evidence’ means clinical data and clinical evaluation results pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s), when used as intended by the manufacturer;
“临床证据”是指与设备相关的临床数据和临床评估结果，其数量和质量足以对设备是否安全并实现预期的临床益处进行合格评估，当按照制造商的意图使用时;
‘clinical performance’ means the ability of a device, resulting from any direct or indirect medical effects which stem from its technical or functional characteristics, including diagnostic characteristics, to achieve its intended purpose as claimed by the manufacturer, thereby leading to a clinical benefit for patients, when used as intended by the manufacturer;
“临床性能”是指器械因技术或功能特性（包括诊断特性）而产生的任何直接或间接医疗效果，实现制造商声称的预期目的的能力，从而在按照制造商的意图使用时为患者带来临床益处;
‘clinical benefit’ means the positive impact of a device on the health of an individual, expressed in terms of a meaningful, measurable, patient-relevant clinical outcome(s), including outcome(s) related to diagnosis, or a positive impact on patient management or public health;
“临床益处”是指设备对个人健康的积极影响，以有意义、可衡量、与患者相关的临床结果表示，包括与诊断相关的结果，或对患者管理或公共卫生的积极影响;
‘investigator’ means an individual responsible for the conduct of a clinical investigation at a clinical investigation site;
“研究者”是指负责在临床研究地点进行临床研究的个人;
‘informed consent’ means a subject's free and voluntary expression of his or her willingness to participate in a particular clinical investigation, after having been informed of all aspects of the clinical investigation that are relevant to the subject's decision to participate or, in the case of minors and of incapacitated subjects, an authorisation or agreement from their legally designated representative to include them in the clinical investigation;
“知情同意”是指受试者在被告知与受试者决定参与临床研究相关的临床研究的所有方面后，自由和自愿地表达他或她参与特定临床研究的意愿，或者对于未成年人和无行为能力的受试者，其法定代表的授权或同意将他们纳入临床研究;
‘ethics committee’ means an independent body established in a Member State in accordance with the law of that Member State and empowered to give opinions for the purposes of this Regulation, taking into account the views of laypersons, in particular patients or patients' organisations;
“伦理委员会”是指根据成员国法律在成员国设立的独立机构，有权为本条例的目的提供意见，同时考虑非专业人士的意见，特别是患者或患者组织的意见;
‘adverse event’ means any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device;
“不良事件”是指在临床研究的背景下，受试者、使用者或其他人发生的任何不良医学事件、意外疾病或伤害或任何不良临床体征，包括异常实验室发现，无论是否与研究设备相关;
‘serious adverse event’ means any adverse event that led to any of the following:
“严重不良事件”是指导致以下任何一种情况的任何不良事件：
death, 死亡
serious deterioration in the health of the subject, that resulted in any of the following:
受试者健康状况严重恶化，导致以下任何一种情况：
life-threatening illness or injury,
危及生命的疾病或伤害，
permanent impairment of a body structure or a body function,
身体结构或身体机能的永久性损伤，
hospitalisation or prolongation of patient hospitalisation,
住院或患者住院时间延长，
medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function,
预防危及生命的疾病或伤害或身体结构或身体功能永久性损伤的医疗或手术干预，
chronic disease, 慢性病
foetal distress, foetal death or a congenital physical or mental impairment or birth defect;
胎儿窘迫、胎儿死亡或先天性身体或精神损伤或先天缺陷;
‘device deficiency’ means any inadequacy in the identity, quality, durability, reliability, safety or performance of an investigational device, including malfunction, use errors or inadequacy in information supplied by the manufacturer;
“器械缺陷”是指研究器械在特性、质量、耐用性、可靠性、安全性或性能方面的任何不足，包括制造商提供的故障、使用错误或信息不足;
‘post-market surveillance’ means all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions;
“上市后监督”是指制造商与其他经济经营者合作开展的所有活动，以制定和更新系统程序，以主动收集和审查从他们投放市场、在市场上提供或投入使用的设备中获得的经验，以确定是否需要立即采取任何必要的纠正或预防措施;
‘market surveillance’ means the activities carried out and measures taken by competent authorities to check and ensure that devices comply with the requirements set out in the relevant Union harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection;
“市场监督”是指主管当局为检查和确保设备符合相关欧盟协调立法中规定的要求而开展的活动和采取的措施，并且不会危及健康、安全或公共利益保护的任何其他方面;
‘recall’ means any measure aimed at achieving the return of a device that has already been made available to the end user;
“召回”是指旨在实现已向最终用户提供的设备的返还的任何措施;
‘withdrawal’ means any measure aimed at preventing a device in the supply chain from being further made available on the market;
“撤回”是指旨在防止供应链中的设备进一步投放市场的任何措施;
‘incident’ means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect;
“事故”是指市场上提供的设备的特性或性能的任何故障或恶化，包括由于人体工程学特征导致的使用错误，以及制造商提供的信息的任何不足和任何不良副作用;
‘serious incident’ means any incident that directly or indirectly led, might have led or might lead to any of the following:
“严重事件”是指直接或间接导致、可能导致或可能导致以下任何事件的任何事件：
the death of a patient, user or other person,
患者、用户或其他人员的死亡，
the temporary or permanent serious deterioration of a patient's, user's or other person's state of health,
患者、使用者或其他人的健康状况暂时或永久严重恶化，
a serious public health threat;
严重的公共卫生威胁;
‘serious public health threat’ means an event which could result in imminent risk of death, serious deterioration in a person's state of health, or serious illness, that may require prompt remedial action, and that may cause significant morbidity or mortality in humans, or that is unusual or unexpected for the given place and time;
“严重公共卫生威胁”是指可能导致迫在眉睫的死亡风险、健康状况严重恶化或严重疾病的事件，可能需要立即采取补救措施，并可能导致人类的严重发病率或死亡率，或在特定地点和时间内不寻常或意外的事件;
‘corrective action’ means action taken to eliminate the cause of a potential or actual non-conformity or other undesirable situation;
“纠正措施”是指为消除潜在或实际不符合项或其他不良情况的原因而采取的行动;
‘field safety corrective action’ means corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market;
“现场安全纠正措施”是指制造商出于技术或医疗原因采取的纠正措施，以防止或降低与市场上提供的设备有关的严重事故风险;
‘field safety notice’ means a communication sent by a manufacturer to users or customers in relation to a field safety corrective action;
“现场安全通知”是指制造商向用户或客户发送的有关现场安全纠正措施的通信;
‘harmonised standard’ means a European standard as defined in point (1)(c) of Article 2 of Regulation (EU) No 1025/2012;
“协调标准”是指法规 （EU） No 1025/2012 第 2 条第 （1）（c） 点中定义的欧洲标准;
‘common specifications’ (CS) means a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system.
“通用规范”（CS）是指除标准外的一组技术和/或临床要求，这些要求提供了遵守适用于设备、过程或系统的法律义务的方法。
Article 3 第3条
Amendment of certain definitions
对某些定义的修正
The Commission is empowered to adopt delegated acts in accordance with Article 115 in order to amend the definition of nanomaterial set out in point (18) and the related definitions in points (19), (20) and (21) of Article 2 in the light of technical and scientific progress and taking into account definitions agreed at Union and international level.
委员会有权根据第115条通过授权法案，以便根据技术和科学进步，并考虑到联盟和国际层面商定的定义，修订第（18）点中规定的纳米材料定义以及第2条第（19）、（20）和（21）点中的相关定义。
Article 4 第4条
Regulatory status of products
产品监管状况
1. 在不影响第2001/83/EC号指令第2（2）条的情况下，根据成员国的正式证实请求，委员会应在咨询根据本条例第103条设立的医疗器械协调小组（“MDCG”）后，通过实施法案，确定特定产品、类别或产品组是否： 属于“医疗器械”或“医疗器械附件”的定义。实施行为应按照本条例第一百一十四条第（三）款所述的审查程序通过。
2. 委员会在与MDCG协商后，也可以主动通过执行法案，就本条第1款所述问题作出决定。实施法案应按照第114条第（3）款所述的审查程序通过。
3. 委员会应确保成员国分享医疗器械、体外诊断医疗器械、医药产品、人体组织和细胞、化妆品、杀菌剂、食品以及必要时其他产品领域的专门知识，以确定产品、产品类别或产品组的适当监管地位。
4. 在审议涉及医药产品、人体组织和细胞、杀菌剂或食品的产品作为器械的可能监管地位时，委员会应确保与欧洲药品管理局（EMA）、欧洲化学品管理局（ECHA）和欧洲食品安全局（EFSA）进行适当程度的磋商。
CHAPTER II 第二章
MAKING AVAILABLE ON THE MARKET AND PUTTING INTO SERVICE OF DEVICES, OBLIGATIONS OF ECONOMIC OPERATORS, REPROCESSING, CE MARKING, FREE MOVEMENT
在市场上提供并投入使用设备，经济运营商的义务，后处理，CE标志，自由流动
Article 5 第5条
Placing on the market and putting into service
投放市场并投入使用
1. 只有当设备符合本条例的规定，并按照其预期目的适当供应和正确安装、维护和使用时，才能投放市场或投入使用。
2. 器械应符合附件一中规定的适用于它的一般安全和性能要求，同时考虑到其预期用途。
3. 符合一般安全和性能要求的证明应包括根据第 61 条进行的临床评估。
4. 在卫生机构内制造和使用的器械应视为已投入使用。
With the exception of the relevant general safety and performance requirements set out in Annex I, the requirements of this Regulation shall not apply to devices, manufactured and used only within health institutions established in the Union, provided that all of the following conditions are met:
the devices are not transferred to another legal entity,
设备不会转让给其他法人实体，
manufacture and use of the devices occur under appropriate quality management systems,
设备的制造和使用是在适当的质量管理体系下进行的，
the health institution justifies in its documentation that the target patient group's specific needs cannot be met, or cannot be met at the appropriate level of performance by an equivalent device available on the market,
卫生机构在其文件中证明，目标患者群体的特定需求无法满足，或者市场上可用的同等设备无法满足适当的性能水平，
the health institution provides information upon request on the use of such devices to its competent authority, which shall include a justification of their manufacturing, modification and use;
卫生机构应要求向其主管当局提供有关此类设备使用情况的信息，其中应包括其制造、修改和使用的理由;
the health institution draws up a declaration which it shall make publicly available, including:
卫生机构起草一份声明，并应向公众公布，包括：
the name and address of the manufacturing health institution;
制造卫生机构的名称和地址;
the details necessary to identify the devices;
识别设备所需的详细信息;
a declaration that the devices meet the general safety and performance requirements set out in Annex I to this Regulation and, where applicable, information on which requirements are not fully met with a reasoned justification therefor,
声明设备符合本法规附件 I 中规定的一般安全和性能要求，并在适用的情况下提供关于哪些要求未完全满足的信息，并为此提供合理的理由，
the health institution draws up documentation that makes it possible to have an understanding of the manufacturing facility, the manufacturing process, the design and performance data of the devices, including the intended purpose, and that is sufficiently detailed to enable the competent authority to ascertain that the general safety and performance requirements set out in Annex I to this Regulation are met;
卫生机构起草的文件可以了解制造设施、制造过程、器械的设计和性能数据，包括预期用途，并且足够详细，使主管当局能够确定满足本法规附件 I 中规定的一般安全和性能要求;
the health institution takes all necessary measures to ensure that all devices are manufactured in accordance with the documentation referred to in point (f), and
卫生机构采取一切必要措施，确保所有设备均按照（f）点所述文件制造，并且
the health institution reviews experience gained from clinical use of the devices and takes all necessary corrective actions.
卫生机构审查从临床使用设备中获得的经验，并采取所有必要的纠正措施。
5. 除附件I中规定的相关一般安全和性能要求外，本法规的要求不适用于仅在欧盟设立的卫生机构内制造和使用的器械，前提是满足以下所有条件：
Member States may require that such health institutions submit to the competent authority any further relevant information about such devices which have been manufactured and used on their territory. Member States shall retain the right to restrict the manufacture and the use of any specific type of such devices and shall be permitted access to inspect the activities of the health institutions.
会员国可要求此类卫生机构向主管当局提交有关在其领土上制造和使用的此类器械的任何进一步相关信息。会员国应保留限制制造和使用任何特定类型的此类器械的权利，并应允许其进入检查卫生机构的活动。
This paragraph shall not apply to devices that are manufactured on an industrial scale.
本款不适用于工业规模制造的器械。
6. 为确保附件一的统一适用，委员会可在必要的范围内通过执行法案，以解决不同的解释和实际适用问题。实施法案应按照第114条第（3）款所述的审查程序通过。
Article 6 第6条
Distance sales 远程销售
1. 根据指令（EU）2015/1535第1（1）条（b）项的定义，通过信息社会服务向在欧盟设立的自然人或法人提供的设备应符合本条例。
2. 在不损害有关医疗专业行使的国家法律的情况下，未投放市场但用于商业活动的设备，无论是作为有偿回报还是免费，用于通过指令 （EU） 2015/1535 第 1 条第 （1） 款 （b） 点定义的信息社会服务或通过其他通信方式提供的诊断或治疗服务， 直接或通过中间人向在联盟设立的自然人或法人应遵守本条例。
3. 根据主管当局的要求，根据第 1 款提供设备或根据第 2 款提供服务的任何自然人或法人应提供有关设备的欧盟符合性声明的副本。
4. 成员国可以保护公众健康为由，要求（欧盟）2015/1535号指令第1条第（1）款（b）项所界定的信息社会服务提供者停止其活动。
Article 7 第7条
Claims 索赔
►C1
In the labelling, instructions for use, making available, putting into service and advertising of devices, it shall be prohibited to use text, names, trade marks, pictures and ◄ figurative or other signs that may mislead the user or the patient with regard to the device's intended purpose, safety and performance by:
►C1 在设备的标签、使用说明、提供、投入使用和广告中，应禁止使用文字、名称、商标、图片和 ◄ 可能误导用户或患者对设备的预期用途、安全性和性能的图形或其他标志：
ascribing functions and properties to the device which the device does not have;
将设备不具备的功能和属性归因于设备;
creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have;
对治疗或诊断、设备不具备的功能或特性产生错误印象;
failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose;
未能告知用户或患者与按照其预期目的使用设备相关的可能风险;
suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.
建议设备的用途，而不是那些声称构成进行合格评定的预期目的的一部分的用途。
Article 8 第8条
Use of harmonised standards
使用协调标准
1. 符合相关协调标准或这些标准的相关部分的器械，其参考文献已在欧盟官方公报上公布，应推定为符合这些标准或其部分所涵盖的本法规的要求。
The first subparagraph shall also apply to system or process requirements to be fulfilled in accordance with this Regulation by economic operators or sponsors, including those relating to quality management systems, risk management, post-market surveillance systems, clinical investigations, clinical evaluation or post-market clinical follow-up (‘PMCF’).
第一项也应适用于经济经营者或申办者根据本条例应满足的系统或工艺要求，包括与质量管理体系、风险管理、上市后监测系统、临床研究、临床评估或上市后临床随访（“PMCF”）有关的要求。
References in this Regulation to harmonised standards shall be understood as meaning harmonised standards the references of which have been published in the Official Journal of the European Union.
本法规中对协调标准的引用应理解为指已在欧盟官方公报上公布的协调标准。
2. 本条例中对协调标准的引用还应包括根据《欧洲药典制定公约》通过的《欧洲药典》专著，特别是关于手术缝合线和医药产品与含有此类药品的器械中使用的材料之间的相互作用的专著，但这些专著的参考文献已在《欧洲联盟官方公报》上发表。
Article 9 第9条
Common specifications 常用规格
1. 在不影响第1条第（2）款和第17条第（5）款以及这些条款规定的最后期限的情况下，如果不存在统一标准或相关的协调标准不足，或需要解决公共卫生问题，委员会在与MDCG协商后，可以通过执行法案通过关于附件一所列的一般安全和性能要求的共同规范（CS）， 附件二和附件三中规定的技术文件、附件十四中规定的临床评估和上市后临床随访或附件十五中规定的临床研究要求。实施法案应按照第114条第（3）款所述的审查程序通过。
2. 符合第 1 款所述 CS 的器械应推定为符合这些 CS 或这些 CS 的相关部分所涵盖的本法规的要求。
3. 制造商应遵守第1款所述的CS，除非他们能够适当地证明他们采用的解决方案确保了至少与之相当的安全和性能水平。
4. 尽管有第3款的规定，附件十六所列产品的制造商应遵守这些产品的相关CS。
Article 10 第10条
General obligations of manufacturers
制造商的一般义务
1. 制造商在将设备投放市场或投入使用时，应确保其设计和制造符合本法规的要求。
2. 制造商应建立、记录、实施和维护附件一第3节所述的风险管理系统。
3. 制造商应根据第六十一条和附件十四规定的要求进行临床评估，包括PMCF。
4. 定制设备以外的设备制造商应为这些设备起草并保持最新的技术文档。技术文件应允许评估设备是否符合本法规的要求。技术文件应包括附件二和附件三所列要素。
The Commission is empowered to adopt delegated acts in accordance with Article 115 amending, in the light of technical progress, the Annexes II and III.
委员会有权根据第115条通过授权法案，根据技术进展情况修订附件二和附件三。
5. 定制设备制造商应根据附件十三第2节的规定，起草、更新并向主管当局提供文件。
6. 如果按照适用的合格评定程序证明符合适用的要求，则除定制或研究设备外的设备制造商应根据第 19 条起草欧盟符合性声明，并根据第 20 条加贴符合性 CE 标志。
7. 制造商应遵守第27条所述与UDI系统有关的义务以及第29条和第31条所述的注册义务。
8. 制造商应将技术文件、欧盟符合性声明以及根据第 56 条颁发的任何相关证书的副本（包括任何修订和补充）保留给主管当局，期限至少为 10 年，自欧盟符合性声明所涵盖的最后一个设备投放市场后。对于植入式器械，该期限应为最后一个器械投放市场后至少 15 年。
Upon request by a competent authority, the manufacturer shall, as indicated therein, provide that technical documentation in its entirety or a summary thereof.
应主管当局的要求，制造商应如其所述提供该技术文件的全部内容或摘要。
A manufacturer with a registered place of business outside the Union shall, in order to allow its authorised representative to fulfil the tasks mentioned in Article 11(3), ensure that the authorised representative has the necessary documentation permanently available.
在欧盟以外设有注册营业地点的制造商，为了使其授权代表能够完成第11条第（3）款所述的任务，应确保授权代表拥有永久可用的必要文件。
9. 制造商应确保程序到位，以保持批量生产符合本条例的要求。应及时充分考虑器械设计或特性的变化以及声明器械符合性的参考的协调标准或CS的变化。除研究器械外，器械制造商应建立、记录、实施、维护、保持最新并不断改进质量管理体系，以确保以最有效的方式和与风险等级和器械类型相称的方式遵守本法规。
The quality management system shall cover all parts and elements of a manufacturer's organisation dealing with the quality of processes, procedures and devices. It shall govern the structure, responsibilities, procedures, processes and management resources required to implement the principles and actions necessary to achieve compliance with the provisions of this Regulation.
质量管理体系应涵盖制造商组织中涉及流程、程序和设备质量的所有部分和要素。它应管理实施为遵守本条例规定而采取的必要原则和行动所需的结构、职责、程序、程序和管理资源。
The quality management system shall address at least the following aspects:
质量管理体系至少应当解决以下几个方面：
a strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for management of modifications to the devices covered by the system;
监管合规战略，包括遵守合格评定程序和系统所涵盖的器械修改管理程序;
identification of applicable general safety and performance requirements and exploration of options to address those requirements;
确定适用的一般安全和性能要求，并探索满足这些要求的备选方案;
responsibility of the management;
管理层的责任;
resource management, including selection and control of suppliers and sub-contractors;
资源管理，包括供应商和分包商的选择和控制;
risk management as set out in in Section 3 of Annex I;
附件一第3节规定的风险管理;
clinical evaluation in accordance with Article 61 and Annex XIV, including PMCF;
根据第 61 条和附件 XIV 进行的临床评估，包括 PMCF;
product realisation, including planning, design, development, production and service provision;
产品实现，包括规划、设计、开发、生产和服务提供;
verification of the UDI assignments made in accordance with Article 27(3) to all relevant devices and ensuring consistency and validity of information provided in accordance with Article 29;
验证根据第27条第（3）款向所有相关设备进行的UDI分配，并确保根据第29条提供的信息的一致性和有效性;
setting-up, implementation and maintenance of a post-market surveillance system, in accordance with Article 83;
根据第83条建立、实施和维护上市后监督系统;
handling communication with competent authorities, notified bodies, other economic operators, customers and/or other stakeholders;
处理与主管当局、公告机构、其他经济运营商、客户和/或其他利益相关者的沟通;
processes for reporting of serious incidents and field safety corrective actions in the context of vigilance;
在警戒背景下报告严重事件和现场安全纠正措施的流程;
management of corrective and preventive actions and verification of their effectiveness;
管理纠正和预防措施并核实其有效性;
processes for monitoring and measurement of output, data analysis and product improvement.
用于监测和测量产出、数据分析和产品改进的流程。
10. 器械制造商应根据第83条实施并及时更新上市后监督系统。
11. 制造商应确保设备随附附件 I 第 23 节中规定的信息，该信息以向用户或患者提供设备的成员国确定的官方联盟语言提供。标签上的细节应不可磨灭，易于阅读，并且对预期用户或患者来说清晰易懂。
12. 制造商如果认为或有理由相信其投放市场或投入使用的设备不符合本条例，应立即采取必要的纠正措施，使该设备符合要求，并酌情撤回或召回。他们应通知相关设备的分销商，并在适用的情况下通知授权代表和进口商。
Where the device presents a serious risk, manufacturers shall immediately inform the competent authorities of the Member States in which they made the device available and, where applicable, the notified body that issued a certificate for the device in accordance with Article 56, in particular, of the non-compliance and of any corrective action taken.
如果器械存在严重风险，制造商应立即通知其提供器械的成员国主管当局，并在适用的情况下，通知根据第56条为器械颁发证书的公告机构，特别是不合规情况和采取的任何纠正措施。
13. 制造商应建立记录和报告事故和现场安全纠正措施的系统，如第 87 条和第 88 条所述。
14. 制造商应主管当局的要求，以有关成员国确定的欧盟官方语言向其提供证明设备符合性所需的所有信息和文件。制造商注册营业地所在成员国的主管当局可要求制造商免费提供设备样品，或在不可行的情况下允许使用设备。制造商应根据主管当局的要求，与主管当局合作，采取任何纠正措施，以消除或减轻其投放市场或投入使用的设备所带来的风险。
If the manufacturer fails to cooperate or the information and documentation provided is incomplete or incorrect, the competent authority may, in order to ensure the protection of public health and patient safety, take all appropriate measures to prohibit or restrict the device's being made available on its national market, to withdraw the device from that market or to recall it until the manufacturer cooperates or provides complete and correct information.
如果制造商不合作或提供的信息和文件不完整或不正确，主管当局可以采取一切适当措施，禁止或限制设备在其国内市场上销售，将设备从该市场撤出或召回，直到制造商合作或提供完整和正确的信息。
If a competent authority considers or has reason to believe that a device has caused damage, it shall, upon request, facilitate the provision of the information and documentation referred to in the first subparagraph to the potentially injured patient or user and, as appropriate, the patient's or user's successor in title, the patient's or user's health insurance company or other third parties affected by the damage caused to the patient or user, without prejudice to data protection rules and, unless there is an overriding public interest in disclosure, without prejudice to the protection of intellectual property rights.
如果主管当局认为或有理由相信设备已经造成损害，它应根据请求，协助向可能受伤的患者或使用者提供第一项所述的信息和文件，并酌情向患者或用户的所有权继承人、患者或用户的健康保险公司或受患者或用户造成的损害影响的其他第三方提供第一项所述的信息和文件， 在不影响数据保护规则的情况下，除非披露有压倒一切的公共利益，否则不影响对知识产权的保护。
The competent authority need not comply with the obligation laid down in the third subparagraph where disclosure of the information and documentation referred to in the first subparagraph is ordinarily dealt with in the context of legal proceedings.
主管当局无须遵守第3项规定的义务，因为第1项所述资料和文件的披露通常是在法律程序中处理的。
15. 如果制造商的设备由其他法人或自然人设计或制造，则该人的身份信息应作为根据第29条第（4）款提交的信息的一部分。
16. 自然人或法人可以根据适用的联盟和国家法律要求赔偿有缺陷的设备造成的损害。
Manufacturers shall, in a manner that is proportionate to the risk class, type of device and the size of the enterprise, have measures in place to provide sufficient financial coverage in respect of their potential liability under Directive 85/374/EEC, without prejudice to more protective measures under national law.
制造商应以与风险等级、设备类型和企业规模相称的方式采取措施，为其根据第85/374/EEC号指令可能承担的责任提供足够的财务保障，但不影响国家法律规定的更多保护措施。
Article 11 第11条
Authorised representative
授权代表
1. 如果器械制造商不在成员国成立，则只有在制造商指定唯一授权代表的情况下，该器械才能投放欧盟市场。
2. 该指定应构成授权代表的授权，只有在授权代表以书面形式接受后才有效，并且至少对同一通用设备组的所有设备有效。
3. 授权代表应执行其与制造商商定的授权中规定的任务。授权代表应根据要求向主管当局提供授权书副本。
The mandate shall require, and the manufacturer shall enable, the authorised representative to perform at least the following tasks in relation to the devices that it covers:
该授权应要求，并且制造商应使授权代表至少执行与其所涵盖的设备相关的以下任务：
verify that the EU declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;
验证是否已经起草了欧盟符合性声明和技术文件，并在适用的情况下，制造商是否进行了适当的合格评定程序;
keep available a copy of the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, issued in accordance with Article 56, at the disposal of competent authorities for the period referred to in Article 10(8);
保留根据第56条颁发的技术文件、欧盟符合性声明的副本，以及（如适用）相关证书的副本，包括任何修订和补充，供主管当局在第10条第（8）款所述期间使用;
comply with the registration obligations laid down in Article 31 and verify that the manufacturer has complied with the registration obligations laid down in Articles 27 and 29;
遵守第31条规定的注册义务，并核实制造商是否遵守了第27条和第29条规定的注册义务;
in response to a request from a competent authority, provide that competent authority with all the information and documentation necessary to demonstrate the conformity of a device, in an official Union language determined by the Member State concerned;
应主管当局的要求，以有关成员国确定的联盟官方语言向该主管当局提供证明设备符合性所需的所有信息和文件;
forward to the manufacturer any request by a competent authority of the Member State in which the authorised representative has its registered place of business for samples, or access to a device and verify that the competent authority receives the samples or is given access to the device;
向制造商转发授权代表在其注册营业地点注册的成员国主管当局提出的任何请求，以提供样品或访问设备，并核实主管当局是否收到样品或获准访问设备;
cooperate with the competent authorities on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices;
与主管当局合作，采取任何预防或纠正措施，以消除或减轻设备带来的风险;
immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated;
立即将医疗保健专业人员、患者和用户关于与其指定设备相关的可疑事件的投诉和报告通知制造商;
terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation.
如果制造商的行为违反其在本条例下的义务，则终止授权。
四、本条第3款所指的授权不得委托制造商履行第10条第（1）款、第（2）款、第（3）款、第（4）款、第（6）款、第（7）款、第（9）款、第（10）款、第（11）款和第（12）款规定的义务。
五、在不影响本条第4款的情况下，如果制造商不在成员国成立，并且未遵守第10条规定的义务，则授权代表应与制造商相同，并与制造商共同承担法律责任。
6. 根据第3款（h）点所述理由终止其任务的授权代表，应立即通知其所在成员国的主管当局，并在适用时通知参与设备合格评定的公告机构终止任务及其原因。
7. 本条例中凡提及制造商注册营业地所在成员国的主管当局，均应理解为提及第1款所述制造商指定的授权代表在其注册营业地所在成员国的主管当局。
Article 12 第12条
Change of authorised representative
更改授权代表
The detailed arrangements for a change of authorised representative shall be clearly defined in an agreement between the manufacturer, where practicable the outgoing authorised representative, and the incoming authorised representative. That agreement shall address at least the following aspects:
更换授权代表的详细安排应在制造商（在切实可行的情况下）与即将离任的授权代表之间的协议中明确规定。该协议至少应涉及以下方面：
the date of termination of the mandate of the outgoing authorised representative and date of beginning of the mandate of the incoming authorised representative;
即将离任的授权代表的授权终止日期和即将上任的授权代表的授权开始日期;
the date until which the outgoing authorised representative may be indicated in the information supplied by the manufacturer, including any promotional material;
制造商提供的信息（包括任何宣传材料）中可能指明即将离任的授权代表的日期;
the transfer of documents, including confidentiality aspects and property rights;
文件的转让，包括保密方面和财产权;
the obligation of the outgoing authorised representative after the end of the mandate to forward to the manufacturer or incoming authorised representative any complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device for which it had been designated as authorised representative.
在授权结束后，即将离任的授权代表有义务将医疗保健专业人员、患者或用户关于与其被指定为授权代表的设备相关的可疑事件的任何投诉或报告转发给制造商或即将上任的授权代表。
Article 13 第13条
General obligations of importers
进口商的一般义务
1. 进口商应仅将符合本条例的器械投放到欧盟市场。
In order to place a device on the market, importers shall verify that:
the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;
该设备已获得 CE 标志，并且已起草该设备的欧盟符合性声明;
a manufacturer is identified and that an authorised representative in accordance with Article 11 has been designated by the manufacturer;
确定制造商，并已根据第11条指定了制造商的授权代表;
the device is labelled in accordance with this Regulation and accompanied by the required instructions for use;
设备按照本法规贴有标签，并附有所需的使用说明;
where applicable, a UDI has been assigned by the manufacturer in accordance with Article 27.
在适用的情况下，制造商已根据第 27 条分配了 UDI。
2. 为了将设备投放市场，进口商应核实：
Where an importer considers or has reason to believe that a device is not in conformity with the requirements of this Regulation, it shall not place the device on the market until it has been brought into conformity and shall inform the manufacturer and the manufacturer's authorised representative. Where the importer considers or has reason to believe that the device presents a serious risk or is a falsified device, it shall also inform the competent authority of the Member State in which the importer is established.
如果进口商认为或有理由相信某种设备不符合本法规的要求，则在符合要求之前不得将该设备投放市场，并应通知制造商和制造商的授权代表。如果进口商认为或有理由相信该器械存在严重风险或为伪造器械，还应通知进口商所在成员国的主管当局。
三、进口商应当在器械或其包装上或器械随附的单据上注明其名称、注册商号或注册商标、其注册营业地点和联系地址，以便确定其所在地。他们应确保任何附加标签不会掩盖制造商提供的标签上的任何信息。
四、进口商应当根据第29条的规定核实设备是否在电子系统中注册。进口商应当按照第三十一条的规定在登记中添加其详细信息。
5. 进口商应确保，在器械由其负责期间，储存或运输条件不会危及其符合附件一中规定的一般安全和性能要求，并应遵守制造商规定的条件（如有）。
6. 进口商应保存投诉、不合格设备、召回和撤回的登记册，并向制造商、授权代表和分销商提供他们要求的任何信息，以便他们调查投诉。
7. 进口商认为或有理由相信其投放市场的器械不符合本条例，应立即通知制造商及其授权代表。进口商应与制造商、制造商的授权代表和主管当局合作，确保采取必要的纠正措施，使该设备符合要求，撤回或召回。如果设备存在严重风险，它们还应立即通知提供设备的成员国主管当局，并在适用的情况下通知根据第 56 条为有关设备颁发证书的指定机构，特别详细说明不合规情况和采取的任何纠正措施。
8. 进口商如收到医护人员、患者或用户关于其投放市场的器械相关疑似事件的投诉或报告，应立即将此信息转发给制造商及其授权代表。
9. 进口商应在第10条第（8）款所述的期限内保留一份欧盟符合性声明的副本，并在适用的情况下保留根据第56条签发的任何相关证书的副本，包括任何修订和补充。
10. 进口商应应主管当局的要求，与主管当局合作，采取任何行动，以消除或减轻其投放市场的设备所构成的风险。进口商应进口商注册营业地所在成员国主管当局的要求，应免费提供设备样品，或在不可行的情况下准许使用设备。
Article 14 第14条
General obligations of distributors
分销商的一般义务
1. 在市场上提供设备时，分销商应在其活动范围内，根据适用的要求采取应有的谨慎措施。
Before making a device available on the market, distributors shall verify that all of the following requirements are met:
the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;
该设备已获得 CE 标志，并且已起草该设备的欧盟符合性声明;
the device is accompanied by the information to be supplied by the manufacturer in accordance with Article 10(11);
设备附有制造商根据第 10（11） 条提供的信息;
for imported devices, the importer has complied with the requirements set out in Article 13(3);
对于进口器械，进口商已遵守第13条第（3）款规定的要求;
that, where applicable, a UDI has been assigned by the manufacturer.
在适用的情况下，制造商已分配了 UDI。
2. 在将设备投放市场之前，分销商应验证是否满足以下所有要求：
In order to meet the requirements referred to in points (a), (b) and (d) of the first subparagraph the distributor may apply a sampling method that is representative of the devices supplied by that distributor.
为了满足第1项（a）、（b）和（d）点所述的要求，分销商可以采用代表该分销商提供的设备的抽样方法。
Where a distributor considers or has reason to believe that a device is not in conformity with the requirements of this Regulation, it shall not make the device available on the market until it has been brought into conformity, and shall inform the manufacturer and, where applicable, the manufacturer's authorised representative, and the importer. Where the distributor considers or has reason to believe that the device presents a serious risk or is a falsified device, it shall also inform the competent authority of the Member State in which it is established.
如果分销商认为或有理由相信设备不符合本法规的要求，则在符合要求之前不得在市场上提供该设备，并应通知制造商，并在适用的情况下通知制造商的授权代表和进口商。如果分销商认为或有理由相信该器械存在严重风险或为伪造器械，还应通知其所在成员国的主管当局。
3. 分销商应确保，在设备由其负责期间，储存或运输条件符合制造商规定的条件。
4. 分销商认为或有理由相信他们在市场上提供的设备不符合本条例，应立即通知制造商，并在适用的情况下通知制造商的授权代表和进口商。分销商应与制造商合作，并在适用的情况下与制造商的授权代表和进口商以及主管当局合作，以确保采取必要的纠正措施，使该设备符合要求，并酌情撤回或召回它。如果分销商认为或有理由相信该设备存在严重风险，它还应立即通知其提供该设备的成员国主管当局，特别是详细说明不合规情况和采取的任何纠正措施。
5. 分销商收到医疗保健专业人员、患者或用户关于与其提供的设备相关的可疑事件的投诉或报告时，应立即将此信息转发给制造商，并在适用的情况下转发给制造商的授权代表和进口商。他们应保留投诉、不合格设备以及召回和撤回的登记册，并随时向制造商和授权代表和进口商通报此类监测情况，并应他们的要求向他们提供任何信息。
6. 分销商应根据主管当局的要求，向其提供其掌握的所有信息和文件，这些信息和文件是证明设备符合性所必需的。
Distributors shall be considered to have fulfilled the obligation referred to in the first subparagraph when the manufacturer or, where applicable, the authorised representative for the device in question provides the required information. Distributors shall cooperate with competent authorities, at their request, on any action taken to eliminate the risks posed by devices which they have made available on the market. Distributors, upon request by a competent authority, shall provide free samples of the device or, where that is impracticable, grant access to the device.
当制造商或相关设备的授权代表（如适用）提供所需信息时，分销商应被视为已履行第一项所述的义务。分销商应根据主管当局的要求，与主管当局合作，采取任何行动来消除他们在市场上提供的设备带来的风险。分销商应主管当局的要求，提供免费的设备样品，或者在不可行的情况下，允许使用设备。
Article 15 第15条
Person responsible for regulatory compliance
监管合规负责人
Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices. The requisite expertise shall be demonstrated by either of the following qualifications:
a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices;
在完成法律、医学、药学、工程学或其他相关科学学科的大学学位或成员国认可的同等学历课程后颁发的文凭、证书或其他正式资格证明，以及至少一年的监管事务或与医疗器械相关的质量管理体系的专业经验;
four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
在医疗器械相关法规事务或质量管理体系方面的四年专业经验。
1. 制造商应在其组织内至少有一名负责监管合规的人员，该人员在医疗器械领域拥有必要的专业知识。必要的专业知识应通过以下资格之一来证明：
Without prejudice to national provisions regarding professional qualifications, manufacturers of custom-made devices may demonstrate the requisite expertise referred to in the first subparagraph by having at least two years of professional experience within a relevant field of manufacturing.
在不损害国家关于专业资格的规定的情况下，定制设备制造商可以通过在相关制造领域拥有至少两年的专业经验来证明第一项所述的必要专门知识。
2. 委员会第2003/361/EC（3）号建议所指的微型和小型企业不应被要求在其组织内有负责监管合规的人员，而应有该人员永久和持续地由其支配。
The person responsible for regulatory compliance shall at least be responsible for ensuring that:
the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;
在发布设备之前，根据制造设备的质量管理体系，对设备的符合性进行适当检查;
the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
技术文档和欧盟符合性声明是起草和保持最新的;
the post-market surveillance obligations are complied with in accordance with Article 10(10);
根据第10条第（10）款的规定，遵守上市后监督义务;
the reporting obligations referred to in Articles 87 to 91 are fulfilled;
履行第八十七条至第九十一条所述的报告义务;
in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.
对于研究设备，发布附件十五第二章第 4.1 节中提及的声明。
3. 负责监管合规的人员至少应负责确保：
4. 如果若干人根据第1款、第2款和第3款共同负责监管合规，则应以书面形式规定其各自的责任范围。
5. 负责监管合规的人员在制造商组织内，无论其是否为该组织的雇员，在正确履行其职责方面都不应处于不利地位。
Authorised representatives shall have permanently and continuously at their disposal at least one person responsible for regulatory compliance who possesses the requisite expertise regarding the regulatory requirements for medical devices in the Union. The requisite expertise shall be demonstrated by either of the following qualifications:
a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices;
在完成法律、医学、药学、工程学或其他相关科学学科的大学学位或成员国认可的同等学历课程后颁发的文凭、证书或其他正式资格证明，以及至少一年的监管事务或与医疗器械相关的质量管理体系的专业经验;
four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
在医疗器械相关法规事务或质量管理体系方面的四年专业经验。
6. 授权代表应永久和持续地拥有至少一名负责监管合规的人员，该人员在欧盟医疗器械的监管要求方面拥有必要的专业知识。必要的专业知识应通过以下资格之一来证明：
Article 16 第16条
Cases in which obligations of manufacturers apply to importers, distributors or other persons
制造商对进口商、分销商或其他人员的义务适用的情况
A distributor, importer or other natural or legal person shall assume the obligations incumbent on manufacturers if it does any of the following:
makes available on the market a device under its name, registered trade name or registered trade mark, except in cases where a distributor or importer enters into an agreement with a manufacturer whereby the manufacturer is identified as such on the label and is responsible for meeting the requirements placed on manufacturers in this Regulation;
在市场上以其名称、注册商号或注册商标提供器械，但分销商或进口商与制造商签订协议，在标签上标明制造商并负责满足本条例对制造商的要求的情况除外;
changes the intended purpose of a device already placed on the market or put into service;
改变已投放市场或投入使用的设备的预期用途;
modifies a device already placed on the market or put into service in such a way that compliance with the applicable requirements may be affected.
修改已投放市场或投入使用的设备，使其可能影响对适用要求的遵守。
1. 分销商、进口商或其他自然人或法人，如果有下列行为之一，应承担制造商的义务：
The first subparagraph shall not apply to any person who, while not considered a manufacturer as defined in point (30) of Article 2, assembles or adapts for an individual patient a device already on the market without changing its intended purpose.
第1项不适用于在不被视为第2条第（30）款所界定的制造商的情况下，在不改变其预期用途的情况下为个别患者组装或改装已上市的器械的任何人。
For the purposes of point (c) of paragraph 1, the following shall not be considered to be a modification of a device that could affect its compliance with the applicable requirements:
provision, including translation, of the information supplied by the manufacturer, in accordance with Section 23 of Annex I, relating to a device already placed on the market and of further information which is necessary in order to market the device in the relevant Member State;
提供（包括翻译）制造商根据附件 I 第 23 节提供的与已投放市场的器械有关的信息，以及在相关成员国销售该器械所需的进一步信息;
changes to the outer packaging of a device already placed on the market, including a change of pack size, if the repackaging is necessary in order to market the device in the relevant Member State and if it is carried out in such conditions that the original condition of the device cannot be affected by it. In the case of devices placed on the market in sterile condition, it shall be presumed that the original condition of the device is adversely affected if the packaging that is necessary for maintaining the sterile condition is opened, damaged or otherwise negatively affected by the repackaging.
如果为了在相关成员国销售器械而需要重新包装，并且在器械的原始状况不受其影响的条件下进行，则更改已投放市场的器械的外包装，包括更改包装尺寸。对于以无菌状态投放市场的器械，如果保持无菌状态所需的包装被打开、损坏或因重新包装而受到其他负面影响，则应推定器械的原始状态受到不利影响。
2. 就第1款（c）项而言，下列情况不应被视为对设备的修改，可能影响其符合适用要求：
3. 进行第2款（a）和（b）点所述任何活动的分销商或进口商应在设备上，或在不可行的情况下，在其包装上或设备随附的文件中注明所进行的活动及其名称、注册商号或注册商标， 注册营业地点和可以联系到的地址，以便确定其位置。
Distributors and importers shall ensure that they have in place a quality management system that includes procedures which ensure that the translation of information is accurate and up-to-date, and that the activities mentioned in points (a) and (b) of paragraph 2 are performed by a means and under conditions that preserve the original condition of the device and that the packaging of the repackaged device is not defective, of poor quality or untidy. The quality management system shall cover, inter alia, procedures ensuring that the distributor or importer is informed of any corrective action taken by the manufacturer in relation to the device in question in order to respond to safety issues or to bring it into conformity with this Regulation.
分销商和进口商应确保其建立质量管理体系，其中包括确保信息翻译准确和最新的程序，并确保第2款（a）和（b）点所述活动的手段和条件保持设备的原始状态，并且重新包装的设备的包装没有缺陷， 质量差或不整洁。除其他外，质量管理体系应包括确保分销商或进口商被告知制造商对有关设备采取的任何纠正措施的程序，以应对安全问题或使其符合本条例。
4. 在将重新贴标或重新包装的器械投放市场前至少28天，从事第2款（a）和（b）点所述任何活动的分销商或进口商应通知制造商和他们计划提供该器械的成员国主管当局，打算提供重新贴标或重新包装的器械，并且， 根据要求，应向制造商和主管当局提供重新贴标或重新包装的设备的样品或模型，包括任何翻译的标签和使用说明。在同一28天内，分销商或进口商应向主管当局提交由指定机构为第2款（a）和（b）项所述活动的器械类型指定的证书，证明分销商或进口商的质量管理体系符合第3款规定的要求。
Article 17 第17条
Single-use devices and their reprocessing
一次性设备及其后处理
1. 一次性器械的再处理和进一步使用只能在国家法律允许的情况下进行，并且只能按照本条的规定进行。
2. 任何自然人或法人对一次性器械进行再加工以使其适合在联盟内进一步使用，应被视为后处理器械的制造商，并应承担本条例规定的制造商义务，其中包括根据本条例第三章与后处理器械的可追溯性有关的义务。就指令 85/374/EEC 第 3（1） 条而言，设备的再加工者应被视为生产商。
By way of derogation from paragraph 2, as regards single-use devices that are reprocessed and used within a health institution, Member States may decide not to apply all of the rules relating to manufacturers' obligations laid down in this Regulation provided that they ensure that:
the safety and performance of the reprocessed device is equivalent to that of the original device and the requirements in points (a), (b), (d), (e), (f), (g) and (h) of Article 5(5) are complied with;
后处理器械的安全性和性能与原始器械相当，并符合第5条第（5）款（a）、（b）、（d）、（e）、（f）、（g）和（h）项的要求;
the reprocessing is performed in accordance with CS detailing the requirements concerning:
再处理是按照 CS 进行的，详细说明了有关以下方面的要求：
风险管理，包括分析结构和材料、设备的相关特性（逆向工程）以及检测原始设备设计变更的程序以及再处理后的计划应用，
验证整个过程的程序，包括清洁步骤，
产品发布和性能测试，
质量管理体系，
报告涉及已重新处理的设备的事件，以及
再处理设备的可追溯性。
3. 通过减损第2款，对于在卫生机构内再加工和使用的一次性器械，成员国可以决定不适用本条例中规定的与制造商义务有关的所有规则，前提是这些规则必须确保：
Member States shall encourage, and may require, health institutions to provide information to patients on the use of reprocessed devices within the health institution and, where appropriate, any other relevant information on the reprocessed devices that patients are treated with.
会员国应鼓励并可能要求卫生机构向患者提供关于在卫生机构内使用再处理器械的信息，并酌情提供有关患者接受治疗的再处理器械的任何其他相关信息。
Member States shall notify the Commission and the other Member States of the national provisions introduced pursuant to this paragraph and the grounds for introducing them. The Commission shall keep the information publicly available.
成员国应将根据本款制定的国家规定及其理由通知委员会和其他成员国。委员会应公开提供信息。
4. 会员国可以选择对应卫生机构要求由外部再加工商再加工的一次性器械适用第3款所述的规定，但条件是将后处理器械全部归还给该卫生机构，并且外部再加工商符合第3款（a）和（b）点所述的要求。
5. 委员会应根据第9条第（1）款，在►M1 2021年5月26日◄之前通过第3款（b）点所述的必要CS。这些 CS 应符合最新的科学证据，并应解决本法规中规定的安全和性能的一般要求的应用。如果这些 CS 在 ► M1 2021 年 5 月 26 日之前未被采用，则应根据涵盖第 3 款 （b） 点所述方面的任何相关协调标准和国家规定进行再处理。是否符合CS，或者在没有CS的情况下，是否符合任何相关的协调标准和国家规定，应由指定机构进行认证。
6. 只有根据本法规投放市场的一次性器械，或在 ►M1 2021 年 5 月 26 日 ◄ 之前根据指令 93/42/EEC 投放市场的一次性器械，才能进行再加工。
7. 只能对根据最新科学证据认为安全的一次性设备进行再处理。
8. 第2款所指法人或自然人的姓名和地址以及附件一第23节所指的其他有关资料应在标签上注明，并在适用时在后处理设备的使用说明中注明。
The name and address of the manufacturer of the original single-use device shall no longer appear on the label, but shall be mentioned in the instructions for use of the reprocessed device.
原始一次性设备制造商的名称和地址不应再出现在标签上，但应在再加工设备的使用说明中提及。
A Member State that permits reprocessing of single-use devices may maintain or introduce national provisions that are stricter than those laid down in this Regulation and which restrict or prohibit, within its territory, the following:
the reprocessing of single-use devices and the transfer of single-use devices to another Member State or to a third country with a view to their reprocessing;
一次性器械的后处理和将一次性器械转让给另一成员国或第三国，以期进行再处理;
the making available or further use of reprocessed single-use devices.
提供或进一步使用再加工的一次性设备。
9. 允许对一次性器械进行再处理的成员国可以维持或引入比本条例规定的更严格的国家规定，并在其领土内限制或禁止以下规定：
Member States shall notify the Commission and the other Member States of those national provisions. The Commission shall make such information publicly available.
会员国应将这些国家规定通知委员会和其他会员国。委员会应向公众提供此类信息。
10. 委员会应在 2024 年 5 月 27 日之前起草一份关于本条实施情况的报告，并提交给欧洲议会和理事会。委员会应根据该报告酌情提出修订本条例的建议。
Article 18 第18条
Implant card and information to be supplied to the patient with an implanted device
植入卡和信息将提供给植入装置的患者
The manufacturer of an implantable device shall provide together with the device the following:
information allowing the identification of the device, including the device name, serial number, lot number, the UDI, the device model, as well as the name, address and the website of the manufacturer;
允许识别设备的信息，包括设备名称、序列号、批号、UDI、设备型号以及制造商的名称、地址和网站;
any warnings, precautions or measures to be taken by the patient or a healthcare professional with regard to reciprocal interference with reasonably foreseeable external influences, medical examinations or environmental conditions;
患者或医疗保健专业人员就合理可预见的外部影响、体检或环境条件的相互干扰而采取的任何警告、预防措施或措施;
any information about the expected lifetime of the device and any necessary follow-up;
有关设备预期寿命和任何必要后续行动的任何信息;
any other information to ensure safe use of the device by the patient, including the information in point (u) of Section 23.4 of Annex I.
确保患者安全使用设备的任何其他信息，包括附件 I 第 23.4 节 （u） 点中的信息。
1. 植入式器械的制造商应与器械一起提供以下内容：
The information referred to in the first subparagraph shall be provided, for the purpose of making it available to the particular patient who has been implanted with the device, by any means that allow rapid access to that information and shall be stated in the language(s) determined by the concerned Member State. The information shall be written in a way that is readily understood by a lay person and shall be updated where appropriate. Updates of the information shall be made available to the patient via the website mentioned in point (a) of the first subparagraph.
为使植入该装置的特定患者能够获得该信息，应以任何能够快速获取该信息的方式提供第一项所述的信息，并应以有关成员国确定的语言说明。信息应以非专业人士易于理解的方式编写，并应在适当时进行更新。信息的更新应通过第1项（a）项所述的网站提供给患者。
In addition, the manufacturer shall provide the information referred to in point (a) of the first subparagraph on an implant card delivered with the device.
此外，制造商应在随设备交付的植入卡上提供第一项（a）点所述的信息。
2. 会员国应要求卫生机构以任何能够快速获得该信息的方式，向任何植入该装置的患者提供第1款所述的信息，并附上植入卡，植入卡应标明其身份。
三、下列植入物应免除本条规定的义务：缝合线、订书钉、牙科填充物、牙套、牙冠、螺钉、楔子、板、电线、销钉、夹子和连接器。委员会有权根据第115条通过授权法案，通过增加其他类型的植入物或从中删除植入物来修订该清单。
Article 19 第19条
EU declaration of conformity
欧盟符合性声明
1. 欧盟符合性声明应说明所涵盖的器械已满足本法规中规定的要求。制造商应不断更新欧盟符合性声明。欧盟符合性声明至少应包含附件 IV 中规定的信息，并应翻译成提供设备的成员国要求的官方联盟语言或语言。
2. 如果就本法规未涵盖的方面而言，器械受其他欧盟法规的约束，这些法规还要求制造商提交欧盟符合性声明，证明已证明符合该法规的要求，则应就适用于该设备的所有欧盟法案起草一份单一的欧盟符合性声明。声明应包含确定与声明有关的欧盟立法所需的所有信息。
3. 通过起草欧盟符合性声明，制造商应承担遵守本法规和适用于该设备的所有其他欧盟立法要求的责任。
4. 委员会有权根据第 115 条通过授权法案，根据技术进步修改附件 IV 中规定的欧盟符合性声明的最低内容。
Article 20 第20条
CE marking of conformity
符合性CE标志
1. 除定制或研究设备外，被认为符合本法规要求的设备应带有附件 V 中所示的符合性 CE 标志。
2. CE标志应遵守法规（EC）No 765/2008第30条规定的一般原则。
3. CE 标志应以明显、清晰和不可磨灭的方式贴在器械或其无菌包装上。如果由于设备的性质而无法或无法保证这种粘贴，则应在包装上贴上 CE 标志。CE标志也应出现在任何使用说明和任何销售包装上。
4、器械投放市场前应加贴CE标志。它后面可能跟着一个象形图或任何其他标记，表明有特殊风险或用途。
5. 在适用的情况下，CE标志后应附有负责第52条规定的合格评定程序的公告机构的识别号。识别号也应在任何提及设备符合 CE 标志要求的宣传材料中注明。
6. 如果器械受其他欧盟法规的约束，该法规也规定了CE标志的粘贴，则CE标志应表明该设备也符合该其他法规的要求。
Article 21 第21条
Devices for special purposes
特殊用途设备
Member States shall not create obstacles to:
investigational devices being supplied to an investigator for the purpose of a clinical investigation if they meet the conditions laid down in Articles 62 to 80 and Article 82, in the implementing acts adopted pursuant to Article 81 and in Annex XV;
为临床研究目的向研究者提供的研究设备，如果它们符合第 62 条至第 80 条和第 82 条、根据第 81 条通过的实施法案和附件 XV 中规定的条件;
custom-made devices being made available on the market if Article 52(8) and Annex XIII have been complied with.
如果遵守了第52（8）条和附件XIII，则在市场上提供定制设备。
1. 会员国不得在下列方面设置障碍：
The devices referred to in the first subparagraph shall not bear the CE marking, with the exception of the devices referred to in Article 74.
除第74条所述设备外，第1项所指的设备不得带有CE标志。
2. 定制设备应附有附件 XIII 第 1 节中提及的声明，该声明应提供给以姓名、首字母缩略词或数字代码标识的特定患者或用户。
Member States may require that the manufacturer of a custom-made device submit to the competent authority a list of such devices which have been made available in their territory.
成员国可要求定制器械的制造商向主管当局提交在其领土内提供的此类器械清单。
三、在交易会、展览、演示或类似活动中，成员国不得对展示不符合本条例的器械设置障碍，但须有明显的标志清楚地表明此类器械仅用于展示或演示目的，并且在符合本条例之前不能提供。
Article 22 第22条
Systems and procedure packs
系统和程序包
Natural or legal persons shall draw up a statement if they combine devices bearing a CE marking with the following other devices or products, in a manner that is compatible with the intended purpose of the devices or other products and within the limits of use specified by their manufacturers, in order to place them on the market as a system or procedure pack:
other devices bearing the CE marking;
其他带有CE标志的设备;
in vitro diagnostic medical devices bearing the CE marking in conformity with Regulation (EU) 2017/746;
符合法规 （EU） 2017/746 的带有 CE 标志的体外诊断医疗器械;
other products which are in conformity with legislation that applies to those products only where they are used within a medical procedure or their presence in the system or procedure pack is otherwise justified.
其他符合法律的产品，这些产品仅在医疗程序中使用或存在于系统或程序包中时才适用于这些产品。
1. 如果自然人或法人以与设备或其他产品的预期用途兼容的方式并在其制造商规定的使用范围内将带有CE标志的设备与下列其他设备或产品组合在一起，则应起草一份声明，以便将其作为系统或程序包投放市场：
In the statement made pursuant to paragraph 1, the natural or legal person concerned shall declare that:
they verified the mutual compatibility of the devices and, if applicable other products, in accordance with the manufacturers' instructions and have carried out their activities in accordance with those instructions;
他们根据制造商的说明验证了设备和其他产品（如果适用）的相互兼容性，并按照这些说明开展了活动;
they packaged the system or procedure pack and supplied relevant information to users incorporating the information to be supplied by the manufacturers of the devices or other products which have been put together;
他们包装了系统或程序包，并向用户提供了相关信息，其中包括设备或其他产品制造商提供的信息;
the activity of combining devices and, if applicable, other products as a system or procedure pack was subject to appropriate methods of internal monitoring, verification and validation.
将设备和其他产品（如适用）组合为系统或程序包的活动受到内部监测、验证和确认的适当方法的约束。
2. 在根据第1款作出的声明中，有关自然人或法人应声明：
3. 任何自然人或法人为投放市场而对第1款所述系统或程序包进行消毒时，应自行选择适用附件九中规定的程序之一或附件十一A部分中规定的程序。这些程序的适用和指定机构的参与应限于与确保无菌有关的程序方面，直到无菌包装被打开或损坏。自然人或法人应起草一份声明，声明已按照制造商的指示进行灭菌。
4. 如果系统或程序包包含不带有 CE 标志的器械，或者所选器械组合与其原始预期用途不兼容，或未按照制造商的说明进行灭菌，则系统或程序包应被视为其本身的器械，并应根据第52条.自然人或法人应承担制造商的义务。
5. 本条第1款所指的系统或程序包本身不应带有额外的CE标志，但应带有本条第1款和第3款所指人员的姓名、注册商号或注册商标，以及可以联系到该人的地址， 以便可以确定此人的位置。系统或程序包应附有附件 I 第 23 节中提及的信息。本条第2款所述的声明应在系统或程序包组合在一起后，在第10条第（8）款适用于已合并的器械的期限内由主管当局处理。如果这些期限不同，则适用最长的期限。
Article 23 第23条
Parts and components 零部件
1. 任何自然人或法人在市场上提供专门用于更换有缺陷或磨损的设备的相同或相似的集成部件或组件的物品，以便在不改变其性能或安全特性或预期用途的情况下维持或恢复设备的功能， 应确保物品不会对设备的安全性和性能产生不利影响。应向成员国主管当局提供佐证。
2. 专门用于更换设备部件或组件且显着改变设备的性能或安全特性或预期用途的物品应被视为设备，并应符合本法规规定的要求。
Article 24 第24条
Free movement 自由移动
Except where otherwise provided for in this Regulation, Member States shall not refuse, prohibit or restrict the making available on the market or putting into service within their territory of devices which comply with the requirements of this Regulation.
除本条例另有规定外，成员国不得拒绝、禁止或限制在其领土内向市场提供或投入使用符合本条例要求的器械。
CHAPTER III 第三章
IDENTIFICATION AND TRACEABILITY OF DEVICES, REGISTRATION OF DEVICES AND OF ECONOMIC OPERATORS, SUMMARY OF SAFETY AND CLINICAL PERFORMANCE, EUROPEAN DATABASE ON MEDICAL DEVICES
器械的识别和可追溯性，器械和经济运营商的注册，安全性和临床性能摘要，欧洲医疗器械数据库
Article 25 第25条
Identification within the supply chain
供应链中的识别
1. 分销商和进口商应与制造商或授权代表合作，以实现器械的适当可追溯性。
Economic operators shall be able to identify the following to the competent authority, for the period referred to in Article 10(8):
any economic operator to whom they have directly supplied a device;
他们直接向其提供设备的任何经济运营商;
any economic operator who has directly supplied them with a device;
直接向他们提供设备的任何经济运营商;
any health institution or healthcare professional to which they have directly supplied a device.
他们直接向其提供设备的任何医疗机构或医疗保健专业人员。
2. 经济经营者应能够向主管当局确认第10条第（8）款所述期间的以下内容：
Article 26 第26条
Medical devices nomenclature
医疗器械命名法
To facilitate the functioning of the European database on medical devices (‘Eudamed’) as referred to in Article 33, the Commission shall ensure that an internationally recognised medical devices nomenclature is available free of charge to manufacturers and other natural or legal persons required by this Regulation to use that nomenclature. The Commission shall also endeavour to ensure that that nomenclature is available to other stakeholders free of charge, where reasonably practicable.
为促进第33条所述欧洲医疗器械数据库（“Eudamed”）的运作，委员会应确保向制造商和本法规要求使用该术语的其他自然人或法人免费提供国际公认的医疗器械命名法。委员会还应努力确保在合理可行的情况下，其他利益攸关方可以免费获得该术语。
Article 27 第27条
Unique Device Identification system
唯一设备识别系统
The Unique Device Identification system (‘UDI system’) described in Part C of Annex VI shall allow the identification and facilitate the traceability of devices, other than custom-made and investigational devices, and shall consist of the following:
production of a UDI that comprises the following:
生产包含以下内容的 UDI：
a UDI device identifier (‘UDI-DI’) specific to a manufacturer and a device, providing access to the information laid down in Part B of Annex VI;
特定于制造商和设备的UDI设备标识符（“UDI-DI”），提供对附件VI中B部分中规定的信息的访问;
a UDI production identifier (‘UDI-PI’) that identifies the unit of device production and if applicable the packaged devices, as specified in Part C of Annex VI;
UDI生产标识符（“UDI-PI”），用于标识设备生产单位以及（如适用）封装设备，如附件VI的C部分所述;
placing of the UDI on the label of the device or on its packaging;
将 UDI 放在设备的标签或包装上;
storage of the UDI by economic operators, health institutions and healthcare professionals, in accordance with the conditions laid down in paragraphs 8 and 9 of this Article respectively;
经济经营者、卫生机构和医疗保健专业人员分别按照本条第8款和第9款规定的条件储存UDI;
establishment of an electronic system for Unique Device Identification (‘UDI database’) in accordance with Article 28.
根据第28条建立唯一设备识别电子系统（“UDI数据库”）。
1. 附件VI中描述的唯一设备识别系统（“UDI系统”）应允许识别和促进设备的可追溯性，但定制和研究设备除外，并应包括以下内容：
The Commission shall, by means of implementing acts, designate one or several entities to operate a system for assignment of UDIs pursuant to this Regulation (‘issuing entity’). That entity or those entities shall satisfy all of the following criteria:
the entity is an organisation with legal personality;
该实体是具有法人资格的组织;
its system for the assignment of UDIs is adequate to identify a device throughout its distribution and use in accordance with the requirements of this Regulation;
其UDI分配系统足以根据本法规的要求在整个分销和使用过程中识别设备;
its system for the assignment of UDIs conforms to the relevant international standards;
其UDI分配系统符合相关国际标准;
the entity gives access to its system for the assignment of UDIs to all interested users in accordance with a set of predetermined and transparent terms and conditions;
该实体根据一套预先确定和透明的条款和条件，允许访问其系统，以便将 UDI 分配给所有感兴趣的用户;
the entity undertakes to do the following:
该实体承诺执行以下操作：
operate its system for the assignment of UDIs for at least 10 years after its designation;
在指定UDI后至少10年内运行其分配UDI系统;
make available to the Commission and to the Member States, upon request, information concerning its system for the assignment of UDIs;
应要求向委员会和成员国提供有关其UDI分配制度的信息;
remain in compliance with the criteria for designation and the terms of designation.
继续遵守指定标准和指定条款。
2. 委员会应通过实施法案，指定一个或几个实体根据本条例运行UDI分配系统（“颁发实体”）。该实体或这些实体应满足以下所有标准：
When designating issuing entities, the Commission shall endeavour to ensure that UDI carriers, as defined in Part C of Annex VI, are universally readable regardless of the system used by the issuing entity, with a view to minimising financial and administrative burdens for economic operators and health institutions.
在指定发证实体时，委员会应努力确保附件六C部分所定义的UDI载体无论发证实体使用何种系统，都具有普遍可读性，以尽量减少经济经营者和卫生机构的财务和行政负担。
3. 在将器械（定制器械除外）投放市场之前，制造商应为该器械分配一个UDI，并在适用的情况下分配给所有更高级别的包装，该UDI是按照委员会根据第2款指定的签发实体的规则创建的。
Before a device, other than a custom-made or investigational device, is placed on the market the manufacturer shall ensure that the information referred to in Part B of Annex VI of the device in question are correctly submitted and transferred to the UDI database referred to in Article 28.
在将器械（定制或研究器械除外）投放市场之前，制造商应确保正确提交相关器械附件VI附件B部分中提及的信息，并将其传输到第28条所述的UDI数据库。
4. UDI 载体应放置在设备的标签和所有更高级别的包装上。更高级别的包装不应被理解为包括集装箱。
5. UDI 应用于报告严重事件和根据第 87 条采取的现场安全纠正措施。
6. 附件 VI C 部分中定义的基本 UDI-DI 应出现在第 19 条所述的欧盟符合性声明中。
7. 作为附件二中提到的技术文件的一部分，制造商应及时更新其分配的所有UDI的清单。
Economic operators shall store and keep, preferably by electronic means, the UDI of the devices which they have supplied or with which they have been supplied, if those devices belong to:
III类植入式器械;
根据第11段（a）点所述措施确定的装置、类别或装置组。
8. 经济经营者应最好通过电子手段储存和保存其提供或已提供的设备的UDI，如果这些设备属于：
9. 卫生机构应最好通过电子手段储存和保存其提供或已提供的设备的UDI，如果这些设备属于III类植入式设备。
For devices other than class III implantable devices, Member States shall encourage, and may require, health institutions to store and keep, preferably by electronic means, the UDI of the devices with which they have been supplied.
对于III类植入式器械以外的器械，成员国应鼓励并可能要求卫生机构储存和保存，最好是以电子方式保存和保存所提供器械的UDI。
Member States shall encourage, and may require, healthcare professionals to store and keep preferably by electronic means, the UDI of the devices with which they have been supplied with.
成员国应鼓励并可能要求医疗保健专业人员存储和保存，最好是通过电子方式保存其所提供设备的UDI。
The Commission is empowered to adopt delegated acts in accordance with Article 115:
amending the list of information set out in Part B of Annex VI in the light of technical progress; and
根据技术进展情况，修订附件六B部分所列资料清单;和
amending Annex VI in the light of international developments and technical progress in the field of Unique Device Identification.
根据唯一器械标识领域的国际发展和技术进步，修订附件六。
10. 委员会有权根据第115条通过授权法案：
The Commission may, by means of implementing acts, specify the detailed arrangements and the procedural aspects for the UDI system with a view to ensuring its harmonised application in relation to any of the following:
determining the devices, categories or groups of devices to which the obligation laid down in paragraph 8 is to apply;
确定第8款规定的义务适用的器械、类别或器械组;
specifying the data to be included in the UDI-PI of specific devices or device groups;
指定要包含在特定设备或设备组的 UDI-PI 中的数据;
11. 委员会可通过实施法案，具体规定UDI制度的详细安排和程序方面，以确保其在以下任何一项方面的统一适用：
The implementing acts referred to in the first subparagraph shall be adopted in accordance with the examination procedure referred to in Article 114(3).
第1项所指的实施行为应按照第114条第（3）款所述的审查程序通过。
When adopting the measures referred to in paragraph 11, the Commission shall take into account all of the following:
confidentiality and data protection as referred to in Articles 109 and 110 respectively;
第109条和第110条分别指明的保密和数据保护;
the risk-based approach;
基于风险的方法;
the cost-effectiveness of the measures;
这些措施的成本效益;
the convergence of UDI systems developed at international level;
在国际层面开发的UDI系统的融合;
the need to avoid duplications in the UDI system;
需要避免UDI系统中的重复;
the needs of the healthcare systems of the Member States, and where possible, compatibility with other medical device identification systems that are used by stakeholders.
成员国医疗保健系统的需求，并在可能的情况下与利益相关者使用的其他医疗器械识别系统的兼容性。
12. 委员会在采取第11款所述措施时，应考虑到以下所有因素：
Article 28 第28条
UDI database UDI 数据库
1. 委员会在与MDCG协商后，应建立和管理UDI数据库，以验证、整理、处理并向公众提供附件VIB部分所述的信息。
2. 在设计UDI数据库时，委员会应考虑到附件VIC部分第5节规定的一般原则。UDI数据库的设计应特别确保其中不包含UDI-PI和任何商业机密产品信息。
3. 附件六B部分所述提供给UDI数据库的核心数据元素应免费向公众开放。
4. UDI数据库的技术设计应确保最大限度地获取其中存储的信息，包括多用户访问和自动上传和下载该信息。委员会应向UDI数据库的制造商和其他用户提供技术和行政支持。
Article 29 第29条
Registration of devices 设备注册
1. 在将器械（定制器械除外）投放市场之前，制造商应根据第27条第（2）款所述的发证实体的规则，为该器械分配附件VI中C部分定义的基本UDI-DI，并应将其与附件VI中B部分中提及的与该器械相关的其他核心数据元素一起提供给UDI数据库。
2. 在根据第22条第（1）款和第（3）款将非定制设备的系统或程序包投放市场之前，负责的自然人或法人应按照签发实体的规则，为该系统或程序包分配一个基本UDI-DI，并应将其与附件VI中B部分中提及的与以下方面相关的其他核心数据元素一起提供给UDI数据库该系统或过程包。
3. 对于第52条第（3）款和第52条第（4）款第2款和第3款所述的合格评定对象的器械，本条第1款所述的基本UDI-DI的分配应在制造商向指定机构申请该评估之前完成。
For the devices referred to in the first subparagraph, the notified body shall include a reference to the Basic UDI-DI on the certificate issued in accordance with point (a) of Section 4 of Chapter I of Annex XII and confirm in Eudamed that the information referred to in Section 2.2 of Part A of Annex VI is correct. After the issuing of the relevant certificate and before placing the device on the market, the manufacturer shall provide the Basic UDI-DI to the UDI database together with the other core data elements referred to in Part B of Annex VI related to that device.
对于第1项所述的器械，公告机构应在根据附件XII第一章第4节（a）点颁发的证书上提及基本UDI-DI，并在Eudamed中确认附件VI第A部分第2.2节中提及的信息是正确的。在颁发相关证书后，在将设备投放市场之前，制造商应向UDI数据库提供基本UDI-DI以及附件VI中提及的与该设备相关的其他核心数据元素。
4. 在将设备投放市场之前，除定制设备外，制造商应输入或在已经提供的情况下，在 Eudamed 中验证附件 VI A 部分第 2 节中提及的信息，但第 2.2 节除外，此后应保持信息更新。
Article 30 第三十条
Electronic system for registration of economic operators
经济经营者登记电子系统
1. 委员会在与MDCG协商后，应建立和管理一个电子系统，以创建第31条第（2）款所述的单一注册号，并整理和处理必要和相称的信息，以识别制造商以及授权代表和进口商（如适用）。关于经济经营者向该电子系统提供的信息的详情载于附件六A部分第1节。
2. 成员国可以维持或引入关于在其领土上提供的器械分销商注册的国家规定。
3. 在将设备（定制设备除外）投放市场后的两周内，进口商应核实制造商或授权代表是否已向电子系统提供第1款所述的信息。
Where applicable, importers shall inform the relevant authorised representative or manufacturer if the information referred to in paragraph 1 is not included or is incorrect. Importers shall add their details to the relevant entry/entries.
在适用的情况下，如果第1段所述的信息不包括在内或不正确，进口商应通知相关授权代表或制造商。进口商应在相关条目中添加其详细信息。
Article 31 第三十一条
Registration of manufacturers, authorised representatives and importers
制造商、授权代表和进口商的注册
一、制造商、授权代表和进口商在将定制设备以外的设备投放市场之前，应向第三十条所述的电子系统提交附件六A部分第1节所述的信息，条件是它们尚未根据本条进行注册。如果合格评定程序根据第52条要求指定机构参与，则在向指定机构提出申请之前，应将附件VIA部分第1节中提及的信息提供给该电子系统。
二、在核实根据第1款输入的数据后，主管当局应从第30条所述的电子系统中获取一个单一注册号（“SRN”），并将其颁发给制造商、授权代表或进口商。
3. 制造商在向指定机构申请合格评定和访问Eudamed时应使用SRN，以履行第29条规定的义务。
四、经济经营者应当在对本条第1款所述信息发生任何变更后一周内，更新第30条所述电子系统中的数据。
5. 经济经营者应在根据第1款提交资料后一年内，以及此后每两年确认一次资料的准确性。如果未能在这些最后期限后六个月内这样做，任何会员国都可以在其领土内采取适当的纠正措施，直到该经济经营者遵守该义务为止。
6. 在不损害经济经营者对数据的责任的情况下，主管当局应核实附件六A部分第1节所述的经确认的数据。
七、根据本条第1款输入的数据，在第30条所指的电子系统中输入，应向公众开放。
8. 根据第111条，主管当局可以使用这些数据向制造商、授权代表或进口商收取费用。
Article 32 第三十二条
Summary of safety and clinical performance
安全性和临床表现总结
1. 对于植入式器械和 III 类器械，除定制或研究器械外，制造商应起草一份安全性和临床性能摘要。
The summary of safety and clinical performance shall be written in a way that is clear to the intended user and, if relevant, to the patient and shall be made available to the public via Eudamed.
安全性和临床表现的摘要应以目标用户清楚的方式编写，如果相关，患者也应清楚，并应通过 Eudamed 向公众提供。
The draft of the summary of safety and clinical performance shall be part of the documentation to be submitted to the notified body involved in the conformity assessment pursuant to Article 52 and shall be validated by that body. After its validation, the notified body shall upload the summary to Eudamed. The manufacturer shall mention on the label or instructions for use where the summary is available.
安全性和临床性能摘要草案应作为根据第52条提交给参与合格评定的指定机构的文件的一部分，并应由该机构验证。经验证后，公告机构应将摘要上传至Eudamed。制造商应在标签或使用说明上注明摘要。
The summary of safety and clinical performance shall include at least the following aspects:
the identification of the device and the manufacturer, including the Basic UDI-DI and, if already issued, the SRN;
设备和制造商的标识，包括基本 UDI-DI 和 SRN（如果已发布）;
the intended purpose of the device and any indications, contraindications and target populations;
设备的预期用途以及任何适应症、禁忌症和目标人群;
a description of the device, including a reference to previous generation(s) or variants if such exist, and a description of the differences, as well as, where relevant, a description of any accessories, other devices and products, which are intended to be used in combination with the device;
设备的描述，包括对上一代产品或变体（如果存在）的引用，以及对差异的描述，以及在相关情况下，对旨在与设备结合使用的任何配件、其他设备和产品的描述;
possible diagnostic or therapeutic alternatives;
可能的诊断或治疗替代方案;
reference to any harmonised standards and CS applied;
参考任何协调标准和适用的 CS;
the summary of clinical evaluation as referred to in Annex XIV, and relevant information on post-market clinical follow-up;
附件十四所述的临床评价摘要，以及上市后临床随访的相关信息;
suggested profile and training for users;
为用户建议的个人资料和培训;
information on any residual risks and any undesirable effects, warnings and precautions.
有关任何残余风险和任何不良影响、警告和预防措施的信息。
2.安全性和临床表现总结应至少包括以下几个方面：
3. 委员会可以通过实施法案，规定安全和临床绩效摘要中应包括的数据要素的形式和列报形式。这些实施行为应根据第114条第（2）款所述的咨询程序通过。
Article 33 第三十三条
European database on medical devices
欧洲医疗器械数据库
The Commission, after consulting the MDCG, shall set up, maintain and manage the European database on medical devices (‘Eudamed’) for the following purposes:
to enable the public to be adequately informed about devices placed on the market, the corresponding certificates issued by notified bodies and about the relevant economic operators;
使公众能够充分了解投放市场的器械、公告机构颁发的相应证书以及相关经济运营商;
to enable unique identification of devices within the internal market and to facilitate their traceability;
在内部市场中实现设备的唯一标识，并促进其可追溯性;
to enable the public to be adequately informed about clinical investigations and to enable sponsors of clinical investigations to comply with obligations under Articles 62 to 80, Article 82, and any acts adopted pursuant to Article 81;
使公众能够充分了解临床研究，并使临床研究的发起人能够遵守第62条至第80条、第82条以及根据第81条通过的任何法案规定的义务;
to enable manufacturers to comply with the information obligations laid down in Articles 87 to 90 or in any acts adopted pursuant to Article 91;
使制造商能够遵守第87条至第90条或根据第91条通过的任何法案中规定的信息义务;
to enable the competent authorities of the Member States and the Commission to carry out their tasks relating to this Regulation on a well-informed basis and to enhance the cooperation between them.
使成员国和委员会的主管当局能够在充分知情的基础上执行与本条例有关的任务，并加强它们之间的合作。
1. 委员会在与MDCG协商后，应建立、维护和管理欧洲医疗器械数据库（“Eudamed”），用于以下目的：
Eudamed shall include the following electronic systems:
the electronic system for registration of devices referred to in Article 29(4);
第29条第（4）款所指的器械注册电子系统;
the UDI-database referred to in Article 28;
第28条所指的UDI数据库;
the electronic system on registration of economic operators referred to in Article 30;
第30条所指的经济经营者登记电子系统;
the electronic system on notified bodies and on certificates referred to in Article 57;
第57条所指的公告机构和证书电子系统;
the electronic system on clinical investigations referred to in Article 73;
第73条所指的临床研究电子系统;
the electronic system on vigilance and post-market surveillance referred to in Article 92;
第92条所指的警戒和上市后监督电子系统;
the electronic system on market surveillance referred to in Article 100.
第100条所指的市场监督电子系统。
2. Eudamed应包括以下电子系统：
3. 在设计Eudamed时，委员会应适当考虑与国家数据库和国家网络界面的兼容性，以便数据的进出口。
4. 数据应由成员国、公告机构、经济运营商和赞助商按照第 2 款所述电子系统的规定输入 Eudamed。委员会应向Eudamed用户提供技术和行政支持。
5. Eudamed整理和处理的所有信息应向成员国和委员会开放。公告机构、经济经营者、赞助商和公众应在第 2 款所述电子系统规定规定的范围内获取信息。
The Commission shall ensure that public parts of Eudamed are presented in a user-friendly and easily-searchable format.
委员会应确保Eudamed的公共部分以用户友好和易于搜索的格式呈现。
6. Eudamed应仅在本条第2款所述的电子系统根据本条例整理和处理信息所需的范围内包含个人数据。个人数据应以允许识别数据主体的形式保存，保存期限不得超过第10条第（8）款所述的期限。
7. 委员会和成员国应确保数据主体能够分别根据第 （EC） 第 45/2001 号条例和第 95/46/EC 号指令有效行使其知情权、访问权、更正权和反对权。他们亦应确保资料当事人可有效行使查阅与其有关资料的权利，并有权更正及删除不准确或不完整的资料。在各自的职责范围内，委员会和成员国应确保根据适用的法律删除不准确和非法处理的数据。更正和删除应尽快进行，但不得迟于数据主体提出请求后 60 天。
8. 委员会应通过执行法案，为建立和维持Eudamed制定必要的详细安排。实施法案应按照第114条第（3）款所述的审查程序通过。在通过这些执行法案时，委员会应确保在制定系统时尽可能避免在系统的同一单元或不同单元中两次输入相同的信息。
9. 关于本条规定的责任以及其中涉及的个人数据的处理，委员会应被视为 Eudamed 及其电子系统的控制者。
Article 34 第三十四条
Functionality of Eudamed
Eudamed的功能
1. 委员会应与MDCG合作，制定Eudamed的功能规范。委员会应在2018年5月26日之前制定实施这些规范的计划。该计划应力求确保Eudamed在允许委员会在2021年3月25日►M1之前发布本条第3款所述通知的日期全面运作，并确保满足本条例第123条和（EU）2017/746条例第113条规定的所有其他相关期限。
2. 委员会应根据独立审计报告，在核实Eudamed已实现全部功能且Eudamed符合根据第1款制定的功能规格时，通知MDCG。
3. 委员会在与MDCG协商后，在认为第2款所述条件已得到满足时，应在《欧洲联盟官方公报》上发布有关通知。
CHAPTER IV 第四章
NOTIFIED BODIES 公告机构
Article 35 第三十五条
Authorities responsible for notified bodies
负责公告机构的机构
1. 任何打算指定合格评定机构为公告机构或已指定指定指定机构根据本规章开展合格评定活动的成员国应指定一个机构（“负责公告机构的机构”），该机构可由国内法规定的独立组成实体组成，并应负责制定和执行必要的评估程序， 指定和通知合格评定机构，并监督指定机构，包括这些机构的分包商和子公司。
2. 负责公告机构的机构应建立、组织和运作，以维护其活动的客观性和公正性，并避免与合格评定机构发生任何利益冲突。
3. 负责公告机构的机构的组织方式应使与指定或通知有关的每项决定都由与评估执行者不同的人员作出。
4. 负责公告机构的主管部门不得从事公告机构在商业或竞争基础上开展的任何活动。
5. 负责公告机构的主管部门应保护其所获得信息的机密性。但是，它应与其他成员国、委员会交换关于公告机构的信息，并在必要时与其他管理当局交换信息。
6. 负责公告机构的当局应有足够数量的主管人员长期可用，以适当地履行其任务。
Where the authority responsible for notified bodies is a different authority from the national competent authority for medical devices, it shall ensure that the national authority responsible for medical devices is consulted on relevant matters.
公告机构主管机关与国家医疗器械主管机关不同的，应当确保就相关事项咨询国家医疗器械主管机关。
7. 成员国应公开关于其关于合格评定机构的评估、指定和通知以及为监测所公布机构而采取的措施的一般信息，以及关于对此类任务产生重大影响的变化。
8. 负责公告机构的主管部门应参加第四十八条规定的同行评议活动。
Article 36 第三十六条
Requirements relating to notified bodies
与公告机构有关的要求
一、公告机构应履行本条例规定的指定任务。它们应满足完成这些任务所需的组织和一般要求以及质量管理、资源和流程要求。具体而言，公告机构应遵守附件七的规定。
In order to meet the requirements referred to in the first subparagraph, notified bodies shall have permanent availability of sufficient administrative, technical and scientific personnel in accordance with Section 3.1.1 of Annex VII and personnel with relevant clinical expertise in accordance with Section 3.2.4 of Annex VII, where possible employed by the notified body itself.
为了满足第1项所述的要求，公告机构应根据附件七第3.1.1节的规定，长期提供足够的行政、技术和科学人员，并根据附件七第3.2.4节的规定，在可能的情况下由公告机构本身雇用具有相关临床专门知识的人员。
The personnel referred to in Sections 3.2.3 and 3.2.7 of Annex VII shall be employed by the notified body itself and shall not be external experts or subcontractors.
附件七第3.2.3节和第3.2.7节中提及的人员应由公告机构本身雇用，不得为外部专家或分包商。
2. 公告机构应向负责公告机构的主管部门提供并应要求提交所有相关文件，包括制造商的文件，以便其开展评估、指定、通知、监测和监督活动，并促进本章所述的评估。
3. 为确保统一适用附件七所列要求，委员会可在必要的范围内通过实施法案，以解决不同的解释和实际适用问题。实施法案应按照第114条第（3）款所述的审查程序通过。
Article 37 第三十七条
Subsidiaries and subcontracting
子公司和分包商
1. 如果公告机构将与合格评定有关的具体任务分包，或将与合格评定有关的具体任务委托给子公司，则应核实该分包商或子公司是否符合附件七中规定的适用要求，并应相应地通知负责公告机构的主管部门。
2. 公告机构应对分包商或子公司代为执行的任务承担全部责任。
3. 公告机构应当公布其子公司名单。
4. 合格评定活动可以分包或由子公司进行，但须相应通知申请合格评定的法人或自然人。
5. 公告机构应将有关核查分包商或子公司资格及其根据本条例开展的工作的所有相关文件交由公告机构负责的当局使用。
Article 38 第三十八条
Application by conformity assessment bodies for designation
合格评定机构申请指定
一、合格评定机构应当向公告机构主管机关提出指定申请。
2. 申请书应具体说明本规章所界定的合格评定活动，以及该机构申请指定的器械类型，并应附有证明符合附件VII的文件。
In respect of the organisational and general requirements and the quality management requirements set out in Sections 1 and 2 of Annex VII, a valid accreditation certificate and the corresponding evaluation report delivered by a national accreditation body in accordance with Regulation (EC) No 765/2008 may be submitted and shall be taken into consideration during the assessment described in Article 39. However, the applicant shall make available all the documentation referred to in the first subparagraph to demonstrate compliance with those requirements upon request.
对于附件VII第1节和第2节中规定的组织和一般要求以及质量管理要求，可以提交有效的认证证书和相应的评估报告，由国家认证机构根据第765/2008号条例（EC）提交，并在第39条所述的评估中予以考虑。但是，申请人应根据要求提供第1项所述的所有文件，以证明其符合这些要求。
3. 每当发生相关变化时，公告机构应更新第 2 款所述文件，以便负责公告机构的主管部门能够监测和核查是否持续遵守附件 VII 中规定的所有要求。
Article 39 第三十九条
Assessment of the application
申请评估
一、通告机关应当在30日内核实第三十八条所指申请是否完整，并要求申请人提供遗漏的信息。申请完成后，该当局应将其送交委员会。
The authority responsible for notified bodies shall review the application and supporting documentation in accordance with its own procedures and shall draw up a preliminary assessment report.
负责公告机构的主管部门应当按照本办法审查申请书和证明文件，并应当编制初步评估报告。
2. 负责公告机构的主管部门应向委员会提交初步评估报告，委员会应立即将其转交MDCG。
3. 在本条第2款所述提交材料后14天内，委员会应与MDCG一起任命一个由三名专家组成的联合评估小组，除非具体情况需要从第40条第（2）款所述名单中选出不同数量的专家。其中一名专家应为委员会的一名代表，负责协调联合评估组的活动。另外两名专家应来自设立申请人合格评定机构的成员国以外的成员国。
The joint assessment team shall be comprised of experts who are competent to assess the conformity assessment activities and the types of devices which are the subject of the application or, in particular when the assessment procedure is initiated in accordance with Article 47(3), to ensure that the specific concern can be appropriately assessed.
联合评估小组应由专家组成，他们有权评估合格评定活动和作为申请标的的器械类型，特别是在根据第47条第（3）款启动评估程序时，以确保能够适当评估具体问题。
4. 联合评估组应在任命后90天内，根据第38条审查与申请一起提交的文件。联合评估组可就申请和计划中的现场评估向负责公告机构的主管部门提供反馈意见，或要求其作出澄清。
The authority responsible for notified bodies together with the joint assessment team shall plan and conduct an on-site assessment of the applicant conformity assessment body and, where relevant, of any subsidiary or subcontractor, located inside or outside the Union, to be involved in the conformity assessment process.
负责公告机构的主管部门应与联合评估小组一起计划并对申请人的合格评定机构以及位于联盟内部或外部的任何子公司或分包商（如相关）进行现场评估，以参与合格评定过程。
The on-site assessment of the applicant body shall be led by the authority responsible for notified bodies.
申请机构的现场评估应由公告机构负责的主管部门牵头。
5. 关于申请人合格评定机构不遵守附件VII所列要求的调查结果，应在评估过程中提出，并由负责公告机构的主管部门和联合评审组进行讨论，以期在申请评估方面达成共识并解决任何分歧意见。
At the end of the on-site assessment, the authority responsible for notified bodies shall list for the applicant conformity assessment body the non-compliances resulting from the assessment and summarise the assessment by the joint assessment team.
现场评定结束时，通告机构主管部门应当向申请合格评定机构列出评定产生的不合格情况，并由联合评定组对评定情况进行总结。
Within a specified timeframe, the applicant conformity assessment body shall submit to the national authority a corrective and preventive action plan to address the non-compliances.
在规定的时限内，申请人合格评定机构应向国家主管部门提交纠正和预防行动计划，以解决不合规问题。
6. 联合评估组应当在完成现场评估后30天内记录与评估有关的剩余分歧意见，并送交公告机构主管部门。
7. 负责公告机构的主管部门在收到申请机构的纠正和预防行动计划后，应评估评估期间发现的不遵守情况是否得到适当处理。该计划应说明所查明的不遵守情事的根本原因，并应包括执行其中行动的时限。
The authority responsible for notified bodies shall having confirmed the corrective and preventive action plan forward it and its opinion thereon to the joint assessment team. The joint assessment team may request of the authority responsible for notified bodies further clarification and modifications.
负责公告机构的主管部门应确认纠正和预防行动计划后，将其及其意见转交联合评估组。联合评估组可要求负责公告机构的主管部门作进一步澄清和修改。
The authority responsible for notified bodies shall draw up its final assessment report which shall include:
负责公告机构的主管部门应起草其最终评估报告，其中应包括：
评估结果，
确认纠正和预防措施已得到适当处理，并在必要时实施，
与联合评估小组的任何剩余分歧意见，以及（如适用）
建议的指定范围。
8. 负责公告机构的主管部门应向委员会、MDCG和联合评估小组提交其最终评估报告和指定草案（如适用）。
9. 联合评估组应在收到这些文件后21天内，就负责公告机构的主管部门编写的评估报告和（如适用）指定草案向委员会提出最后意见，委员会应立即将该最后意见提交MDCG。在收到联合评估组的意见后42天内，MDCG应就指定草案提出建议，负责公告机构的主管当局在决定指定机构时应适当考虑该建议。
10. 委员会可以通过实施法令，采取措施，规定第38条所述指定申请的程序和报告以及对本条所述申请的评估的详细安排。实施法案应按照第114条第（3）款所述的审查程序通过。
Article 40 第四十条
Nomination of experts for joint assessment of applications for notification
提名专家共同评估通知申请
一、成员国和委员会应提名具有医疗器械合格评定机构评定资格的专家参加第39条和第48条所述的活动。
2. 委员会应备存一份根据本条第1款提名的专家名单，并附上关于其具体能力和专门知识领域的资料。该清单应通过第57条所述的电子系统提供给会员国主管当局。
Article 41 第四十一条
Language requirements 语言要求
All documents required pursuant to Articles 38 and 39 shall be drawn up in a language or languages which shall be determined by the Member State concerned.
根据第38条和第39条要求的所有文件应以有关成员国确定的一种或多种语言起草。
Member States, in applying the first paragraph, shall consider accepting and using a commonly understood language in the medical field, for all or part of the documentation concerned.
会员国在适用第1款时，应考虑对全部或部分有关文件接受和使用医学领域普遍理解的语言。
The Commission shall provide translations of the documentation pursuant to Articles 38 and 39, or parts thereof into an official Union language, such as is necessary for that documentation to be readily understood by the joint assessment team appointed in accordance with Article 39(3).
委员会应根据第38条和第39条提供文件或其部分文件的翻译成联盟官方语言，以使根据第39条第（3）款任命的联合评估小组易于理解该文件所必需的。
Article 42 第四十二条
Designation and notification procedure
指定和通知程序
1. 成员国只能指定已完成根据第39条进行的评估并符合附件VII的合格评定机构。
2. 成员国应使用委员会开发和管理的公告机构数据库（NANDO）中的电子通知工具，将其指定的合格评定机构通知委员会和其他成员国。
三、通知应使用本条第13款所述代码明确规定指定范围，说明本规章所界定的合格评定活动和公告机构有权评估的器械类型，并在不影响第四十四条的情况下，说明与指定有关的任何条件。
4. 通知应附有负责被通知机构的主管部门的最终评估报告、第39条第（9）款所述联合评估小组的最终意见以及MDCG的建议。如果发出通知的会员国不遵循MDCG的建议，它应提供有充分根据的理由。
5. 在不影响第四十四条的情况下，通知成员国应将与指定有关的任何条件通知委员会和其他成员国，并就为确保定期监测公告机构并继续满足附件七规定的要求而作出的安排提供书面证据。
6. 在第 2 款所述通知发出后 28 天内，成员国或委员会可就公告机构或负责公告机构的主管当局对其进行监督提出书面反对意见，并提出其论点。如无人反对，委员会应在收到第2款所述通知后42天内在NANDO上公布通知。
7. 当成员国或委员会根据第6款提出反对意见时，委员会应在第6款所述期限届满后10天内将该事项提交MDCG。在与有关各方协商后，MDCG应最迟在提交其审议后40天内提出意见。如果MDCG认为可以接受通知，委员会应在14天内在NANDO上公布通知。
8. 如果根据第7款征求MDCG的意见后，确认现有的反对意见或提出其他反对意见，则通知的成员国应在收到MDCG的意见后40天内对该意见作出书面答复。答复应解决意见中提出的反对意见，并说明通知成员国决定指定或不指定合格评定机构的理由。
9. 如果通知成员国决定维持其指定合格评定机构的决定，并根据第8款说明理由，委员会应在收到通知后14天内在NANDO上公布通知。
10. 在NANDO上发布通知时，委员会还应将与被通知机构的通知有关的信息以及本条第4款所述的文件以及本条第7款和第8款所述的意见和答复添加到第57条所指的电子系统中。
11. 该指定应在NANDO上发布通知后的第二天生效。公布的通知应说明被通知机构合法合格评定活动的范围。
12. 有关合格评定机构只有在根据第11款指定生效后，才能开展指定机构的活动。
13. 委员会应在2017年11月26日之前，通过实施法案，制定一份代码和相应类型的设备清单，以明确指定公告机构的范围。实施法案应按照第114条第（3）款所述的审查程序通过。委员会在与MDCG协商后，可根据第48条所述协调活动提供的信息更新该清单。
Article 43 第四十三条
Identification number and list of notified bodies
识别号和公告机构名单
1. 委员会应根据第42条第（11）款的规定，为通知生效的每个公告机构分配一个识别号。即使根据几项联盟法案通知该机构，它也应分配一个识别号码。如果根据本条例成功指定，则根据第90/385/EEC和93/42/EEC号指令通知的机构应保留根据这些指令分配给它们的识别号。
2. 委员会应向NANDO的公众提供根据本条例通知的机构名单，包括已分配给它们的识别号和本条例中定义的合格评定活动以及已通知它们的设备类型。缔约国还应将该清单列入第五十七条所指的电子系统。委员会应确保该名单是最新的。
Article 44 第四十四条
Monitoring and re-assessment of notified bodies
对公告机构的监测和重新评估
1. 公告机构应毫不拖延，至迟在15天内，将可能影响其遵守附件VII所列要求或影响其开展与其被指定器械有关的合格评定活动的能力的相关变更通知负责公告机构。
2. 负责公告机构的主管部门应监督在其领土上设立的公告机构及其子公司和分包商，以确保持续遵守本条例规定的要求并履行其义务。各公告机构应根据其负责公告机构的主管部门的要求，提供所有必要的相关资料和文件，使主管机构、委员会和其他会员国能够核查遵守情况。
3. 如果委员会或成员国当局向在另一成员国领土上设立的公告机构提交关于该公告机构进行的合格评定的请求，则应将该请求的副本送交该另一成员国负责公告机构的主管部门。有关公告机构应毫不迟延地在15天内对请求作出答复。负责设立该机构的成员国公告机构的当局应确保任何其他成员国当局或委员会提交的请求由公告机构解决，除非有正当理由不这样做，在这种情况下，该事项可提交MDCG。
4. 负责公告机构的主管部门应至少每年一次重新评估在各自领土上设立的公告机构，并酌情重新评估这些公告机构负责的子公司和分包商是否仍然符合附件七规定的要求和履行其义务。审查应包括对每个指定机构进行现场审计，必要时对其子公司和分包商进行现场审计。
The authority responsible for notified bodies shall conduct its monitoring and assessment activities according to an annual assessment plan to ensure that it can effectively monitor the continued compliance of the notified body with the requirements of this Regulation. That plan shall provide a reasoned schedule for the frequency of assessment of the notified body and, in particular, associated subsidiaries and subcontractors. The authority shall submit its annual plan for monitoring or assessment for each notified body for which it is responsible to the MDCG and to the Commission.
负责公告机构的主管部门应根据年度评估计划开展监测和评估活动，以确保其能够有效监测公告机构是否继续遵守本条例的要求。该计划应为指定机构，特别是相关子公司和分包商的评估频率提供合理的时间表。主管当局应向MDCG和委员会提交其负责的每个指定机构的年度监测或评估计划。
5. 负责公告机构的主管部门对公告机构的监督应包括对公告机构人员的观察审计，必要时包括子公司和分包商的任何人员，因为这些人员正在制造商的工厂进行质量管理体系评估。
6. 由负责公告机构的主管部门对公告机构进行的监测应考虑市场监督、警戒和上市后监督产生的数据，以帮助指导其活动。
The authority responsible for notified bodies shall provide for a systematic follow-up of complaints and other information, including from other Member States, which may indicate non-fulfilment of the obligations by a notified body or its deviation from common or best practice.
负责公告机构的主管部门应提供对投诉和其他信息的系统跟踪，包括来自其他会员国的投诉和其他信息，这些信息可能表明公告机构未履行义务或偏离了共同做法或最佳做法。
7. 除定期监测或现场评估外，负责公告机构的主管部门在必要时，还可以进行临时通知、突击或“有原因”审查，以解决特定问题或核实遵守情况。
8. 负责公告机构的主管部门应审查公告机构对制造商技术文件的评估，特别是第45条中进一步概述的临床评估文件。
9. 负责公告机构的主管部门应记录和记录有关公告机构不遵守附件七所列要求的任何调查结果，并应监测纠正和预防措施的及时执行情况。
10. 在通知指定机构后5年，此后每5年，应由该机构所在成员国的公告机构主管部门和联合评估小组按照第39条所述程序进行全面重新评估，以确定该公告机构是否仍满足附件VII中规定的要求。
The authority responsible for notified bodies of the Member State in which the notified body is established may conduct a complete re-assessment prior to the dates referred to in the first subparagraph, upon request by the notified body or where, based on the results of the annual assessments conducted in accordance with paragraph 4 of this Article, it has concerns regarding the continued fulfilment by the notified body of the requirements set out in Annex VII.
负责设立该公告机构的成员国公告机构的主管部门，经公告机构请求，或根据根据本条第4款进行的年度评估结果，可在第一项所述日期之前进行全面重新评估， 委员会对公告机构继续履行附件七中规定的要求表示关切。
Complete re-assessments that have already started prior to 11 March 2023 shall continue to be conducted, unless the authority responsible for notified bodies of the Member State in which the notified body is established decides to suspend or terminate the ongoing complete re-assessment, taking into account its own resources and the resources of the notified body already spent on the re-assessment, as well as the results of the annual assessments conducted in accordance with paragraph 4 of this Article. Before suspending or terminating an ongoing complete re-assessment, the authority responsible for notified bodies shall hear the notified body concerned.
在 2023 年 3 月 11 日之前已经开始的全面重新评估应继续进行，除非负责设立公告机构的成员国公告机构的主管部门决定暂停或终止正在进行的全面重新评估，同时考虑到其自身资源和已用于重新评估的公告机构的资源， 以及根据本条第4款进行的年度评估的结果。在暂停或终止正在进行的全面重新评估之前，负责公告机构的主管部门应听取有关公告机构的意见。
11. 委员会有权根据第115条通过授权法案，以修正第10款，以修改该款所述全面重新评估的频率。
12. 成员国应至少每年向委员会和MDCG报告一次其对指定机构以及酌情子公司和分包商的监测和现场评估活动。报告应详细说明这些活动的结果，包括根据第7款开展的活动，并应由MDCG和委员会视为机密;但是，它应包含应公开的摘要。
The summary of the report shall be uploaded to the electronic system referred to in Article 57.
报告摘要应上传至第五十七条所述的电子系统。
Article 45 第四十五条
Review of notified body assessment of technical documentation and clinical evaluation documentation
审查公告机构对技术文件和临床评估文件的评估
1. 作为对公告机构持续监测的一部分，负责公告机构的主管部门应审查适当数量的公告机构对制造商技术文件的评估，特别是附件二第6.1节（c）和（d）点所述的临床评估文件，以验证公告机构根据制造商提供的信息得出的结论。负责公告机构的主管部门应在场外和现场进行审查。
2. 根据第1款对要审查的文件进行抽样，应有计划，并代表公告机构认证的器械的类型和风险，特别是高风险器械，并适当说明理由并记录在抽样计划中，抽样计划应由负责公告机构的主管部门根据要求向MDCG提供。
3. 负责公告机构的主管部门应审查公告机构的评估是否适当，并应检查所使用的程序、相关文件和公告机构得出的结论。这种检查应包括指定机构评估所依据的制造商的技术文件和临床评估文件。此类审查应使用 CS 进行。
四、这些审查还应构成根据第44条第（10）款对公告机构进行重新评估和第47条第（3）款所述的联合评估活动的一部分。审查应利用适当的专门知识进行。
5. 根据负责公告机构或联合评估小组的主管部门的审查和评估报告，第七章所述的市场监督、警戒和上市后监督活动的意见，对技术进展的持续监测，或对有关器械安全和性能的关切和新出现的问题的确定， MDCG可以建议根据本条进行的抽样涵盖指定机构评估的技术文件和临床评估文件的更大或更少比例。
六、委员会可通过实施法案，采取措施，规定对本条所述技术文件和临床评估文件评估的审查的详细安排、相关文件和协调。实施法案应按照第114条第（3）款所述的审查程序通过。
Article 46 第四十六条
Changes to designations and notifications
对指定和通知的更改
1. 负责指定机构的主管部门应将指定指定公告机构的任何相关变更通知委员会和其他成员国。
The procedures described in Article 39 and in Article 42 shall apply to extensions of the scope of the designation.
第三十九条和第四十二条所述程序应适用于指定范围的扩大。
For changes to the designation other than extensions of its scope, the procedures laid down in the following paragraphs shall apply.
除扩大其范围外，对指定的更改应适用下列各款规定的程序。
2. 委员会应立即在NANDO上公布修改后的通知。委员会应立即在第57条所述的电子系统中输入有关指定机构名称变更的信息。
3. 如果公告机构决定停止其合格评定活动，则应尽快通知公告机构的主管部门和有关制造商，如果计划停止，则应在停止活动前一年通知该主管部门和有关制造商。在指定机构停止活动后，证书的有效期为九个月，条件是另一指定机构已书面确认其将承担这些证书所涵盖的设备的责任。新的公告机构应在该期限结束前完成对受影响设备的全面评估，然后再为这些设备颁发新证书。如果指定机构已停止活动，则负责指定机构的主管部门应撤回指定。
4. 如果负责公告机构的主管部门确定某公告机构不再符合附件七规定的要求，或未能履行其义务或未实施必要的纠正措施，则该主管部门应根据未能满足这些要求或履行这些义务的严重程度，暂停、限制或全部或部分撤销指定。暂停不得超过一年，同一期间可延长一次。
The authority responsible for notified bodies shall immediately inform the Commission and the other Member States of any suspension, restriction or withdrawal of a designation.
负责公告机构的主管部门应立即将任何中止、限制或撤销指定的情况通知委员会和其他成员国。
五、被暂停、限制或者全部或者部分撤销的，公告机构最迟应在10日内通知有关生产企业。
6. 在限制、中止或撤销指定的情况下，负责公告机构的主管部门应采取适当步骤，确保保存有关公告机构的档案，并应其他成员国负责公告机构的主管部门和负责市场监督的主管部门提供。
In the event of restriction, suspension or withdrawal of a designation, the authority responsible for notified bodies shall:
assess the impact on the certificates issued by the notified body;
评估对指定机构颁发的证书的影响;
submit a report on its findings to the Commission and the other Member States within three months of having notified the changes to the designation;
在通知指定变更后三个月内向委员会和其他成员国提交关于其调查结果的报告;
require the notified body to suspend or withdraw, within a reasonable period of time determined by the authority, any certificates which were unduly issued to ensure the safety of devices on the market;
要求指定机构在主管当局确定的合理期限内暂停或撤回为确保市场上设备安全而不当签发的任何证书;
enter into the electronic system referred to in Article 57 information in relation to certificates of which it has required their suspension or withdrawal;
将第57条所指的与证书有关的信息输入其要求暂停或撤销的电子系统;
inform the competent authority for medical devices of the Member State in which the manufacturer has its registered place of business through the electronic system referred to in Article 57 of the certificates for which it has required suspension or withdrawal. That competent authority shall take the appropriate measures, where necessary to avoid a potential risk to the health or safety of patients, users or others.
通过第57条所述的电子系统，将要求暂停或撤销的证书通知制造商注册营业地所在成员国的医疗器械主管当局。该主管当局应在必要时采取适当措施，避免对患者、用户或其他人的健康或安全造成潜在风险。
7. 在限制、中止或撤销指定的情况下，负责指定机构的主管当局应：
With the exception of certificates unduly issued, and where a designation has been suspended or restricted, the certificates shall remain valid in the following circumstances:
the authority responsible for notified bodies has confirmed, within one month of the suspension or restriction, that there is no safety issue in relation to certificates affected by the suspension or restriction, and the authority responsible for notified bodies has outlined a timeline and actions anticipated to remedy the suspension or restriction; or
负责公告机构的主管部门已在暂停或限制后一个月内确认，受暂停或限制影响的证书不存在安全问题，并且负责公告机构的主管部门已概述了对暂停或限制进行补救的时间表和预期采取的行动;或
the authority responsible for notified bodies has confirmed that no certificates relevant to the suspension will be issued, amended or re-issued during the course of the suspension or restriction, and states whether the notified body has the capability of continuing to monitor and remain responsible for existing certificates issued for the period of the suspension or restriction. In the event that the authority responsible for notified bodies determines that the notified body does not have the capability to support existing certificates issued, the manufacturer shall provide, to the competent authority for medical devices of the Member State in which the manufacturer of the device covered by the certificate has its registered place of business, within three months of the suspension or restriction, a written confirmation that another qualified notified body is temporarily assuming the functions of the notified body to monitor and remain responsible for the certificates during the period of suspension or restriction.
负责公告机构的主管部门已确认，在暂停或限制期间，不会颁发、修改或重新颁发与暂停有关的证书，并说明公告机构是否有能力继续监测和继续对暂停或限制期间颁发的现有证书负责。如果负责公告机构的主管当局确定该公告机构没有能力支持所颁发的现有证书，制造商应向证书所涵盖的器械制造商注册营业地所在成员国的医疗器械主管当局提供： 在暂停或限制后三个月内，书面确认另一个合格的公告机构暂时承担该公告机构的职能，在暂停或限制期间监督证书并继续对证书负责。
8. 除不当签发的证书外，如果指定被暂停或限制，证书在下列情况下应继续有效：
With the exception of certificates unduly issued, and where a designation has been withdrawn, the certificates shall remain valid for a period of nine months in the following circumstances:
where the competent authority for medical devices of the Member State in which the manufacturer of the device covered by the certificate has its registered place of business has confirmed that there is no safety issue associated with the devices in question; and
证书所涵盖的器械制造商注册营业地所在成员国的医疗器械主管当局已确认不存在与有关器械相关的安全问题;和
another notified body has confirmed in writing that it will assume immediate responsibilities for those devices and will have completed assessment of them within twelve months of the withdrawal of the designation.
另一个公告机构已书面确认，它将对这些设备承担直接责任，并将在撤销指定后十二个月内完成对这些设备的评估。
9. 除不当签发的证书外，如果指定已被撤销，则在下列情况下，证书的有效期为九个月：
In the circumstances referred to in the first subparagraph, the competent authority for medical devices of the Member State in which the manufacturer of the device covered by the certificate has its place of business may extend the provisional validity of the certificates for further periods of three months, which altogether shall not exceed twelve months.
在第一项所述情形下，证书所涵盖的器械制造商营业地所在成员国的医疗器械主管机关可以将证书的临时有效期再延长三个月，总共不得超过十二个月。
The authority or the notified body assuming the functions of the notified body affected by the change of designation shall immediately inform the Commission, the other Member States and the other notified bodies thereof.
承担受指定变更影响的被通知机构职能的主管部门或公告机构应立即通知委员会、其他成员国和其他公告机构。
Article 47 第四十七条
Challenge to the competence of notified bodies
对公告机构权限的挑战
1. 委员会应与MDCG一道，调查所有提请其注意的关于指定机构或其一个或多个子公司或分包商继续履行附件VII中规定的要求或其所承担的义务的案件。缔约国应确保向负责公告机构的有关当局通报情况，并给予机会调查这些关切。
2. 发出通知的成员国应根据要求向委员会提供关于指定有关通知机构的所有资料。
3. 如果对指定机构或该指定机构的子公司或分包商持续遵守附件 VII 中规定的要求存在合理关切，并且负责指定机构的主管部门的调查被认为未完全解决这些问题或应要求，委员会可酌情启动第 39 条第 （3） 款和第 （4） 款所述的评估程序负责公告机构的机构。评估的报告和结果应遵循第39条的原则。或者，根据问题的严重程度，委员会可以与MDCG一起要求负责公告机构的当局允许根据第40条确定的名单中最多两名专家参加现场评估，作为根据第44条和第44条第（4）款所述的年度评估计划中的监测和评估活动的一部分。
4. 如果委员会确定某一指定机构不再符合其指定要求，则应相应通知通知的成员国，并要求其采取必要的纠正措施，包括在必要时暂停、限制或撤销指定。
Where the Member State fails to take the necessary corrective measures, the Commission may, by means of implementing acts, suspend, restrict or withdraw the designation. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3). It shall notify the Member State concerned of its decision and update NANDO and the electronic system referred to in Article 57.
如果成员国未能采取必要的纠正措施，委员会可以通过实施法案的方式暂停、限制或撤销指定。实施法案应按照第114条第（3）款所述的审查程序通过。它应将其决定通知有关成员国，并更新NANDO和第57条所述的电子系统。
5. 委员会应确保在调查过程中获得的所有机密资料得到相应处理。
Article 48 第四十八条
Peer review and exchange of experience between authorities responsible for notified bodies
负责公告机构的主管部门之间的同行审查和经验交流
The Commission shall provide for the organisation of exchange of experience and coordination of administrative practice between the authorities responsible for notified bodies. Such exchange shall cover elements including:
development of best practice documents relating to the activities of the authorities responsible for notified bodies;
制定与负责公告机构的主管部门的活动有关的最佳做法文件;
development of guidance documents for notified bodies in relation to the implementation of this Regulation;
为公告机构制定与实施本条例有关的指导文件;
training and qualification of the experts referred to in Article 40;
第40条所指专家的培训和资格认证;
monitoring of trends relating to changes to notified body designations and notifications and trends in certificate withdrawals and transfers between notified bodies;
监测与公告机构指定和通知变更有关的趋势，以及公告机构之间证书撤销和转让的趋势;
monitoring of the application and applicability of scope codes referred to in Article 42(13);
监督第42条第（13）款所述范围代码的适用和适用性;
development of a mechanism for peer reviews between authorities and the Commission;
建立主管部门与委员会之间的同行审查机制;
methods of communication to the public on the monitoring and surveillance activities of authorities and the Commission on notified bodies.
向公众通报当局和委员会关于指定机构的监测和监视活动的方法。
1. 委员会应规定组织负责公告机构的主管当局之间的经验交流和行政实践的协调。这种交换应包括以下要素：
2. 负责公告机构的主管部门应通过根据本条第1款制定的机制，每三年参加一次同行评审。这种审查通常应与第39条所述的现场联合评估同时进行。或者，主管部门可以选择将这种审查作为第44条所述监测活动的一部分。
3. 委员会应参与组织工作，并为同行评议机制的实施提供支持。
4. 委员会应编制一份同行评议活动的年度总结报告，并应向公众公布。
五、委员会可通过执行法案，采取措施，规定本条第1款所述同行评审机制、培训和资格的详细安排和有关文件。实施法案应按照第114条第（3）款所述的审查程序通过。
Article 49 第四十九条
Coordination of notified bodies
公告机构的协调
The Commission shall ensure that appropriate coordination and cooperation between notified bodies is put in place and operated in the form of a coordination group of notified bodies in the field of medical devices, including in vitro diagnostic medical devices. This group shall meet on a regular basis and at least annually.
委员会应确保在医疗器械（包括体外诊断医疗器械）领域以公告机构协调小组的形式在公告机构之间建立适当的协调与合作。该小组应定期举行会议，至少每年举行一次会议。
The bodies notified under this Regulation shall participate in the work of that group.
根据本条例通知的机构应参加该小组的工作。
The Commission may establish the specific arrangements for the functioning of the coordination group of notified bodies.
委员会可就公告机构协调小组的运作作出具体安排。
Article 50 第五十条
List of standard fees
标准费用清单
Notified bodies shall establish lists of their standard fees for the conformity assessment activities that they carry out and shall make those lists publicly available.
公告机构应为其开展的合格评定活动制定其标准费用清单，并应将这些清单公之于众。
CHAPTER V 第五章
CLASSIFICATION AND CONFORMITY ASSESSMENT
分类和合格评定
SECTION 1 第1节
Classification 分类
Article 51 第五十一条
Classification of devices
设备分类
1. 器械应分为I类、IIa类、IIb类和III类，同时考虑到器械的预期用途及其固有风险。分类应按照附件八进行。
二、制造商与有关公告机构之间因适用附件八而产生的任何争议，应提交制造商注册营业地所在成员国的主管当局作出决定。如果制造商在欧盟没有注册营业地点，并且尚未指定授权代表，则该事项应提交附件IX第2.2节第（b）点最后缩进处提及的授权代表注册营业地所在的成员国主管当局。如果有关公告机构是在制造商以外的成员国设立的，主管当局应在与指定指定通知机构的成员国主管当局协商后通过其决定。
The competent authority of the Member State in which the manufacturer has its registered place of business shall notify the MDCG and the Commission of its decision. The decision shall be made available upon request.
制造商注册营业地所在成员国的主管当局应将其决定通知MDCG和委员会。应根据要求提供该决定。
At the request of a Member State the Commission shall after consulting the MDCG, decide, by means of implementing acts, on the following:
application of Annex VIII to a given device, or category or group of devices, with a view to determining the classification of such devices;
将附件八应用于某一特定器械、类别或器械组，以确定此类器械的分类;
that a device, or category or group of devices, shall for reasons of public health based on new scientific evidence, or based on any information which becomes available in the course of the vigilance and market surveillance activities be reclassified, by way of derogation from Annex VIII.
出于公共卫生原因，应根据新的科学证据，或基于在警戒和市场监督活动过程中获得的任何信息，对器械或器械类别或组器械进行重新分类，以减损附件八的方式。
3. 应成员国的请求，委员会应在与MDCG协商后，通过实施法案就以下事项作出决定：
4. 委员会还可以主动在与MDCG协商后，通过执行法案，就第3款（a）和（b）点所述问题作出决定。
5. 为确保附件八的统一适用，并考虑到有关科学委员会的有关科学意见，委员会可在必要的范围内通过执行法案，以解决不同的解释和实际应用问题。
六、本条第三款、第四款和第五款所指的实施行为，应按照第一百一十四条第（三）款所述的审查程序通过。
SECTION 2 第2节
Conformity assessment 合格评定
Article 52 第五十二条
Conformity assessment procedures
合格评定程序
1. 在将器械投放市场之前，制造商应根据附件九至十一中规定的适用合格评定程序对该器械的合格评定进行合格评定。
2. 在将未投放市场的器械投入使用之前，制造商应根据附件九至十一中规定的适用合格评定程序对该器械的合格性进行评估。
3. 除定制或研究器械外，III类器械的制造商应接受附件IX规定的合格评定。或者，制造商可以选择应用附件X中规定的合格评定以及附件XI中规定的合格评定。
4. 除定制或研究器械外，IIb类器械的制造商应接受附件IX第一章和第三章规定的合格评定，并包括对该附件第4节规定的技术文件的评估，每个通用器械组至少一个代表性器械。
However, for class IIb implantable devices, except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors, the assessment of the technical documentation as specified in Section 4 of Annex IX shall apply for every device.
但是，对于IIb类植入式器械，缝合线、订书钉、牙科填充物、牙套、牙冠、螺钉、楔块、板、电线、销钉、夹子和连接器除外，附件IX第4节规定的技术文件评估应适用于每个器械。
Alternatively, the manufacturer may choose to apply a conformity assessment based on type examination as specified in Annex X coupled with a conformity assessment based on product conformity verification as specified in Annex XI.
或者，制造商可以选择应用基于附件X中规定的型式检验的合格评定，以及基于附件XI中规定的产品合格评定的合格评定。
5. 鉴于与本条第4款第二项所列豁免器械中使用的技术相似的成熟技术，正在其他IIb类植入式器械中使用的技术，或为保护患者、使用者或其他人员的健康和安全或公共卫生的其他方面而合理， 委员会有权根据第115条通过授权法案，通过在该清单中增加其他类型的IIb类植入式器械或从中删除该清单来修改该清单。
6. 除定制或研究器械外，IIa类器械的制造商应接受附件九第一章和第三章规定的合格评定，并包括对该附件第4节规定的技术文件的评估，每类器械至少一个代表性器械。
Alternatively, the manufacturer may choose to draw up the technical documentation set out in Annexes II and III coupled with a conformity assessment as specified in Section 10 or Section 18 of Annex XI. The assessment of the technical documentation shall apply for at least one representative device for each category of devices.
或者，制造商可以选择起草附件 II 和 III 中规定的技术文件，以及附件 XI 第 10 节或第 18 节规定的合格评定。技术文档的评估应适用于每类设备至少一个具有代表性的设备。
Manufacturers of class I devices, other than custom-made or investigational devices, shall declare the conformity of their products by issuing the EU declaration of conformity referred to in Article 19 after drawing up the technical documentation set out in Annexes II and III. If those devices are placed on the market in sterile condition, have a measuring function or are reusable surgical instruments, the manufacturer shall apply the procedures set out in Chapters I and III of Annex IX, or in Part A of Annex XI. However, the involvement of the notified body in those procedures shall be limited:
in the case of devices placed on the market in sterile condition, to the aspects relating to establishing, securing and maintaining sterile conditions;
对于以无菌状态投放市场的器械，与建立、确保和维持无菌条件有关的方面;
in the case of devices with a measuring function, to the aspects relating to the conformity of the devices with the metrological requirements;
对于具有测量功能的设备，与设备是否符合计量要求有关;
in the case of reusable surgical instruments, to the aspects relating to the reuse of the device, in particular cleaning, disinfection, sterilization, maintenance and functional testing and the related instructions for use.
在可重复使用的手术器械的情况下，与设备的重复使用有关的方面，特别是清洁、消毒、灭菌、维护和功能测试以及相关的使用说明。
7. 除定制或研究设备外，第一类器械的制造商应在起草附件二和附件三中规定的技术文件后，通过发布第 19 条所述的欧盟符合性声明来声明其产品的符合性。如果这些器械在无菌状态下投放市场，具有测量功能或可重复使用的手术器械，制造商应采用附件九第一章和第三章或附件十一A部分规定的程序。但是，在下列情况下，指定机构对这些程序的参与应受到限制：
8. 定制器械制造商在将此类器械投放市场之前，应遵循附件十三中规定的程序，并起草该附件第1节中规定的声明。
In addition to the procedure applicable pursuant to the first subparagraph, manufacturers of class III custom-made implantable devices shall be subject to the conformity assessment as specified in Chapter I of Annex IX. Alternatively, the manufacturer may choose to apply a conformity assessment as specified in Part A of Annex XI.
除根据第1项适用的程序外，第三类定制植入式器械的制造商应接受附件九第一章规定的合格评定。或者，制造商可以选择应用附件XI的A部分中规定的合格评定。
九、除本条第三款、第四款、第六款或第七款规定的适用程序外，对于第1条第（8）款第1项所指的装置，还应适用附件九第5.2节或附件十第6节规定的程序。
10. 除根据本条第3款、第4款、第6款或第7款适用的程序外，对于根据第1条第（6）款（f）项或（g）项以及第1条第（10）款第1项所涵盖的器械，则适用附件九第5.3节或附件十第6节规定的程序， 如适用，也应适用。
11. 除根据第3、4、6或7款适用的程序外，对于由拟通过体孔进入人体或涂抹在皮肤上的物质或物质组合组成的装置，以及被人体吸收或局部分散在人体中的装置， 附件 IX 第 5.4 节或附件 X 第 6 节（如适用）规定的程序也应适用。
12. 设立公告机构的成员国可要求以该成员国确定的联盟官方语言提供与第1至第7款和第9至第11款所述程序有关的所有或某些文件，包括技术文件、审计、评估和检查报告。如无此要求，则这些文件应以指定机构可接受的任何国际电联官方语言提供。
13. 研究设备应符合第 62 条至第 81 条规定的要求。
The Commission may, by means of implementing acts, specify detailed arrangements and procedural aspects with a view to ensuring the harmonised application of the conformity assessment procedures by the notified bodies for any of the following aspects:
the frequency and the sampling basis of the assessment of the technical documentation on a representative basis as set out in the third paragraph of Section 2.3 and in Section 3.5 of Annex IX in the case of class IIa and class IIb devices, and in Section 10.2 of Annex XI in the case of class IIa devices;
第2.3节第3段和附件IX第3.5节（IIa类和IIb类器械）以及附件XI第10.2节（IIa类器械）规定的技术文件评估的频率和抽样基础;
the minimum frequency of unannounced on-site audits and sample tests to be conducted by notified bodies in accordance with Section 3.4 of Annex IX, taking into account the risk-class and the type of device;
公告机构根据附件九第3.4节进行的突击现场审核和抽样测试的最低频率，同时考虑到风险等级和设备类型;
the physical, laboratory or other tests to be carried out by notified bodies in the context of sample tests, assessment of the technical documentation and type examination in accordance with Sections 3.4 and 4.3 of Annex IX, Section 3 of Annex X and Section 15 of Annex XI.
根据附件 IX 第 3.4 和 4.3 节、附件 X 第 3 节和附件 XI 第 15 节，由指定机构在样品测试、技术文件评估和型式检查的背景下进行的物理、实验室或其他测试。
14. 委员会可以通过实施法案，具体规定详细的安排和程序方面，以确保各公告机构在以下任何方面统一适用合格评定程序：
The implementing acts referred to in the first subparagraph shall be adopted in accordance with the examination procedure referred to in Article 114(3).
第1项所指的实施行为应按照第114条第（3）款所述的审查程序通过。
Article 53 第五十三条
Involvement of notified bodies in conformity assessment procedures
公告机构参与合格评定程序
1. 如果合格评定程序需要指定机构的参与，制造商可以向其选择的指定机构提出申请，前提是所选的指定机构被指定用于与相关器械类型相关的合格评定活动。制造商不得与另一个指定机构同时提交同一合格评定程序的申请。
二、有关公告机构应通过第57条所述的电子系统，在公告机构作出合格评定决定之前撤回申请的制造商通知其他公告机构。
3. 在根据第1款向指定机构提出申请时，制造商应声明他们是否在该指定机构作出决定之前撤回了向该指定机构提出的申请，并提供有关先前被另一指定机构拒绝的同一合格评定申请的信息。
4. 指定机构可能要求制造商提供任何信息或数据，这些信息或数据对于正确执行所选的合格评定程序是必要的。
5. 公告机构和公告机构的人员应以最高程度的职业操守和特定领域必要的技术和科学能力开展合格评定活动，并应不受任何可能影响其判断或合格评定结果的压力和诱因，特别是财务压力和诱因， 特别是对于对这些活动的结果感兴趣的个人或团体。
Article 54 第五十四条
Clinical evaluation consultation procedure for certain class III and class IIb devices
某些III类和IIb类器械的临床评估咨询程序
In addition to the procedures applicable pursuant to Article 52, a notified body shall also follow the procedure regarding clinical evaluation consultation as specified in Section 5.1 of Annex IX or as referred to in Section 6 of Annex X, as applicable, when performing a conformity assessment of the following devices:
class III implantable devices, and
III类植入式装置，以及
class IIb active devices intended to administer and/or remove a medicinal product, as referred to in Section 6.4 of Annex VIII (Rule 12).
IIb类有源器械，用于管理和/或移除医药产品，如附件VIII第6.4节（第12条）所述。
一、除第五十二条规定的适用程序外，指定机构在对下列器械进行合格评定时，还应遵循附件九第5.1节或附件十第6节规定的临床评价咨询程序：
The procedure referred to in paragraph 1 shall not be required for the devices referred to therein:
in the case of renewal of a certificate issued under this Regulation;
在根据本条例签发的证书续期的情况下;
where the device has been designed by modifying a device already marketed by the same manufacturer for the same intended purpose, provided that the manufacturer has demonstrated to the satisfaction of the notified body that the modifications do not adversely affect the benefit-risk ratio of the device; or
如果该器械是通过修改同一制造商已经销售的器械来设计相同的预期目的，前提是制造商已向指定机构证明这些修改不会对器械的收益风险比产生不利影响;或
where the principles of the clinical evaluation of the device type or category have been addressed in a CS referred to in Article 9 and the notified body confirms that the clinical evaluation of the manufacturer for this device is in compliance with the relevant CS for clinical evaluation of that kind of device.
如果设备类型或类别的临床评估原则已在第 9 条所述的 CS 中得到解决，并且公告机构确认制造商对该设备的临床评估符合该类型设备临床评估的相关 CS。
2. 对于本款所述的器械，不应要求执行第1款所述程序：
三、公告机构应通过第五十七条所指的电子系统，将是否适用本条第1款所述程序通知主管机关、被公告机构主管机关和委员会。该通知应附有临床评价评估报告。
4. 委员会应制定一份年度概述，说明已遵守附件九第5.1节规定和附件十第6节所述程序的器械。年度概览应包括根据本条第3款和附件九第5.1节（e）项发出的通知，以及公告机构未听取专家小组意见的案例清单。委员会应将本概述提交给欧洲议会、理事会和MDCG。
五、欧盟委员会应在2025年5月27日前起草一份关于本条实施情况的报告，并提交给欧洲议会和理事会。报告应考虑到MDCG的年度概览和任何可用的相关建议。委员会应酌情根据该报告提出对本条例的修正建议。
Article 55 第五十五条
Mechanism for scrutiny of conformity assessments of certain class III and class IIb devices
某些III类和IIb类器械合格评定审查机制
1. 公告机构应将其授予根据第54条第（1）款进行合格评定的器械的证书通知主管当局。此类通知应通过第57条所述的电子系统进行，并应包括根据第32条进行的安全和临床表现摘要、被通知机构的评估报告、附件I第23.4节所述的使用说明，以及附件IX第5.1节或附件X第6节所述专家小组的科学意见（如适用）， 如适用。如果公告机构与专家小组之间存在意见分歧，也应包括充分的理由。
2. 主管当局和委员会（如适用）可基于合理关切，根据第44条、第45条、第46条、第47条或第94条适用进一步程序，并在认为必要时根据第95条和第97条采取适当措施。
3. MDCG和委员会（如适用）可基于合理关切，要求专家小组就任何器械的安全性和性能提供科学建议。
Article 56 第五十六条
Certificates of conformity
合格证书
1. 公告机构根据附件 IX、X 和 XI 颁发的证书应采用公告机构所在成员国确定的联盟官方语言，或以公告机构可接受的联盟官方语言发布。证书的最低内容应见附件十二。
2. 证书的有效期为五年。根据制造商的申请，证书的有效期可以再延长，每次不超过五年，根据适用的合格评定程序进行重新评估。只要证书补充的证书有效，证书的任何补充就应继续有效。
3. 公告机构可以对某些患者群体的器械预期用途施加限制，或要求制造商根据附件十四的B部分进行特定的PMCF研究。
4. 如果公告机构发现制造商不再满足本条例的要求，则应考虑到相称性原则，暂停或撤销颁发的证书或对其施加任何限制，除非制造商在公告机构规定的适当期限内采取适当的纠正措施，以确保遵守此类要求。公告机构应说明其决定的理由。
5. 公告机构应将有关所颁发证书（包括其修订和补充）以及暂停、恢复、撤销或拒绝证书和对证书施加的限制的任何信息输入第五十七条所述的电子系统。此类信息应向公众开放。
6. 鉴于技术进步，委员会有权根据第115条通过授权法案，修改附件十二中规定的证书的最低内容。
Article 57 第五十七条
Electronic system on notified bodies and on certificates of conformity
公告机构和合格证书电子系统
The Commission, after consulting the MDCG, shall set up and manage an electronic system to collate and process the following information:
the list of subsidiaries referred to in Article 37(3);
第37条第（3）款所指的子公司名单;
the list of experts referred to in Article 40(2);
第40条第（2）款所指的专家名单;
the information relating to the notification referred to in Article 42(10) and the amended notifications referred to in Article 46(2);
与第42条第（10）款所述的通知和第46条第（2）款所述的经修订的通知有关的信息;
the list of notified bodies referred to in Article 43(2);
第43条第（2）款所指的公告机构名单;
the summary of the report referred to in Article 44(12);
第44条第（12）款所述的报告摘要;
the notifications for conformity assessments and certificates referred to in Articles 54(3) and 55(1);
第54条第（3）款和第55条第（1）款所述的合格评定和证书通知;
withdrawal or refusals of applications for the certificates as referred to in Article 53(2) and Section 4.3 of Annex VII;
撤回或驳回第53条第（2）款和附件VII第4.3节所述的证书申请;
the information regarding certificates referred to in Article 56(5);
第56条第（5）款所指的有关证书的信息;
the summary of safety and clinical performance referred to in Article 32.
第32条所述的安全性和临床表现摘要。
1. 委员会在与MDCG协商后，应建立和管理一个电子系统，以整理和处理以下信息：
2. 成员国主管当局、委员会、指定机构（如适用）以及本条例或（EU）2017/746条例其他部分规定时，应向公众提供电子系统整理和处理的信息。
Article 58 第五十八条
Voluntary change of notified body
自愿变更公告机构
In cases where a manufacturer terminates its contract with a notified body and enters into a contract with another notified body in respect of the conformity assessment of the same device, the detailed arrangements for the change of notified body shall be clearly defined in an agreement between the manufacturer, the incoming notified body and, where practicable the outgoing notified body. That agreement shall cover at least the following aspects:
the date on which the certificates issued by the outgoing notified body become invalid;
即将离任的通知机构签发的证书失效的日期;
the date until which the identification number of the outgoing notified body may be indicated in the information supplied by the manufacturer, including any promotional material;
制造商提供的信息（包括任何宣传材料）中可注明即将发出的通知机构的识别号的日期;
the transfer of documents, including confidentiality aspects and property rights;
文件的转让，包括保密方面和财产权;
the date after which the conformity assessment tasks of the outgoing notified body is assigned to the incoming notified body;
即将离任的公告机构的合格评定任务分配给即将上任的公告机构的日期;
the last serial number or lot number for which the outgoing notified body is responsible.
即将离任的公告机构负责的最后一个序列号或批号。
1. 如果制造商终止与指定机构的合同，并就同一器械的合格评定与另一公告机构签订合同，则变更公告机构的详细安排应在制造商、即将成立的公告机构和 在可行的情况下，即将离任的通知机构。该协议至少应包括以下方面：
2. 即将离任的公告机构应当在证书失效之日撤销其为有关器械颁发的证书。
Article 59 第五十九条
Derogation from the conformity assessment procedures
减损合格评定程序
1. 通过减损本条例第52条，或在2020年4月24日至2021年5月25日期间，通过减损第90/385/EEC号指令第9（1）和（2）条或第93/42/EEC号指令第11（1）至（6）条，任何主管当局均可根据正当理由授权， （a） 在有关成员国领土内投放市场或投入使用的特定器械，而该器械尚未执行这些条款所述的适用程序，但使用该器械符合公共卫生或患者安全或健康的利益。
2. 成员国应将授权根据第1款将器械投放市场或投入使用的任何决定通知委员会和其他成员国，如果这种授权被批准用于单个患者以外的用途。
The Member State may inform the Commission and the other Member States of any authorisation granted in accordance with Article 9(9) of Directive 90/385/EEC or Article 11(13) of Directive 93/42/EEC before 24 April 2020.
成员国可在2020年4月24日之前将根据第90/385/EEC号指令第9（9）条或第93/42/EEC号指令第11（13）条授予的任何授权通知委员会和其他成员国。
3. ►M1 在根据本条第2款发出通知后，在与公共卫生或患者安全或健康有关的特殊情况下，委员会可以通过实施法案，在有限的时间内延长成员国根据本条第1款授予的授权的有效期，或者， 在2020年4月24日之前，根据第90/385/EEC号指令第9（9）条或第93/42/EEC号指令第11（13）条授予联盟领土，并规定设备可以投放市场或投入使用的条件。实施法案应按照第114条第（3）款所述的审查程序通过。◄
On duly justified imperative grounds of urgency relating to the health and safety of humans, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 114(4).
根据与人类健康和安全有关的有正当理由的紧急理由，委员会应根据第114条第（4）款所述程序立即通过适用的实施法案。
Article 60 第六十条
Certificate of free sale
免费销售证书
1. 为出口目的，应制造商或授权代表的要求，制造商或授权代表在其注册营业地所在的成员国应签发免费销售证书，声明制造商或授权代表（如适用）在其领土上有注册营业地，并且根据本条例带有CE标志的有关设备可以在联盟中销售。免费销售证书应列出根据第 29 条提供给 UDI 数据库的设备的基本 UDI-DI。如果指定机构根据第56条签发了证书，则自由销售证书应载明附件十二第二章第3节所述的指定机构签发的证书的唯一编号。
2. 委员会可通过执行法律，建立自由销售证书的模式，同时考虑到使用自由销售证书的国际惯例。这些实施行为应根据第114条第（2）款所述的咨询程序通过。
CHAPTER VI 第六章
CLINICAL EVALUATION AND CLINICAL INVESTIGATIONS
临床评估和临床研究
Article 61 第六十一条
Clinical evaluation 临床评估
1. 在设备预期用途的正常条件下，确认符合附件 I 中规定的相关一般安全和性能要求，并评估附件 I 第 1 节和第 8 节中提及的不良副作用和收益风险比的可接受性，应基于提供足够临床证据的临床数据， 如适用，包括附件三中提及的相关数据。
The manufacturer shall specify and justify the level of clinical evidence necessary to demonstrate conformity with the relevant general safety and performance requirements. That level of clinical evidence shall be appropriate in view of the characteristics of the device and its intended purpose.
制造商应指定并证明证明符合相关一般安全和性能要求所需的临床证据水平。鉴于器械的特性及其预期用途，该水平的临床证据应是适当的。
To that end, manufacturers shall plan, conduct and document a clinical evaluation in accordance with this Article and Part A of Annex XIV.
为此，制造商应根据本条和附件十四的A部分计划、实施和记录临床评估。
2. 对于第54条第（1）款（b）项所指的所有III类器械和IIb类器械，制造商可以在进行临床评估和/或调查之前咨询第106条所述的专家组，以审查制造商的预期临床开发策略和临床研究建议。制造商应适当考虑专家小组的意见。这种考虑应记录在本条第12款所述的临床评价报告中。
The manufacturer may not invoke any rights to the views expressed by the expert panel with regard to any future conformity assessment procedure.
制造商不得援引专家小组就任何未来合格评定程序所表达的意见的任何权利。
A clinical evaluation shall follow a defined and methodologically sound procedure based on the following:
a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device, where the following conditions are satisfied:
在满足以下条件的情况下，对目前可用的与设备的安全性、性能、设计特性和预期用途相关的相关科学文献进行批判性评估：
根据附件 XIV 第 3 节，证明为预期目的而接受临床评估的器械等同于数据相关的器械，并且
数据充分证明符合相关的一般安全和性能要求;
a critical evaluation of the results of all available clinical investigations, taking duly into consideration whether the investigations were performed under Articles 62 to 80, any acts adopted pursuant to Article 81, and Annex XV; and
对所有现有临床研究的结果进行严格评估，同时适当考虑研究是否根据第62条至第80条、根据第81条通过的任何法案和附件十五进行;和
a consideration of currently available alternative treatment options for that purpose, if any.
考虑目前可用的替代治疗方案（如果有的话）。
3. 临床评估应遵循基于以下内容的明确且方法学合理的程序：
In the case of implantable devices and class III devices, clinical investigations shall be performed, except if:
该设备是通过对同一制造商已经销售的设备进行修改而设计的，
根据附件 XIV 第 3 节，制造商已证明修改后的设备等同于已上市的设备，并且该演示已获得公告机构的认可，并且
对上市器械的临床评估足以证明修改后的器械符合相关的安全性和性能要求。
4. 对于植入式器械和 III 类器械，应进行临床调查，但以下情况除外：
In this case, the notified body shall check that the PMCF plan is appropriate and includes post market studies to demonstrate the safety and performance of the device.
在这种情况下，指定机构应检查 PMCF 计划是否合适，并包括上市后研究以证明设备的安全性和性能。
In addition, clinical investigations need not be performed in the cases referred to in paragraph 6.
此外，在第6段所述情况下，无需进行临床调查。
A manufacturer of a device demonstrated to be equivalent to an already marketed device not manufactured by him, may also rely on paragraph 4 in order not to perform a clinical investigation provided that the following conditions are fulfilled in addition to what is required in that paragraph:
两家制造商签订了合同，明确允许第二台设备的制造商持续完全访问技术文档，并且
原始临床评估已按照本法规的要求进行，
and the manufacturer of the second device provides clear evidence thereof to the notified body.
第二种设备的制造商向指定机构提供明确的证据。
5. 被证明等同于非其制造的已上市器械的器械的制造商，如果除该款要求外，还满足以下条件，也可以依赖第4款不进行临床研究：
The requirement to perform clinical investigations pursuant to paragraph 4 shall not apply to implantable devices and class III devices:
which have been lawfully placed on the market or put into service in accordance with Directive 90/385/EEC or Directive 93/42/EEC and for which the clinical evaluation:
已根据指令 90/385/EEC 或指令 93/42/EEC 合法投放市场或投入使用，并且临床评估：
基于足够的临床数据，以及
符合相关产品特定 CS 的临床评估，用于该类型器械的临床评估（如果此类 CS 可用）;或
that are sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips or connectors for which the clinical evaluation is based on sufficient clinical data and is in compliance with the relevant product-specific CS, where such a CS is available.
缝合线、订书钉、牙科填充物、牙套、牙冠、螺钉、楔子、板、电线、销钉、夹子或连接器，其临床评估基于足够的临床数据，并符合相关产品特定的 CS（如果有此类 CS）。
6. 根据第4款进行临床研究的要求不适用于植入式器械和III类器械：
7. 根据第6款不适用第4款的情况，应在制造商的临床评估报告和指定机构的临床评估评估报告中说明理由。
8. 鉴于与本条第6款（b）项所列豁免器械中使用的技术相似的成熟技术，正在其他器械中使用的技术，或为了保护患者、用户或其他人员的健康和安全或公共卫生的其他方面而有正当理由，委员会有权根据第115条通过授权法案，修改所提及的豁免器械清单根据第52条第（4）款第2项和第6款第（b）项的规定，将其他类型的植入式或III类器械添加到该清单中或从中删除器械。
9. 对于附件十六中列出的没有预期医疗目的的产品，根据本章和附件十四和十五证明临床益处的要求应理解为证明设备性能的要求。这些产品的临床评估应基于有关安全性的相关数据，包括来自上市后监测、PMCF 的数据，以及在适用的情况下进行特定临床研究的数据。应对这些产品进行临床调查，除非有充分理由依赖来自类似医疗器械的现有临床数据。
10. 在不影响第4款的情况下，如果根据临床数据证明符合一般安全和性能要求被认为不合适，则应根据制造商的风险管理结果和对器械与人体之间相互作用的具体情况的考虑，为任何此类例外提供充分的理由， 预期的临床性能和制造商的声明。在这种情况下，制造商应在附件II中提及的技术文件中适当地证明，为什么它认为仅基于非临床测试方法（包括性能评估、台架测试和临床前评估）的结果证明符合一般安全和性能要求是充分的。
11. 临床评估及其文件应在有关器械的整个生命周期内更新，包括根据附件十四 B 部分和第 84 条所述的上市后监督计划实施制造商的 PMCF 计划获得的临床数据。
For class III devices and implantable devices, the PMCF evaluation report and, if indicated, the summary of safety and clinical performance referred to in Article 32 shall be updated at least annually with such data.
对于III类器械和植入式器械，PMCF评估报告以及第32条所述的安全性和临床性能摘要（如有说明）应至少每年更新一次。
12. 临床评估、其结果和由此得出的临床证据应记录在附件十四第4节所述的临床评估报告中，除定制器械外，该报告应是附件II中提及的与有关器械有关的技术文件的一部分。
13. 在必要时，为确保附件十四的统一适用，委员会可在适当考虑技术和科学进展的情况下，在必要的范围内通过执行行动，以解决不同的解释和实际应用问题。实施法案应按照第114条第（3）款所述的审查程序通过。
Article 62 第六十二条
General requirements regarding clinical investigations conducted to demonstrate conformity of devices
关于为证明器械符合性而进行的临床研究的一般要求
Clinical investigations shall be designed, authorised, conducted, recorded and reported in accordance with the provisions of this Article and of Articles 63 to 80, the acts adopted pursuant to Article 81, and Annex XV, where carried out as part of the clinical evaluation for conformity assessment purposes, for one or more of the following purposes:
to establish and verify that, under normal conditions of use, a device is designed, manufactured and packaged in such a way that it is suitable for one or more of the specific purposes listed in point (1) of Article 2, and achieves the performance intended as specified by its manufacturer;
确定并验证在正常使用条件下，设备的设计、制造和包装方式使其适合第2条第（1）款所列的一项或多项特定目的，并达到其制造商规定的预期性能;
to establish and verify the clinical benefits of a device as specified by its manufacturer;
建立和验证制造商指定的器械的临床益处;
to establish and verify the clinical safety of the device and to determine any undesirable side-effects, under normal conditions of use of the device, and assess whether they constitute acceptable risks when weighed against the benefits to be achieved by the device.
在设备正常使用条件下，建立和验证设备的临床安全性并确定任何不良副作用，并评估它们在权衡设备所实现的益处时是否构成可接受的风险。
1. 临床研究应根据本条和第六十三条至第八十条、根据第八十一条通过的法案和附件十五的规定设计、授权、进行、记录和报告，如果作为合格评定目的的临床评估的一部分进行，用于以下一个或多个目的：
2. 如果临床研究的发起人未在联盟成立，则该发起人应确保在联盟中设立自然人或法人作为其法定代表人。该法定代表人应负责确保保荐人遵守本条例规定的义务，并应是本条例规定的与保荐人进行所有通信的收件人。与该法定代表人的任何通信均应视为与保荐人的通信。
Member States may choose not to apply the first subparagraph to clinical investigations to be conducted solely on their territory, or on their territory and the territory of a third country, provided that they ensure that the sponsor establishes at least a contact person on their territory in respect of that clinical investigation who shall be the addressee for all communications with the sponsor provided for in this Regulation.
成员国可以选择不将第一项适用于仅在其领土上或在其领土和第三国领土上进行的临床研究，前提是它们确保申办者在其领土上至少就该临床研究设立一名联系人，该联系人应是本条例规定的与申办者进行的所有通信的收件人。
3. 临床研究的设计和进行应确保参与临床研究的受试者的权利、安全、尊严和福祉得到保护，并凌驾于所有其他利益之上，并且产生的临床数据在科学上有效、可靠和可靠。
Clinical investigations shall be subject to scientific and ethical review. The ethical review shall be performed by an ethics committee in accordance with national law. Member States shall ensure that the procedures for review by ethics committees are compatible with the procedures set out in this Regulation for the assessment of the application for authorisation of a clinical investigation. At least one lay person shall participate in the ethical review.
临床研究应接受科学和伦理审查。伦理审查应由伦理委员会根据国家法律进行。成员国应确保伦理委员会的审查程序与本法规中规定的评估临床研究授权申请的程序相一致。伦理审查应至少有一名非专业人士参加。
A clinical investigation as referred to in paragraph 1 may be conducted only where all of the following conditions are met:
the clinical investigation is the subject of an authorisation by the Member State(s) in which the clinical investigation is to be conducted, in accordance with this Regulation, unless otherwise stated;
除非另有说明，否则临床研究应根据本条例进行临床研究的成员国授权;
an ethics committee, set up in accordance with national law, has not issued a negative opinion in relation to the clinical investigation, which is valid for that entire Member State under its national law;
根据国家法律设立的伦理委员会没有就临床研究发表否定意见，根据其国内法，该意见对整个成员国有效;
the sponsor, or its legal representative or a contact person pursuant to paragraph 2, is established in the Union;
保荐人、其法定代表人或第2款规定的联系人，在联盟内成立;
vulnerable populations and subjects are appropriately protected in accordance with Articles 64 to 68;
根据第64条至第68条，弱势群体和主体得到适当保护;
the anticipated benefits to the subjects or to public health justify the foreseeable risks and inconveniences and compliance with this condition is constantly monitored;
对受试者或公共卫生的预期益处证明可预见的风险和不便是合理的，并不断监测对这种情况的遵守情况;
the subject or, where the subject is not able to give informed consent, his or her legally designated representative has given informed consent in accordance with Article 63;
当事人，或者，当事人不能给予知情同意的，其法定代理人已依照第六十三条的规定给予知情同意;
the subject or, where the subject is not able to give informed consent, his or her legally designated representative, has been provided with the contact details of an entity where further information can be received in case of need;
受试者，或者，如果受试者无法给予知情同意，则向其法定指定的代表提供实体的联系方式，以便在需要时可以收到进一步的信息;
the rights of the subject to physical and mental integrity, to privacy and to the protection of the data concerning him or her in accordance with Directive 95/46/EC are safeguarded;
根据第95/46/EC号指令，主体的身心完整、隐私权和保护与他或她有关的数据的权利得到保障;
the clinical investigation has been designed to involve as little pain, discomfort, fear and any other foreseeable risk as possible for the subjects, and both the risk threshold and the degree of distress are specifically defined in the clinical investigation plan and constantly monitored;
临床研究旨在尽可能少地涉及受试者的疼痛、不适、恐惧和任何其他可预见的风险，并且风险阈值和痛苦程度都在临床研究计划中明确定义并持续监测;
the medical care provided to the subjects is the responsibility of an appropriately qualified medical doctor or, where appropriate, a qualified dental practitioner or any other person entitled by national law to provide the relevant patient care under clinical investigation conditions;
向受试者提供的医疗服务由具有适当资格的医生负责，或在适当情况下由合格的牙科医生或国家法律有权在临床调查条件下提供相关患者护理的任何其他人负责;
no undue influence, including that of a financial nature, is exerted on the subject, or, where applicable, on his or her legally designated representatives, to participate in the clinical investigation;
不得对受试者施加不当影响，包括经济性质的影响，或在适用的情况下对其合法指定的代表施加不当影响，以参与临床研究;
the investigational device(s) in question conform(s) to the applicable general safety and performance requirements set out in Annex I apart from the aspects covered by the clinical investigation and that, with regard to those aspects, every precaution has been taken to protect the health and safety of the subjects. This includes, where appropriate, technical and biological safety testing and pre-clinical evaluation, as well as provisions in the field of occupational safety and accident prevention, taking into consideration the state of the art;
除临床研究涵盖的方面外，所讨论的研究设备符合附件 I 中规定的适用的一般安全和性能要求，并且在这些方面已采取一切预防措施来保护受试者的健康和安全。这包括酌情进行技术和生物安全测试和临床前评估，以及职业安全和事故预防领域的规定，同时考虑到最先进的技术;
the requirements of Annex XV are fulfilled.
符合附件十五的要求。
4. 只有在满足以下所有条件的情况下，才能进行第1款所述的临床调查：
5.任何受试者，或在受试者无法给予知情同意的情况下，其法定指定代表，可以在不造成任何损害且无需提供任何理由的情况下，随时通过撤销其知情同意书退出临床研究。在不损害第95/46/EC号指令的情况下，撤回知情同意不应影响撤回之前已经开展的活动和基于知情同意获得的数据的使用。
6. 研究者应是从事相关成员国认可的有资格担任研究者职务的职业的人，因为在患者护理方面具有必要的科学知识和经验。参与进行临床研究的其他人员，应当具备相关医学领域和临床研究方法方面的教育、培训或经验，具备执行其任务的适当资格。
7. 进行临床研究的设施应适合于临床研究，并应与拟使用器械的设施相似。
Article 63 第六十三条
Informed consent 知情同意
1. 知情同意书应由进行第2款（c）项所述面谈的人员和当事人书写、注明日期并签字，如果当事人不能给予知情同意，则由其法定指定代表在根据第2款得到适当通知后签字。如果当事人无法书写，可以在至少一名公正的证人在场的情况下，通过适当的替代方式给予同意并记录在案。在这种情况下，证人应在知情同意书上签字并注明日期。当事人，或在当事人不能给予知情同意的情况下，应酌情向其法定指定代表提供给予知情同意的文件或记录的副本。知情同意书应记录在案。应给予受试者或其法定代表足够的时间考虑其参与临床研究的决定。
Information given to the subject or, where the subject is not able to give informed consent, his or her legally designated representative for the purposes of obtaining his or her informed consent shall:
enable the subject or his or her legally designated representative to understand:
使受试者或其法定代表人了解：
the nature, objectives, benefits, implications, risks and inconveniences of the clinical investigations;
临床研究的性质、目的、益处、影响、风险和不便之处;
the subject's rights and guarantees regarding his or her protection, in particular his or her right to refuse to participate in and the right to withdraw from the clinical investigation at any time without any resulting detriment and without having to provide any justification;
受试者在保护方面的权利和保障，特别是他或她拒绝参与和随时退出临床研究的权利，而不会造成任何损害，也无需提供任何理由;
the conditions under which the clinical investigations is to be conducted, including the expected duration of the subject's participation in the clinical investigation; and
进行临床研究的条件，包括受试者参与临床研究的预期持续时间;和
the possible treatment alternatives, including the follow-up measures if the participation of the subject in the clinical investigation is discontinued;
可能的治疗方案，包括受试者停止参与临床研究时的后续措施;
be kept comprehensive, concise, clear, relevant, and understandable to the subject or his or her legally designated representative;
保持全面、简洁、清晰、相关，并且对当事人或其法定代理人易于理解;
be provided in a prior interview with a member of the investigating team who is appropriately qualified under national law;
在与根据国家法律具有适当资格的调查小组成员事先面谈时提供;
include information about the applicable damage compensation system referred to in Article 69; and
包括有关第69条所述适用的损害赔偿制度的信息;和
include the Union-wide unique single identification number of the clinical investigation referred to in Article 70(1) and information about the availability of the clinical investigation results in accordance with paragraph 6 of this Article.
包括第70条第（1）款所指的临床研究的全联盟唯一单一识别号，以及根据本条第6款的规定，有关临床研究结果可用性的信息。
2. 提供给受试者的信息，或在受试者无法给予知情同意的情况下，其法定指定代表为获得其知情同意而应：
3. 第2款所述资料应以书面形式编写，并提供给当事人，或在当事人不能给予知情同意时，由其法定指定代表提供。
4. 在第2款（c）项所述的面谈中，应特别注意特定患者群体和个别受试者的信息需求，以及提供信息的方法。
5. 在第二款（c）项所述的面谈中，应核实受试者是否理解了该信息。
6. 应告知受试者，无论临床研究结果如何，都将根据第77条第（5）款的规定，在第73条所指的临床研究电子系统中提供临床研究报告和以预期用户可理解的措辞呈现的摘要，并应尽可能告知， 当它们可用时。
7. 本条例不妨碍国家法律要求，除法定代表人给予的知情同意外，能够形成意见和评估提供给他或她的信息的未成年人也应同意参加临床调查。
Article 64 第六十四条
Clinical investigations on incapacitated subjects
对无行为能力受试者的临床研究
In the case of incapacitated subjects who have not given, or have not refused to give, informed consent before the onset of their incapacity, a clinical investigation may be conducted only where, in addition to the conditions set out in Article 62(4), all of the following conditions are met:
the informed consent of their legally designated representative has been obtained;
已获得其法定指定代理人的知情同意;
the incapacitated subjects have received the information referred to in Article 63(2) in a way that is adequate in view of their capacity to understand it;
无行为能力的受试者已以充分的方式接收了第63条第（2）款所述的信息，以充分的方式理解了这些信息;
the explicit wish of an incapacitated subject who is capable of forming an opinion and assessing the information referred to in Article 63(2) to refuse participation in, or to withdraw from, the clinical investigation at any time, is respected by the investigator;
研究者尊重能够形成意见并评估第 63（2） 条所述信息的无行为能力受试者随时拒绝参与或退出临床研究的明确愿望;
no incentives or financial inducements are given to subjects or their legally designated representatives, except for compensation for expenses and loss of earnings directly related to the participation in the clinical investigation;
除了对与参与临床研究直接相关的费用和收入损失的补偿外，不给予受试者或其法定指定代表任何奖励或经济诱因;
the clinical investigation is essential with respect to incapacitated subjects and data of comparable validity cannot be obtained in clinical investigations on persons able to give informed consent, or by other research methods;
对于无行为能力的受试者，临床调查是必不可少的，在对能够给予知情同意的人的临床调查中，或通过其他研究方法无法获得具有可比有效性的数据;
the clinical investigation relates directly to a medical condition from which the subject suffers;
临床调查与受试者所患的医疗状况直接相关;
there are scientific grounds for expecting that participation in the clinical investigation will produce a direct benefit to the incapacitated subject outweighing the risks and burdens involved.
有科学依据可以预期，参与临床研究将对无行为能力的受试者产生直接益处，超过所涉及的风险和负担。
1. 对于在丧失行为能力发生之前未给予或未拒绝给予知情同意的无行为能力受试者，只有在除第62条第（4）款规定的条件外，还满足以下所有条件的情况下，才能进行临床调查：
2. 受试者应尽可能参加知情同意程序。
Article 65 第六十五条
Clinical investigations on minors
未成年人的临床研究
A clinical investigation on minors may be conducted only where, in addition to the conditions set out in Article 62(4), all of the following conditions are met:
除第62条第（4）款规定的条件外，还符合以下所有条件时，才能对未成年人进行临床调查：
the informed consent of their legally designated representative has been obtained;
已获得其法定指定代理人的知情同意;
the minors have received the information referred to in Article 63(2) in a way adapted to their age and mental maturity and from investigators or members of the investigating team who are trained or experienced in working with children;
未成年人以适合其年龄和心智成熟度的方式，以及从受过儿童工作培训或有经验的调查人员或调查组成员那里获得第63条第（2）款所述的信息;
the explicit wish of a minor who is capable of forming an opinion and assessing the information referred to in Article 63(2) to refuse participation in, or to withdraw from, the clinical investigation at any time, is respected by the investigator;
能够形成意见并评估第 63 条第 （2） 款所述信息的未成年人随时拒绝参与或退出临床调查的明确意愿，得到研究者的尊重;
no incentives or financial inducements are given to the subject or his or her legally designated representative except for compensation for expenses and loss of earnings directly related to the participation in the clinical investigation;
除了对与参与临床研究直接相关的费用和收入损失的补偿外，不给予受试者或其合法指定代表任何奖励或经济诱因;
the clinical investigation is intended to investigate treatments for a medical condition that only occurs in minors or the clinical investigation is essential with respect to minors to validate data obtained in clinical investigations on persons able to give informed consent or by other research methods;
临床调查旨在调查仅发生在未成年人身上的医疗状况的治疗方法，或者对未成年人进行临床调查是必不可少的，以验证在临床调查中获得的数据，这些数据涉及能够给予知情同意的人或其他研究方法;
the clinical investigation either relates directly to a medical condition from which the minor concerned suffers or is of such a nature that it can only be carried out on minors;
临床调查要么与有关未成年人所患的医疗状况直接相关，要么具有只能对未成年人进行的性质;
there are scientific grounds for expecting that participation in the clinical investigation will produce a direct benefit to the minor subject outweighing the risks and burdens involved;
有科学依据可以预期，参与临床研究将对未成年受试者产生直接益处，超过所涉及的风险和负担;
the minor shall take part in the informed consent procedure in a way adapted to his or her age and mental maturity;
未成年人应以适合其年龄和心智成熟度的方式参加知情同意程序;
if during a clinical investigation the minor reaches the age of legal competence to give informed consent as defined in national law, his or her express informed consent shall be obtained before that subject can continue to participate in the clinical investigation.
如果在临床调查期间，未成年人达到国家法律规定的给予知情同意的法律行为能力年龄，则应在该受试者继续参与临床调查之前获得他或她的明确知情同意。
Article 66 第六十六条
Clinical investigations on pregnant or breastfeeding women
孕妇或哺乳期妇女的临床研究
A clinical investigation on pregnant or breastfeeding women may be conducted only where, in addition to the conditions set out in Article 62(4), all of the following conditions are met:
只有在除第62条第（4）款规定的条件外，还满足以下所有条件的情况下，才能对孕妇或哺乳期妇女进行临床调查：
the clinical investigation has the potential to produce a direct benefit for the pregnant or breastfeeding woman concerned, or her embryo, foetus or child after birth, outweighing the risks and burdens involved;
临床研究有可能为有关孕妇或哺乳期妇女，或其胚胎、胎儿或出生后的孩子带来直接益处，超过所涉及的风险和负担;
where research is undertaken on breastfeeding women, particular care is taken to avoid any adverse impact on the health of the child;
在对母乳喂养妇女进行研究时，应特别注意避免对儿童健康产生任何不利影响;
no incentives or financial inducements are given to the subject except for compensation for expenses and loss of earnings directly related to the participation in the clinical investigation.
除了对与参与临床研究直接相关的费用和收入损失的补偿外，没有给予受试者任何激励或经济诱因。
Article 67 第六十七条
Additional national measures
其他国家措施
Member States may maintain additional measures regarding persons performing mandatory military service, persons deprived of liberty, persons who, due to a judicial decision, cannot take part in clinical investigations, or persons in residential care institutions.
会员国可以对服义务兵役的人、被剥夺自由的人、因司法决定而不能参加临床调查的人或寄宿照料机构的人采取额外措施。
Article 68 第六十八条
Clinical investigations in emergency situations
紧急情况下的临床检查
By way of derogation from point (f) of Article 62(4), from points (a) and (b) of Article 64(1) and from points (a) and (b) of Article 65, informed consent to participate in a clinical investigation may be obtained, and information on the clinical investigation may be given, after the decision to include the subject in the clinical investigation, provided that that decision is taken at the time of the first intervention on the subject, in accordance with the clinical investigation plan for that clinical investigation and that all of the following conditions are fulfilled:
due to the urgency of the situation, caused by a sudden life-threatening or other sudden serious medical condition, the subject is unable to provide prior informed consent and to receive prior information on the clinical investigation;
由于情况紧急，由突发危及生命或其他突发严重医疗状况引起，受试者无法提供事先知情同意书并获得有关临床研究的事先信息;
there are scientific grounds to expect that participation of the subject in the clinical investigation will have the potential to produce a direct clinically relevant benefit for the subject resulting in a measurable health-related improvement alleviating the suffering and/or improving the health of the subject, or in the diagnosis of its condition;
有科学依据可以预期，受试者参与临床研究将有可能为受试者产生直接的临床相关益处，从而产生可衡量的与健康相关的改善，减轻受试者的痛苦和/或改善其健康状况，或诊断其病情;
it is not possible within the therapeutic window to supply all prior information to and obtain prior informed consent from his or her legally designated representative;
在治疗窗口内，不可能向其法定指定代表提供所有事先信息并获得其事先知情同意;
the investigator certifies that he or she is not aware of any objections to participate in the clinical investigation previously expressed by the subject;
研究者证明他或她不知道受试者先前表达的任何参与临床研究的反对意见;
the clinical investigation relates directly to the subject's medical condition because of which it is not possible within the therapeutic window to obtain prior informed consent from the subject or from his or her legally designated representative and to supply prior information, and the clinical investigation is of such a nature that it may be conducted exclusively in emergency situations;
临床调查与受试者的医疗状况直接相关，因此在治疗窗口内不可能获得受试者或其法定代表的事先知情同意并提供事先信息，并且临床调查的性质可以仅在紧急情况下进行;
the clinical investigation poses a minimal risk to, and imposes a minimal burden on, the subject in comparison with the standard treatment of the subject's condition.
与受试者病情的标准治疗相比，临床研究对受试者构成的风险最小，对受试者施加的负担最小。
1. 通过减损第62条第（4）款（f）项、第64条第（1）款（a）项和（b）项以及第65条（a）和（b）项，在决定将受试者纳入临床研究后，可以获得参与临床研究的知情同意，并提供有关临床研究的信息， 前提是该决定是在对受试者进行首次干预时根据该临床研究的临床研究计划做出的，并且满足以下所有条件：
Following an intervention pursuant to paragraph 1 of this Article, informed consent in accordance with Article 63 shall be sought to continue the participation of the subject in the clinical investigation, and information on the clinical investigation shall be given, in accordance with the following requirements:
regarding incapacitated subjects and minors, the informed consent shall be sought by the investigator from his or her legally designated representative without undue delay and the information referred to in Article 63(2) shall be given as soon as possible to the subject and to his or her legally designated representative;
对于无行为能力的受试者和未成年人，研究者应立即征求其法定代理人的知情同意，并应尽快将第六十三条第（二）款所述的信息提供给受试者及其法定指定代理人;
regarding other subjects, the informed consent shall be sought by the investigator without undue delay from the subject or his or her legally designated representative, whichever can be done sooner, and the information referred to in Article 63(2) shall be given as soon as possible to the subject or his or her legally designated representative, as applicable.
对于其他受试者，研究者应立即向受试者或其法定指定代表征得知情同意，以较早者为准，并应尽快将第 63 条第 （2） 款所述信息提供给受试者或其法定指定代表， 如适用。
二、在根据本条第一款进行干预后，应根据第六十三条寻求知情同意，以继续受试者参与临床调查，并应根据下列要求提供有关临床调查的信息：
For the purposes of point (b) where informed consent has been obtained from the legally designated representative, informed consent to continue the participation in the clinical investigation shall be obtained from the subject as soon as he or she is capable of giving informed consent.
就 （b） 点而言，如果已获得法定指定代表的知情同意，则应在受试者有能力给予知情同意后立即获得受试者继续参与临床研究的知情同意。
3. 如果受试者或其法定代表（如适用）不同意，则应告知他或她有权反对使用从临床调查中获得的数据。
Article 69 第六十九条
Damage compensation 损害赔偿
1. 成员国应确保以保险、担保或类似安排的形式，对受试者因参与在其领土上进行的临床调查而遭受的任何损害进行赔偿，并与其目的相等，并适合风险的性质和程度。
2. 申办者和研究者应以适合进行临床研究的成员国的形式使用第 1 款所述的系统。
Article 70 第七十条
Application for clinical investigations
临床研究申请
一、临床研究的发起人应向进行临床研究的成员国（在本条中称为“有关成员国”）提交申请，并附上附件十五第二章所述的文件。
The application shall be submitted by means of the electronic system referred to in Article 73, which shall generate a Union-wide unique single identification number for the clinical investigation, which shall be used for all relevant communication in relation to that clinical investigation. Within 10 days of it receiving the application, the Member State concerned shall notify the sponsor as to whether the clinical investigation falls within the scope of this Regulation and as to whether the application dossier is complete in accordance with Chapter II of Annex XV.
申请应通过第73条所述的电子系统提交，该系统应为临床研究生成一个全联盟唯一的单一识别号，该识别号应用于与该临床研究有关的所有相关通信。在收到申请后10天内，有关成员国应通知申办者临床研究是否属于本条例的范围，以及申请档案是否符合附件XV第二章的规定。
2. 在附件十五第二章所述文件发生任何变更后一周内，保荐人应更新第七十三条所述电子系统中的相关数据，并使该变更清晰可辨。应通过该电子系统将最新情况通知有关会员国。
三、有关成员国认为申请的临床研究不属于本条例范围或者申请档案不完整的，应当通知申办者，并规定申办者通过第七十三条所述电子系统发表意见或完成申请的时限不超过10天。有关会员国可酌情将这一期限延长至多20天。
Where the sponsor has not provided comments nor completed the application within the time limit referred to in the first subparagraph, the application shall be deemed to have lapsed. Where the sponsor considers the application does fall under the scope of this Regulation and/or is complete but the Member State concerned does not, the application shall be considered to have been rejected. The Member State concerned shall provide for an appeal procedure in respect of such refusal.
保荐人未在第一项规定的期限内提出意见或者未完成申请的，视为申请失效。如果发起人认为申请确实属于本条例的范围和/或完整，但有关成员国没有，则该申请应被视为已被驳回。有关会员国应规定对这种驳回的上诉程序。
The Member State concerned shall notify the sponsor within five days of receipt of the comments or of the requested additional information, whether the clinical investigation is considered as falling within the scope of this Regulation and the application is complete.
有关成员国应在收到意见或所要求的额外信息后五天内通知申办者，临床研究是否被视为属于本法规的范围，以及申请是否完成。
4. 有关会员国也可将第1款和第3款所述期限各延长五天。
五、就本章而言，根据第1款或第3款通知担保人的日期为申请的生效日期。未通知保荐人的，确认日期应分别为第1款、第3款和第4款所述期限的最后一天。
6. 在评估申请期间，成员国可以要求担保人提供补充资料。第7款（b）项规定的期限届满应自第一次请求之日起暂停，直至收到补充资料为止。
The sponsor may start the clinical investigation in the following circumstances:
in the case of investigational class I devices or in the case of non-invasive class IIa and class IIb devices, unless otherwise stated by national law, immediately after the validation date of the application pursuant to paragraph 5, and provided that a negative opinion which is valid for the entire Member State, under national law, has not been issued by an ethics committee in the Member State concerned in respect of the clinical investigation;
对于研究性 I 类器械或非侵入性 IIa 类和 IIb 类器械，除非国家法律另有规定，否则在根据第 5 款的申请生效日期后立即进行，并且根据国内法对整个成员国有效的否定意见，相关成员国的伦理委员会尚未就临床研究发表否定意见;
in the case of investigational devices, other than those referred to in point (a), as soon as the Member State concerned has notified the sponsor of its authorisation, and provided that a negative opinion which is valid for the entire Member State, under national law, has not been issued by an ethics committee in the Member State concerned in respect of the clinical investigation. The Member State shall notify the sponsor of the authorisation within 45 days of the validation date referred to in paragraph 5. The Member State may extend this period by a further 20 days for the purpose of consulting with experts.
对于研究器械，除（a）点所述的器械外，一旦有关成员国已将其授权通知申办者，并且根据国内法对整个成员国有效的否定意见，则相关成员国的伦理委员会尚未就临床研究发表否定意见。成员国应在第5款所述生效日期后45天内将授权通知发起人。会员国可将这一期限再延长20天，以便与专家进行磋商。
7.申办者在下列情况下可以启动临床研究：
8. 委员会有权根据第115条通过授权法案，根据技术进步和全球监管发展，修订附件十五第二章规定的要求。
9. 为确保统一适用附件十五第二章规定的要求，委员会可在必要的范围内通过执行法案，以解决不同的解释和实际应用问题。实施法案应按照第114条第（3）款所述的审查程序通过。
Article 71 第七十一条
Assessment by Member States
会员国的评估
1. 成员国应确保验证和评估申请或决定申请的人员没有利益冲突，独立于申办者、相关研究者以及资助临床研究的自然人或法人，并且不受任何其他不当影响。
2. 会员国应确保由适当数量的集体具备必要资格和经验的人员共同进行评估。
Member States shall assess whether the clinical investigation is designed in such a way that potential remaining risks to subjects or third persons, after risk minimization, are justified, when weighed against the clinical benefits to be expected. They shall, while taking into account applicable CS or harmonised standards, examine in particular:
the demonstration of compliance of the investigational device(s) with the applicable general safety and performance requirements, apart from the aspects covered by the clinical investigation, and whether, with regard to those aspects, every precaution has been taken to protect the health and safety of the subjects. This includes, where appropriate, assurance of technical and biological safety testing and pre-clinical evaluation;
除了临床研究涵盖的方面外，研究设备是否符合适用的一般安全和性能要求，以及在这些方面是否采取了一切预防措施来保护受试者的健康和安全。这包括在适当情况下保证技术和生物安全测试以及临床前评估;
whether the risk-minimisation solutions employed by the sponsor are described in harmonised standards and, in those cases where the sponsor does not use harmonised standards, whether the risk-minimisation solutions provide a level of protection that is equivalent to that provided by harmonised standards;
保荐人采用的风险最小化解决方案是否在统一标准中描述，在保荐人不使用统一标准的情况下，风险最小化解决方案是否提供与协调标准提供的保护水平相当的保护;
whether the measures planned for the safe installation, putting into service and maintenance of the investigational device are adequate;
为安全安装、投入使用和维护研究设备而计划的措施是否充分;
the reliability and robustness of the data generated in the clinical investigation, taking account of statistical approaches, design of the investigation and methodological aspects, including sample size, comparator and endpoints;
临床研究中产生的数据的可靠性和稳健性，同时考虑统计方法、调查设计和方法学方面，包括样本量、比较对象和终点;
whether the requirements of Annex XV are met;
是否符合附件十五的要求;
in the case of devices for sterile use, evidence of the validation of the manufacturer's sterilisation procedures or information on the reconditioning and sterilisation procedures which have to be conducted by the investigation site;
如属无菌用器械，须提供制造商的灭菌程序验证的证据，或调查现场必须进行的翻新及灭菌程序资料;
the demonstration of the safety, quality and usefulness of any components of animal or human origin or of substances, which may be considered medicinal products in accordance with Directive 2001/83/EC.
证明任何动物或人类来源的成分或物质的安全性、质量和有用性，根据指令 2001/83/EC，这些成分可被视为医药产品。
3. 成员国应评估临床研究的设计方式，即在风险最小化后，在权衡预期的临床益处时，对受试者或第三人的潜在剩余风险是合理的。在考虑适用的CS或协调标准的同时，他们应特别审查：
Member States shall refuse the authorisation of the clinical investigation if:
the application dossier submitted pursuant to Article 70(1) remains incomplete;
根据第70条第（1）款提交的申请档案仍然不完整;
the device or the submitted documents, especially the investigation plan and the investigator's brochure, do not correspond to the state of scientific knowledge, and the clinical investigation, in particular, is not suitable for providing evidence for the safety, performance characteristics or benefit of the device on subjects or patients,
设备或提交的文件，尤其是调查计划和研究者手册，与科学知识状态不符，尤其是临床研究不适合为设备对受试者或患者的安全性、性能特征或益处提供证据，
the requirements of Article 62 are not met, or
不符合第 62 条的要求，或
any assessment under paragraph 3 is negative.
根据第3款作出的任何评估都是否定的。
4. 在下列情况下，成员国应拒绝对临床研究的授权：
Member States shall provide for an appeal procedure in respect of a refusal pursuant to the first subparagraph.
会员国应规定对根据第一项提出的驳回的上诉程序。
Article 72 第七十二条
Conduct of a clinical investigation
进行临床调查
1. 申办者和研究者应确保临床研究按照批准的临床研究计划进行。
In order to verify that the rights, safety and well-being of subjects are protected, that the reported data are reliable and robust, and that the conduct of the clinical investigation is in compliance with the requirements of this Regulation, the sponsor shall ensure adequate monitoring of the conduct of a clinical investigation. The extent and nature of the monitoring shall be determined by the sponsor on the basis of an assessment that takes into consideration all characteristics of the clinical investigation including the following:
the objective and methodology of the clinical investigation; and
临床研究的目标和方法;和
the degree of deviation of the intervention from normal clinical practice.
干预与正常临床实践的偏差程度。
2. 为了验证受试者的权利、安全和福祉得到保护，报告的数据是否可靠和可靠，以及临床研究的进行是否符合本法规的要求，申办者应确保对临床研究的进行进行充分监测。监测的范围和性质应由申办者根据评估确定，该评估应考虑临床研究的所有特征，包括以下内容：
3. 所有临床研究信息均应由申办者或研究者（如适用）记录、处理、处理和存储，以便准确报告、解释和验证，同时根据适用的个人数据保护法律保护记录和受试者的个人数据的机密性。
4. 应采取适当的技术和组织措施，以保护所处理的信息和个人数据免遭未经授权或非法的访问、披露、传播、更改、破坏或意外丢失，尤其是在处理涉及通过网络传输的情况下。
5. 成员国应在适当级别视察调查地点，以检查临床研究是否按照本条例的要求和批准的调查计划进行。
6. 发起人应建立紧急情况程序，以便能够立即识别并在必要时立即召回调查中使用的设备。
Article 73 第七十三条
Electronic system on clinical investigations
临床研究电子系统
The Commission shall, in collaboration with the Member States, set up, manage and maintain an electronic system:
to create the single identification numbers for clinical investigations referred to in Article 70(1);
为第70条第（1）款所述的临床研究创建单一识别号;
to be used as an entry point for the submission of all applications or notifications for clinical investigations referred to in Articles 70, 74, 75 and 78 and for all other submission of data, or processing of data in this context;
用作提交第70条、第74条、第75条和第78条所述临床研究的所有申请或通知的切入点，以及所有其他数据提交或在此背景下处理数据的切入点;
for the exchange of information relating to clinical investigations in accordance with this Regulation between the Member States and between them and the Commission including the exchange of information referred to in Articles 70 and 76;
根据本条例，成员国之间以及成员国与委员会之间交流与临床研究有关的信息，包括第70条和第76条所述的信息交流;
for information to be provided by the sponsor in accordance with Article 77, including the clinical investigation report and its summary as required in paragraph 5 of that Article;
申办者根据第77条提供的信息，包括该条第5款要求的临床研究报告及其摘要;
for reporting on serious adverse events and device deficiencies and related updates referred to in Article 80.
报告第80条所述的严重不良事件和设备缺陷以及相关更新。
1. 委员会应与成员国合作，建立、管理和维护电子系统：
2. 在建立本条第1款所述的电子系统时，委员会应确保其与根据欧洲议会和理事会第536/2014号条例（EU）第81条建立的人用医药临床试验的欧盟数据库具有互操作性（4），涉及器械的临床研究与该法规下的临床试验相结合。
The information referred to in point (c) of paragraph 1 shall only be accessible to the Member States and the Commission. The information referred to in the other points of that paragraph shall be accessible to the public, unless, for all or parts of that information, confidentiality of the information is justified on any of the following grounds:
protection of personal data in accordance with Regulation (EC) No 45/2001;
根据第 45/2001 号条例 （EC） 保护个人数据;
protection of commercially confidential information, especially in the investigators brochure, in particular through taking into account the status of the conformity assessment for the device, unless there is an overriding public interest in disclosure;
保护商业机密信息，特别是在研究者手册中，特别是通过考虑器械合格评定的状态，除非披露有压倒一切的公共利益;
effective supervision of the conduct of the clinical investigation by the Member State(s) concerned.
有效监督有关成员国开展临床研究。
3. 第1款（c）项所述的信息只有成员国和委员会才能获得。该款其他各点所指的信息应向公众开放，除非该信息的全部或部分基于以下任何理由证明该信息的机密性是合理的：
4. 不得公开受试者的个人数据。
5. 第1款所指的电子系统的用户界面应以本联盟所有正式语文提供。
Article 74 第七十四条
Clinical investigations regarding devices bearing the CE marking
带有CE标志的器械的临床研究
1. 如果要进行临床调查，以便在其预期目的范围内进一步评估已经根据第 20 条第 （1） 款带有 CE 标志的器械（“PMCF 调查”），并且调查将涉及将受试者置于在该器械正常使用条件下执行的程序之外的程序，并且这些附加程序是侵入性的或繁琐的， 发起人应至少在开始前30天通过第七十三条所述的电子系统通知有关成员国。保荐人应将附件十五第二章中提到的文件作为通知的一部分。第62条第（4）款第（b）至（k）和（m）项►C1点，第75条、第76条和第77条，第80条第（5）款和第（6）款，以及附件十五的有关规定◄应适用于PMCF的调查。
2. 如果根据第20条第（1）款的规定，已经带有CE标志的器械在其预期目的范围之外进行临床调查，则应适用第62条至第81条。
Article 75 第七十五条
Substantial modifications to clinical investigations
对临床研究进行重大修改
1. 如果申办者打算对临床研究进行修改，而这些修改可能对受试者的安全、健康或权利或研究产生的临床数据的稳健性或可靠性产生重大影响，则应在一周内通过第 73 条所述的电子系统通知正在或将要进行临床研究的成员国这些修改的原因和性质为何。作为通知的一部分，发起人应包括附件十五第二章所述相关文件的更新版本。对相关文件的更改应清晰可辨。
二、成员国应按照第七十一条规定的程序，对临床研究进行任何重大修改。
The sponsor may implement the modifications referred to in paragraph 1 at the earliest 38 days after the notification referred to in that paragraph, unless:
the Member State in which the clinical investigation is being or is to be conducted has notified the sponsor of its refusal based on the grounds referred to in Article 71(4) or on considerations of public health, subject and user safety or health, of public policy, or
正在或将要进行临床研究的成员国已根据第71条第（4）款所述的理由或基于公共卫生、受试者和用户安全或健康、公共政策的考虑通知申办者拒绝，或
an ethics committee in that Member State has issued a negative opinion in relation to the substantial modification to the clinical investigation, which, in accordance with national law, is valid for that entire Member State.
该成员国的伦理委员会对临床研究的重大修改发表了否定意见，根据国家法律，该修改对整个成员国有效。
3. 保荐人最早可在收到第1款所述通知后38天内实施该款所述的修改，除非：
4. 有关会员国可将第3款所述期限再延长7天，以便与专家进行磋商。
Article 76 第七十六条
Corrective measures to be taken by Member States and information exchange between Member States
会员国应采取的纠正措施和会员国之间的信息交流
Where a Member State in which a clinical investigation is being or is to be conducted has grounds for considering that the requirements set out in this Regulation are not met, it may take at least any of the following measures on its territory:
revoke the authorisation for the clinical investigation;
撤销临床研究授权;
suspend or terminate the clinical investigation;
暂停或终止临床研究;
require the sponsor to modify any aspect of the clinical investigation.
要求申办者修改临床研究的任何方面。
1. 如果正在或将要进行临床研究的成员国有理由认为不符合本条例规定的要求，则该成员国可在其领土上至少采取以下任何措施：
2. 有关会员国在采取第1款所述任何措施之前，除需要立即采取行动外，应征求保荐人或调查员或两者的意见。该意见应在七天内提出。
三、如果成员国已采取本条第1款所述措施或拒绝进行临床研究，或已收到申办者以安全为由提前终止临床研究的通知，则该成员国应通过第73条所述的电子系统将相应的决定及其理由通知所有成员国和委员会。
4. 如果提案国在成员国作出决定之前撤回申请，则应通过第七十三条所述的电子系统向所有成员国和委员会提供该信息。
Article 77 第七十七条
Information from the sponsor at the end of a clinical investigation or in the event of a temporary halt or early termination
申办者在临床研究结束时或暂时停止或提前终止时提供的信息
一、申办者暂时停止或提前终止临床研究的，应当在15日内通过第七十三条所指的电子系统，将暂时停止或者提前终止的情况通知临床研究暂时停止或提前终止的成员国，并说明理由。如果申办者出于安全原因暂时停止或提前终止临床研究，应在24小时内通知正在进行临床研究的所有成员国。
2. 临床研究的结束应被视为与最后一名受试者的最后一次就诊相吻合，除非临床研究计划中规定了该结束的另一个时间点。
3. 申办者应将该临床研究在该成员国的临床研究结束通知正在进行临床研究的每个成员国。该通知应在与该成员国有关的临床研究结束后15天内发出。
4. 如果一项研究在一个以上的成员国进行，申办者应将该临床研究在所有成员国的临床研究结束通知进行该临床研究的所有成员国。该通知应在临床研究结束后 15 天内发出。
5. 无论临床研究结果如何，申办者应在临床研究结束后一年内或提前终止或暂时停止后三个月内，向进行临床研究的成员国提交附件十五第一章第2.8节和第三章第7节所述的临床研究报告。
The clinical investigation report shall be accompanied by a summary presented in terms that are easily understandable to the intended user. Both the report and summary shall be submitted by the sponsor by means of the electronic system referred to in Article 73.
临床研究报告应附有以预期用户易于理解的术语呈现的摘要。报告和摘要均应由保荐人通过第七十三条所述的电子系统提交。
Where, for scientific reasons, it is not possible to submit the clinical investigation report within one year of the end of the investigation, it shall be submitted as soon as it is available. In such case, the clinical investigation plan referred to in Section 3 of Chapter II of Annex XV shall specify when the results of the clinical investigation are going to be available, together with a justification.
因科学原因不能在研究结束后一年内提交临床研究报告的，应当尽快提交。在这种情况下，附件十五第二章第3节所指的临床研究计划应具体说明何时提供临床研究结果，并说明理由。
6. 委员会应发布关于临床研究报告摘要的内容和结构的指南。
In addition, the Commission may issue guidelines for the formatting and sharing of raw data, for cases where the sponsor decides to share raw data on a voluntary basis. Those guidelines may take as a basis and adapt, where possible, existing guidelines for sharing of raw data in the field of clinical investigations.
此外，对于发起人决定在自愿基础上共享原始数据的情况，委员会可以发布原始数据的格式和共享指南。这些指南可以作为基础，并在可能的情况下调整现有的临床研究领域原始数据共享指南。
七、本条第五款所指的摘要和临床研究报告，最迟应在器械依照第二十九条注册之时及投放市场前，通过第七十三条所指的电子系统向公众公开。在提早终止或暂时中止的情况下，摘要和报告应在提交后立即向公众开放。
If the device is not registered in accordance with Article 29 within one year of the summary and the report having been entered into the electronic system pursuant to paragraph 5 of this Article, they shall become publicly accessible at that point in time.
如果该设备在摘要后一年内未根据第29条进行注册，并且报告已根据本条第5款输入电子系统，则该设备应在该时间点向公众开放。
Article 78 第七十八条
Coordinated assessment procedure for clinical investigations
临床研究的协调评估程序
1. 通过第七十三条所述的电子系统，为第七十条的目的，在一个以上成员国进行的临床研究的发起人可以提交一份申请，该申请在收到后以电子方式传送给将要进行临床研究的所有成员国。
2. 申办者应在第 1 款所述的单一申请中提议，将进行临床研究的成员国之一作为协调成员国。进行临床研究的成员国应在提交申请后六天内同意由其中一人担任协调成员国。如果它们不能就协调会员国达成一致，则由提案国提议的协调会员国承担这一角色。
3. 在第2款所述协调成员国的指导下，有关成员国应协调其对申请的评估，特别是对附件十五第二章所述文件的评估。
However, the completeness of the documentation referred to in Sections 1.13, 3.1.3, 4.2, 4.3 and 4.4 of Chapter II of Annex XV shall be assessed separately by each Member State concerned in accordance with Article 70(1) to (5).
但是，附件十五第二章第1.13、3.1.3、4.2、4.3和4.4节所述文件的完整性应由各有关成员国根据第70条第（1）款至第（5）款分别评估。
With regard to documentation other than that referred to in the second subparagraph of paragraph 3, the coordinating Member State shall:
within six days of receipt of the single application, notify the sponsor that it is the coordinating Member State (‘notification date’);
在收到单一申请后六天内，通知发起人其为协调成员国（“通知日期”）;
for the purpose of the validation of the application, take into account any considerations submitted within seven days of the notification date by any Member State concerned;
为了验证申请，考虑任何有关成员国在通知日期后七天内提出的任何考虑;
within 10 days of the notification date, assess whether the clinical investigation falls within the scope of this Regulation and whether the application is complete, and shall notify the sponsor accordingly. Article 70(1) and (3) to (5) shall apply to the coordinating Member State in relation to that assessment;
自通知之日起10日内，评估临床研究是否属于本规程范围，申请是否完成，并据此通知申办者。第70条第（1）款和第（3）款至第（5）款应适用于与该评估有关的协调成员国;
establish the results of its assessment in a draft assessment report to be transmitted within 26 days of the validation date to the Member States concerned. By day 38 after the validation date, the other Member States concerned shall transmit their comments and proposals on the draft assessment report and the underlying application to the coordinating Member State which shall take due account of those comments and proposals in its finalisation of the final assessment report, to be transmitted within 45 days of the validation date to the sponsor and the other Member States concerned.
在评估报告草案中确定其评估结果，并在审定日期后26天内转交有关会员国。在审定日期后第38天，其他有关会员国应将其对评估报告草案和相关申请的评论意见和建议转交协调会员国，协调会员国在定稿最后评估报告时应适当考虑这些意见和建议，并在审定日期后45天内转交提案国和其他有关会员国。
4. 对于第3款第2项所指文件以外的文件，协调会员国应：
The final assessment report shall be taken into account by all Member States concerned when deciding on the sponsor's application in accordance with Article 70(7).
根据第70条第（7）款，在决定担保人的申请时，所有有关成员国都应考虑最终评估报告。
5. 关于对第3款第2项所述文件的评估，各有关会员国可一次性要求提案国提供补充资料。提案国应在有关成员国规定的期限内提交所要求的补充资料，该期限不得超过收到请求之日起12天。根据第4款（d）项规定的最后期限届满，应自请求之日起暂停，直至收到补充资料为止。
6. 对于IIb类和III类器械，协调成员国也可将第4款所述期限再延长50天，以便与专家进行磋商。
7. 委员会可通过实施法案，进一步规定有关会员国在决定保荐人的申请时应考虑的协调评估的程序和时限。这些实施行为还可以规定在根据本条第12款进行重大修改的情况下，在根据第80条第（4）款报告不良事件的情况下，在医疗器械和医药产品之间的组合产品进行临床研究的情况下，进行协调评估的程序和时限。 后者正在根据 （EU） No 536/2014 条例同时对临床试验进行协调评估。实施法案应按照第114条第（3）款所述的审查程序通过。
8. 如果协调成员国关于协调评估领域的结论是，在符合具体条件的情况下，临床调查的进行是可以接受的或可以接受的，则该结论应视为所有有关成员国的结论。
Notwithstanding the first subparagraph, a Member State concerned may only disagree with the conclusion of the coordinating Member State concerning the area of coordinated assessment on the following grounds:
尽管有第1项的规定，有关会员国只能基于以下理由不同意协调会员国关于协调评估领域的结论：
when it considers that participation in the clinical investigation would lead to a subject receiving treatment inferior to that received in normal clinical practice in that Member State concerned;
当它认为参与临床研究将导致受试者接受的治疗不如在有关成员国的正常临床实践中接受的治疗时;
infringement of national law; or
违反国家法律;或
considerations as regards subject safety and data reliability and robustness submitted under point (d) of paragraph 4.
根据第4段（d）点提交的关于主题安全性和数据可靠性和稳健性的考虑。
Where one of the Member States concerned disagrees with the conclusion on the basis of the second subparagraph of this paragraph, it shall communicate its disagreement, together with a detailed justification, through the electronic system referred to in Article 73, to the Commission, to all other Member States concerned and to the sponsor.
如果有关会员国之一不同意根据本款第二项得出的结论，它应通过第七十三条所述的电子系统将其不同意并详细说明，通知委员会、所有其他有关会员国和提案国。
9. 如果协调成员国关于协调评估领域的结论是临床研究不可接受，则该结论应视为所有有关成员国的结论。
10. 如果有关成员国不同意协调成员国关于第8款第2项所述任何理由的结论，或根据正当理由认为附件十五第二章第1.13、3.1.3、4.2、4.3和4.4节所述的方面没有得到遵守，则应拒绝批准进行临床研究， 或者伦理委员会对该临床研究发表了否定意见，根据国家法律，该意见对整个成员国有效。该会员国应规定对这种拒绝的上诉程序。
11. 各有关成员国应通过第73条所述的电子系统通知申办者，说明临床研究是否获得授权、是否在有条件的情况下获得授权或授权是否被拒绝。根据第4款（d）点的规定，协调会员国应在转交最后评估报告后五天内以单一决定的方式进行通知。如果临床研究的授权受条件限制，则这些条件只能是就其性质而言，在获得授权时无法满足。
12. 第75条所指的任何重大修改，应通过第73条所指的电子系统通知有关成员国。对本条第8款第2项所述是否存在不同意见的理由的任何评估，均应在协调成员国的指导下进行，但对附件十五第二章第1.13、3.1.3、4.2、4.3和4.4节的重大修改除外，应由各有关成员国分别评估。
13. 委员会应为协调会员国完成本章规定的任务提供行政支持。
14. 在2027年5月25日之前，本条规定的程序应仅由拟进行临床研究并同意适用的成员国适用。自 2027 年 5 月 26 日起，所有会员国都必须适用这一程序。
Article 79 第七十九条
Review of coordinated assessment procedure
审查协调评估程序
By 27 May 2026, the Commission shall submit to the European Parliament and to the Council a report on experience gained from the application of Article 78 and, if necessary, propose a review of Article 78(14) and point (h) of Article 123(3).
在2026年5月27日之前，委员会应向欧洲议会和理事会提交一份关于从第78条的适用中获得的经验的报告，并在必要时提出对第78条第（14）款和第123条第（3）款（h）项的审查。
Article 80 第八十条
Recording and reporting of adverse events that occur during clinical investigations
记录和报告临床研究期间发生的不良事件
The sponsor shall fully record all of the following:
any adverse event of a type identified in the clinical investigation plan as being critical to the evaluation of the results of that clinical investigation;
临床研究计划中确定的对评估该临床研究结果至关重要的任何不良事件;
any serious adverse event;
任何严重的不良事件;
any device deficiency that might have led to a serious adverse event if appropriate action had not been taken, intervention had not occurred, or circumstances had been less fortunate;
如果没有采取适当的行动、没有进行干预或情况不那么幸运，可能导致严重不良事件的任何设备缺陷;
any new findings in relation to any event referred to in points (a) to (c).
与（a）至（c）点所述任何事件有关的任何新发现。
1. 主办方应完整记录以下所有内容：
The sponsor shall report, without delay to all Member States in which the clinical investigation is being conducted, all of the following by means of the electronic system referred to in Article 73:
any serious adverse event that has a causal relationship with the investigational device, the comparator or the investigation procedure or where such causal relationship is reasonably possible;
任何与研究设备、比较器或调查程序有因果关系的严重不良事件，或这种因果关系是合理的;
any device deficiency that might have led to a serious adverse event if appropriate action had not been taken, intervention had not occurred, or circumstances had been less fortunate;
如果没有采取适当的行动、没有进行干预或情况不那么幸运，可能导致严重不良事件的任何设备缺陷;
any new findings in relation to any event referred to in points (a) and (b).
与（a）和（b）点所述任何事件有关的任何新发现。
2. 申办者应毫不拖延地通过第73条所述的电子系统向进行临床研究的所有成员国报告以下所有情况：
The period for reporting shall take account of the severity of the event. Where necessary to ensure timely reporting, the sponsor may submit an initial report that is incomplete followed up by a complete report.
报告期限应考虑到事件的严重性。在必要时，为确保及时报告，保荐人可以提交一份不完整的初步报告，然后提交一份完整的报告。
Upon request by any Member State in which the clinical investigation is being conducted, the sponsor shall provide all information referred to in paragraph 1.
应进行临床研究的任何成员国的要求，申办者应提供第1款所述的所有信息。
三、申办者还应通过第七十三条所述的电子系统，向进行临床研究的成员国报告本条第2款所述在第三国发生的任何事件，这些事件是根据与适用于本条例所涵盖的临床研究的临床研究计划相同的临床研究计划进行的。
4.如果申办者使用了第78条所述的单一申请，则申办者应通过第73条所述的电子系统报告本条第2款所述的任何事件。收到报告后，应以电子方式传送给正在进行临床研究的所有成员国。
Under the direction of the coordinating Member State referred to in Article 78(2), the Member States shall coordinate their assessment of serious adverse events and device deficiencies to determine whether to modify, suspend or terminate the clinical investigation or whether to revoke the authorisation for that clinical investigation.
在第78条第（2）款所述的协调成员国的指导下，成员国应协调其对严重不良事件和器械缺陷的评估，以确定是否修改、暂停或终止临床研究，或是否撤销该临床研究的授权。
This paragraph shall not affect the rights of the other Member States to perform their own evaluation and to adopt measures in accordance with this Regulation in order to ensure the protection of public health and patient safety. The coordinating Member State and the Commission shall be kept informed of the outcome of any such evaluation and the adoption of any such measures.
本款不应影响其他成员国根据本条例进行自己的评估和采取措施以确保保护公众健康和患者安全的权利。应随时向协调会员国和委员会通报任何此类评估的结果和采取的任何此类措施。
5. 对于第74条第（1）款所述的PMCF调查，应适用第87条至第90条以及根据第91条通过的法案中关于警戒的规定，而不是本条。
6. 尽管有第5款的规定，本条应适用于严重不良事件与先前研究程序之间已确定因果关系的情况。
Article 81 第八十一条
Implementing acts 执行行为
The Commission may, by means of implementing acts, establish the detailed arrangements and procedural aspects necessary for the implementation of this Chapter as regards the following:
委员会可以通过执行法案，就下列事项制定执行本章所需的详细安排和程序方面：
harmonised electronic forms for the application for clinical investigations and their assessment as referred to in Articles 70 and 78, taking into account specific categories or groups of devices;
第70条和第78条所述的临床研究申请及其评估的统一电子表格，同时考虑到特定类别或组别的器械;
the functioning of the electronic system referred to in Article 73;
第73条所指电子系统的运作;
harmonised electronic forms for the notification of PMCF investigations as referred to in Article 74(1), and of substantial modifications as referred to in Article 75;
第74条第（1）款所述的PMCF调查通知以及第75条所述的重大修改的统一电子表格;
the exchange of information between Member States as referred to in Article 76;
第76条所指的成员国之间的信息交流;
harmonised electronic forms for the reporting of serious adverse events and device deficiencies as referred to in Article 80;
第80条所述的用于报告严重不良事件和设备缺陷的统一电子表格;
the timelines for the reporting of serious adverse events and device deficiencies, taking into account the severity of the event to be reported as referred to in Article 80;
报告严重不良事件和设备缺陷的时间表，同时考虑到第80条所述要报告的事件的严重程度;
uniform application of the requirements regarding the clinical evidence or data needed to demonstrate compliance with the general safety and performance requirements set out in Annex I.
统一应用有关临床证据或数据的要求，以证明符合附件I中规定的一般安全性和性能要求。
The implementing acts referred to in the first paragraph shall be adopted in accordance with the examination procedure referred to in Article 114(3).
第1款所指的实施行为应按照第114条第（3）款所述的审查程序通过。
Article 82 第八十二条
Requirements regarding other clinical investigations
关于其他临床检查的要求
1.非按照第62条第（1）款所列目的进行的临床研究，应符合第62条第（2）款和第（3）款第（b）、（c）、（d）、（f）、（h）、（l）项和第62条第（6）款的规定。
2. 为了保护受试者的权利、安全、尊严和福祉，以及非为第62条第（1）款所列目的而进行的临床研究的科学和伦理完整性，每个成员国应根据每个有关成员国的规定，对此类调查提出任何额外要求。
CHAPTER VII 第七章
POST-MARKET SURVEILLANCE, VIGILANCE AND MARKET SURVEILLANCE
上市后监督、警戒和市场监督
SECTION 1 第1节
Post-market surveillance
上市后监督
Article 83 第八十三条
Post-market surveillance system of the manufacturer
制造商的上市后监控系统
1. 对于每种器械，制造商应以与风险等级相称且适合器械类型的方式规划、建立、记录、实施、维护和更新上市后监督系统。该体系应是第10条第（9）款所述制造商质量管理体系的组成部分。
2. 上市后监督系统应适合于积极和系统地收集、记录和分析有关器械整个生命周期的质量、性能和安全性的相关数据，并得出必要的结论，并确定、实施和监测任何预防和纠正措施。
Data gathered by the manufacturer's post-market surveillance system shall in particular be used:
to update the benefit-risk determination and to improve the risk management as referred to in Chapter I of Annex I;
更新附件一第一章所述的惠益-风险确定并改进风险管理;
to update the design and manufacturing information, the instructions for use and the labelling;
更新设计和制造信息、使用说明和标签;
to update the clinical evaluation;
更新临床评估;
to update the summary of safety and clinical performance referred to in Article 32;
更新第32条所述的安全性和临床表现摘要;
for the identification of needs for preventive, corrective or field safety corrective action;
确定预防性、纠正性或现场安全纠正措施的需要;
for the identification of options to improve the usability, performance and safety of the device;
确定提高设备可用性、性能和安全性的选项;
when relevant, to contribute to the post-market surveillance of other devices; and
在相关情况下，为其他器械的上市后监督做出贡献;和
to detect and report trends in accordance with Article 88.
根据第88条发现和报告趋势。
3. 制造商上市后监督系统收集的数据尤其应用于：
The technical documentation shall be updated accordingly.
技术文档应相应更新。
4. 如果在上市后监督过程中发现需要采取预防或纠正措施，或两者兼而有之，制造商应采取适当措施，并通知有关主管当局，并在适用时通知机构。发现严重事故或者实施现场安全纠正措施的，应当按照第八十七条的规定进行报告。
Article 84 第八十四条
Post-market surveillance plan
上市后监督计划
The post-market surveillance system referred to in Article 83 shall be based on a post-market surveillance plan, the requirements for which are set out in
►C2
Section 1 of Annex III. ◄ For devices other than custom-made devices, the post-market surveillance plan shall be part of the technical documentation specified in Annex II.
第83条所指的上市后监督制度应以上市后监督计划为基础，其要求载于附件III第►C2节第1节。◄ 对于定制设备以外的设备，上市后监督计划应是附件 II 中规定的技术文件的一部分。
Article 85 第八十五条
Post-market surveillance report
上市后监督报告
Manufacturers of class I devices shall prepare a post-market surveillance report summarising the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan referred to in Article 84 together with a rationale and description of any preventive and corrective actions taken. The report shall be updated when necessary and made available to the competent authority upon request.
第一类器械制造商应准备一份上市后监督报告，总结根据第84条所述的上市后监督计划收集的上市后监督数据的分析结果和结论，并说明所采取的任何预防和纠正措施的理由和说明。报告应在必要时更新，并应要求向主管当局提供。
Article 86 第八十六条
Periodic safety update report
定期安全更新报告
Manufacturers of class IIa, class IIb and class III devices shall prepare a periodic safety update report (‘PSUR’) for each device and where relevant for each category or group of devices summarising the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan referred to in Article 84 together with a rationale and description of any preventive and corrective actions taken. Throughout the lifetime of the device concerned, that PSUR shall set out:
the conclusions of the benefit-risk determination;
收益-风险确定的结论;
the main findings of the PMCF; and
PMCF的主要发现;和
the volume of sales of the device and an estimate evaluation of the size and other characteristics of the population using the device and, where practicable, the usage frequency of the device.
设备的销售量，以及对使用该设备的人群的规模和其他特征的估计评估，以及在可行的情况下，设备的使用频率。
1. IIa类、IIb类和III类器械的制造商应为每一种器械以及每一类或每类器械（如与每类或每组器械相关）准备一份定期安全更新报告（“PSUR”），总结根据第84条所述上市后监督计划收集的上市后监督数据的分析结果和结论，以及所采取的任何预防和纠正措施的理由和说明。在相关设备的整个生命周期内，PSUR 应规定：
Manufacturers of class IIb and class III devices shall update the PSUR at least annually. That PSUR shall, except in the case of custom-made devices, be part of the technical documentation as specified in Annexes II and III.
IIb 类和 III 类器械的制造商应至少每年更新一次 PSUR。除定制设备外，PSUR应成为附件II和III中规定的技术文件的一部分。
Manufacturers of class IIa devices shall update the PSUR when necessary and at least every two years. That PSUR shall, except in the case of custom-made devices, be part of the technical documentation as specified in Annexes II and III.
IIa 类器械的制造商应在必要时至少每两年更新一次 PSUR。除定制设备外，PSUR应成为附件II和III中规定的技术文件的一部分。
For custom-made devices, the PSUR shall be part of the documentation referred to in Section 2 of Annex XIII.
对于定制设备，PSUR 应是附件 XIII 第 2 节中提到的文件的一部分。
2. 对于III类器械或植入式器械，制造商应通过第92条所述的电子系统向根据第52条参与合格评定的公告机构提交PSUR。公告机构应审查报告，并将其评估结果添加到该电子系统中，并详细说明所采取的任何行动。此类PSUR和公告机构的评估应通过该电子系统提供给主管当局。
3. 对于第2款所述器械以外的器械，制造商应向参与合格评定的指定机构提供PSUR，并应要求向主管当局提供PSUR。
SECTION 2 第2节
Vigilance 警惕
Article 87 第八十七条
Reporting of serious incidents and field safety corrective actions
报告严重事故和现场安全纠正措施
Manufacturers of devices made available on the Union market, other than investigational devices, shall report, to the relevant competent authorities, in accordance with Articles 92(5) and (7), the following:
any serious incident involving devices made available on the Union market, except expected side-effects which are clearly documented in the product information and quantified in the technical documentation and are subject to trend reporting pursuant to Article 88;
涉及在欧盟市场上销售的设备的任何严重事件，但产品信息中明确记录并在技术文件中量化并根据第 88 条进行趋势报告的预期副作用除外;
any field safety corrective action in respect of devices made available on the Union market, including any field safety corrective action undertaken in a third country in relation to a device which is also legally made available on the Union market, if the reason for the field safety corrective action is not limited to the device made available in the third country.
对在欧盟市场上提供的设备采取的任何现场安全纠正措施，包括在第三国就同样合法在欧盟市场上提供的设备采取的任何现场安全纠正措施，如果现场安全纠正措施的原因不限于在第三国提供的设备。
1. 除研究器械外，在欧盟市场上销售的器械制造商应根据第92条第（5）款和第（7）款向有关主管当局报告以下内容：
The reports referred to in the first subparagraph shall be submitted through the electronic system referred to in Article 92.
第1项所指的报告应通过第92条所指的电子系统提交。
2. 作为一般规则，第1款所指的报告期限应考虑到严重事件的严重性。
3. 制造商应在确定该事件与其设备之间的因果关系或这种因果关系是合理的后立即报告第 1 款 （a） 项所述的任何严重事件，并且不迟于他们意识到该事件后 15 天。
4. 尽管有第3款的规定，在发生严重公共卫生威胁时，应立即提供第1款所述的报告，且不得迟于制造商意识到该威胁后2天。
5. 尽管有第 3 款的规定，如果发生死亡或人员健康状况意外严重恶化，则应在制造商确定后立即提供报告，或在怀疑设备与严重事件之间存在因果关系时立即提供报告，但不得迟于制造商意识到严重事件之日起 10 天。
6. 在必要时，为确保及时报告，制造商可以提交一份不完整的初步报告，然后提交一份完整的报告。
7. 如果制造商在意识到可能应报告的事件后不确定该事件是否可报告，则仍应在第 2 款至第 5 款规定的时限内提交报告。
8. 除制造商需要立即采取现场安全纠正措施的紧急情况外，制造商应在采取现场安全纠正行动之前，不得无故拖延地报告第1款（b）点所述的现场安全纠正措施。
9. 对于同一设备或设备类型发生的类似严重事故，如果已经确定了根本原因或实施了现场安全纠正措施，或者事故很常见且有据可查，制造商可以提供定期总结报告，而不是个别严重事故报告，条件是第89条第（9）款所述的协调主管当局， 经与第92条第（8）款（a）项所述的主管当局协商，已与制造商就定期摘要报告的格式、内容和频率达成一致。如果第92条第（8）款（a）和（b）项提及单一主管当局，制造商可以在与该主管当局达成协议后提供定期摘要报告。
10. 会员国应采取适当措施，例如组织有针对性的宣传活动，鼓励和帮助卫生保健专业人员、用户和患者向主管当局报告第1款（a）项所述的可疑严重事件。
The competent authorities shall record centrally at national level reports they receive from healthcare professionals, users and patients.
主管当局应在国家一级集中记录他们从医疗保健专业人员、用户和患者那里收到的报告。
11. 如果成员国主管当局从医疗保健专业人员、用户或患者那里获得关于第1款（a）点所述疑似严重事件的报告，则应采取必要措施，确保毫不拖延地将疑似严重事件通知有关器械制造商。
Where the manufacturer of the device concerned considers that the incident is a serious incident, it shall provide a report in accordance with paragraphs 1 to 5 of this Article on that serious incident to the competent authority of the Member State in which that serious incident occurred and shall take the appropriate follow-up action in accordance with Article 89.
如果有关设备的制造商认为该事件是严重事件，则应根据本条第1款至第5款的规定，向发生该严重事件的成员国主管当局提供报告，并应根据第89条采取适当的后续行动。
Where the manufacturer of the device concerned considers that the incident is not a serious incident or is an expected undesirable side-effect, which will be covered by trend reporting in accordance with Article 88, it shall provide an explanatory statement. If the competent authority does not agree with the conclusion of the explanatory statement, it may require the manufacturer to provide a report in accordance with paragraphs 1 to 5 of this Article and require it to ensure that appropriate follow-up action is taken in accordance with Article 89.
如果有关设备的制造商认为该事件不是严重事件或预期的不良副作用，将根据第88条进行趋势报告，则应提供解释性说明。如果主管当局不同意解释性声明的结论，它可以要求制造商根据本条第1款至第5款提供报告，并要求其确保根据第89条采取适当的后续行动。
Article 88 第八十八条
Trend reporting 趋势报告
1. 制造商应通过第92条所述的电子系统，报告非严重事件或预期不良副作用的事件的频率或严重程度的任何统计学上显着增加，这些事件可能对附件I第1节和第8节所述的惠益-风险分析►C2产生重大影响，并且◄已经导致或可能导致对患者健康或安全的风险， 用户或其他人员在权衡预期利益时是不可接受的。在技术文档和产品信息中规定的特定时期内，应与相关设备或类别或设备组的此类事件的可预见频率或严重程度进行比较，以确定显着增加。
The manufacturer shall specify how to manage the incidents referred to in the first subparagraph and the methodology used for determining any statistically significant increase in the frequency or severity of such incidents, as well as the observation period, in the post-market surveillance plan referred to in Article 84.
制造商应具体说明如何管理第1项所述事件，以及用于确定第84条所述上市后监督计划中此类事件的频率或严重程度的任何统计学显着增加以及观察期的方法。
2. 主管当局可以对第1款所述的趋势报告进行自己的评估，并要求制造商根据本条例采取适当措施，以确保保护公众健康和患者安全。各主管当局应将评估结果和采取的措施通知委员会、其他主管当局和颁发证书的指定机构。
Article 89 第八十九条
Analysis of serious incidents and field safety corrective actions
严重事故分析和现场安全纠正措施
1. 在根据第87条第（1）款报告严重事件后，制造商应立即对严重事件和有关设备进行必要的调查。这应包括对事故进行风险评估和现场安全纠正行动，同时酌情考虑到本条第3款所述的标准。
The manufacturer shall co-operate with the competent authorities and where relevant with the notified body concerned during the investigations referred to in the first subparagraph and shall not perform any investigation which involves altering the device or a sample of the batch concerned in a way which may affect any subsequent evaluation of the causes of the incident, prior to informing the competent authorities of such action.
在第一项所述的调查期间，制造商应与主管当局合作，并在相关情况下与有关公告机构合作，不得进行任何涉及改变设备或有关批次样品的调查，以免影响对事故原因的任何后续评估， 在将此类行动通知主管当局之前。
2. 会员国应采取必要措施，确保其主管当局在国家一级集中评估在其领土内发生的严重事件，或在其领土内已经或将要采取的现场安全纠正行动，并根据第87条获悉的任何信息， 如果可能，与制造商一起，并在相关情况下与有关公告机构一起。
3. 在第2款所述的评估中，主管当局应评估所报告的严重事件所产生的风险，并评估任何相关的现场安全纠正措施，同时考虑到对公众健康的保护以及诸如因果关系、可检测性和问题再次发生的可能性、设备的使用频率等标准， 发生直接或间接伤害的可能性、伤害的严重程度、设备的临床益处、预期和潜在用户以及受影响的人群。主管当局还应评估制造商设想或采取的现场安全纠正措施的充分性，以及采取任何其他纠正措施的必要性和种类，特别是考虑到附件一所载的固有安全原则。
Upon request by the national competent authority, manufacturers shall provide all documents necessary for the risk assessment.
应国家主管部门的要求，制造商应提供风险评估所需的所有文件。
4. 主管当局应监督制造商对严重事故的调查。必要时，主管当局可以干预制造商的调查或启动独立调查。
5. 制造商应通过第92条所述的电子系统向主管当局提交一份最终报告，说明其调查结果。报告应载列结论，并酌情说明应采取的纠正措施。
6. 对于第1条第（8）款所指的器械，如果严重事故或现场安全纠正措施可能与单独使用将被视为医药产品的物质有关，则评估主管当局或本条第9款所指的协调主管当局应： 根据第52（9）条，将该严重事件或现场安全纠正措施通知国家主管当局或EMA，具体取决于哪个机构发布了关于该物质的科学意见。
In the case of devices covered by this Regulation in accordance with point (g) of Article 1(6) and where the serious incident or field safety corrective action may be related to the derivatives of tissues or cells of human origin utilised for the manufacture of the device, and in the case of devices falling under this Regulation pursuant to Article 1(10), the competent authority or the coordinating competent authority referred to in paragraph 9 of this Article shall inform the competent authority for human tissues and cells that was consulted by the notified body in accordance with Article 52(10).
对于根据第1条第（6）款（g）项，本条例所涵盖的器械，如果严重事故或现场安全纠正措施可能与用于制造该器械的人源性组织或细胞的衍生物有关，并且根据第1（10）条属于本条例的器械， 本条第9款所指的主管机关或协调主管机关应通知被通告机构根据第52条第（10）款咨询的人体组织和细胞主管机关。
七、在按照本条第3款进行评估后，评估主管当局应通过第九十二条所述的电子系统，毫不迟延地将制造商为尽量减少再次发生严重事故的风险而采取或设想采取的纠正措施通知其他主管当局， 包括有关基础事件及其评估结果的信息。
8. 制造商应确保通过现场安全通知立即提请有关设备用户注意所采取的现场安全纠正措施的信息。现场安全通知应以采取现场安全纠正措施的成员国确定的联盟官方语言进行编辑。除紧急情况外，外地安全通知草案的内容应提交评估主管当局，或在第9款所述情况下，应提交协调主管当局，以便其提出意见。除非个别会员国的情况有正当理由，否则所有会员国的现场安全通知内容应一致。
The field safety notice shall allow the correct identification of the device or devices involved, in particular by including the relevant UDIs, and the correct identification, in particular, by including the SRN, if already issued, of the manufacturer that has undertaken the field safety corrective action. The field safety notice shall explain, in a clear manner, without understating the level of risk, the reasons for the field safety corrective action with reference to the device malfunction and associated risks for patients, users or other persons, and shall clearly indicate all the actions to be taken by users.
现场安全通知应允许正确识别所涉及的一个或多个设备，特别是包括相关的 UDI，以及正确识别，特别是包括已采取现场安全纠正措施的制造商的 SRN（如果已发布）。现场安全通知应以清晰的方式解释，但不得低估风险水平，参考设备故障和患者、用户或其他人员的相关风险采取现场安全纠正措施的原因，并应明确说明用户应采取的所有行动。
The manufacturer shall enter the field safety notice in the electronic system referred to in Article 92 through which that notice shall be accessible to the public.
制造商应将现场安全通知输入第92条所述的电子系统，公众应通过该系统访问该通知。
The competent authorities shall actively participate in a procedure in order to coordinate their assessments referred to in paragraph 3 in the following cases:
where there is concern regarding a particular serious incident or cluster of serious incidents relating to the same device or type of device of the same manufacturer in more than one Member State;
对一个以上成员国的同一器械或同一制造商的器械类型有关的特定严重事件或严重事件集群表示关切;
where the appropriateness of a field safety corrective action that is proposed by a manufacturer in more than one Member State is in question.
制造商在多个成员国提出的现场安全纠正措施的适当性存在问题。
9. 在下列情况下，主管当局应积极参与程序，以协调第3款所述的评估：
That coordinated procedure shall cover the following:
该协调程序应包括以下内容：
必要时，根据具体情况指定一个协调主管当局;
确定协调评估过程，包括协调主管当局的任务和责任以及其他主管当局的参与。
Unless otherwise agreed between the competent authorities, the coordinating competent authority shall be the competent authority of the Member State in which the manufacturer has its registered place of business.
除非主管当局另有约定，协调主管当局应为制造商注册营业地所在成员国的主管当局。
The coordinating competent authority shall, through the electronic system referred to in Article 92, inform the manufacturer, the other competent authorities and the Commission that it has assumed the role of coordinating authority.
协调主管当局应通过第92条所述的电子系统通知制造商、其他主管当局和委员会，它已承担协调当局的角色。
10. 指定协调主管当局不应影响其他主管当局根据本条例进行自己的评估和采取措施以确保保护公众健康和患者安全的权利。应随时向协调主管当局和委员会通报任何此类评估的结果和采取的任何此类措施。
11. 委员会应向协调主管当局提供行政支持，以完成本章规定的任务。
Article 90 第九十条
Analysis of vigilance data
警戒数据分析
The Commission shall, in collaboration with the Member States, put in place systems and processes to actively monitor the data available in the electronic system referred to in Article 92, in order to identify trends, patterns or signals in the data that may reveal new risks or safety concerns.
委员会应与成员国合作，建立系统和程序，积极监测第92条所述电子系统中的可用数据，以识别数据中可能揭示新风险或安全问题的趋势、模式或信号。
Where a previously unknown risk is identified or the frequency of an anticipated risk significantly and adversely changes the benefit-risk determination, the competent authority or, where appropriate, the coordinating competent authority shall inform the manufacturer, or where applicable the authorised representative, which shall then take the necessary corrective actions.
如果发现以前未知的风险或预期风险的频率显着不利地改变了收益-风险的确定，主管当局或协调主管当局（如适用）应通知制造商，或在适用的情况下通知授权代表，然后授权代表应采取必要的纠正措施。
Article 91 第九十一条
Implementing acts 执行行为
The Commission may, by means of implementing acts, and after consultation of the MDCG, adopt the detailed arrangements and procedural aspects necessary for the implementation of Articles 85 to 90 and 92 as regards the following:
委员会可通过执行法案，并在与MDCG协商后，通过执行第85条至第90条和第92条所需的详细安排和程序方面，涉及以下方面：
the typology of serious incidents and field safety corrective actions in relation to specific devices, or categories or groups of devices;
与特定设备、设备类别或设备组相关的严重事件的类型和现场安全纠正措施;
the reporting of serious incidents and field safety corrective actions and field safety notices, and the provision of periodic summary reports, post-market surveillance reports, PSURs and trend reports by manufacturers as referred to in Articles 85, 86, 87, 88 and 89 respectively;
报告严重事故和现场安全纠正措施以及现场安全通知，并分别由制造商提供定期总结报告、上市后监督报告、PSUR 和趋势报告，分别如第 85、86、87、88 和 89 条所述;
standard structured forms for electronic and non-electronic reporting, including a minimum data set for reporting of suspected serious incidents by healthcare professionals, users and patients;
电子和非电子报告的标准结构化表格，包括医护人员、用户和患者报告疑似严重事件的最低数据集;
timelines for the reporting of field safety corrective actions, and for the provision by manufacturers of periodic summary reports and trend reports, taking into account the severity of the incident to be reported as referred to in Article 87;
报告现场安全纠正措施的时间表，以及制造商提供定期总结报告和趋势报告的时间表，同时考虑到第87条所述要报告的事件的严重性;
harmonised forms for the exchange of information between competent authorities as referred to in Article 89;
第89条所述主管当局之间信息交流的统一形式;
procedures for the designation of a coordinating competent authority; the coordinated evaluation process, including tasks and responsibilities of the coordinating competent authority and involvement of other competent authorities in this process.
指定协调主管当局的程序;协调评价过程，包括协调主管当局的任务和责任以及其他主管当局参与这一过程。
The implementing acts referred to in the first paragraph shall be adopted in accordance with the examination procedure referred to in Article 114(3).
第1款所指的实施行为应按照第114条第（3）款所述的审查程序通过。
Article 92 第九十二条
Electronic system on vigilance and on post-market surveillance
关于警戒和上市后监督的电子系统
The Commission shall, in collaboration with the Member States, set up and manage an electronic system to collate and process the following information:
the reports by manufacturers on serious incidents and field safety corrective actions referred to in Article 87(1) and Article 89(5);
制造商关于第87条第（1）款和第89条第（5）款所述的严重事故和现场安全纠正措施的报告;
the periodic summary reports by manufacturers referred to in Article 87(9);
第87条第（9）款所指的制造商的定期总结报告;
the reports by manufacturers on trends referred to in Article 88;
制造商关于第88条所述趋势的报告;
the PSURs referred to in Article 86;
第 86 条所述的 PSUR;
the field safety notices by manufacturers referred to in Article 89(8);
第89条第（8）款所指的制造商的现场安全通知;
the information to be exchanged between the competent authorities of the Member States and between them and the Commission in accordance with Article 89(7) and (9).
根据第89条第（7）款和第（9）款，成员国主管当局之间以及它们与委员会之间交换的信息。
1. 委员会应与成员国合作，建立和管理一个电子系统，以整理和处理下列信息：
That electronic system shall include relevant links to the UDI database.
该电子系统应包括与UDI数据库的相关链接。
二、本条第1款所指的资料应通过电子系统提供给成员国主管当局和委员会。被公布机构也应有权查阅该信息，只要该信息与它们根据第53条颁发证书的器械有关。
3. 委员会应确保医疗保健专业人员和公众能够适当地使用第1款所述的电子系统。
4. 根据委员会与第三国主管当局或国际组织之间的安排，委员会可准许这些主管当局或国际组织在适当级别使用第1款所述的电子系统。这些安排应以互惠为基础，并作出与欧盟同等的保密和数据保护规定。
五、第八十七条第一款（a）项所指的严重事件报告，一经收到，应通过本条第一款所指的电子系统自动传送事件发生地成员国的主管当局。
六、第八十八条第（一）款所指的趋势报告，一经收到后，应通过本条第1款所指的电子系统自动传送事件发生地成员国的主管当局。
The reports on field safety corrective actions referred to in point (b) of Article 87(1) shall be automatically transmitted upon receipt via the electronic system referred to in paragraph 1 of this Article to the competent authorities of the following Member States:
the Member States in which the field safety corrective action is being or is to be undertaken;
正在或将要采取现场安全纠正行动的成员国;
the Member State in which the manufacturer has its registered place of business.
制造商注册营业地所在的成员国。
7. 第87条第（1）款（b）项所述的现场安全纠正措施报告，一经收到后，应通过本条第1款所述的电子系统自动传送下列成员国主管当局：
The periodic summary reports referred to in Article 87(9) shall be automatically transmitted upon receipt via the electronic system referred to in paragraph 1 of this Article to the competent authority of:
the Member State or Member States participating in the coordination procedure in accordance with Article 89(9) and which have agreed on the periodic summary report;
根据第89条第（9）款参加协调程序并已就定期总结报告达成一致意见的一个或多个成员国;
the Member State in which the manufacturer has its registered place of business.
制造商注册营业地所在的成员国。
八、第八十七条第（九）项所指的定期总结报告，一经收到后，应通过本条第一款所指的电子系统自动传送下列主管机关：
9. 本条第5款至第8款所述信息一经收到后，应通过本条第1款所指的电子系统自动传送给根据第56条为有关设备颁发证书的公告机构。
SECTION 3 第 3 节
Market surveillance 市场监督
Article 93 第九十三条
Market surveillance activities
市场监督活动
1. 主管当局应对器械的符合性特征和性能进行适当检查，包括酌情审查文件，并在充分样品的基础上进行物理或实验室检查。主管当局尤其应考虑到有关风险评估和风险管理、警戒数据和投诉的既定原则。
2. 主管当局应制定年度监督活动计划，并分配足够数量的物质和主管人力资源，以便开展这些活动，同时考虑到MDCG根据第105条制定的欧洲市场监督计划和当地情况。
In order to fulfil the obligations laid down in paragraph 1, the competent authorities:
may require economic operators to, inter alia, make available the documentation and information necessary for the purpose of carrying out the authorities' activities and, where justified, to provide the necessary samples of devices or access to devices free of charge; and
除其他外，可要求经济经营者提供开展当局活动所需的文件和资料，并在正当情况下免费提供必要的设备样品或获取设备;和
shall carry out both announced and, if necessary, unannounced inspections of the premises of economic operators, as well as suppliers and/or subcontractors, and, where necessary, at the facilities of professional users.
应对经济经营者、供应商和/或分包商的场所进行宣布和必要时突击检查，并在必要时对专业用户的设施进行检查。
3. 为了履行第1款规定的义务，主管当局：
四、主管机关应编制其监督活动结果的年度摘要，并通过第一百条所述的电子系统向其他主管机关提供。
5. 主管当局可以没收、销毁或以其他方式使存在不可接受风险的设备或伪造设备无法使用，如果它们认为有必要这样做，以保护公众健康。
6. 在为第1款所述目的进行的每次视察之后，主管当局应就视察结果提出报告，说明视察结果是否符合本条例所适用的法律和技术要求。报告应列出任何需要采取的纠正措施。
七、进行视察的主管机关应将本条第6款所指报告的内容通知被视察的经济经营者。在通过最终报告之前，主管当局应给予该经济经营者提出意见的机会。该最终检查报告应输入第100条规定的电子系统。
8. 成员国应审查和评估其市场监督活动的运作情况。这种审查和评估应至少每四年进行一次，其结果应通知其他会员国和委员会。各成员国应通过第100条所述的电子系统向公众提供结果摘要。
9. 成员国主管当局应协调其市场监督活动，相互合作，相互分享其结果，并与委员会分享其结果，以便在所有成员国提供统一和高水平的市场监督。
Where appropriate, the competent authorities of the Member States shall agree on work-sharing, joint market surveillance activities and specialisation.
在适当情况下，成员国主管当局应就工作分担、联合市场监督活动和专业化达成一致。
10. 如果一个成员国的多个机构负责市场监督和外部边境管制，这些机构应相互合作，分享与其作用和职能有关的信息。
11. 在适当情况下，成员国主管当局应与第三国主管当局合作，以期交流信息和技术支持，并促进与市场监督有关的活动。
Article 94 第九十四条
Evaluation of devices suspected of presenting an unacceptable risk or other non-compliance
评估怀疑存在不可接受风险或其他不合规行为的器械
Where the competent authorities of a Member State, based on data obtained by vigilance or market surveillance activities or on other information, have reason to believe that a device:
如果成员国主管当局根据通过警戒或市场监督活动获得的数据或其他信息，有理由相信设备：
may present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health; or
可能对患者、用户或其他人员的健康或安全，或对保护公众健康的其他方面构成不可接受的风险;或
otherwise does not comply with the requirements laid down in this Regulation,
否则不符合本条例规定的要求，
they shall carry out an evaluation of the device concerned covering all requirements laid down in this Regulation relating to the risk presented by the device, or to any other non-compliance of the device.
他们应对有关器械进行评估，涵盖本法规中规定的与器械带来的风险或器械的任何其他不合规性有关的所有要求。
The relevant economic operators shall cooperate with the competent authorities.
有关经济经营者应当与主管部门合作。
Article 95 第九十五条
Procedure for dealing with devices presenting an unacceptable risk to health and safety
处理对健康和安全构成不可接受风险的器械的程序
1. 如果主管当局在根据第94条进行评估后，发现该器械对患者、用户或其他人员的健康或安全，或对保护公众健康的其他方面构成不可接受的风险，则应立即要求有关器械的制造商、其授权代表和所有其他相关经济经营者采取一切适当和正当的纠正措施，使该器械遵守本法规中有关器械所呈现风险的要求，并以与风险性质相称的方式，限制器械在市场上的供应，使器械的供应符合特定要求，将器械从市场上撤出， 或在明确定义并传达给相关经济运营商的合理期限内召回它。
2. 主管当局应毫不迟延地将评估结果和要求经济经营者采取的行动通知委员会、其他成员国以及根据第56条为有关装置颁发证书的公告机构通知机构， 通过第100条所述的电子系统。
三、第1款所指的经济经营者应毫不拖延地确保在联盟内对其在市场上提供的所有有关设备采取一切适当的纠正措施。
4. 如果第1款所指的经济经营者未在第1款所述期限内采取适当的纠正措施，主管当局应采取一切适当措施，禁止或限制在本国市场上销售该设备，将该设备从该市场撤出或召回。
The competent authorities shall notify the Commission, the other Member States and the notified body referred to in paragraph 2 of this Article, without delay, of those measures, by means of the electronic system referred to in Article 100.
主管当局应通过第100条所述的电子系统，毫不迟延地将这些措施通知委员会、其他成员国和本条第2款所述的通知机构。
5. 第4款所指的通知应包括所有可用的细节，特别是识别和追踪不合规装置所需的数据、装置的来源、所指控的不遵守情约的性质和原因以及所涉及的风险、所采取的国家措施的性质和持续时间以及有关经济经营者提出的论点。
6. 启动程序的成员国以外的成员国应毫不拖延地通过第100条所述的电子系统，向委员会和其他成员国通报它们所掌握的与有关装置不遵守规定的任何其他有关信息，以及它们就有关装置采取的任何措施。
In the event of disagreement with the notified national measure, they shall, without delay, inform the Commission and the other Member States of their objections, by means of the electronic system referred to in Article 100.
如果对所通知的国家措施有异议，它们应毫不拖延地通过第100条所述的电子系统将其反对意见通知委员会和其他成员国。
7. 在收到第4款所述通知后两个月内，如果一成员国或委员会未对一成员国采取的任何措施提出异议，则这些措施应视为有正当理由。
In that case, all Member States shall ensure that corresponding appropriate restrictive or prohibitive measures, including withdrawing, recalling or limiting the availability of the device on their national market, are taken without delay in respect of the device concerned.
在这种情况下，所有成员国应确保毫不拖延地对有关器械采取相应的适当限制性或禁止性措施，包括撤回、召回或限制该器械在其本国市场上的供应。
Article 96 第九十六条
Procedure for evaluating national measures at Union level
评估联盟一级国家措施的程序
1. 如果一个成员国在收到第95条第（4）款所述通知后两个月内对另一个成员国采取的措施提出异议，或者委员会认为该措施违反欧盟法律，委员会应在与有关主管当局协商后，并在必要时， 有关经济经营者，评估该国家措施。根据评估结果，委员会可通过执行法案来决定国家措施是否合理。实施法案应按照第114条第（3）款所述的审查程序通过。
二、如果委员会认为本条第1款所述的国家措施是正当的，应适用第95条第（7）款第2项。如果委员会认为国家措施不合理，有关会员国应撤回该措施。
Where the Commission does not adopt a decision pursuant to paragraph 1 of this Article within eight months of receipt of the notification referred to in Article 95(4), the national measure shall be considered to be justified.
如果委员会在收到第95条第（4）款所述通知后8个月内未根据本条第1款作出决定，则应认为该国家措施是合理的。
3. 如果成员国或委员会认为，通过成员国或有关成员国采取的措施，无法令人满意地减轻设备对健康和安全的风险，委员会可应成员国的请求或主动采取实施行动的方式， 确保保护健康和安全的必要和正当措施，包括限制或禁止将有关设备投放市场和投入使用的措施。实施法案应按照第114条第（3）款所述的审查程序通过。
Article 97 第九十七条
Other non-compliance 其他不合规行为
1. 如果成员国主管当局在根据第94条进行评估后，发现器械不符合本条例规定的要求，但不会对患者、用户或其他人员的健康或安全构成不可接受的风险，也不会对保护公众健康的其他方面构成不可接受的风险， 它们应要求有关经济经营者在明确界定并传达给经济经营者且与不遵守行为相称的合理期限内结束有关不遵守行为。
二、经济经营者未在本条第1款所述期限内制止不遵守情事的，有关成员国应毫不迟延地采取一切适当措施，限制或禁止该产品在市场上销售，或确保该产品被召回或从市场上撤出。该成员国应毫不拖延地通过第100条所述的电子系统将这些措施通知委员会和其他成员国。
3. 为确保本条的统一适用，委员会可通过执行法令，具体规定主管当局应采取的适当措施，以处理特定类型的不遵守情事。实施法案应按照第114条第（3）款所述的审查程序通过。
Article 98 第九十八条
Preventive health protection measures
预防性健康保护措施
1. 如果成员国在进行评估后表明存在与器械或特定类别或器械组有关的潜在风险，认为为了保护患者、用户或其他人的健康和安全或公共卫生的其他方面，应禁止在市场上提供或投入使用器械或特定类别或组的器械， 限制或受特定要求约束，或该器械或类别或器械组应从市场上撤出或召回，它可以采取任何必要和合理的措施。
二、第1款所指的成员国应立即通过第100条所指的电子系统通知委员会和所有其他成员国，说明其决定的理由。
3. 委员会应与MDCG协商，并在必要时与有关经济经营者协商，评估所采取的国家措施。委员会可以通过执行法案来决定国家措施是否合理。如果委员会在收到通知后六个月内仍未作出决定，则国家措施应视为正当理由。实施法案应按照第114条第（3）款所述的审查程序通过。
4. 如果本条第3款所述的评估表明，应禁止、限制或根据特定要求在市场上提供或投入使用某种器械、特定类别或一组器械，或应在所有成员国撤出或召回此类器械或类别或组械，以保护患者的健康和安全， 使用者或其他人员或公共卫生的其他方面，委员会可以通过实施法案，采取必要和正当的措施。实施法案应按照第114条第（3）款所述的审查程序通过。
Article 99 第九十九条
Good administrative practice
良好的行政做法
一、成员国主管机关依照第九十五条至第九十八条采取的任何措施，均应说明其所依据的确切理由。如果这种措施是针对特定的经济经营者采取的，主管当局应毫不拖延地将该措施通知有关经济经营者，并应同时将有关成员国的法律或行政惯例所规定的补救措施以及这种补救措施的时限告知该经济经营者。措施具有普遍适用性的，应当适当公布。
2. 除因对人类健康或安全造成不可接受的风险而需要立即采取行动的情况外，有关经济经营者应有机会在采取任何措施之前明确规定的适当期限内向主管当局提出意见。
Where action has been taken without the economic operator having had the opportunity to make submissions as referred to in the first subparagraph, it shall be given the opportunity to make submissions as soon as possible and the action taken shall be reviewed promptly thereafter.
如果经济经营者没有机会提出第1项所述的划界案，则应给予其尽快划界的机会，并应在其后迅速审查所采取的行动。
3. 所采取的任何措施，在经济经营者证明其已采取有效的纠正措施并且该装置符合本条例的要求后，应立即撤回或修改。
4. 如果根据第95条至第98条采取的措施涉及指定机构参与合格评定的器械，主管当局应通过第100条所述的电子系统将所采取的措施通知有关公告机构和负责该公告机构的主管部门。
Article 100 第一百条
Electronic system on market surveillance
市场监督电子系统
The Commission, in collaboration with the Member States, shall set up and manage an electronic system to collate and process the following information:
summaries of the results of the surveillance activities referred to in Article 93(4);
第93条第（4）款所述监视活动的结果摘要;
the final inspection report referred to in Article 93(7);
第93条第（7）款所述的最终检查报告;
information in relation to devices presenting an unacceptable risk to health and safety as referred to in Article 95(2), (4) and (6);
与第95条第（2）、（4）和（6）款所述的对健康和安全构成不可接受风险的器械有关的信息;
information in relation to non-compliance of products as referred to in Article 97(2);
与第97条第（2）款所述的产品不合规有关的信息;
information in relation to the preventive health protection measures referred to in Article 98(2);
与第98条第（2）款所述的预防性健康保护措施有关的信息;
summaries of the results of the reviews and assessments of the market surveillance activities of the Member States referred to in 93(8).
第93（8）条所述成员国市场监督活动的审查和评估结果摘要。
1. 委员会应与成员国合作，建立和管理一个电子系统，以整理和处理下列信息：
二、本条第1款所指的信息应立即通过电子系统传送给所有有关主管当局，并在适用时传送给根据第56条为有关设备颁发证书的公告机构，并可供成员国和委员会查阅。
三、成员国之间交换的信息不得公开，如果这样做可能会损害成员国之间的市场监督活动和合作。
CHAPTER VIII 第八章
COOPERATION BETWEEN MEMBER STATES, MEDICAL DEVICE COORDINATION GROUP, EXPERT LABORATORIES, EXPERT PANELS AND DEVICE REGISTERS
成员国、医疗器械协调小组、专家实验室、专家小组和器械登记册之间的合作
Article 101 第101条
Competent authorities 主管当局
The Member States shall designate the competent authority or authorities responsible for the implementation of this Regulation. They shall entrust their authorities with the powers, resources, equipment and knowledge necessary for the proper performance of their tasks pursuant to this Regulation. The Member States shall communicate the names and contact details of the competent authorities to the Commission which shall publish a list of competent authorities.
成员国应指定负责实施本条例的主管当局。它们应赋予其当局必要的权力、资源、设备和知识，以便根据本条例适当地履行其任务。成员国应将主管当局的名称和联系方式通知委员会，委员会应公布主管当局名单。
Article 102 第一百零二条
Cooperation 合作
1. 成员国主管当局应相互合作并与委员会合作。委员会应规定组织必要的信息交流，以便统一适用本条例。
2. 成员国应在委员会的支持下，酌情参与国际层面制定的倡议，以确保监管机构在医疗器械领域的合作。
Article 103 第103条
Medical Device Coordination Group
医疗器械协调小组
1. 特此成立医疗器械协调小组（“MDCG”）。
2. 每个成员国应向MDCG任命一名成员和一名候补成员，任期三年，可连任，各一名成员和一名候补成员，具有医疗器械领域专业知识，一名成员和一名候补成员，具有体外诊断医疗器械领域的专门知识。一个会员国可以选择只任命一名成员和一名候补成员，每个成员在这两个领域都有专门知识。
The members of the MDCG shall be chosen for their competence and experience in the field of medical devices and in vitro diagnostic medical devices. They shall represent the competent authorities of the Member States. The names and affiliation of members shall be made public by the Commission.
MDCG的成员应根据其在医疗器械和体外诊断医疗器械领域的能力和经验进行选择。他们应代表成员国的主管当局。委员会成员的姓名和所属关系应由委员会公布。
The alternates shall represent and vote for the members in their absence.
候补委员应代表委员缺席并投票选举委员。
3. MDCG应定期举行会议，并视情况需要，应委员会或成员国的要求举行会议。会议应由因其在医疗器械领域的作用和专业知识而任命的成员，或因其在体外诊断医疗器械领域的专业知识而任命的成员，或因其在这两个领域的专业知识而任命的成员或其候补成员（视情况而定）出席。
4. MDCG应尽最大努力达成共识。如果无法达成这种协商一致意见，MDCG应由其成员的过半数决定。立场不同的成员可以要求将其立场和立场所依据的理由记录在MDCG的立场中。
5. MDCG应由委员会的一名代表担任主席。主席不得参加MDCG的表决。
6. MDCG可根据具体情况邀请专家和其他第三方出席会议或提供书面意见。
7. MDCG可以设立常设或临时小组。在适当情况下，应以观察员的身份邀请代表医疗器械行业、医疗保健专业人员、实验室、患者和消费者利益的组织参加这些小组。
The MDCG shall establish its rules of procedure which shall, in particular, lay down procedures for the following:
采纳意见或建议或其他立场，包括在紧急情况下;
将任务下放给报告和共同报告成员;
关于利益冲突的第107条的执行;
小组的运作。
8. MDCG应制定其议事规则，其中特别应规定以下程序：
9. MDCG应具有本条例第105条和条例（EU）2017/746第99条规定的任务。
Article 104 第一百零四条
Support by the Commission
委员会的支持
The Commission shall support the functioning of the cooperation between national competent authorities. It shall, in particular, provide for the organisation of exchanges of experience between the competent authorities and provide technical, scientific and logistic support to the MDCG and its sub-groups. It shall organise the meetings of the MDCG and its sub-groups, participate in those meetings and ensure the appropriate follow-up.
委员会应支持国家主管当局之间合作的运作。它尤其应规定组织主管当局之间的经验交流，并向MDCG及其分组提供技术、科学和后勤支持。它应组织MDCG及其分组的会议，参加这些会议，并确保采取适当的后续行动。
Article 105 第一百零五条
Tasks of the MDCG
MDCG的任务
Under this Regulation, the MDCG shall have the following tasks:
根据本条例，MDCG应具有以下任务：
to contribute to the assessment of applicant conformity assessment bodies and notified bodies pursuant to the provisions set out in Chapter IV;
根据第四章的规定，为申请人合格评定机构和公告机构的评估做出贡献;
to advise the Commission, at its request, in matters concerning the coordination group of notified bodies as established pursuant to Article 49;
应委员会的要求，就与根据第49条设立的公告机构协调小组有关的事项向委员会提供咨询意见;
to contribute to the development of guidance aimed at ensuring effective and harmonised implementation of this Regulation, in particular regarding the designation and monitoring of notified bodies, application of the general safety and performance requirements and conduct of clinical evaluations and investigations by manufacturers, assessment by notified bodies and vigilance activities;
为制定旨在确保有效和协调实施本法规的指南做出贡献，特别是关于指定和监测公告机构、应用一般安全和性能要求以及制造商进行临床评估和调查、公告机构评估和警戒活动;
to contribute to the continuous monitoring of technical progress and assessment of whether the general safety and performance requirements laid down in this Regulation and Regulation (EU) 2017/746 are adequate to ensure safety and performance of devices, and thereby contribute to identifying whether there is a need to amend Annex I to this Regulation;
有助于持续监测技术进展，并评估本法规和法规 （EU） 2017/746 中规定的一般安全和性能要求是否足以确保设备的安全和性能，从而有助于确定是否需要修订本法规附件 I;
to contribute to the development of device standards, of CS and of scientific guidelines, including product specific guidelines, on clinical investigation of certain devices in particular implantable devices and class III devices;
为制定器械标准、CS 和科学指南（包括产品特定指南）做出贡献，以研究某些器械（特别是植入式器械和 III 类器械）的临床研究;
to assist the competent authorities of the Member States in their coordination activities in particular in the fields of classification and the determination of the regulatory status of devices, clinical investigations, vigilance and market surveillance including the development and maintenance of a framework for a European market surveillance programme with the objective of achieving efficiency and harmonisation of market surveillance in the Union, in accordance with Article 93;
协助成员国主管当局开展协调活动，特别是在分类和确定器械监管状态、临床调查、警戒和市场监督等领域，包括制定和维护欧洲市场监督计划框架，以实现欧盟市场监督的效率和协调， 根据第93条;
to provide advice, either on its own initiative or at request of the Commission, in the assessment of any issue related to the implementation of this Regulation;
主动或应委员会的要求，在评估与实施本条例有关的任何问题时提供建议;
to contribute to harmonised administrative practice with regard to devices in the Member States.
促进成员国在器械方面的统一行政实践。
Article 106 第一百零六条
Provision of scientific, technical and clinical opinions and advice
提供科学、技术和临床意见和建议
1. 委员会应通过实施法案并与MDCG协商，规定指定专家小组评估本条第9款所述相关医学领域的临床评估，并根据法规（EU）2017/746第48（6）条就某些体外诊断医疗器械的性能评估提出意见，并： 必要时，对于器械类别或组，或与器械类别或组相关的特定危害，遵守最高科学能力、公正、独立和透明的原则。在委员会决定根据本条第7款指定专家实验室时，也应适用同样的原则。
2. 在委员会与MDCG协商后，确定需要提供与实施本条例有关的一致的科学、技术和/或临床建议或实验室专业知识的领域，可以指定专家小组和专家实验室。专家小组和专家实验室可以常设或临时任命。
3. 专家小组应由委员会根据该领域的最新临床、科学或技术专门知识任命的顾问组成，其地域分布应反映国际电联科学和临床方法的多样性。委员会应根据必要需要确定每个小组的成员人数。
The members of expert panels shall perform their tasks with impartiality and objectivity. They shall neither seek nor take instructions from notified bodies or manufacturers. Each member shall draw up a declaration of interests, which shall be made publicly available.
专家小组成员应当公正客观地执行任务。他们不得寻求或接受指定机构或制造商的指示。每个成员应起草一份利益申报表，并应向公众公布。
The Commission shall establish systems and procedures to actively manage and prevent potential conflicts of interest.
委员会应建立积极管理和防止潜在利益冲突的制度和程序。
4. 专家小组在准备科学意见时，应考虑包括患者组织和医护人员在内的利益相关者提供的相关信息。
5. 委员会在与MDCG协商后，可在《欧洲联盟官方公报》和委员会网站上公布意见后，任命专家小组顾问。根据任务类型和对特定专门知识的需要，专家小组的顾问最多可任命三年，其任期可延长。
6. 委员会在与MDCG协商后，可将顾问列入现有专家的中央名单，这些专家虽然未被正式任命为专家组成员，但可以根据需要提供咨询意见并支持专家组的工作。该名单应在委员会网站上公布。
The Commission may, by means of implementing acts and following consultation with the MDCG, designate expert laboratories, on the basis of their expertise in:
物理化学表征，或
微生物学、生物相容性、机械、电气、电子或非临床生物学和毒理学测试
of specific devices, categories or groups of devices.
特定设备、设备类别或设备组。
7. 委员会可通过执行法案和与MDCG协商，根据专家实验室在以下方面的专门知识指定专家实验室：
The Commission shall only designate expert laboratories for which a Member State or the Joint Research Centre has submitted an application for designation.
委员会只应指定成员国或联合研究中心已提交指定申请的专家实验室。
Expert laboratories shall satisfy the following criteria:
have adequate and appropriately qualified staff with adequate knowledge and experience in the field of the devices for which they are designated;
拥有足够和适当合格的员工，在指定设备领域具有足够的知识和经验;
possess the necessary equipment to carry out the tasks assigned to them;
拥有必要的设备来执行分配给他们的任务;
have the necessary knowledge of international standards and best practices;
具备必要的国际标准和最佳实践知识;
have an appropriate administrative organisation and structure;
有适当的行政组织和结构;
ensure that their staff observe the confidentiality of information and data obtained in carrying out their tasks.
确保其员工遵守在执行任务时获得的信息和数据的机密性。
8. 专家实验室应符合下列标准：
九、被任命从事相关医学领域临床评价的专家小组应当完成第五十四条第一款、第六十一条第二款及附件九第五条第一款或附件十第六款规定的任务。
Expert panels and expert laboratories may have the following tasks, depending on the requisite needs:
to provide scientific, technical and clinical assistance to the Commission and the MDCG in relation to the implementation of this Regulation;
就本规例的实施，向委员会和MDCG提供科学、技术和临床援助;
to contribute to the development and maintenance of appropriate guidance and CS for:
为制定和维护适当的指南和 CS 做出贡献：
临床研究，
临床评价和PMCF，
绩效评估和上市后绩效跟进，
物理化学表征，以及
微生物学、生物相容性、机械、电气、电子或非临床毒理学测试
for specific devices, or a category or group of devices, or for specific hazards related to a category or group of devices;
对于特定设备，或一类或一组设备，或与一类或一组设备相关的特定危险;
to develop and review clinical evaluation guidance and performance evaluation guidance for performance of conformity assessment in line with the state of the art with regard to clinical evaluation, performance evaluation, physico-chemical characterisation, and microbiological, biocompatibility, mechanical, electrical, electronic or non-clinical toxicological testing;
根据临床评估、性能评估、物理化学表征以及微生物、生物相容性、机械、电气、电子或非临床毒理学测试方面的最新技术，制定和审查符合评定性评估的临床评估指南和性能评估指南;
to contribute to the development of standards at international level, ensuring that such standards reflect the state of the art;
为国际层面的标准制定做出贡献，确保这些标准反映最先进的技术水平;
to provide opinions in response to consultations by manufacturers in accordance with Article 61(2), notified bodies and Member States in accordance with paragraphs 11 to 13 of this Article.
根据第61条第（2）款，根据制造商、公告机构和成员国根据本条第11款至第13款进行的磋商，提供意见。
to contribute to identification of concerns and emerging issues on the safety and performance of medical devices;
有助于确定有关医疗器械安全性和性能的关注点和新出现的问题;
to provide views in accordance with Article 48(4) of Regulation (EU) 2017/746 on the performance evaluation of certain in vitro diagnostic medical devices.
根据法规（EU）2017/746第48（4）条对某些体外诊断医疗器械的性能评估提供意见。
10. 专家小组和专家实验室根据必要需要，可能有下列任务：
11. 委员会应为成员国、公告机构和制造商获得专家小组和专家实验室提供的咨询意见提供便利，这些咨询意见除其他外，涉及评估器械符合性的适当数据集的标准，特别是关于临床评估所需的临床数据，关于物理化学特性， 以及微生物学、生物相容性、机械、电气、电子和非临床毒理学测试。
12. 专家小组成员在根据第9款通过其科学意见时，应尽最大努力达成共识。如果不能达成共识，专家小组应由其成员的过半数作出决定，科学意见应提及不同的立场及其依据。
The Commission shall publish the scientific opinion and advice delivered in accordance with paragraphs 9 and 11 of this Article, ensuring consideration of aspects of confidentiality as set out in Article 109. The clinical evaluation guidance referred to in point (c) of paragraph 10 shall be published following consultation with the MDCG.
委员会应公布根据本条第9款和第11款提出的科学意见和建议，确保考虑第109条规定的保密方面。第10段（c）点所述的临床评估指南应在与MDCG协商后公布。
13. 委员会可要求制造商和公告机构为专家小组和专家实验室提供的建议支付费用。费用的结构和水平以及可收回费用的规模和结构应由委员会通过执行法案通过，同时考虑到充分执行本条例的目标、保护健康和安全、支持创新和成本效益以及积极参与专家小组的必要性。实施法案应按照第114条第（3）款所述的审查程序通过。
14. 根据本条第13款规定的程序应向委员会支付的费用应以透明的方式，并根据所提供服务的费用确定。如果根据附件IX第5.1节（c）点启动临床评估咨询程序，涉及第2003/361/EC号建议书所指的微型、小型或中型企业的制造商，应支付的费用应减少。
15. 委员会有权根据第115条通过授权法案，修改本条第10款所述专家小组和专家实验室的任务。
Article 107 第一百零七条
Conflict of interests 利益冲突
1. MDCG成员、其小组成员以及专家小组和专家实验室成员不得在医疗器械行业拥有可能影响其公正性的财务或其他利益。他们应承诺以独立的方式为公共利益行事。他们应申报其在医疗器械行业可能拥有的任何直接或间接利益，并在发生相关变化时更新该声明。利益申报应在委员会网站上公开。本条不适用于参加MDCG小组的利益攸关方组织的代表。
2. MDCG逐案邀请的专家和其他第三方应声明他们在有关问题上可能拥有的任何利益。
Article 108 第一百零八条
Device registers and databanks
设备寄存器和数据库
The Commission and the Member States shall take all appropriate measures to encourage the establishment of registers and databanks for specific types of devices setting common principles to collect comparable information. Such registers and databanks shall contribute to the independent evaluation of the long-term safety and performance of devices, or the traceability of implantable devices, or all of such characteristics.
委员会和成员国应采取一切适当措施，鼓励为特定类型的设备建立登记册和数据库，制定收集可比信息的共同原则。此类登记册和数据库应有助于独立评估器械的长期安全性和性能，或植入式器械的可追溯性，或所有这些特性。
CHAPTER IX 第九章
CONFIDENTIALITY, DATA PROTECTION, FUNDING AND PENALTIES
保密、数据保护、资金和处罚
Article 109 第一百零九条
Confidentiality 保密性
Unless otherwise provided for in this Regulation and without prejudice to existing national provisions and practices in the Member States on confidentiality, all parties involved in the application of this Regulation shall respect the confidentiality of information and data obtained in carrying out their tasks in order to protect the following:
personal data, in accordance with Article 110;
根据第110条的个人数据;
commercially confidential information and trade secrets of a natural or legal person, including intellectual property rights; unless disclosure is in the public interest;
自然人或法人的商业机密信息和商业秘密，包括知识产权;除非披露符合公众利益;
the effective implementation of this Regulation, in particular for the purpose of inspections, investigations or audits.
有效执行本条例，特别是为了检查、调查或审计。
一、除本条例另有规定外，在不影响成员国现行国家保密规定和惯例的情况下，参与适用本条例的所有各方均应尊重在执行任务时获得的信息和数据的机密性，以保护以下内容：
2. 在不妨碍第1款的情况下，主管当局之间以及主管当局与委员会之间在保密基础上交换的信息，未经原发当局事先同意，不得披露。
3. 第1款和第2款不影响委员会、会员国和公告机构在交流情报和传播警告方面的权利和义务，也不影响有关人员根据刑法提供情报的义务。
4. 委员会和成员国可以与与其缔结双边或多边保密安排的第三国的监管机构交换机密信息。
Article 110 第一百一十条
Data protection 数据保护
1. 成员国应将指令 95/46/EC 应用于根据本条例在成员国进行的个人数据处理。
2. 第45/2001号条例（EC）应适用于委员会根据本条例进行的个人数据处理。
Article 111 第一百一十一条
Levying of fees 收取费用
1. 本条例不妨碍成员国对本条例规定的活动征收费用的可能性，但收费水平应以透明的方式并根据成本回收原则确定。
2. 会员国应在通过收费结构和水平前至少三个月通知委员会和其他会员国。收费的结构和水平应根据要求向公众公布。
Article 112 第一百一十二条
Funding of activities related to designation and monitoring of notified bodies
为指定和监测公告机构相关活动提供资金
The costs associated with joint assessment activities shall be covered by the Commission. The Commission shall, by means of implementing acts, lay down the scale and structure of recoverable costs and other necessary implementing rules. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).
与联合评估活动有关的费用应由委员会承担。委员会应通过执行法案，规定可收回费用的规模和结构以及其他必要的实施细则。实施法案应按照第114条第（3）款所述的审查程序通过。
Article 113 第一百一十三条
Penalties 处罚
The Member States shall lay down the rules on penalties applicable for infringement of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate, and dissuasive. The Member States shall notify the Commission of those rules and of those measures by
►M1
25 February 2021 ◄ and shall notify it, without delay, of any subsequent amendment affecting them.
成员国应制定适用于违反本条例规定的处罚规则，并应采取一切必要措施确保这些规则得到执行。规定的处罚应有效、相称和劝阻。成员国应在 ►M1 2021 年 2 月 25 日 ◄ 之前将这些规则和这些措施通知委员会，并应毫不拖延地将影响这些规则和措施的任何后续修正案通知委员会。
CHAPTER X 第十章
FINAL PROVISIONS 最后条款
Article 114 第一百一十四条
Committee procedure 委员会程序
1. 委员会应由医疗器械委员会协助。该委员会应为第182/2011号条例（EU）所指的委员会。
2. 在提及本款时，应适用第 182/2011 号法规 （EU） 第 4 条。
3. 凡提及本款，应适用第182/2011号条例（EU）第5条。
Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply.
如果委员会没有发表意见，委员会不得通过实施法案草案，并适用（欧盟）第182/2011号条例第5（4）条第3款。
4. 在提及本款时，应适用（欧盟）第182/2011号条例第8条及其第4条或第5条（视情况而定）。
Article 115 第一百一十五条
Exercise of the delegation
行使授权
1. 委员会有权根据本条规定的条件通过授权法案。
2. 委员会应自2017年5月25日起，自2017年5月25日起，授予委员会第1条第（5）款、第3条、第10条第（4）款、第19条第（4）款、第27条第（10）款、第44条第（11）款、第52条第（5）款、第56条第（6）款、第61条第（8）款、第70条第（8）款和第106条第（15）款所指的通过授权法案的权力，为期五年。委员会应至迟在五年期终了前九个月就权力下放问题起草一份报告。权力下放应默许延长相同期限，除非欧洲议会或理事会不迟于每个期限结束前三个月反对延长。
3. 第1条第（5）款、第3条、第10条第（4）款、第18条第（3）款、第19条第（4）款、第27条第（10款）、第44条第（11）款、第52条第（5）款、第56条第（6）款、第61条第（8）款、第70条第（8）款和第106条第（15）款所指的权力下放可由欧洲议会或理事会随时撤销。撤销决定应终止该决定所规定的权力的下放。该决定应在《欧洲联盟官方公报》公布后的第二天或其中规定的较晚日期生效。它不应影响任何已经生效的授权行为的有效性。
4. 在通过授权法案之前，委员会应根据 2016 年 4 月 13 日《关于改进立法的机构间协议》中规定的原则，咨询各会员国指定的专家。
5. 一旦通过授权法案，委员会应同时将其通知欧洲议会和理事会。
6. 根据第1条第（5）款、第3条、第10条第（4）款、第18条第（3）款、第19条第（4）款、第27条第（10）款、第44条第（11）款、第52条第（5）款、第56条第（6）款、第61条第（8）款、第70条第（8）款和第106条第（15）款通过的授权法案，只有在欧洲议会或理事会在向欧洲议会和理事会发出该法案通知后三个月内未表示反对，或者如果： 在该期限届满之前，欧洲议会和理事会都已通知委员会，他们不会反对。该期限应由欧洲议会或理事会倡议延长三个月。
Article 116 第一百一十六条
Separate delegated acts for different delegated powers
针对不同的授权，分别采用授权行为
The Commission shall adopt a separate delegated act in respect of each power delegated to it pursuant to this Regulation.
委员会应就根据本条例授予它的每项权力通过一项单独的授权法案。
Article 117 第一百一十七条
Amendment to Directive 2001/83/EC
指令2001/83/EC修正案
In Annex I to Directive 2001/83/EC, point 12 of Section 3.2. is replaced by the following:
在指令 2001/83/EC 的附件 I 中，第 3.2 节的第 12 点。替换为以下内容：
‘(12) Where, in accordance with the second subparagraph of Article 1(8) or the second subparagraph of Article 1(9) of Regulation (EU) 2017/745 of the European Parliament and of the Council (
*1
), a product is governed by this Directive, the marketing authorisation dossier shall include, where available, the results of the assessment of the conformity of the device part with the relevant general safety and performance requirements set out in Annex I to that Regulation contained in the manufacturer's EU declaration of conformity or the relevant certificate issued by a notified body allowing the manufacturer to affix a CE marking to the medical device.
“（12） 如果根据欧洲议会和理事会 （*1） 法规 （EU） 2017/745 第 1（8） 条第 2 款或第 1（9） 款第 2 款，产品受本指令管辖，则上市许可档案应包括（如有）器械部件是否符合附件 I 中规定的相关一般安全和性能要求的评估结果制造商的欧盟符合性声明或指定机构颁发的相关证书中包含的法规，允许制造商在医疗器械上贴上 CE 标志。
If the dossier does not include the results of the conformity assessment referred to in the first subparagraph and where for the conformity assessment of the device, if used separately, the involvement of a notified body is required in accordance with Regulation (EU) 2017/745, the authority shall require the applicant to provide an opinion on the conformity of the device part with the relevant general safety and performance requirements set out in Annex I to that Regulation issued by a notified body designated in accordance with that Regulation for the type of device in question.
如果档案不包括第一项所述的合格评定结果，并且对于器械的合格评定，如果单独使用，则根据法规 （EU） 2017/745 需要指定机构的参与，主管部门应要求申请人就器械部件是否符合附件 I 中规定的相关一般安全和性能要求提供意见。该法规由根据该法规指定的指定机构针对相关设备类型发布。
Article 118 第一百一十八条
Amendment to Regulation (EC) No 178/2002
第178/2002号条例（EC）修正案
In the third paragraph of Article 2 of Regulation (EC) No 178/2002, the following point is added:
在（EC）第178/2002号条例第2条第3款中，增加了以下几点：
‘(i) medical devices within the meaning of Regulation (EU) 2017/745 of the European Parliament and of the Council (
*2
).
'（i） 欧洲议会和理事会 （*2） 法规 （EU） 2017/745 所指的医疗器械。
Article 119 第一百一十九条
Amendment to Regulation (EC) No 1223/2009
法规 （EC） No 1223/2009 的修正案
In Article 2 of Regulation (EC) No 1223/2009, the following paragraph is added:
在法规（EC）No 1223/2009第2条中，增加了以下段落：
'4. 委员会可应成员国的请求或主动采取必要措施，确定某一特定产品或一组产品是否属于“化妆品”的定义范围。这些措施应根据第32条第（2）款所述的监管程序采取。
Article 120 第一百二十条
Transitional provisions 过渡性规定
1. 自 ► M1 2021 年 5 月 26 日起 ◄ ，根据第 90/385/EEC 和 93/42/EEC 指令发布任何有关指定机构的通知均无效。
2. 2017 年 5 月 25 日之前由指定机构根据指令 90/385/EEC 和 93/42/EEC 颁发的证书应有效期至证书上注明的期限结束，但根据第 90/385/EEC 号指令附件 4 或第 93/42/EEC 号指令附件 IV 颁发的证书最迟将于 2022 年 5 月 27 日失效。
Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC from 25 May 2017 that were still valid on 26 May 2021 and that have not been withdrawn afterwards shall remain valid after the end of the period indicated on the certificate until the date set out in paragraph 3a of this Article applicable for the relevant risk class of the devices. Certificates issued by notified bodies in accordance with those Directives from 25 May 2017 that were still valid on 26 May 2021 and that have expired before 20 March 2023 shall be considered to be valid until the dates set out in paragraph 3a of this Article only if one of the following conditions is fulfilled:
自2017年5月25日起，由公告机构根据第90/385/EEC号和93/42/EEC号指令签发的证书，在2021年5月26日仍然有效且此后未被撤销的，应在证书上注明的期限结束后继续有效，直至本条第3a款规定的适用于设备相关风险等级的日期。自2017年5月25日起，由公告机构颁发的证书，在2021年5月26日仍然有效，并在2023年3月20日之前到期，只有在满足以下条件之一的情况下，才应被视为有效期至本条第3a款规定的日期：
before the date of expiry of the certificate, the manufacturer and a notified body have signed a written agreement in accordance with Section 4.3, second subparagraph, of Annex VII to this Regulation for the conformity assessment in respect of the device covered by the expired certificate or in respect of a device intended to substitute that device;
在证书到期日之前，制造商和指定机构已根据本法规附件VII第4.3节第二项签署了一份书面协议，对过期证书所涵盖的器械或旨在替代该器械的器械进行合格评定;
a competent authority of a Member State has granted a derogation from the applicable conformity assessment procedure in accordance with Article 59(1) of this Regulation or has required the manufacturer, in accordance with Article 97(1) of this Regulation, to carry out the applicable conformity assessment procedure.
成员国主管当局已根据本条例第59条第（1）款准予减损适用的合格评定程序，或已根据本规章第97条第（1）款要求制造商执行适用的合格评定程序。
三、通过减损第5条，只要符合本条第3c款规定的条件，本条第3a款和第3b款所指的设备可以投放市场或投入使用，直至这些款规定的日期为止。
Devices which have a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and that is valid by virtue of paragraph 2 of this Article may be placed on the market or put into service until the following dates:
31 December 2027, for all class III devices, and for class IIb implantable devices except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors;
2027 年 12 月 31 日，适用于所有 III 类器械和 IIb 类植入式器械，缝合线、订书钉、牙科填充物、牙套、牙冠、螺钉、楔子、板、电线、销钉、夹子和连接器除外;
31 December 2028, for class IIb devices other than those covered by point (a) of this paragraph, for class IIa devices, and for class I devices placed on the market in sterile condition or having a measuring function.
2028 年 12 月 31 日，适用于本段 （a） 点涵盖的 IIb 类器械、IIa 类器械以及以无菌状态投放市场或具有测量功能的 I 类器械。
3a.具有根据指令 90/385/EEC 或指令 93/42/EEC 颁发的证书且根据本条第 2 款有效的设备可以在以下日期之前投放市场或投入使用：
3b.根据指令 93/42/EEC 的合格评定程序不需要指定机构参与的器械，其符合性声明是在 2021 年 5 月 26 日之前起草的，并且根据本法规的合格评定程序需要指定机构的参与，可以在 2028 年 12 月 31 日之前投放市场或投入使用。
Devices referred to in paragraphs 3a and 3b of this Article may be placed on the market or put into service until the dates referred to in those paragraphs only if the following conditions are met:
those devices continue to comply with Directive 90/385/EEC or Directive 93/42/EEC, as applicable;
这些设备继续符合指令 90/385/EEC 或指令 93/42/EEC（如适用）;
there are no significant changes in the design and intended purpose;
设计和预期目的没有重大变化;
the devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health;
这些设备不会对患者、用户或其他人员的健康或安全，或对保护公众健康的其他方面构成不可接受的风险;
no later than 26 May 2024, the manufacturer has put in place a quality management system in accordance with Article 10(9);
不迟于2024年5月26日，制造商已根据第10（9）条建立质量管理体系;
no later than 26 May 2024, the manufacturer or the authorised representative has lodged a formal application with a notified body in accordance with Section 4.3, first subparagraph, of Annex VII for conformity assessment in respect of a device referred to in paragraph 3a or 3b of this Article or in respect of a device intended to substitute that device, and, no later than 26 September 2024, the notified body and the manufacturer have signed a written agreement in accordance with Section 4.3, second subparagraph, of Annex VII.
不迟于2024年5月26日，制造商或授权代表已根据附件VII第4.3节第1项的规定向指定机构提交正式申请，要求对本条第3a款或第3b款所述的器械或旨在替代该器械的器械进行合格评定， 并且，不迟于 2024 年 9 月 26 日，公告机构和制造商已根据附件 VII 第 4.3 节第 2 项签署书面协议。
3c.本条第3a款和第3b款所指的设备只有在满足下列条件的情况下，才能投放市场或投入使用，直至这些款所指的日期：
三维。通过减损本条第3款，本条例有关上市后监督、市场监督、警戒、经济经营者和设备登记的要求应适用于本条第3a款和第3b款所述的设备，以取代指令90/385/EEC和93/42/EEC中的相应要求。
3e.在不损害第四章和本条第1款的情况下，颁发本条第3a款所指证书的公告机构应继续负责就其所认证的器械的适用要求进行适当的监督，除非制造商已与根据第42条指定的公告机构商定，后者应进行这种监督。
No later than 26 September 2024, the notified body that has signed the written agreement referred to in paragraph 3c, point (e), of this Article shall be responsible for the surveillance in respect of the devices covered by the written agreement. Where the written agreement covers a device intended to substitute a device which has a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC, the surveillance shall be conducted in respect of the device that is being substituted.
不迟于 2024 年 9 月 26 日，签署本条第 3c 款 （e） 项所述书面协议的公告机构应负责对书面协议所涵盖的设备进行监督。如果书面协议涵盖旨在替代具有根据指令 90/385/EEC 或指令 93/42/EEC 颁发证书的器械的器械，则应对被替换的器械进行监视。
The arrangements for the transfer of the surveillance from the notified body that issued the certificate to the notified body designated in accordance with Article 42 shall be clearly defined in an agreement between the manufacturer and the notified body designated in accordance with Article 42 and, where practicable, the notified body that issued the certificate. The notified body designated in accordance with Article 42 shall not be responsible for conformity assessment activities carried out by the notified body that issued the certificate.
制造商与根据第42条指定的公告机构以及在可行的情况下，颁发证书的公告机构之间的协议中应明确规定将监督从颁发证书的公告机构转移到根据第42条指定的公告机构的安排。根据第42条指定的公告机构不对颁发证书的公告机构进行的合格评定活动负责。
3楼。根据第5条的减损，第三类定制植入式器械可以在2026年5月26日之前投放市场或投入使用，而无需根据第52条第（8）款第2项所述的合格评定程序由指定机构颁发证书，但不得迟于2024年5月26日， 制造商或授权代表已根据附件VII第4.3节第1项向指定机构提交正式合格评定申请，并且不迟于2024年9月26日，指定机构与制造商已根据附件VII第4.3节第2项签署书面协议。
4. 在2021年5月26日之前根据指令90/385/EEC和93/42/EEC合法投放市场的器械，以及根据本条第3、3a、3b和3f款自2021年5月26日起合法投放市场的器械，可以继续在市场上销售或投入使用。
5. 通过减损指令 90/385/EEC 和 93/42/EEC，符合本法规的器械可在 ►M1 2021 年 5 月 26 日之前投放市场。
6. 通过减损指令 90/385/EEC 和 93/42/EEC，可以在 2021 年 5 月 26 日之前指定和通知符合本法规的合格评定机构。根据本规指定和通知的公告机构，可在2021年5月26日前执行本规例规定的合格评定程序，并按照本规例颁发证书。
7. 对于受第54条规定的磋商程序约束的器械，本条第5款应适用，但必须对MDCG和专家小组进行了必要的任命。
8. 通过减损第10a条、第90/385/EEC号指令第10b（1）条和第11（5）条（a）点以及第93/42/EEC号指令第14（1）和（2）条、第14a（1）条（a）和（b）点以及第16（5）条，制造商、授权代表、进口商和公告机构，从第123条第（3）款（d）点所述日期的较晚者开始至18个月结束之后，遵守本条例第29（4）、31（1）和56（5）条应被视为符合成员国分别根据第90/385/EEC指令第10a条或第93/42/EEC指令第14（1）和（2）条通过的法律和法规，分别符合第90/385/EEC号指令第10b（1）条（a）项或第93/42/EEC号指令第14a（1）条（a）和（b）点，以及， 分别是第2010/227/EU号决定中规定的第90/385/EEC号指令第11（5）条或第93/42/EEC号指令第16（5）条。
9. 成员国主管当局根据第90/385/EEC号指令第9条第（9）款或第93/42/EEC号指令第11（13）条授予的授权应保持授权中注明的有效性。
10. 根据第1条第（6）款第（g）项属于本条例范围的器械，如果已根据2021年5月26日之前在成员国生效的规则合法投放市场或投入使用，可以继续在有关成员国投放市场并投入使用。
11. 在 ►M1 2021 年 5 月 26 日之前，已根据第 90/385/EEC 指令第 10 条或指令 93/42/EEC 第 15 条开始进行的临床研究可以继续进行。但是，自 2021 年 5 月 26 日 ◄ M1 起，严重不良事件和设备缺陷的报告应按照本法规进行。
12. 在委员会根据第27条第（2）款指定发行实体之前，GS1、HIBCC和ICCBBA应被视为指定发行实体。
Article 121 第一百二十一条
Evaluation 评估
By 27 May 2027, the Commission shall assess the application of this Regulation and produce an evaluation report on the progress towards achievement of the objectives contained herein including an assessment of the resources required to implement this Regulation. Special attention shall be given to the traceability of medical devices through the storage, pursuant to Article 27, of the UDI by economic operators, health institutions and health professionals.
在2027年5月27日之前，委员会应评估本条例的适用情况，并就实现本条例所载目标的进展情况提出评估报告，包括评估实施本条例所需的资源。应特别注意经济经营者、卫生机构和卫生专业人员根据《UDI》第27条储存医疗器械的可追溯性。
Article 122 第一百二十二条
Repeal 废除
Without prejudice to Article 120(3) to (3e) and (4) of this Regulation, and without prejudice to the obligations of the Member States and manufacturers as regards vigilance and to the obligations of manufacturers as regards the making available of documentation, under Directives 90/385/EEC and 93/42/EEC, those Directives are repealed with effect from 26 May 2021, with the exception of:
在不影响本条例第120（3）至（3e）和（4）条的情况下，在不影响成员国和制造商在警惕方面的义务以及制造商在提供文件方面的义务的情况下，根据第90/385/EEC号指令和93/42/EEC号指令，这些指令自2021年5月26日起废止， 以下情况除外：
第90/385/EEC号指令第8条和第10条、第10b（1）条（b）和（c）项、第10b（2）条和第10b（3）条，以及相应附件中规定的与警戒和临床调查有关的义务，自本条例第123（3）条（d）点所述日期的较晚者起废止;
第90/385/EEC号指令第10a条第（1）款第（a）项和第11条第（5）款，以及与设备和经济经营者注册有关的义务，以及相应附件中规定的证书通知的义务，自本条例第123条第（3）款（d）点所述日期（以较晚者为准）后18个月起废止;
第93/42/EEC号指令第10条、第14a（1）条（c）和（d）项、第14a（2）条、第14a（3）条和第15条，以及相应附件中规定的与警戒和临床调查有关的义务，自本条例第123条第（3）款（d）点所述日期的较晚者起废止;和
第14条第（1）款和第（2）款、第14a（1）条（a）和（b）点以及第93/42/EEC号指令第16（5）条，以及与设备和经济经营者注册有关的义务，以及相应附件中规定的证书通知的义务，这些义务自本条例第123条第（3）款（d）点所述日期（以较晚者为准）后18个月起废止;和
指令90/385/EEC第9（9）条和指令93/42/EEC第11（13）条，自2020年4月24日起废止。
As regards the devices referred to in Article 120(3) to (3e) and (4) of this Regulation, the Directives referred to in the first paragraph of this Article shall continue to apply to the extent necessary for the application of those paragraphs.
对于本条例第120条第（3）款至第（3e）款和第（4）款所述的设备，本条第1款所述的指令应在适用这些款所需的范围内继续适用。
Notwithstanding the first paragraph, Regulations (EU) No 207/2012 and (EU) No 722/2012 shall remain in force and continue to apply unless and until repealed by implementing acts adopted by the Commission pursuant to this Regulation.
尽管有第1款的规定，（EU）第207/2012号条例和（EU）第722/2012号条例应继续有效并继续适用，除非且直至委员会根据本条例通过的实施法案废除。
References to the repealed Directives shall be understood as references to this Regulation and shall be read in accordance with the correlation table laid down in Annex XVII to this Regulation.
对已废止指令的引用应理解为对本条例的引用，并应根据本规则附件XVII中规定的相关表进行解读。
Article 123 第一百二十三条
Entry into force and date of application
生效日期和适用日期
一、本条例自《欧洲联盟官方公报》公布后第二十天起生效。
By way of derogation from paragraph 2:
通过减损第2款：
Articles 35 to 50 shall apply from 26 November 2017. However, from that date until
►M1
26 May 2021 ◄ , the obligations on notified bodies pursuant to Articles 35 to 50 shall apply only to those bodies which submit an application for designation in accordance with Article 38;
第35条至第50条自2017年11月26日起适用。但是，从该日期起至►M1 2021年5月26日◄，公告机构根据第35条至第50条承担的义务仅适用于根据第38条提交指定申请的机构;
Articles 101 and 103 shall apply from 26 November 2017;
第101条和第103条自2017年11月26日起适用;
Article 102 shall apply from 26 May 2018;
第102条自2018年5月26日起适用;
without prejudice to the obligations on the Commission pursuant to Article 34, where, due to circumstances that could not reasonably have been foreseen when drafting the plan referred to in Article 34(1), Eudamed is not fully functional on
►M1
26 May 2021 ◄ , the obligations and requirements that relate to Eudamed shall apply from the date corresponding to six months after the date of publication of the notice referred to in Article 34(3). The provisions referred to in the preceding sentence are:
在不影响委员会根据第34条承担的义务的情况下，如果由于在起草第34条第（1）款所述计划时无法合理预见的情况，Eudamed在2021年5月26日◄M1未完全发挥作用，则与Eudamed有关的义务和要求应自第34条第（3）款所述通知发布之日起六个月后适用。前一句所指的规定是：
第40条第（2）款第二句，
第44条第（12）款第2项，
第46条第（7）款（d）和（e）项，
第78条第1款至第13款，
第89条第（5）款和第（7）款，以及第89条第（8）款第3项，
第93条第（4）款、第（7）款和第（8）款，
第97条第（2）款最后一句，
Until Eudamed is fully functional, the corresponding provisions of Directives 90/385/EEC and 93/42/EEC shall continue to apply for the purpose of meeting the obligations laid down in the provisions listed in the first paragraph of this point regarding exchange of information including, and in particular, information regarding vigilance reporting, clinical investigations, registration of devices and economic operators, and certificate notifications.
在Eudamed完全发挥作用之前，指令90/385/EEC和93/42/EEC的相应规定应继续适用，以履行本点第一段中关于交换信息的规定中规定的义务，特别是有关警戒报告、临床调查、设备注册和经济运营商的信息。 和证书通知。
Article 29(4) and Article 56(5) shall apply from 18 months after the later of the dates referred to in point (d);
第29条第（4）款和第56条第（5）款应自（d）点所述日期（以较晚者为准）后18个月起适用;
for implantable devices and for class III devices Article 27(4) shall apply from 26 May 2021. For class IIa and class IIb devices Article 27(4) shall apply from 26 May 2023. For class I devices Article 27(4) shall apply from 26 May 2025;
对于植入式器械和III类器械，第27（4）条应自2021年5月26日起适用。对于IIa类和IIb类器械，第27（4）条应自2023年5月26日起适用。对于I类器械，第27条第（4）款自2025年5月26日起适用;
with regard to reusable devices that are required to bear the UDI carrier on the device itself, Article 27(4) shall apply to:
对于需要在设备本身上携带UDI载体的可重复使用设备，第27条第（4）款应适用于：
implantable devices and class III devices from 26 May 2023;
自 2023 年 5 月 26 日起，植入式器械和 III 类器械;
class IIa and class IIb devices from 26 May 2025;
自 2025 年 5 月 26 日起的 IIa 类和 IIb 类设备;
class I devices from 26 May 2027;
自 2027 年 5 月 26 日起的 I 类设备;
The procedure set out in Article 78 shall apply from 26 May 2027, without prejudice to Article 78(14);
第78条规定的程序自2027年5月26日起适用，不影响第78条第（14）款;
Article 120(12) shall apply from 26 May 2019;
第120（12）条自2019年5月26日起适用;
Article 59 shall apply from 24 April 2020.
第59条自2020年4月24日起适用。
This Regulation shall be binding in its entirety and directly applicable in all Member States.
本条例对所有成员国均具有约束力，并直接适用于所有成员国。
ANNEXES 附件
|
I |
General safety and performance requirements |
|
II |
Technical documentation 技术文档 |
|
III |
Technical documentation on post-market surveillance |
|
IV |
EU declaration of conformity |
|
V |
CE marking of conformity |
|
VI |
Information to be submitted upon the registration of devices and economic operators in accordance with Articles 29(4) and 31; core data elements to be provided to the UDI database together with the UDI-DI in accordance with Articles 28 and 29;and the UDI system |
|
VII |
Requirements to be met by notified bodies |
|
VIII |
Classification rules 分类规则 |
|
IX |
Conformity assessment based on a quality management system and assessment of the technical documentation |
|
X |
Conformity assessment based on type examination |
|
XI |
Conformity assessment based on product conformity verification |
|
XII |
Certificates issued by a notified body |
|
XIII |
Procedure for custom-made devices |
|
XIV |
Clinical evaluation and post-market clinical follow-up |
|
XV |
Clinical investigations 临床检查 |
|
XVI |
List of groups of products without an intended medical purpose referred to in Article 1(2) |
|
XVII |
Correlation table 相关表 |
ANNEX I 附件一
GENERAL SAFETY AND PERFORMANCE REQUIREMENTS
一般安全和性能要求
CHAPTER I 第一章
GENERAL REQUIREMENTS 一般要求
|
1. |
Devices shall achieve the performance intended by their manufacturer and shall be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose. They shall be safe and effective and shall not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety, taking into account the generally acknowledged state of the art. |
|
2. |
The requirement in this Annex to reduce risks as far as possible means the reduction of risks as far as possible without adversely affecting the benefit-risk ratio. |
|
3. |
Manufacturers shall establish, implement, document and maintain a risk management system. Risk management shall be understood as a continuous iterative process throughout the entire lifecycle of a device, requiring regular systematic updating. In carrying out risk management manufacturers shall:
(a) （一）
establish and document a risk management plan for each device;
(b) （二）
identify and analyse the known and foreseeable hazards associated with each device;
(c) （三）
estimate and evaluate the risks associated with, and occurring during, the intended use and during reasonably foreseeable misuse;
(d) （四）
eliminate or control the risks referred to in point (c) in accordance with the requirements of Section 4;
(e) （五）
evaluate the impact of information from the production phase and, in particular, from the post-market surveillance system, on hazards and the frequency of occurrence thereof, on estimates of their associated risks, as well as on the overall risk, benefit-risk ratio and risk acceptability; and
(f) （六）
based on the evaluation of the impact of the information referred to in point (e), if necessary amend control measures in line with the requirements of Section 4. |
|
4. |
Risk control measures adopted by manufacturers for the design and manufacture of the devices shall conform to safety principles, taking account of the generally acknowledged state of the art. To reduce risks, Manufacturers shall manage risks so that the residual risk associated with each hazard as well as the overall residual risk is judged acceptable. In selecting the most appropriate solutions, manufacturers shall, in the following order of priority:
(a) （一）
eliminate or reduce risks as far as possible through safe design and manufacture;
(b) （二）
where appropriate, take adequate protection measures, including alarms if necessary, in relation to risks that cannot be eliminated; and
(c) （三）
provide information for safety (warnings/precautions/contra-indications) and, where appropriate, training to users. Manufacturers shall inform users of any residual risks. |
|
5. |
In eliminating or reducing risks related to use error, the manufacturer shall:
(a) （一）
reduce as far as possible the risks related to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and
(b) （二）
give consideration to the technical knowledge, experience, education, training and use environment, where applicable, and the medical and physical conditions of intended users (design for lay, professional, disabled or other users). |
|
6. |
The characteristics and performance of a device shall not be adversely affected to such a degree that the health or safety of the patient or the user and, where applicable, of other persons are compromised during the lifetime of the device, as indicated by the manufacturer, when the device is subjected to the stresses which can occur during normal conditions of use and has been properly maintained in accordance with the manufacturer's instructions. |
|
7. |
Devices shall be designed, manufactured and packaged in such a way that their characteristics and performance during their intended use are not adversely affected during transport and storage, for example, through fluctuations of temperature and humidity, taking account of the instructions and information provided by the manufacturer. |
|
8. |
All known and foreseeable risks, and any undesirable side-effects, shall be minimised and be acceptable when weighed against the evaluated benefits to the patient and/or user arising from the achieved performance of the device during normal conditions of use. |
|
9. |
For the devices referred to in Annex XVI, the general safety requirements set out in Sections 1 and 8 shall be understood to mean that the device, when used under the conditions and for the purposes intended, does not present a risk at all or presents a risk that is no more than the maximum acceptable risk related to the product's use which is consistent with a high level of protection for the safety and health of persons. |
CHAPTER II 第二章
REQUIREMENTS REGARDING DESIGN AND MANUFACTURE
关于设计和制造的要求
10. Chemical, physical and biological properties
10. 化学、物理和生物性质
|
10.1. |
Devices shall be designed and manufactured in such a way as to ensure that the characteristics and performance requirements referred to in Chapter I are fulfilled. Particular attention shall be paid to:
(a) （一）
the choice of materials and substances used, particularly as regards toxicity and, where relevant, flammability;
(b) （二）
the compatibility between the materials and substances used and biological tissues, cells and body fluids, taking account of the intended purpose of the device and, where relevant, absorption, distribution, metabolism and excretion;
(c) （三）
the compatibility between the different parts of a device which consists of more than one implantable part;
(d) （四）
the impact of processes on material properties;
(e) （五）
where appropriate, the results of biophysical or modelling research the validity of which has been demonstrated beforehand;
(f) （六）
the mechanical properties of the materials used, reflecting, where appropriate, matters such as strength, ductility, fracture resistance, wear resistance and fatigue resistance;
(g) （七）
surface properties; and 表面特性;和
(h) （八）
the confirmation that the device meets any defined chemical and/or physical specifications. |
|
10.2. |
Devices shall be designed, manufactured and packaged in such a way as to minimise the risk posed by contaminants and residues to patients, taking account of the intended purpose of the device, and to the persons involved in the transport, storage and use of the devices. Particular attention shall be paid to tissues exposed to those contaminants and residues and to the duration and frequency of exposure. |
|
10.3. |
Devices shall be designed and manufactured in such a way that they can be used safely with the materials and substances, including gases, with which they enter into contact during their intended use; if the devices are intended to administer medicinal products they shall be designed and manufactured in such a way as to be compatible with the medicinal products concerned in accordance with the provisions and restrictions governing those medicinal products and that the performance of both the medicinal products and of the devices is maintained in accordance with their respective indications and intended use. |
|
10.4. |
Substances 物质 10.4.1. Design and manufacture of devices Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks posed by substances or particles, including wear debris, degradation products and processing residues, that may be released from the device. Devices, or those parts thereof or those materials used therein that:
—
are invasive and come into direct contact with the human body,
具有侵入性并与人体直接接触，
—
(re)administer medicines, body liquids or other substances, including gases, to/from the body, or
（重新）向身体/从身体施用药物、体液或其他物质，包括气体，或
—
transport or store such medicines, body fluids or substances, including gases, to be (re)administered to the body,
运输或储存此类药物、体液或物质，包括气体，以（重新）施用到身体， shall only contain the following substances in a concentration that is above 0,1 % weight by weight (w/w) where justified pursuant to Section 10.4.2:
(a) （一）
substances which are carcinogenic, mutagenic or toxic to reproduction (‘CMR’), of category 1A or 1B, in accordance with Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council (
5
), or
(b) （二）
substances having endocrine-disrupting properties for which there is scientific evidence of probable serious effects to human health and which are identified either in accordance with the procedure set out in Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (
6
) or, once a delegated act has been adopted by the Commission pursuant to the first subparagraph of Article 5(3) of Regulation (EU) No 528/2012 of the European Parliament and the Council (
7
), in accordance with the criteria that are relevant to human health amongst the criteria established therein. 10.4.2. Justification regarding the presence of CMR and/or endocrine-disrupting substances The justification for the presence of such substances shall be based upon:
(a) （一）
an analysis and estimation of potential patient or user exposure to the substance;
(b) （二）
an analysis of possible alternative substances, materials or designs, including, where available, information about independent research, peer-reviewed studies, scientific opinions from relevant scientific committees and an analysis of the availability of such alternatives;
(c) （三）
argumentation as to why possible substance and/ or material substitutes, if available, or design changes, if feasible, are inappropriate in relation to maintaining the functionality, performance and the benefit-risk ratios of the product; including taking into account if the intended use of such devices includes treatment of children or treatment of pregnant or breastfeeding women or treatment of other patient groups considered particularly vulnerable to such substances and/or materials; and
(d) （四）
where applicable and available, the latest relevant scientific committee guidelines in accordance with Sections 10.4.3. and 10.4.4. 10.4.3. Guidelines on phthalates For the purposes of Section 10.4., the Commission shall, as soon as possible and by 26 May 2018, provide the relevant scientific committee with a mandate to prepare guidelines that shall be ready before 26 May 2020. The mandate for the committee shall encompass at least a benefit-risk assessment of the presence of phthalates which belong to either of the groups of substances referred to in points (a) and (b) of Section 10.4.1. The benefit-risk assessment shall take into account the intended purpose and context of the use of the device, as well as any available alternative substances and alternative materials, designs or medical treatments. When deemed appropriate on the basis of the latest scientific evidence, but at least every five years, the guidelines shall be updated. 10.4.4. Guidelines on other CMR and endocrine-disrupting substances Subsequently, the Commission shall mandate the relevant scientific committee to prepare guidelines as referred to in Section 10.4.3. also for other substances referred to in points (a) and (b) of Section 10.4.1., where appropriate. 10.4.5. Labelling 10.4.5. 标签 Where devices, parts thereof or materials used therein as referred to in Section 10.4.1. contain substances referred to in points (a) or (b) of Section 10.4.1. in a concentration above 0,1 % weight by weight (w/w), the presence of those substances shall be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging, with the list of such substances. If the intended use of such devices includes treatment of children or treatment of pregnant or breastfeeding women or treatment of other patient groups considered particularly vulnerable to such substances and/or materials, information on residual risks for those patient groups and, if applicable, on appropriate precautionary measures shall be given in the instructions for use. |
|
10.5. |
Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks posed by the unintentional ingress of substances into the device taking into account the device and the nature of the environment in which it is intended to be used. |
|
10.6. |
Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks linked to the size and the properties of particles which are or can be released into the patient's or user's body, unless they come into contact with intact skin only. Special attention shall be given to nanomaterials. |
11. Infection and microbial contamination
11. 感染和微生物污染
|
11.1. |
Devices and their manufacturing processes shall be designed in such a way as to eliminate or to reduce as far as possible the risk of infection to patients, users and, where applicable, other persons. The design shall:
(a) （一）
reduce as far as possible and appropriate the risks from unintended cuts and pricks, such as needle stick injuries,
(b) （二）
allow easy and safe handling,
(c) （三）
reduce as far as possible any microbial leakage from the device and/or microbial exposure during use, and
(d) （四）
prevent microbial contamination of the device or its content such as specimens or fluids. |
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11.2. |
Where necessary devices shall be designed to facilitate their safe cleaning, disinfection, and/or re-sterilisation. |
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11.3. |
Devices labelled as having a specific microbial state shall be designed, manufactured and packaged to ensure that they remain in that state when placed on the market and remain so under the transport and storage conditions specified by the manufacturer. |
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11.4. |
Devices delivered in a sterile state shall be designed, manufactured and packaged in accordance with appropriate procedures, to ensure that they are sterile when placed on the market and that, unless the packaging which is intended to maintain their sterile condition is damaged, they remain sterile, under the transport and storage conditions specified by the manufacturer, until that packaging is opened at the point of use. It shall be ensured that the integrity of that packaging is clearly evident to the final user. |
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11.5. |
Devices labelled as sterile shall be processed, manufactured, packaged and, sterilised by means of appropriate, validated methods. |
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11.6. |
Devices intended to be sterilised shall be manufactured and packaged in appropriate and controlled conditions and facilities. |
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11.7. |
Packaging systems for non-sterile devices shall maintain the integrity and cleanliness of the product and, where the devices are to be sterilised prior to use, minimise the risk of microbial contamination; the packaging system shall be suitable taking account of the method of sterilisation indicated by the manufacturer. |
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11.8. |
The labelling of the device shall distinguish between identical or similar devices placed on the market in both a sterile and a non-sterile condition additional to the symbol used to indicate that devices are sterile. |
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12. |
Devices incorporating a substance considered to be a medicinal product and devices that are composed of substances or of combinations of substances that are absorbed by or locally dispersed in the human body.
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13. |
Devices incorporating materials of biological origin 包含生物来源材料的设备
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14. |
Construction of devices and interaction with their environment 设备的构造及其与环境的交互
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15. |
Devices with a diagnostic or measuring function 具有诊断或测量功能的设备
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16. |
Protection against radiation 防辐射保护 16.1. General 16.1. 一般规定
(a) （一）
Devices shall be designed, manufactured and packaged in such a way that exposure of patients, users and other persons to radiation is reduced as far as possible, and in a manner that is compatible with the intended purpose, whilst not restricting the application of appropriate specified levels for therapeutic and diagnostic purposes.
(b) （二）
The operating instructions for devices emitting hazardous or potentially hazardous radiation shall contain detailed information as to the nature of the emitted radiation, the means of protecting the patient and the user, and on ways of avoiding misuse and of reducing the risks inherent to installation as far as possible and appropriate. Information regarding the acceptance and performance testing, the acceptance criteria, and the maintenance procedure shall also be specified. 16.2. Intended radiation
(a) （一）
Where devices are designed to emit hazardous, or potentially hazardous, levels of ionizing and/or non-ionizing radiation necessary for a specific medical purpose the benefit of which is considered to outweigh the risks inherent to the emission, it shall be possible for the user to control the emissions. Such devices shall be designed and manufactured to ensure reproducibility of relevant variable parameters within an acceptable tolerance.
(b) （二）
Where devices are intended to emit hazardous, or potentially hazardous, ionizing and/or non-ionizing radiation, they shall be fitted, where possible, with visual displays and/or audible warnings of such emissions.
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17. |
Electronic programmable systems — devices that incorporate electronic programmable systems and software that are devices in themselves 电子可编程系统 — 包含电子可编程系统和软件的设备，这些系统和软件本身就是设备
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18. |
Active devices and devices connected to them 活动设备和连接到它们的设备
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19. |
Particular requirements for active implantable devices 有源植入式器械的特殊要求
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20. |
Protection against mechanical and thermal risks 防止机械和热风险
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21. |
Protection against the risks posed to the patient or user by devices supplying energy or substances 防止供应能量或物质的设备对患者或用户构成的风险
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22. |
Protection against the risks posed by medical devices intended by the manufacturer for use by lay persons 防止制造商拟供非专业人士使用的医疗器械带来的风险
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CHAPTER III 第三章
REQUIREMENTS REGARDING THE INFORMATION SUPPLIED WITH THE DEVICE
有关设备随附信息的要求
23. Label and instructions for use
23. 标签和使用说明
23.1. General requirements regarding the information supplied by the manufacturer
23.1. 关于制造商提供的信息的一般要求
Each device shall be accompanied by the information needed to identify the device and its manufacturer, and by any safety and performance information relevant to the user, or any other person, as appropriate. Such information may appear on the device itself, on the packaging or in the instructions for use, and shall, if the manufacturer has a website, be made available and kept up to date on the website, taking into account the following:
每个设备都应附有识别设备及其制造商所需的信息，以及与用户或任何其他人相关的任何安全和性能信息（视情况而定）。此类信息可能出现在设备本身、包装上或使用说明中，如果制造商有网站，则应在网站上提供并保持最新，同时考虑到以下几点：
The medium, format, content, legibility, and location of the label and instructions for use shall be appropriate to the particular device, its intended purpose and the technical knowledge, experience, education or training of the intended user(s). In particular, instructions for use shall be written in terms readily understood by the intended user and, where appropriate, supplemented with drawings and diagrams.
标签和使用说明的媒介、格式、内容、易读性和位置应适合特定设备、其预期用途以及预期用户的技术知识、经验、教育或培训。特别是，使用说明应以预期用户易于理解的术语编写，并在适当的情况下辅以附图和图表。
The information required on the label shall be provided on the device itself. If this is not practicable or appropriate, some or all of the information may appear on the packaging for each unit, and/or on the packaging of multiple devices.
标签上所需的信息应在设备本身上提供。如果这不可行或不合适，则部分或全部信息可能会出现在每个单元的包装上和/或多个设备的包装上。
Labels shall be provided in a human-readable format and may be supplemented by machine-readable information, such as radio-frequency identification (‘RFID’) or bar codes.
标签应以人类可读的格式提供，并可辅以机器可读信息，例如射频识别 （'RFID'） 或条形码。
Instructions for use shall be provided together with devices. By way of exception, instructions for use shall not be required for class I and class IIa devices if such devices can be used safely without any such instructions and unless otherwise provided for elsewhere in this Section.
使用说明应与设备一起提供。作为例外，如果 I 类和 IIa 类设备可以在没有任何此类说明的情况下安全使用，并且除非本节其他地方另有规定，否则不需要使用说明。
Where multiple devices are supplied to a single user and/or location, a single copy of the instructions for use may be provided if so agreed by the purchaser who in any case may request further copies to be provided free of charge.
如果向单个用户和/或地点提供多个设备，则在购买者同意的情况下，可以提供使用说明的单一副本，在任何情况下都可以要求免费提供更多副本。
Instructions for use may be provided to the user in non-paper format (e.g. electronic) to the extent, and only under the conditions, set out in Regulation (EU) No 207/2012 or in any subsequent implementing rules adopted pursuant to this Regulation.
使用说明可以以非纸质格式（例如电子形式）提供给用户，但仅限于法规 （EU） No 207/2012 或根据本法规通过的任何后续实施规则中规定的条件。
Residual risks which are required to be communicated to the user and/or other person shall be included as limitations, contra-indications, precautions or warnings in the information supplied by the manufacturer.
需要传达给用户和/或其他人的剩余风险应作为限制、禁忌症、预防措施或警告包含在制造商提供的信息中。
Where appropriate, the information supplied by the manufacturer shall take the form of internationally recognised symbols. Any symbol or identification colour used shall conform to the harmonised standards or CS. In areas for which no harmonised standards or CS exist, the symbols and colours shall be described in the documentation supplied with the device.
在适当的情况下，制造商提供的信息应采用国际公认的符号形式。使用的任何符号或识别颜色均应符合协调标准或CS。在没有统一标准或 CS 的区域，符号和颜色应在设备随附的文档中描述。
23.2. Information on the label
23.2. 标签上的信息
The label shall bear all of the following particulars:
标签应标明以下所有细节：
the name or trade name of the device;
设备的名称或商品名称;
the details strictly necessary for a user to identify the device, the contents of the packaging and, where it is not obvious for the user, the intended purpose of the device;
用户识别设备、包装内容以及（如果用户不明显）设备的预期用途所必需的详细信息;
the name, registered trade name or registered trade mark of the manufacturer and the address of its registered place of business;
制造商的名称、注册商号或注册商标及其注册营业地点的地址;
if the manufacturer has its registered place of business outside the Union, the name of the authorised representative and address of the registered place of business of the authorised representative;
如果制造商的注册营业地点在欧盟以外，则授权代表的名称和授权代表的注册营业地点地址;
where applicable, an indication that the device contains or incorporates:
在适用的情况下，指示设备包含或包含：
药物物质，包括人体血液或血浆衍生物，或
人类来源的组织或细胞或其衍生物，或
法规 （EU） No 722/2012 中提及的动物源性组织或细胞或其衍生物;
where applicable, information labelled in accordance with Section 10.4.5.;
在适用的情况下，根据第 10.4.5 节标记的信息;
the lot number or the serial number of the device preceded by the words LOT NUMBER or SERIAL NUMBER or an equivalent symbol, as appropriate;
批号或设备序列号前面的“批号”或“序列号”或等效符号（视情况而定）;
the UDI carrier referred to in Article 27(4) and Part C of Annex VI;
第27条第（4）款和附件VI的C部分所指的UDI承运人;
an unambiguous indication of t the time limit for using or implanting the device safely, expressed at least in terms of year and month, where this is relevant;
明确指出安全使用或植入设备的时间限制，至少以年和月表示，如果相关;
where there is no indication of the date until when it may be used safely, the date of manufacture. This date of manufacture may be included as part of the lot number or serial number, provided the date is clearly identifiable;
如无注明可安全使用的日期，则为制造日期。该制造日期可以作为批号或序列号的一部分包含在内，前提是该日期清晰可辨;
an indication of any special storage and/or handling condition that applies;
任何适用的特殊储存和/或处理条件的指示;
if the device is supplied sterile, an indication of its sterile state and the sterilisation method;
如果器械是无菌的，则说明其无菌状态和灭菌方法;
warnings or precautions to be taken that need to be brought to the immediate attention of the user of the device, and to any other person. This information may be kept to a minimum in which case more detailed information shall appear in the instructions for use, taking into account the intended users;
需要立即提请设备用户和任何其他人注意的警告或预防措施。这些信息可以保持在最低限度，在这种情况下，更详细的信息应出现在使用说明中，同时考虑到目标用户;
if the device is intended for single use, an indication of that fact. A manufacturer's indication of single use shall be consistent across the Union;
如果设备仅供一次性使用，则说明该事实。制造商的一次性使用标志应在整个联盟内保持一致;
if the device is a single-use device that has been reprocessed, an indication of that fact, the number of reprocessing cycles already performed, and any limitation as regards the number of reprocessing cycles;
如果设备是经过再处理的一次性设备，则说明这一事实、已经执行的再处理周期数以及有关再处理周期数的任何限制;
if the device is custom-made, the words ‘custom-made device’;
如果设备是定制的，则为“定制设备”字样;
an indication that the device is a medical device. If the device is intended for clinical investigation only, the words ‘exclusively for clinical investigation’;
表明该设备是医疗设备。如果设备仅用于临床研究，则应注明“专门用于临床研究”字样;
in the case of devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed in the human body, the overall qualitative composition of the device and quantitative information on the main constituent or constituents responsible for achieving the principal intended action;
对于由旨在通过体孔引入人体或施加在皮肤上的物质或物质组合组成的装置，以及被人体吸收或局部分散在人体中的装置，则装置的总体定性组成和负责实现主要预期作用的主要成分的定量信息;
for active implantable devices, the serial number, and for other implantable devices, the serial number or the lot number.
对于有源植入式设备，序列号，对于其他植入式设备，序列号或批号。
23.3. Information on the packaging which maintains the sterile condition of a device (‘sterile packaging’)
23.3. 保持器械无菌状态的包装信息（“无菌包装”）
The following particulars shall appear on the sterile packaging:
无菌包装上应注明以下细节：
an indication permitting the sterile packaging to be recognised as such,
允许无菌包装被识别为无菌包装的指示，
a declaration that the device is in a sterile condition,
设备处于无菌状态的声明，
the method of sterilisation,
灭菌方法，
the name and address of the manufacturer,
制造商的名称和地址，
a description of the device,
设备的描述，
if the device is intended for clinical investigations, the words ‘exclusively for clinical investigations’,
如果设备用于临床研究，则“专门用于临床研究”字样，
if the device is custom-made, the words ‘custom-made device’,
如果设备是定制的，则“定制设备”字样，
the month and year of manufacture,
制造月份和年份，
an unambiguous indication of the time limit for using or implanting the device safely expressed at least in terms of year and month, and
至少以年和月表示安全使用或植入设备的时间限制的明确指示，以及
an instruction to check the instructions for use for what to do if the sterile packaging is damaged or unintentionally opened before use.
检查使用说明的说明，了解在使用前无菌包装损坏或无意打开时该怎么办。
23.4. Information in the instructions for use
23.4. 使用说明中的信息
The instructions for use shall contain all of the following particulars:
使用说明应包含以下所有细节：
the particulars referred to in points (a), (c), (e), (f), (k), (l), (n) and (r) of Section 23.2;
第 23.2 条第 （a）、（c）、（e）、（f）、（k）、（l）、（n） 和 （r） 点所述的细节;
the device's intended purpose with a clear specification of indications, contra-indications, the patient target group or groups, and of the intended users, as appropriate;
设备的预期用途，并酌情明确说明适应症、禁忌症、患者目标群体和预期用户;
where applicable, a specification of the clinical benefits to be expected.
在适用的情况下，应说明预期的临床益处。
where applicable, links to the summary of safety and clinical performance referred to in Article 32;
在适用的情况下，链接到第32条所述的安全性和临床表现摘要;
the performance characteristics of the device;
设备的性能特征;
where applicable, information allowing the healthcare professional to verify if the device is suitable and select the corresponding software and accessories;
在适用的情况下，允许医疗保健专业人员验证设备是否合适并选择相应的软件和配件的信息;
any residual risks, contra-indications and any undesirable side-effects, including information to be conveyed to the patient in this regard;
任何残留风险、禁忌症和任何不良副作用，包括在这方面向患者传达的信息;
specifications the user requires to use the device appropriately, e.g. if the device has a measuring function, the degree of accuracy claimed for it;
用户正确使用设备所需的规格，例如，如果设备具有测量功能，则要求的精度程度;
details of any preparatory treatment or handling of the device before it is ready for use or during its use, such as sterilisation, final assembly, calibration, etc., including the levels of disinfection required to ensure patient safety and all available methods for achieving those levels of disinfection;
在准备使用之前或使用过程中对设备进行的任何准备处理或处理的详细信息，例如灭菌、最终组装、校准等，包括确保患者安全所需的消毒水平以及达到这些消毒水平的所有可用方法;
any requirements for special facilities, or special training, or particular qualifications of the device user and/or other persons;
对设备用户和/或其他人的特殊设施、特殊培训或特殊资格的任何要求;
the information needed to verify whether the device is properly installed and is ready to perform safely and as intended by the manufacturer, together with, where relevant:
验证设备是否正确安装并准备好安全运行并按照制造商的预期执行所需的信息，以及相关信息：
预防性和定期维护以及任何准备性清洁或消毒的性质和频率的详细信息，
识别任何消耗性组件以及如何更换它们，
有关任何必要校准的信息，以确保设备在其预期使用寿命内正常安全地运行，以及
消除参与安装、校准或维修设备的人员所遇到的风险的方法;
if the device is supplied sterile, instructions in the event of the sterile packaging being damaged or unintentionally opened before use;
如果设备是无菌的，则在使用前无菌包装损坏或无意打开的情况下的说明;
if the device is supplied non-sterile with the intention that it is sterilised before use, the appropriate instructions for sterilisation;
如果器械是非无菌的，目的是在使用前进行灭菌，则适当的灭菌说明;
if the device is reusable, information on the appropriate processes for allowing reuse, including cleaning, disinfection, packaging and, where appropriate, the validated method of re-sterilisation appropriate to the Member State or Member States in which the device has been placed on the market. Information shall be provided to identify when the device should no longer be reused, e.g. signs of material degradation or the maximum number of allowable reuses;
如果器械可重复使用，则提供关于允许重复使用的适当流程的信息，包括清洁、消毒、包装，以及在适当情况下，适用于该器械投放市场的一个或多个成员国的经过验证的再灭菌方法。应提供信息以确定何时不应再重复使用设备，例如材料降解的迹象或允许重复使用的最大次数;
an indication, if appropriate, that a device can be reused only if it is reconditioned under the responsibility of the manufacturer to comply with the general safety and performance requirements;
在适当的情况下，表明只有在制造商的责任下对设备进行翻新以符合一般安全和性能要求时，才能重复使用;
if the device bears an indication that it is for single use, information on known characteristics and technical factors known to the manufacturer that could pose a risk if the device were to be re-used. This information shall be based on a specific section of the manufacturer's risk management documentation, where such characteristics and technical factors shall be addressed in detail. If in accordance with point (d) of Section 23.1. no instructions for use are required, this information shall be made available to the user upon request;
如果设备带有一次性使用的指示，则有关制造商已知的已知特性和技术因素的信息，如果该设备被重复使用，可能会造成风险。该信息应基于制造商风险管理文档的特定部分，其中应详细说明此类特性和技术因素。如果符合第 23.1 节 （d） 点。不需要使用说明，这些信息应根据要求提供给用户;
for devices intended for use together with other devices and/or general purpose equipment:
对于打算与其他设备和/或通用设备一起使用的设备：
识别此类装置或设备的信息，以便获得安全组合，和/或
有关对设备和设备组合的任何已知限制的信息;
if the device emits radiation for medical purposes:
如果设备出于医疗目的发射辐射：
关于发射辐射的性质、类型以及酌情的强度和分布的详细资料，
在使用设备期间保护患者、用户或其他人免受意外辐射的方法;
information that allows the user and/or patient to be informed of any warnings, precautions, contra-indications, measures to be taken and limitations of use regarding the device. That information shall, where relevant, allow the user to brief the patient about any warnings, precautions, contra-indications, measures to be taken and limitations of use regarding the device. The information shall cover, where appropriate:
允许用户和/或患者了解有关设备的任何警告、预防措施、禁忌症、要采取的措施和使用限制的信息。在相关情况下，该信息应允许用户向患者简要介绍有关设备的任何警告、预防措施、禁忌症、要采取的措施和使用限制。在适当情况下，该信息应包括：
在设备发生故障或性能变化可能影响安全时应采取的警告、预防措施和/或措施，
关于暴露于合理可预见的外部影响或环境条件的警告、预防措施和/或措施，例如磁场、外部电和电磁效应、静电放电、与诊断或治疗程序相关的辐射、压力、湿度或温度，
在特定的诊断调查、评估或治疗或其他程序（例如设备发出的电磁干扰）影响其他设备期间，设备存在合理可预见的干扰风险，应采取的警告、预防措施和/或措施，
如果该设备旨在管理人类或动物来源的医药产品、组织或细胞，或其衍生物或生物物质，则在选择要输送的物质方面存在任何限制或不相容性，
与作为设备组成部分纳入设备的药用物质或生物材料相关的警告、预防措施和/或限制;和
与设备中含有或由 CMR 物质或内分泌干扰物质组成的材料相关的预防措施，或可能导致患者或使用者致敏或过敏反应的材料;
in the case of devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body and that are absorbed by or locally dispersed in the human body, warnings and precautions, where appropriate, related to the general profile of interaction of the device and its products of metabolism with other devices, medicinal products and other substances as well as contra-indications, undesirable side-effects and risks relating to overdose;
对于由拟引入人体的物质或物质组合组成的装置，以及被人体吸收或局部分散在人体中的装置，在适当情况下，与装置及其与其他装置的代谢产物相互作用的一般概况有关的警告和预防措施， 药品和其他物质以及与过量有关的禁忌症、不良副作用和风险;
in the case of implantable devices, the overall qualitative and quantitative information on the materials and substances to which patients can be exposed;
在植入式设备的情况下，关于患者可以接触到的材料和物质的总体定性和定量信息;
warnings or precautions to be taken in order to facilitate the safe disposal of the device, its accessories and the consumables used with it, if any. This information shall cover, where appropriate:
为便于安全处置设备、其附件和与之一起使用的消耗品（如果有）而应采取的警告或预防措施。在适当情况下，这些信息应包括：
感染或微生物危害，例如被人类来源的潜在传染性物质污染的外植体、针头或手术设备，以及
物理危害，例如锐器。
If in accordance with the point (d) of Section 23.1 no instructions for use are required, this information shall be made available to the user upon request;
如果根据第 23.1 节 （d） 点不需要使用说明，则应根据要求向用户提供此信息;
for devices intended for use by lay persons, the circumstances in which the user should consult a healthcare professional;
对于拟供非专业人士使用的器械，用户应咨询医护人员的情况;
for the devices covered by this Regulation pursuant to Article 1(2), information regarding the absence of a clinical benefit and the risks related to use of the device;
对于本法规根据第1条第（2）款所涵盖的器械，有关缺乏临床益处以及与使用该器械相关的风险的信息;
date of issue of the instructions for use or, if they have been revised, date of issue and identifier of the latest revision of the instructions for use;
使用说明的发布日期，或如已修订，则发布日期和最新修订的使用说明的标识符;
a notice to the user and/or patient that any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established;
向用户和/或患者发出通知，告知与设备有关的任何严重事件应报告给制造商和用户和/或患者所在成员国的主管当局;
information to be supplied to the patient with an implanted device in accordance with Article 18;
根据第 18 条向植入装置患者提供的信息;
for devices that incorporate electronic programmable systems, including software, or software that are devices in themselves, minimum requirements concerning hardware, IT networks characteristics and IT security measures, including protection against unauthorised access, necessary to run the software as intended.
对于包含电子可编程系统（包括软件）或本身就是设备的软件的设备，有关硬件、IT 网络特性和 IT 安全措施的最低要求，包括防止未经授权的访问，这是按预期运行软件所必需的。
ANNEX II 附件二
TECHNICAL DOCUMENTATION 技术文档
The technical documentation and, if applicable, the summary thereof to be drawn up by the manufacturer shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the elements listed in this Annex.
制造商拟编制的技术文件及其摘要（如适用）应以清晰、有条理、易于搜索和明确的方式呈现，并应特别包括本附件中列出的内容。
1. DEVICE DESCRIPTION AND SPECIFICATION, INCLUDING VARIANTS AND ACCESSORIES
1. 设备描述和规格，包括型号和附件
1.1. Device description and specification
1.1. 设备描述和规范
product or trade name and a general description of the device including its intended purpose and intended users;
产品或商品名称以及设备的一般描述，包括其预期用途和预期用户;
the Basic UDI-DI as referred to in Part C of Annex VI assigned by the manufacturer to the device in question, as soon as identification of this device becomes based on a UDI system, or otherwise a clear identification by means of product code, catalogue number or other unambiguous reference allowing traceability;
一旦该设备的识别基于UDI系统，或通过产品代码、目录号或其他允许可追溯的明确参考，制造商分配给相关设备的附件VI中C部分中提及的基本UDI-DI;
the intended patient population and medical conditions to be diagnosed, treated and/or monitored and other considerations such as patient selection criteria, indications, contra-indications, warnings;
要诊断、治疗和/或监测的预期患者群体和医疗状况以及其他考虑因素，例如患者选择标准、适应症、禁忌症、警告;
principles of operation of the device and its mode of action, scientifically demonstrated if necessary;
设备的工作原理及其作用方式，必要时科学证明;
the rationale for the qualification of the product as a device;
将产品鉴定为器械的理由;
the risk class of the device and the justification for the classification rule(s) applied in accordance with Annex VIII;
器械的风险等级以及根据附件VIII适用的分类规则的理由;
an explanation of any novel features;
对任何新功能的解释;
a description of the accessories for a device, other devices and other products that are not devices, which are intended to be used in combination with it;
设备、其他设备和其他非设备产品的附件描述，旨在与之结合使用;
a description or complete list of the various configurations/variants of the device that are intended to be made available on the market;
拟在市场上提供的设备的各种配置/变体的描述或完整列表;
a general description of the key functional elements, e.g. its parts/components (including software if appropriate), its formulation, its composition, its functionality and, where relevant, its qualitative and quantitative composition. Where appropriate, this shall include labelled pictorial representations (e.g. diagrams, photographs, and drawings), clearly indicating key parts/components, including sufficient explanation to understand the drawings and diagrams;
对关键功能要素的一般描述，例如其零件/组件（包括软件，如适用）、其配方、组成、功能以及（如相关）其定性和定量组成。在适当的情况下，这应包括带标签的图形表示（例如图表、照片和图纸），清楚地指出关键部件/组件，包括对理解图纸和图表的充分解释;
a description of the raw materials incorporated into key functional elements and those making either direct contact with the human body or indirect contact with the body, e.g., during extracorporeal circulation of body fluids;
描述掺入关键功能元素的原材料以及与人体直接接触或间接接触的原材料，例如在体液的体外循环过程中;
technical specifications, such as features, dimensions and performance attributes, of the device and any variants/configurations and accessories that would typically appear in the product specification made available to the user, for example in brochures, catalogues and similar publications.
技术规格，例如设备的功能、尺寸和性能属性，以及通常出现在提供给用户的产品规格中的任何变体/配置和附件，例如在手册、目录和类似出版物中。
1.2. Reference to previous and similar generations of the device
1.2. 参考设备的上一代和类似世代
an overview of the previous generation or generations of the device produced by the manufacturer, where such devices exist;
制造商生产的上一代或几代设备（如果存在此类设备）的概述;
an overview of identified similar devices available on the Union or international markets, where such devices exist.
欧盟或国际市场上已确定的类似设备（如果存在此类设备）的概述。
2. INFORMATION TO BE SUPPLIED BY THE MANUFACTURER
2. 制造商提供的信息
A complete set of:
一整套：
器械及其包装上的一个或多个标签，例如单件包装、销售包装、运输包装（在特定管理条件下），采用拟销售器械的成员国接受的语言;和
以计划销售设备的成员国接受的语言使用说明。
3. DESIGN AND MANUFACTURING INFORMATION
3. 设计制造信息
information to allow the design stages applied to the device to be understood;
使应用于设备的设计阶段能够理解的信息;
complete information and specifications, including the manufacturing processes and their validation, their adjuvants, the continuous monitoring and the final product testing. Data shall be fully included in the technical documentation;
完整的信息和规格，包括制造工艺及其验证、佐剂、持续监控和最终产品测试。数据应完全包含在技术文件中;
identification of all sites, including suppliers and sub-contractors, where design and manufacturing activities are performed.
识别进行设计和制造活动的所有地点，包括供应商和分包商。
4. GENERAL SAFETY AND PERFORMANCE REQUIREMENTS
4. 一般安全和性能要求
The documentation shall contain information for the demonstration of conformity with the general safety and performance requirements set out in Annex I that are applicable to the device taking into account its intended purpose, and shall include a justification, validation and verification of the solutions adopted to meet those requirements. The demonstration of conformity shall include:
文件应包含用于证明符合附件 I 中规定的适用于设备的一般安全和性能要求的信息，同时考虑到其预期用途，并应包括为满足这些要求而采用的解决方案的理由、验证和验证。符合性证明应包括：
the general safety and performance requirements that apply to the device and an explanation as to why others do not apply;
适用于设备的一般安全和性能要求，以及为什么其他要求不适用;
the method or methods used to demonstrate conformity with each applicable general safety and performance requirement;
用于证明符合每个适用的一般安全和性能要求的方法或方法;
the harmonised standards, CS or other solutions applied; and
所采用的协调标准、CS 或其他解决方案;和
the precise identity of the controlled documents offering evidence of conformity with each harmonised standard, CS or other method applied to demonstrate conformity with the general safety and performance requirements. The information referred to under this point shall incorporate a cross-reference to the location of such evidence within the full technical documentation and, if applicable, the summary technical documentation.
受控文件的准确标识，提供符合每个协调标准、CS 或其他用于证明符合一般安全和性能要求的方法的证据。本点所指的信息应包括对完整技术文件中此类证据位置的交叉引用，并在适用时纳入简要技术文件中。
5. BENEFIT-RISK ANALYSIS AND RISK MANAGEMENT
5. 收益风险分析与风险管理
The documentation shall contain information on:
文件应包含以下信息：
the benefit-risk analysis referred to in Sections 1 and 8 of Annex I, and
附件一第1节和第8节中提及的惠益-风险分析，以及
the solutions adopted and the results of the risk management referred to in Section 3 of Annex I.
附件一第3节中提到的所采用的解决方案和风险管理的结果。
6. PRODUCT VERIFICATION AND VALIDATION
6. 产品验证和确认
The documentation shall contain the results and critical analyses of all verifications and validation tests and/or studies undertaken to demonstrate conformity of the device with the requirements of this Regulation and in particular the applicable general safety and performance requirements.
文件应包含为证明设备符合本法规要求，特别是适用的一般安全和性能要求而进行的所有验证和验证测试和/或研究的结果和批判性分析。
6.1. Pre-clinical and clinical data
6.1. 临床前和临床数据
results of tests, such as engineering, laboratory, simulated use and animal tests, and evaluation of published literature applicable to the device, taking into account its intended purpose, or to similar devices, regarding the pre-clinical safety of the device and its conformity with the specifications;
测试结果，例如工程、实验室、模拟使用和动物试验，以及适用于该器械的已发表文献的评估，同时考虑到其预期目的，或类似器械，关于该器械的临床前安全性及其与规范的符合性;
detailed information regarding test design, complete test or study protocols, methods of data analysis, in addition to data summaries and test conclusions regarding in particular:
有关测试设计、完整的测试或研究方案、数据分析方法的详细信息，以及数据摘要和测试结论，特别是：
设备的生物相容性，包括识别与患者或用户直接或间接接触的所有材料;
物理、化学和微生物表征;
电气安全和电磁兼容性;
软件验证和确认（描述软件设计和开发过程以及软件验证的证据，如成品设备中使用的。此信息通常应包括在最终发布之前在内部和模拟或实际用户环境中执行的所有验证、确认和测试的摘要结果。它还应解决制造商提供的信息中标识的所有不同的硬件配置和操作系统（如适用）;
稳定性，包括保质期;和
Where applicable, conformity with the provisions of Directive 2004/10/EC of the European Parliament and of the Council (
9
) shall be demonstrated.
在适用的情况下，应证明符合欧洲议会和理事会指令 2004/10/EC （9） 的规定。
Where no new testing has been undertaken, the documentation shall incorporate a rationale for that decision. An example of such a rationale would be that biocompatibility testing on identical materials was conducted when those materials were incorporated in a previous version of the device that has been legally placed on the market or put into service;
如果没有进行新的测试，文件应包括该决定的理由。这种理由的一个例子是，当相同材料被纳入已合法投放市场或投入使用的器械的先前版本时，对这些材料进行了生物相容性测试;
the clinical evaluation report and its updates and the clinical evaluation plan referred to in Article 61(12) and Part A of Annex XIV;
第61条第（12）款和附件十四A部分所述的临床评价报告及其更新和临床评价计划;
the PMCF plan and PMCF evaluation report referred to in Part B of Annex XIV or a justification why a PMCF is not applicable.
附件十四B部分提及的PMCF计划和PMCF评估报告，或PMCF不适用的理由。
6.2. Additional information required in specific cases
6.2. 特定情况下所需的其他信息
Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product within the meaning of point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma, as referred to in the first subparagraph of Article 1(8), a statement indicating this fact. In this case, the documentation shall identify the source of that substance and contain the data of the tests conducted to assess its safety, quality and usefulness, taking account of the intended purpose of the device.
如果器械包含一种物质作为不可分割的部件，如果单独使用，可被视为指令2001/83/EC第1条第2款所指的医药产品，包括第1条第（8）款所述的源自人血液或人血浆的医药产品， 表明这一事实的声明。在这种情况下，文件应确定该物质的来源，并包含为评估其安全性、质量和有用性而进行的测试数据，同时考虑到设备的预期用途。
Where a device is manufactured utilising tissues or cells of human or animal origin, or their derivatives, and is covered by this Regulation in accordance with points (f) and (g) of Article 1(6, and where a device incorporates, as an integral part, tissues or cells of human origin or their derivatives that have an action ancillary to that of the device and is covered by this Regulation in accordance with the first subparagraph of Article 1(10), a statement indicating this fact. In such a case, the documentation shall identify all materials of human or animal origin used and provide detailed information concerning the conformity with Sections 13.1. or 13.2., respectively, of Annex I.
如果器械是利用人类或动物来源的组织或细胞或其衍生物制造的，并且根据第1条第（6）款（f）和（g）项受本条例的约束，并且该器械将人源的组织或细胞或其衍生物作为组成部分，这些组织或细胞具有与该器械的作用相辅相成，并且根据第1项的规定，本条例所涵盖的第1条第（10）款，表明这一事实的声明。在这种情况下，文件应标识所使用的所有人类或动物来源的材料，并提供有关符合第 13.1 节的详细信息。或附件一的13.2.。
In the case of devices that are composed of substances or combinations of substances that are intended to be introduced into the human body and that are absorbed by or locally dispersed in the human body, detailed information, including test design, complete test or study protocols, methods of data analysis, and data summaries and test conclusions, regarding studies in relation to:
对于由打算引入人体并被人体吸收或局部分散在人体中的物质或物质组合组成的装置，详细信息，包括测试设计、完整的测试或研究方案、数据分析方法以及数据摘要和测试结论， 关于以下方面的研究：
吸收、分布、代谢和排泄;
考虑到目标人群及其相关医疗状况，这些物质或其在人体中代谢产物与其他器械、医药产品或其他物质的可能相互作用;
毒性，包括单剂量毒性、重复剂量毒性、遗传毒性、致癌性以及生殖和发育毒性，视设备暴露的程度和性质而定。
In the absence of such studies, a justification shall be provided.
如无此类研究，应说明理由。
In the case of devices containing CMR or endocrine-disrupting substances referred to in Section 10.4.1 of Annex I, the justification referred to in Section 10.4.2 of that Annex.
对于含有附件一第10.4.1节所述CMR或内分泌干扰物质的器械，则该附件第10.4.2节所述的理由。
In the case of devices placed on the market in a sterile or defined microbiological condition, a description of the environmental conditions for the relevant manufacturing steps. In the case of devices placed on the market in a sterile condition, a description of the methods used, including the validation reports, with respect to packaging, sterilisation and maintenance of sterility. The validation report shall address bioburden testing, pyrogen testing and, if applicable, testing for sterilant residues.
对于以无菌或定义的微生物状态投放市场的设备，则描述相关制造步骤的环境条件。对于以无菌状态投放市场的器械，请说明所使用的方法，包括验证报告，涉及包装、灭菌和保持无菌。验证报告应涉及生物负荷测试、热原测试以及（如适用）灭菌剂残留测试。
In the case of devices placed on the market with a measuring function, a description of the methods used in order to ensure the accuracy as given in the specifications.
对于投放市场的具有测量功能的设备，请描述为确保规格中给出的准确性而使用的方法。
If the device is to be connected to other device(s) in order to operate as intended, a description of this combination/configuration including proof that it conforms to the general safety and performance requirements when connected to any such device(s) having regard to the characteristics specified by the manufacturer.
如果设备要连接到其他设备以按预期运行，则此组合/配置的描述，包括证明它在连接到任何此类设备时符合一般安全和性能要求，同时考虑到制造商指定的特性。
ANNEX III 附件三
TECHNICAL DOCUMENTATION ON POST-MARKET SURVEILLANCE
上市后监督技术文件
The technical documentation on post-market surveillance to be drawn up by the manufacturer in accordance with Articles 83 to 86 shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the elements described in this Annex.
制造商根据第83条至第86条拟定的上市后监督技术文件应以清晰、有条理、易于检索和明确的方式提交，并应特别包括本附件所述的内容。
|
1. |
The post-market surveillance plan drawn up in accordance with Article 84. The manufacturer shall prove in a post-market surveillance plan that it complies with the obligation referred to in Article 83.
(a) （一）
The post-market surveillance plan shall address the collection and utilization of available information, in particular:
—
information concerning serious incidents, including information from PSURs, and field safety corrective actions;
有关严重事件的信息，包括来自PSUR的信息，以及现场安全纠正措施;
—
records referring to non-serious incidents and data on any undesirable side-effects;
提及非严重事件的记录和任何不良副作用的数据;
—
information from trend reporting;
来自趋势报告的信息;
—
relevant specialist or technical literature, databases and/or registers;
相关专家或技术文献、数据库和/或登记册;
—
information, including feedbacks and complaints, provided by users, distributors and importers; and
用户、分销商和进口商提供的信息，包括反馈和投诉;和
—
publicly available information about similar medical devices.
有关类似医疗器械的公开信息。
(b) （二）
The post-market surveillance plan shall cover at least:
—
a proactive and systematic process to collect any information referred to in point (a). The process shall allow a correct characterisation of the performance of the devices and shall also allow a comparison to be made between the device and similar products available on the market;
收集（a）点所述任何信息的积极和系统的过程。该过程应允许对设备的性能进行正确表征，并应允许将设备与市场上的类似产品进行比较;
—
effective and appropriate methods and processes to assess the collected data;
评估所收集数据的有效和适当的方法和程序;
—
suitable indicators and threshold values that shall be used in the continuous reassessment of the benefit-risk analysis and of the risk management as referred to in Section 3 of Annex I;
（a） 在不断重新评估附件一第3节所述的惠益-风险分析和风险管理时应使用的适当指标和阈值;
—
effective and appropriate methods and tools to investigate complaints and analyse market-related experience collected in the field;
调查投诉和分析在实地收集的与市场有关的经验的有效和适当的方法和工具;
—
methods and protocols to manage the incidents subject to the trend report as provided for in Article 88, including the methods and protocols to be used to establish any statistically significant increase in the frequency or severity of incidents as well as the observation period;
根据第88条的规定，管理受趋势报告约束的事件的方法和协议，包括用于确定事件频率或严重程度以及观察期的任何统计学上显着增加的方法和协议;
—
methods and protocols to communicate effectively with competent authorities, notified bodies, economic operators and users;
与主管当局、公告机构、经济运营商和用户进行有效沟通的方法和协议;
—
reference to procedures to fulfil the manufacturers obligations laid down in Articles 83, 84 and 86;
提及履行第83条、第84条和第86条规定的制造商义务的程序;
—
systematic procedures to identify and initiate appropriate measures including corrective actions;
确定和启动适当措施的系统程序，包括纠正措施;
—
effective tools to trace and identify devices for which corrective actions might be necessary; and
追踪和识别可能需要采取纠正措施的设备的有效工具;和
—
a PMCF plan as referred to in Part B of Annex XIV, or a justification as to why a PMCF is not applicable.
附件十四B部分所述的PMCF计划，或PMCF不适用的理由。 |
|
2. |
The PSUR referred to in Article 86 and the post-market surveillance report referred to in Article 85. |
ANNEX IV 附件四
EU DECLARATION OF CONFORMITY
欧盟符合性声明
The EU declaration of conformity shall contain all of the following information:
欧盟符合性声明应包含以下所有信息：
Name, registered trade name or registered trade mark and, if already issued, SRN as referred to in Article 31 of the manufacturer, and, if applicable, its authorised representative, and the address of their registered place of business where they can be contacted and their location be established;
制造商的名称、注册商号或注册商标，以及（如果已签发）第 31 条所述的 SRN，以及（如适用）其授权代表，以及可以联系到他们的注册营业地点的地址和确定其位置的地址;
A statement that the EU declaration of conformity is issued under the sole responsibility of the manufacturer;
欧盟符合性声明由制造商全权负责的声明;
The Basic UDI-DI as referred to in Part C of Annex VI;
附件VIC部分所述的基本UDI-DI;
Product and trade name, product code, catalogue number or other unambiguous reference allowing identification and traceability of the device covered by the EU declaration of conformity, such as a photograph, where appropriate, as well as its intended purpose. Except for the product or trade name, the information allowing identification and traceability may be provided by the Basic UDI-DI referred to in point 3;
产品和商品名称、产品代码、目录号或其他明确的参考，允许识别和追溯欧盟符合性声明所涵盖的设备，例如照片（如照片）（如适用）及其预期用途。除产品或商品名称外，允许识别和可追溯性的信息可由第 3 点中提及的基本 UDI-DI 提供;
Risk class of the device in accordance with the rules set out in Annex VIII;
根据附件VIII中规定的规则，器械的风险等级;
A statement that the device that is covered by the present declaration is in conformity with this Regulation and, if applicable, with any other relevant Union legislation that provides for the issuing of an EU declaration of conformity;
一份声明，说明本声明所涵盖的设备符合本法规，并在适用的情况下符合规定发布欧盟符合性声明的任何其他相关欧盟立法;
References to any CS used and in relation to which conformity is declared;
对使用的任何 CS 的引用以及与此相关的符合性声明;
Where applicable, the name and identification number of the notified body, a description of the conformity assessment procedure performed and identification of the certificate or certificates issued;
在适用的情况下，指定机构的名称和识别号、所执行的合格评定程序的说明以及颁发的证书的标识;
Where applicable, additional information;
在适用的情况下，附加信息;
Place and date of issue of the declaration, name and function of the person who signed it as well as an indication for, and on behalf of whom, that person signed, signature.
声明的签发地点和日期、签署声明的人的姓名和职务，以及签署声明的人和代表谁签署的声明。
ANNEX V 附件五
CE MARKING OF CONFORMITY
符合性CE标志
1. The CE marking shall consist of the initials ‘CE’ taking the following form:
1. CE标志应由首字母“CE”组成，其形式如下：
2. If the CE marking is reduced or enlarged, the proportions given in the above graduated drawing shall be respected.
2.如果CE标志被缩小或扩大，应遵守上述渐变图中给出的比例。
3. The various components of the CE marking shall have substantially the same vertical dimension, which may not be less than 5 mm. This minimum dimension may be waived for small-scale devices.
3. CE标志的各个组成部分应具有基本相同的垂直尺寸，不得小于5毫米。对于小型设备，可以免除此最小尺寸。
ANNEX VI 附件六
INFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF DEVICES AND ECONOMIC OPERATORS IN ACCORDANCE WITH ARTICLES 29(4) AND 31, CORE DATA ELEMENTS TO BE PROVIDED TO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN ACCORDANCE WITH ARTICLES 28 AND 29, AND THE UDI SYSTEM
根据第29条第（4）款和第31条对设备和经济运营商进行注册时应提交的信息，根据第28条和第29条向UDI-DI和UDI系统提供的核心数据元素
PART A 第一部分
INFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF DEVICES AND ECONOMIC OPERATORS IN ACCORDANCE WITH ARTICLES 29(4) AND 31
根据第29条第（4）款和第31条对设备和经济运营商进行注册时应提交的信息
Manufacturers or, when applicable, authorised representatives, and, when applicable, importers shall submit the information referred to in Section 1 and shall ensure that the information on their devices referred to in Section 2 is complete, correct and updated by the relevant party.
制造商或授权代表（如适用）以及进口商（如适用）应提交第 1 节所述的信息，并应确保第 2 节所述的有关其设备的信息完整、正确并由相关方更新。
1. Information relating to the economic operator
1. 与经济经营者有关的信息
type of economic operator(manufacturer, authorised representative, or importer),
经济经营者类型（制造商、授权代表或进口商），
name, address and contact details of the economic operator,
经济经营者的名称、地址和联系方式，
where submission of information is carried out by another person on behalf of any of the economic operators mentioned under Section 1.1, the name, address and contact details of that person,
如果信息是由另一人代表第 1.1 节所述的任何经济经营者提交的，则该人的姓名、地址和联系方式，
name address and contact details of the person or persons responsible for regulatory compliance referred to in Article 15.
第 15 条所述负责监管合规的人员的姓名、地址和联系方式。
2. Information relating to the device
2. 与设备相关的信息
Basic UDI-DI, 基本 UDI-DI，
type, number and expiry date of the certificate issued by the notified body and the name or identification number of that notified body and the link to the information that appears on the certificate and was entered by the notified body in the electronic system on notified bodies and certificates,
公告机构签发的证书的类型、编号和到期日，以及该公告机构的名称或识别号码，以及证书上出现的、由公告机构在公告机构和证书电子系统中输入的信息的链接，
Member State in which the device is to or has been placed on the market in the Union,
设备将进入或已经投放欧盟市场的成员国，
in the case of class IIa, class IIb or class III devices: Member States where the device is or is to be made available,
对于IIa类、IIb类或III类器械：提供或将要提供该器械的成员国，
risk class of the device,
设备的风险等级，
reprocessed single-use device (y/n),
再处理的一次性设备 （Y/N），
presence of a substance which, if used separately, may be considered to be a medicinal product and name of that substance,
存在一种物质，如果单独使用，可被视为医药产品和该物质的名称，
presence of a substance which, if used separately, may be considered to be a medicinal product derived from human blood or human plasma and name of this substance,
存在一种物质，如果单独使用，可被视为源自人体血液或人体血浆的医药产品以及该物质的名称，
presence of tissues or cells of human origin, or their derivatives (y/n),
存在人源性组织或细胞或其衍生物 （Y/N），
presence of tissues or cells of animal origin, or their derivatives, as referred to in Regulation (EU) No 722/2012 (y/n),
存在法规 （EU） No 722/2012 （y/n） 中提及的动物源性组织或细胞或其衍生物，
where applicable, the single identification number of the clinical investigation or investigations conducted in relation to the device or a link to the clinical investigation registration in the electronic system on clinical investigations,
在适用的情况下，与设备有关的临床研究或研究的单一识别号或临床研究注册的链接，
in the case of devices listed in Annex XVI, specification as to whether the intended purpose of the device is other than a medical purpose,
对于附件十六所列的器械，请说明该器械的预期用途是否不是医疗目的，
in the case of devices designed and manufactured by another legal or natural person as referred in Article 10(15), the name, address and contact details of that legal or natural person,
如果设备由第10条第（15）款所述的另一法人或自然人设计和制造，则该法人或自然人的姓名、地址和联系方式，
in the case of class III or implantable devices, the summary of safety and clinical performance,
对于III类或植入式器械，安全性和临床表现总结，
status of the device (on the market, no longer placed on the market, recalled, field safety corrective action initiated).
设备的状态（在市场上，不再投放市场，召回，现场安全纠正措施启动）。
PART B B部分
CORE DATA ELEMENTS TO BE PROVIDED TO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN ACCORDANCE WITH ARTICLES 28 AND 29
根据第28条和第29条，与UDI-DI一起提供给UDI数据库的核心数据元素
The manufacturer shall provide to the UDI database the UDI-DI and all of the following information relating to the manufacturer and the device:
制造商应向 UDI 数据库提供 UDI-DI 以及与制造商和设备相关的以下所有信息：
quantity per package configuration,
每个包配置的数量，
the Basic UDI-DI as referred to in Article 29 and any additional UDI-DIs,
第 29 条中提及的基本 UDI-DI 和任何其他 UDI-DI，
the manner in which production of the device is controlled (expiry date or manufacturing date, lot number, serial number),
控制设备生产的方式（有效期或制造日期、批号、序列号），
if applicable, the unit of use UDI-DI (where a UDI is not labelled on the device at the level of its unit of use, a ‘unit of use’ DI shall be assigned so as to associate the use of a device with a patient),
如果适用，使用单位 UDI-DI（如果 UDI 未在其使用单位级别上标记，则应分配“使用单位”DI，以便将设备的使用与患者相关联），
name and address of the manufacturer (as indicated on the label),
制造商的名称和地址（如标签上所示），
the SRN issued in accordance with Article 31(2),
根据第31条第（2）款签发的SRN，
if applicable, name and address of the authorised representative (as indicated on the label),
如适用，授权代表的姓名和地址（如标签上所示），
the medical device nomenclature code as provided for in Article 26,
第26条规定的医疗器械命名代码，
risk class of the device,
设备的风险等级，
if applicable, name or trade name,
如果适用，名称或商品名称，
if applicable, device model, reference, or catalogue number,
如果适用，设备型号、参考编号或目录号，
if applicable, clinical size (including volume, length, gauge, diameter),
如果适用，临床尺寸（包括体积、长度、规格、直径），
additional product description (optional),
附加产品描述（可选），
if applicable, storage and/or handling conditions (as indicated on the label or in the instructions for use),
如果适用，储存和/或处理条件（如标签或使用说明中所示），
if applicable, additional trade names of the device,
如果适用，设备的其他商品名称，
labelled as a single-use device (y/n),
标记为一次性设备 （Y/N），
if applicable, the maximum number of reuses,
如果适用，最大重复使用次数，
device labelled sterile (y/n),
设备标记为无菌 （Y/N），
need for sterilisation before use (y/n),
使用前需要灭菌 （Y/N），
containing latex (y/n), 含乳胶 （Y/N），
where applicable, information labelled in accordance with Section 10.4.5 of Annex I,
在适用的情况下，根据附件 I 第 10.4.5 节标记的信息，
URL for additional information, such as electronic instructions for use (optional),
其他信息的 URL，例如电子使用说明（可选），
if applicable, critical warnings or contra-indications,
如果适用，严重警告或禁忌症，
status of the device (on the market, no longer placed on the market, recalled, field safety corrective action initiated).
设备的状态（在市场上，不再投放市场，召回，现场安全纠正措施启动）。
PART C C部分
THE UDI SYSTEM UDI 系统
1. Definitions 1. 定义
Automatic identification and data capture (‘AIDC’)
自动识别和数据采集 （'AIDC'）
AIDC is a technology used to automatically capture data. AIDC technologies include bar codes, smart cards, biometrics and RFID.
AIDC 是一种用于自动捕获数据的技术。AIDC 技术包括条形码、智能卡、生物识别和 RFID。
Basic UDI-DI 基本 UDI-DI
The Basic UDI-DI is the primary identifier of a device model. It is the DI assigned at the level of the device unit of use. It is the main key for records in the UDI database and is referenced in relevant certificates and EU declarations of conformity.
基本 UDI-DI 是设备型号的主要标识符。它是在设备使用单位级别分配的 DI。它是 UDI 数据库中记录的主要密钥，并在相关证书和欧盟符合性声明中引用。
Unit of Use DI
使用单位 DI
The Unit of Use DI serves to associate the use of a device with a patient in instances in which a UDI is not labelled on the individual device at the level of its unit of use, for example in the event of several units of the same device being packaged together.
使用单位 DI 用于在单个设备上未在其使用单位级别上标记 UDI 的情况下，例如，在同一设备的多个单元打包在一起的情况下，将设备的使用与患者相关联。
Configurable device 可配置设备
A configurable device is a device that consists of several components which can be assembled by the manufacturer in multiple configurations. Those individual components may be devices in themselves.
可配置设备是由多个组件组成的设备，制造商可以将其组装成多种配置。这些单独的组件本身可能是设备。
Configurable devices include computed tomography (CT) systems, ultrasound systems, anaesthesia systems, physiological Monitoring systems, radiology information systems (RIS).
可配置设备包括计算机断层扫描 （CT） 系统、超声系统、麻醉系统、生理监测系统、放射信息系统 （RIS）。
Configuration 配置
Configuration is a combination of items of equipment, as specified by the manufacturer, that operate together as a device to achieve an intended purpose. The combination of items may be modified, adjusted or customized to meet specific needs.
配置是制造商指定的设备项目的组合，这些设备作为设备一起运行以实现预期目的。项目的组合可以修改、调整或定制以满足特定需求。
Configurations include inter alia:
配置包括：
龙门架、管子、工作台、控制台和其他设备，可以配置/组合以在计算机断层扫描中提供预期功能。
呼吸机、呼吸回路、蒸发器相结合，在麻醉中发挥预期功能。
UDI-DI UDI-DI型
The UDI-DI is a unique numeric or alphanumeric code specific to a model of device and that is also used as the ‘access key’ to information stored in a UDI database.
UDI-DI 是特定于设备型号的唯一数字或字母数字代码，也用作存储在 UDI 数据库中的信息的“访问密钥”。
Human Readable Interpretation (‘HRI’)
人类可读口译 （'HRI'）
HRI is a legible interpretation of the data characters encoded in the UDI carrier.
HRI 是对 UDI 载波中编码的数据字符的清晰解释。
Packaging levels 包装水平
Packaging levels means the various levels of device packaging that contain a defined quantity of devices, such as a carton or case.
包装级别是指包含定义数量的设备（如纸箱或箱子）的各种设备包装级别。
UDI-PI UDI-PI型
The UDI-PI is a numeric or alphanumeric code that identifies the unit of device production.
UDI-PI 是用于标识设备生产单位的数字或字母数字代码。
The different types of UDI-PIs include serial number, lot number, software identification and manufacturing or expiry date or both types of date.
不同类型的 UDI-PI 包括序列号、批号、软件标识和制造或到期日期，或两者兼而有之。
Radio Frequency Identification RFID
射频识别RFID
RFID is a technology that uses communication through the use of radio waves to exchange data between a reader and an electronic tag attached to an object, for the purpose of identification.
RFID是一种通过使用无线电波进行通信的技术，在阅读器和附着在物体上的电子标签之间交换数据，以达到识别的目的。
Shipping containers 集装箱
A shipping container is a container in relation to which traceability is controlled by a process specific to logistics systems.
海运集装箱是一种集装箱，其可追溯性由特定于物流系统的流程控制。
Unique Device Identifier (‘UDI’)
唯一设备标识符 （'UDI'）
The UDI is a series of numeric or alphanumeric characters that is created through a globally accepted device identification and coding standard. It allows the unambiguous identification of a specific device on the market. The UDI is comprised of the UDI-DI and the UDI-PI.
UDI 是通过全球公认的设备标识和编码标准创建的一系列数字或字母数字字符。它允许明确识别市场上的特定设备。UDI 由 UDI-DI 和 UDI-PI 组成。
The word ‘Unique’ does not imply serialisation of individual production units.
“独特”一词并不意味着单个生产单元的序列化。
UDI carrier UDI 载体
The UDI carrier is the means of conveying the UDI by using AIDC and, if applicable, its HRI.
UDI 载体是使用 AIDC 及其 HRI（如果适用）传输 UDI 的手段。
UDI carriers include, inter alia, ID/linear bar code, 2D/Matrix bar code, RFID.
UDI 载体包括 ID/线性条码、2D/矩阵条码、RFID。
2. General requirements 2. 一般要求
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2.1. |
The affixing of the UDI is an additional requirement — it does not replace any other marking or labelling requirements laid down in Annex I to this Regulation. |
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2.2. |
The manufacturer shall assign and maintain unique UDIs for its devices. |
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2.3. |
Only the manufacturer may place the UDI on the device or its packaging. |
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2.4. |
Only coding standards provided by issuing entities designated by the Commission pursuant to Article 27(2) may be used. |
3. The UDI 3. UDI
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3.1. |
A UDI shall be assigned to the device itself or its packaging. Higher levels of packaging shall have their own UDI. |
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3.2. |
Shipping containers shall be exempted from the requirement in Section 3.1. By way of example, a UDI shall not be required on a logistics unit; where a healthcare provider orders multiple devices using the UDI or model number of individual devices and the manufacturer places those devices in a container for shipping or to protect the individually packaged devices, the container (logistics unit) shall not be subject to UDI requirements. |
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3.3. |
The UDI shall contain two parts: a UDI-DI and a UDI-PI. |
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3.4. |
The UDI-DI shall be unique at each level of device packaging. |
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3.5. |
If a lot number, serial number, software identification or expiry date appears on the label, it shall be part of the UDI-PI. If there is also a manufacturing date on the label, it does not need to be included in the UDI-PI. If there is only a manufacturing date on the label, this shall be used as the UDI-PI. |
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3.6. |
Each component that is considered to be a device and is commercially available on its own shall be assigned a separate UDI unless the components are part of a configurable device that is marked with its own UDI. |
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3.7. |
Systems and procedure packs as referred to in Article 22 shall be assigned and bear their own UDI. |
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3.8. |
The manufacturer shall assign the UDI to a device following the relevant coding standard. |
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3.9. |
A new UDI-DI shall be required whenever there is a change that could lead to misidentification of the device and/or ambiguity in its traceability; in particular, any change of one of the following UDI database data elements shall require a new UDI-DI:
(a) （一）
name or trade name,
(b) （二）
device version or model,
(c) （三）
labelled as single use,
(d) （四）
packaged sterile, 包装无菌，
(e) （五）
need for sterilization before use,
(f) （六）
quantity of devices provided in a package,
(g) （七）
critical warnings or contra-indications: e.g. containing latex or DEHP. |
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3.10. |
Manufacturers that repackage and/or relabel devices, with their own label shall retain a record of the original device manufacturer's UDI. |
4. UDI carrier 4. UDI载体
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4.1. |
The UDI carrier (AIDC and HRI representation of the UDI) shall be placed on the label or on the device itself and on all higher levels of device packaging. Higher levels do not include shipping containers. |
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4.2. |
In the event of there being significant space constraints on the unit of use packaging, the UDI carrier may be placed on the next higher packaging level. |
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4.3. |
For single-use devices of classes I and IIa packaged and labelled individually, the UDI carrier shall not be required to appear on the packaging but it shall appear on a higher level of packaging, e.g. a carton containing several individually packaged devices. However, when the healthcare provider is not expected to have access, in cases such as in home healthcare settings, to the higher level of device packaging, the UDI shall be placed on the packaging of the individual device. |
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4.4. |
For devices exclusively intended for retail point of sale the UDI-PIs in AIDC shall not be required to appear on the point of sale packaging. |
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4.5. |
When AIDC carriers other than the UDI carrier are part of the product labelling, the UDI carrier shall be readily identifiable. |
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4.6. |
If linear bar codes are used, the UDI-DI and UDI-PI may be concatenated or non-concatenated in two or more bar codes. All parts and elements of the linear bar code shall be distinguishable and identifiable. |
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4.7. |
If there are significant constraints limiting the use of both AIDC and HRI on the label, only the AIDC format shall be required to appear on the label. For devices intended to be used outside healthcare facilities, such as devices for home care, the HRI shall however appear on the label even if this results in there being no space for the AIDC. |
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4.8. |
The HRI format shall follow the rules of the UDI code-issuing entity. |
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4.9. |
If the manufacturer is using RFID technology, a linear or 2D bar code in line with the standard provided by the issuing entities shall also be provided on the label. |
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4.10. |
Devices that are reusable shall bear a UDI carrier on the device itself. The UDI carrier for reusable devices that require cleaning, disinfection, sterilisation or refurbishing between patient uses shall be permanent and readable after each process performed to make the device ready for the subsequent use throughout the intended lifetime of the device. The requirement of this Section shall not apply to devices in the following circumstances:
(a) （一）
any type of direct marking would interfere with the safety or performance of the device;
(b) （二）
the device cannot be directly marked because it is not technologically feasible. |
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4.11. |
The UDI carrier shall be readable during normal use and throughout the intended lifetime of the device. |
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4.12. |
If the UDI carrier is readily readable or, in the case of AIDC, scannable, through the device's packaging, the placing of the UDI carrier on the packaging shall not be required. |
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4.13. |
In the case of single finished devices made up of multiple parts that must be assembled before their first use, it shall be sufficient to place the UDI carrier on only one part of each device. |
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4.14. |
The UDI carrier shall be placed in a manner such that the AIDC can be accessed during normal operation or storage. |
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4.15. |
Bar code carriers that include both a UDI-DI and a UDI-PI may also include essential data for the device to operate or other data. |
5. General principles of the UDI database
5. UDI数据库的一般原则
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5.1. |
The UDI database shall support the use of all core UDI database data elements referred to in Part B of this Annex. |
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5.2. |
Manufacturers shall be responsible for the initial submission and updates of the identifying information and other device data elements in the UDI database. |
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5.3. |
Appropriate methods/procedures for validation of the data provided shall be implemented. |
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5.4. |
Manufacturers shall periodically verify the correctness of all of the data relevant to devices they have placed on the market, except for devices that are no longer available on the market. |
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5.5. |
The presence of the device UDI-DI in the UDI database shall not be assumed to mean that the device is in conformity with this Regulation. |
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5.6. |
The database shall allow for the linking of all the packaging levels of the device. |
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5.7. |
The data for new UDI-DIs shall be available at the time the device is placed on the market. |
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5.8. |
Manufacturers shall update the relevant UDI database record within 30 days of a change being made to an element, which does not require a new UDI-DI. |
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5.9. |
Internationally-accepted standards for data submission and updates shall, wherever possible, be used by the UDI database. |
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5.10. |
The user interface of the UDI database shall be available in all official languages of the Union. The use of free-text fields shall, however, be minimized in order to reduce translations. |
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5.11. |
Data relating to devices that are no longer available on the market shall be retained in the UDI database. |
6. Rules for specific device types
6. 特定设备类型的规则
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6.1. |
Implantable devices: 植入式设备：
6.1.1.
Implantable devices shall, at their lowest level of packaging (‘unit packs’), be identified, or marked using AIDC, with a UDI (UDI-DI + UDI-PI);
6.1.2.
The UDI-PI shall have at least the following characteristics:
(a) （一）
the serial number for active implantable devices,
(b) （二）
the serial number or lot number for other implantable devices.
6.1.3.
The UDI of the implantable device shall be identifiable prior to implantation. |
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6.2. |
Reusable devices requiring cleaning, disinfection, sterilisation or refurbishing between uses 需要在两次使用之间进行清洁、消毒、灭菌或翻新的可重复使用的设备
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6.3. |
Systems and procedure packs as referred to in Article 22 第22条所述的系统和程序包
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6.4. |
Configurable devices: 可配置设备：
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6.5. |
Device Software 设备软件 6.5.1. UDI assignment Criteria The UDI shall be assigned at the system level of the software. Only software which is commercially available on its own and software which constitutes a device in itself shall be subject to that requirement. The software identification shall be considered to be the manufacturing control mechanism and shall be displayed in the UDI-PI.
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ANNEX VII 附件七
REQUIREMENTS TO BE MET BY NOTIFIED BODIES
公告机构应满足的要求
1. ORGANISATIONAL AND GENERAL REQUIREMENTS
1. 组织和一般要求
1.1. Legal status and organisational structure
1.1. 法律地位和组织结构
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1.1.1. |
Each notified body shall be established under the national law of a Member State, or under the law of a third country with which the Union has concluded an agreement in this respect. Its legal personality and status shall be fully documented. Such documentation shall include information about ownership and the legal or natural persons exercising control over the notified body. |
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1.1.2. |
If the notified body is a legal entity that is part of a larger organisation, the activities of that organisation as well as its organisational structure and governance, and the relationship with the notified body shall be clearly documented. In such cases, the requirements of Section 1.2 are applicable to both the notified body and the organisation to which it belongs. |
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1.1.3. |
If a notified body wholly or partly owns legal entities established in a Member State or in a third country or is owned by another legal entity, the activities and responsibilities of those entities, as well as their legal and operational relationships with the notified body, shall be clearly defined and documented. Personnel of those entities performing conformity assessment activities under this Regulation shall be subject to the applicable requirements of this Regulation. |
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1.1.4. |
The organisational structure, allocation of responsibilities, reporting lines and operation of the notified body shall be such that they ensure that there is confidence in the performance by the notified body and in the results of the conformity assessment activities it conducts. |
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1.1.5. |
The notified body shall clearly document its organisational structure and the functions, responsibilities and authority of its top-level management and of other personnel who may have an influence upon the performance by the notified body and upon the results of its conformity assessment activities. |
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1.1.6. |
The notified body shall identify the persons in top-level management that have overall authority and responsibility for each of the following:
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the provision of adequate resources for conformity assessment activities;
为合格评定活动提供充足的资源;
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the development of procedures and policies for the operation of the notified body;
制定指定机构运作的程序和政策;
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the supervision of implementation of the procedures, policies and quality management systems of the notified body;
监督指定机构的程序、政策和质量管理体系的实施情况;
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the supervision of the notified body's finances;
对公告机构财务的监督;
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the activities and decisions taken by the notified body, including contractual agreements;
指定机构的活动和决定，包括合同协议;
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the delegation of authority to personnel and/or committees, where necessary, for the performance of defined activities;
必要时将权力下放给人事和/或委员会，以执行规定的活动;
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the interaction with the authority responsible for notified bodies and the obligations regarding communications with other competent authorities, the Commission and other notified bodies.
与负责公告机构的主管部门的互动，以及与其他主管当局、委员会和其他公告机构沟通的义务。 |
1.2. Independence and impartiality
1.2. 独立性和公正性
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1.2.1. |
The notified body shall be a third-party body that is independent of the manufacturer of the device in relation to which it performs conformity assessment activities. The notified body shall also be independent of any other economic operator having an interest in the device as well as of any competitors of the manufacturer. This does not preclude the notified body from carrying out conformity assessment activities for competing manufacturers. |
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1.2.2. |
The notified body shall be organised and operated so as to safeguard the independence, objectivity and impartiality of its activities. The notified body shall document and implement a structure and procedures for safeguarding impartiality and for promoting and applying the principles of impartiality throughout its organisation, personnel and assessment activities. Such procedures shall provide for the identification, investigation and resolution of any case in which a conflict of interest may arise, including involvement in consultancy services in the field of devices prior to taking up employment with the notified body. The investigation, outcome and its resolution shall be documented. |
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1.2.3. |
The notified body, its top-level management and the personnel responsible for carrying out the conformity assessment tasks shall not:
(a) （一）
be the designer, manufacturer, supplier, installer, purchaser, owner or maintainer of devices which they assess, nor the authorised representative of any of those parties. Such restriction shall not preclude the purchase and use of assessed devices that are necessary for the operations of the notified body and the conduct of the conformity assessment, or the use of such devices for personal purposes;
(b) （二）
be involved in the design, manufacture or construction, marketing, installation and use, or maintenance of the devices for which they are designated, nor represent the parties engaged in those activities;
(c) （三）
engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are designated;
(d) （四）
offer or provide any service which may jeopardise the confidence in their independence, impartiality or objectivity. In particular, they shall not offer or provide consultancy services to the manufacturer, its authorised representative, a supplier or a commercial competitor as regards the design, construction, marketing or maintenance of devices or processes under assessment, and
(e) （五）
be linked to any organisation which itself provides consultancy services as referred to in point (d). Such restriction does not preclude general training activities that are not client specific and that relate to regulation of devices or to related standards. |
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1.2.4. |
Involvement in consultancy services in the field of devices prior to taking up employment with a notified body shall be fully documented at the time of employment and potential conflicts of interest shall be monitored and resolved in accordance with this Annex. Personnel who were formerly employed by a specific client, or provided consultancy services in the field of devices to that specific client prior to taking up employment with a notified body, shall not be assigned for conformity assessment activities for that specific client or companies belonging to the same group for a period of three years. |
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1.2.5. |
The impartiality of notified bodies, of their top-level management and of the assessment personnel shall be guaranteed. The level of the remuneration of the top-level management and assessment personnel of a notified body and subcontractors, involved in assessment activities shall not depend on the results of the assessments. Notified bodies shall make publicly available the declarations of interest of their top-level management. |
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1.2.6. |
If a notified body is owned by a public entity or institution, independence and absence of any conflict of interest shall be ensured and documented between, on the one hand, the authority responsible for notified bodies and/or the competent authority and, on the other hand, the notified body. |
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1.2.7. |
The notified body shall ensure and document that the activities of its subsidiaries or subcontractors, or of any associated body, including the activities of its owners do not affect its independence, impartiality or the objectivity of its conformity assessment activities. |
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1.2.8. |
The notified body shall operate in accordance with a set of consistent, fair and reasonable terms and conditions, taking into account the interests of small and medium-sized enterprises as defined in Recommendation 2003/361/EC in relation to fees. |
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1.2.9. |
The requirements laid down in this Section in no way preclude exchanges of technical information and regulatory guidance between a notified body and a manufacturer applying for conformity assessment. |
1.3. Confidentiality 1.3. 保密
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1.3.1. |
The notified body shall have documented procedures in place ensuring that its personnel, committees, subsidiaries, subcontractors, and any associated body or personnel of external bodies respect the confidentiality of the information which comes into its possession during the performance of conformity assessment activities, except when disclosure is required by law. |
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1.3.2. |
The personnel of a notified body shall observe professional secrecy in carrying out their tasks under this Regulation or any provision of national law giving effect to it, except in relation to the authorities responsible for notified bodies, competent authorities for medical devices in the Member States or the Commission. Proprietary rights shall be protected. The notified body shall have documented procedures in place in respect of the requirements of this Section. |
1.4. Liability 1.4. 责任
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1.4.1. |
The notified body shall take out appropriate liability insurance for its conformity assessment activities, unless liability is assumed by the Member State in question in accordance with national law or that Member State is directly responsible for the conformity assessment. |
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1.4.2. |
The scope and overall financial value of the liability insurance shall correspond to the level and geographic scope of activities of the notified body and be commensurate with the risk profile of the devices certified by the notified body. The liability insurance shall cover cases where the notified body may be obliged to withdraw, restrict or suspend certificates. |
1.5. Financial requirements
1.5. 财务要求
The notified body shall have at its disposal the financial resources required to conduct its conformity assessment activities within its scope of designation and related business operations. It shall document and provide evidence of its financial capacity and its long-term economic viability, taking into account, where relevant, any specific circumstances during an initial start-up phase.
指定机构应拥有在其指定范围内开展合格评定活动和相关业务运营所需的财政资源。它应记录并提供其财务能力和长期经济可行性的证据，并酌情考虑到初始启动阶段的任何具体情况。
1.6. Participation in coordination activities
1.6. 参与协调活动
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1.6.1. |
The notified body shall participate in, or ensure that its assessment personnel is informed of, any relevant standardisation activities and in the activities of the notified body coordination group referred to in Article 49 and that its assessment and decision-making personnel are informed of all relevant legislation, guidance and best practice documents adopted in the framework of this Regulation. |
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1.6.2. |
The notified body shall take into consideration guidance and best practice documents. |
2. QUALITY MANAGEMENT REQUIREMENTS
2、质量管理要求
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2.1. |
The notified body shall establish, document, implement, maintain and operate a quality management system that is appropriate to the nature, area and scale of its conformity assessment activities and is capable of supporting and demonstrating the consistent fulfilment of the requirements of this Regulation. |
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2.2. |
The quality management system of the notified body shall address at least the following:
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management system structure and documentation, including policies and objectives for its activities;
管理体系结构和文件，包括其活动的政策和目标;
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policies for assignment of activities and responsibilities to personnel;
为人员分配活动和责任的政策;
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assessment and decision-making processes in accordance with the tasks, responsibilities and role of the notified body's personnel and top-level management;
根据指定机构人员和高层管理人员的任务、责任和作用进行评估和决策过程;
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the planning, conduct, evaluation and, if necessary, adaptation of its conformity assessment procedures;
其合格评定程序的规划、实施、评估和必要时的调整;
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control of documents; 文件控制;
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control of records; 记录控制;
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management reviews; 管理审查;
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internal audits; 内部审计;
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corrective and preventive actions;
纠正和预防措施;
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complaints and appeals; and
投诉和上诉;和
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continuous training. 持续培训。
Where documents are used in various languages, the notified body shall ensure and control that they have the same content. |
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2.3. |
The top-level management of the notified body shall ensure that the quality management system is fully understood, implemented and maintained throughout the notified body organisation including subsidiaries and subcontractors involved in conformity assessment activities pursuant to this Regulation. |
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2.4. |
The notified body shall require all personnel to formally commit themselves by a signature or equivalent to comply with the procedures defined by the notified body. That commitment shall cover aspects relating to confidentiality and to independence from commercial and other interests, and any existing or prior association with clients. The personnel shall be required to complete written statements indicating their compliance with confidentiality, independence and impartiality principles. |
3. RESOURCE REQUIREMENTS
3. 资源需求
3.1. General 3.1. 概述
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3.1.1. |
Notified bodies shall be capable of carrying out all the tasks falling to them under this Regulation with the highest degree of professional integrity and the requisite competence in the specific field, whether those tasks are carried out by notified bodies themselves or on their behalf and under their responsibility. In particular, notified bodies shall have the necessary personnel and possess or have access to all equipment, facilities and competence needed to perform properly the technical, scientific and administrative tasks entailed in the conformity assessment activities in relation to which they have been designated. Such requirement presupposes at all times and for each conformity assessment procedure and each type of devices in relation to which they have been designated, that the notified body has permanent availability of sufficient administrative, technical and scientific personnel who possess experience and knowledge relating to the relevant devices and the corresponding technologies. Such personnel shall be in sufficient numbers to ensure that the notified body in question can perform the conformity assessment tasks, including the assessment of the medical functionality, clinical evaluations and the performance and safety of devices, for which it has been designated, having regard to the requirements of this Regulation, in particular, those set out in Annex I. A notified body's cumulative competences shall be such as to enable it to assess the types of devices for which it is designated. The notified body shall have sufficient internal competence to critically evaluate assessments conducted by external expertise. Tasks which a notified body is precluded from subcontracting are set out in Section 4.1. Personnel involved in the management of the operation of a notified body's conformity assessment activities for devices shall have appropriate knowledge to set up and operate a system for the selection of assessment and verification staff, for verification of their competence, for authorisation and allocation of their tasks, for organisation of their initial and ongoing training and for the assignment of their duties and the monitoring of those staff, in order to ensure that personnel who carry out and perform assessment and verification operations are competent to fulfil the tasks required of them. The notified body shall identify at least one individual within its top-level management as having overall responsibility for all conformity assessment activities in relation to devices. |
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3.1.2. |
The notified body shall ensure that personnel involved in conformity assessment activities maintain their qualification and expertise by implementing a system for exchange of experience and a continuous training and education programme. |
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3.1.3. |
The notified body shall clearly document the extent and limits of duties and responsibilities and the level of authorisation of the personnel, including any subcontractors and external experts, involved in conformity assessment activities and inform those personnel accordingly. |
3.2. Qualification criteria in relation to personnel
3.2. 与人员有关的资格标准
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3.2.1. |
The Notified Body shall establish and document qualification criteria and procedures for selection and authorisation of persons involved in conformity assessment activities, including as regards knowledge, experience and other competence required, and the required initial and ongoing training. The qualification criteria shall address the various functions within the conformity assessment process, such as auditing, product evaluation or testing, technical documentation review and decision-making, as well as the devices, technologies and areas, such as biocompatibility, sterilisation, tissues and cells of human and animal origin and clinical evaluation, covered by the scope of designation. |
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3.2.2. |
The qualification criteria referred to in Section 3.2.1 shall refer to the scope of a notified body's designation in accordance with the scope description used by the Member State for the notification referred to in Article 42(3), providing a sufficient level of detail for the required qualification within the subdivisions of the scope description. Specific qualification criteria shall be defined at least for the assessment of:
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the pre-clinical evaluation,
临床前评价，
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clinical evaluation, 临床评价，
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tissues and cells of human and animal origin,
人类和动物来源的组织和细胞，
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functional safety, 功能安全，
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software, 软件
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packaging, 包装
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devices that incorporate as an integral part a medicinal product,
将医药产品作为组成部分的器械，
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devices that are composed of substances or of combinations of substances that are absorbed by or locally dispersed in the human body and
由被人体吸收或局部分散的物质或物质组合组成的装置，以及
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the different types of sterilisation processes.
不同类型的灭菌过程。 |
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3.2.3. |
The personnel responsible for establishing qualification criteria and for authorising other personnel to perform specific conformity assessment activities shall be employed by the notified body itself and shall not be external experts or subcontracted. They shall have proven knowledge and experience in all of the following:
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Union devices legislation and relevant guidance documents;
工会器械立法和相关指导文件;
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the conformity assessment procedures provided for in this Regulation;
本规例规定的合格评定程序;
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a broad base of knowledge of device technologies and the design and manufacture of devices;
设备技术以及设备设计和制造的广泛知识基础;
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the notified body's quality management system, related procedures and the required qualification criteria;
公告机构的质量管理体系、相关程序和所需的资格标准;
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training relevant to personnel involved in conformity assessment activities in relation to devices;
与参与器械合格评定活动的人员相关的培训;
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adequate experience in conformity assessments under this Regulation or previously applicable law within a notified body.
在指定机构内根据本法规或先前适用的法律进行合格评定方面具有足够的经验。 |
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3.2.4. |
The notified body shall have permanent availability of personnel with relevant clinical expertise and where possible such personnel shall be employed by the notified body itself. Such personnel shall be integrated throughout the notified body's assessment and decision-making process in order to:
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identify when specialist input is required for the assessment of the clinical evaluation conducted by the manufacturer and identify appropriately qualified experts;
确定何时需要专家意见来评估制造商进行的临床评估，并确定具有适当资格的专家;
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appropriately train external clinical experts in the relevant requirements of this Regulation, CS, guidance and harmonised standards and ensure that the external clinical experts are fully aware of the context and implications of their assessment and the advice they provide;
就本规例、CS、指南和统一标准的相关要求对外部临床专家进行适当培训，并确保外部临床专家充分了解其评估的背景和影响以及他们提供的建议;
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be able to review and scientifically challenge the clinical data contained within the clinical evaluation, and any associated clinical investigations, and appropriately guide external clinical experts in the assessment of the clinical evaluation presented by the manufacturer;
能够审查和科学地质疑临床评估中包含的临床数据，以及任何相关的临床研究，并适当指导外部临床专家对制造商提出的临床评估进行评估;
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be able to scientifically evaluate and, if necessary, challenge the clinical evaluation presented, and the results of the external clinical experts' assessment of the manufacturer's clinical evaluation;
能够科学地评估并在必要时对所提出的临床评估以及外部临床专家对制造商临床评估的评估结果提出质疑;
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be able to ascertain the comparability and consistency of the assessments of clinical evaluations conducted by clinical experts;
能够确定临床专家进行的临床评估评估的可比性和一致性;
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be able to make an assessment of the manufacturer's clinical evaluation and a clinical judgement of the opinion provided by any external expert and make a recommendation to the notified body's decision maker; and
能够对制造商的临床评估和对任何外部专家提供的意见进行临床判断，并向指定机构的决策者提出建议;和
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be able to draw up records and reports demonstrating that the relevant conformity assessment activities have been appropriately carried out.
能够起草记录和报告，证明相关的合格评定活动已经适当地进行。 |
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3.2.5. |
The personnel responsible for carrying out product-related reviews (product reviewers), such as technical documentation reviews or type examination, including aspects such as clinical evaluation, biological safety, sterilisation and software validation, shall have all of the following proven qualifications:
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successful completion of a university or a technical college degree or equivalent qualification in relevant studies, e.g. medicine, pharmacy, engineering or other relevant sciences;
成功完成大学或技术学院学位或相关研究的同等资格，例如医学、药学、工程学或其他相关科学;
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four years' professional experience in the field of healthcare products or related activities, such as in manufacturing, auditing or research, of which two years shall be in the design, manufacture, testing or use of the device or technology to be assessed or related to the scientific aspects to be assessed;
在医疗保健产品或相关活动领域（例如制造、审核或研究）的四年专业经验，其中两年应从事设计、制造、测试或使用待评估的设备或技术或与待评估的科学方面相关的工作;
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knowledge of device legislation, including the general safety and performance requirements set out in Annex I;
了解器械法规，包括附件 I 中规定的一般安全和性能要求;
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appropriate knowledge and experience of relevant harmonised standards, CS and guidance documents;
对相关协调标准、CS 和指导文件有适当的知识和经验;
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appropriate knowledge and experience of risk management and related device standards and guidance documents;
风险管理及相关器械标准和指导文件的适当知识和经验;
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appropriate knowledge and experience of clinical evaluation;
适当的临床评估知识和经验;
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appropriate knowledge of the devices which they are assessing;
对他们正在评估的设备有适当的了解;
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appropriate knowledge and experience of the conformity assessment procedures laid down in Annexes IX to XI, in particular of the aspects of those procedures for which they are responsible, and adequate authorisation for carrying out those assessments;
对附件九至附件十一中规定的合格评定程序的适当知识和经验，特别是附件九至附件十一中规定的合格评定程序的各个方面，以及进行这些评定的充分授权;
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the ability to draw up records and reports demonstrating that the relevant conformity assessment activities have been appropriately carried out.
能够起草记录和报告，证明相关的合格评定活动已适当开展。 |
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3.2.6. |
The personnel responsible for carrying out audits of the manufacturer's quality management system (site auditors) shall have all of the following proven qualifications:
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successful completion of a university or a technical college degree or equivalent qualification in relevant studies, such as medicine, pharmacy, engineering or other relevant sciences;
成功完成大学或技术学院学位或相关研究的同等资格，例如医学、药学、工程学或其他相关科学;
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four years' professional experience in the field of healthcare products or related activities, such as in manufacturing, auditing or research, of which two years shall be in the area of quality management;
在医疗保健产品或相关活动领域（例如制造、审核或研究）的四年专业经验，其中两年应在质量管理领域;
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appropriate knowledge of devices legislation as well as related harmonised standards, CS and guidance documents;
对器械法规以及相关的协调标准、CS 和指导文件有适当的了解;
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appropriate knowledge and experience of risk management and related device standards and guidance documents;
风险管理及相关器械标准和指导文件的适当知识和经验;
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appropriate knowledge of quality management systems and related standards and guidance documents;
对质量管理体系及相关标准和指导文件有适当的了解;
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appropriate knowledge and experience of the conformity assessment procedures laid down in Annexes IX to XI, in particular of the aspects of those procedures for which they are responsible, and adequate authorisation for carrying out those audits;
对附件九至附件十一中规定的合格评定程序的适当知识和经验，特别是他们负责的程序的各个方面，以及进行这些审核的充分授权;
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training in auditing techniques enabling them to challenge quality management systems;
审核技术培训，使他们能够挑战质量管理体系;
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the ability to draw up records and reports demonstrating that the relevant conformity assessment activities have been appropriately carried out.
能够起草记录和报告，证明相关的合格评定活动已适当开展。 |
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3.2.7. |
The personnel with overall responsibility for final reviews and decision-making on certification shall be employed by the notified body itself and shall not be external experts or be subcontracted. Those personnel shall, as a group, have proven knowledge and comprehensive experience of all of the following:
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devices legislation and relevant guidance documents;
器械法规和相关指导文件;
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the device conformity assessments relevant to this Regulation;
与本法规相关的器械合格评定;
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the types of qualifications, experience and expertise relevant to device conformity assessment;
与器械合格评定相关的资格、经验和专业知识的类型;
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a broad base of knowledge of device technologies, including sufficient experience of conformity assessment of devices being reviewed for certification, the device industry and the design and manufacture of devices;
广泛的器械技术知识基础，包括对正在审查认证的器械、器械行业以及器械设计和制造的器械进行合格评定的充分经验;
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the notified body's quality management system, related procedures and the required qualifications for personnel involved;
公告机构的质量管理体系、相关程序和相关人员所需的资格;
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the ability to draw up records and reports demonstrating that the conformity assessment activities have been appropriately carried out.
能够起草记录和报告，证明合格评定活动已适当开展。 |
3.3. Documentation of qualification, training and authorisation of personnel
3.3. 人员资格、培训和授权文件
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3.3.1. |
The notified body shall have a procedure in place to fully document the qualification of each member of personnel involved in conformity assessment activities and the satisfaction of the qualification criteria referred to in Section 3.2. Where in exceptional circumstances the fulfilment of the qualification criteria set out in Section 3.2. cannot be fully demonstrated, the notified body shall justify to the authority responsible for notified bodies the authorisation of those members of personnel to carry out specific conformity assessment activities. |
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3.3.2. |
For all of its personnel referred to in Sections 3.2.3 to 3.2.7, the notified body shall establish and maintain up to date:
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a matrix detailing the authorisations and responsibilities of the personnel in respect of conformity assessment activities; and
详细说明人员在合格评定活动方面的授权和责任的矩阵;和
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records attesting to the required knowledge and experience for the conformity assessment activity for which they are authorised. The records shall contain a rationale for defining the scope of the responsibilities for each of the assessment personnel and records of the conformity assessment activities carried out by each of them.
证明其被授权的合格评定活动所需的知识和经验的记录。记录应包含界定每个评估人员职责范围的理由，以及他们每个人开展的合格评定活动的记录。 |
3.4. Subcontractors and external experts
3.4. 分包商和外部专家
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3.4.1. |
Notified bodies may, without prejudice to Section 3.2, subcontract certain clearly defined component parts of a conformity assessment activity. The subcontracting of the auditing of quality management systems or of product related reviews as a whole shall not be permitted; nevertheless parts of those activities may be conducted by subcontractors and external auditors and experts working on behalf of the notified body. The notified body in question shall retain full responsibility for being able to produce appropriate evidence of the competence of subcontractors and experts to fulfil their specific tasks, for making a decision based on a subcontractor's assessment and for the work conducted by subcontractors and experts on its behalf. The following activities may not be subcontracted by notified bodies:
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review of the qualifications and monitoring of the performance of external experts;
审查外部专家的资格并监督其表现;
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auditing and certification activities where the subcontracting in question is to auditing or certification organisations;
审核和认证活动，其中有关分包是审核或认证组织;
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allocation of work to external experts for specific conformity assessment activities; and
将工作分配给外部专家进行特定的合格评定活动;和
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final review and decision making functions.
最终审查和决策职能。 |
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3.4.2. |
Where a notified body subcontracts certain conformity assessment activities either to an organisation or an individual, it shall have a policy describing the conditions under which subcontracting may take place, and shall ensure that:
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the subcontractor meets the relevant requirements of this Annex;
分包商符合本附件的有关要求;
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subcontractors and external experts do not further subcontract work to organisations or personnel; and
分包商和外部专家不会进一步将工作分包给组织或人员;和
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the natural or legal person that applied for conformity assessment has been informed of the requirements referred to in the first and second indent.
申请合格评定的自然人或法人已被告知第一和第二缩进中提到的要求。 Any subcontracting or consultation of external personnel shall be properly documented, shall not involve any intermediaries and shall be subject to a written agreement covering, among other things, confidentiality and conflicts of interest. The notified body in question shall take full responsibility for the tasks performed by subcontractors. |
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3.4.3. |
Where subcontractors or external experts are used in the context of a conformity assessment, in particular regarding novel, invasive and implantable devices or technologies, the notified body in question shall have internal competence in each product area for which it is designated that is adequate for the purpose of leading the overall conformity assessment, verifying the appropriateness and validity of expert opinions and making decisions on certification. |
3.5. Monitoring of competences, training and exchange of experience
3.5. 能力监测、培训和经验交流
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3.5.1. |
The notified body shall establish procedures for the initial evaluation and on-going monitoring of the competence, conformity assessment activities and performance of all internal and external personnel, and subcontractors, involved in conformity assessment activities. |
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3.5.2. |
Notified bodies shall review at regular intervals, the competence of their personnel, identify training needs and draw up a training plan to maintain the required level of qualification and knowledge of individual personnel. That review shall at a minimum, verify that personnel:
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are aware of Union and national law in force on devices, relevant harmonised standards, CS, guidance documents and the results of the coordination activities referred to in Section 1.6; and
了解关于设备、相关协调标准、CS、指导文件以及第 1.6 节中提及的协调活动结果的现行欧盟和国家法律;和
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take part in the internal exchange of experience and the continuous training and education programme referred to in Section 3.1.2.
参加第 3.1.2 节所述的内部经验交流和持续培训和教育计划。 |
4. PROCESS REQUIREMENTS 4. 工艺要求
4.1. General 4.1. 总则
The notified body shall have in place documented processes and sufficiently detailed procedures for the conduct of each conformity assessment activity for which it is designated, comprising the individual steps from pre-application activities up to decision making and surveillance and taking into account, when necessary, the respective specificities of the devices.
指定机构应制定书面流程和足够详细的程序，以开展其指定的每项合格评定活动，包括从申请前活动到决策和监督的各个步骤，并在必要时考虑设备的各自特性。
The requirements laid down in Sections 4.3, 4.4, 4.7 and 4.8 shall be fulfilled as part of the internal activities of notified bodies and shall not be subcontracted.
第 4.3、4.4、4.7 和 4.8 节中规定的要求应作为指定机构内部活动的一部分来满足，不得分包。
4.2. Notified body quotations and pre-application activities
4.2. 公告机构报价和申请前活动
The notified body shall:
公告机构应：
publish a publicly available description of the application procedure by which manufacturers can obtain certification from it. That description shall include which languages are acceptable for submission of documentation and for any related correspondence;
发布公开的申请程序说明，制造商可以通过该程序获得认证。该说明应包括哪些语文可以用于提交文件和任何相关信函;
have documented procedures relating to, and documented details about, fees charged for specific conformity assessment activities and any other financial conditions relating to notified bodies' assessment activities for devices;
有与特定合格评定活动收取的费用有关的程序和记录细节，以及与公告机构器械评估活动相关的任何其他财务状况;
have documented procedures in relation to advertising of their conformity assessment services. Those procedures shall ensure that advertising or promotional activities in no way imply or are capable of leading to an inference that their conformity assessment will offer manufacturers earlier market access or be quicker, easier or less stringent than that of other notified bodies;
有关于其合格评定服务广告的书面程序。这些程序应确保广告或促销活动绝不暗示或能够导致推论，即其合格评定将为制造商提供更早的市场准入，或比其他公告机构更快、更容易或更不严格;
have documented procedures requiring the review of pre-application information, including the preliminary verification that the product is covered by this Regulation and its classification, prior to issuing any quotation to the manufacturer relating to a specific conformity assessment; and
在向制造商发出与特定合格评定有关的任何报价之前，已记录在案的程序，要求审查申请前信息，包括初步验证产品是否受本法规及其分类的约束;和
ensure that all contracts relating to the conformity assessment activities covered by this Regulation are concluded directly between the manufacturer and the notified body and not with any other organisation.
确保与本法规所涵盖的合格评定活动有关的所有合同都是在制造商和指定机构之间直接签订的，而不是与任何其他组织签订的。
4.3. Application review and contract
4.3. 申请审查和合同
The notified body shall require a formal application signed by a manufacturer or an authorised representative containing all of the information and the manufacturer's declarations required by the relevant conformity assessment as referred to in Annexes IX to XI.
指定机构应要求制造商或授权代表签署正式申请，其中包含附件 IX 至 XI 中提及的相关合格评定所需的所有信息和制造商的声明。
The contract between a notified body and a manufacturer shall take the form of a written agreement signed by both parties. It shall be kept by the notified body. This contract shall have clear terms and conditions and contain obligations that enable the notified body to act as required under this Regulation, including an obligation on the manufacturer to inform the notified body of vigilance reports, the right of the notified body to suspend, restrict or withdraw certificates issued and the duty of the notified body to fulfil its information obligations.
指定机构与制造商之间的合同应采用双方签署的书面协议的形式。它应由指定机构保存。本合同应有明确的条款和条件，并包含使公告机构能够按照本条例的要求行事的义务，包括制造商有义务向公告机构通报警戒报告，公告机构有权暂停、限制或撤销已颁发的证书，以及公告机构履行其信息义务的义务。
The notified body shall have documented procedures to review applications, addressing:
公告机构应有审查申请的书面程序，涉及：
the completeness of those applications with respect to the requirements of the relevant conformity assessment procedure, as referred to in the corresponding Annex, under which approval has been sought,
这些申请是否符合相应附件中提及的相关合格评定程序的要求，并据以寻求批准，
the verification of the qualification of products covered by those applications as devices and their respective classifications,
验证这些应用所涵盖的器械产品及其各自分类的资格，
whether the conformity assessment procedures chosen by the applicant are applicable to the device in question under this Regulation,
申请人选择的合格评定程序是否适用于本规例规定的有关器械，
the ability of the notified body to assess the application based on its designation, and
指定机构根据其指定评估申请的能力，以及
the availability of sufficient and appropriate resources.
提供充足和适当的资源。
The outcome of each review of an application shall be documented. Refusals or withdrawals of applications shall be notified to the electronic system referred to in Article 57 and shall be accessible to other notified bodies.
每次对申请的审查结果都应记录在案。驳回或撤回申请应通知第五十七条所述的电子系统，并应向其他公告机构开放。
4.4. Allocation of resources
4.4. 资源分配
The notified body shall have documented procedures to ensure that all conformity assessment activities are conducted by appropriately authorised and qualified personnel who are sufficiently experienced in the evaluation of the devices, systems and processes and related documentation that are subject to conformity assessment.
指定机构应制定书面程序，以确保所有合格评定活动均由经过适当授权的合格人员进行，这些人员在评估受合格评定的设备、系统和工艺以及相关文件方面具有足够的经验。
For each application, the notified body shall determine the resources needed and identify one individual responsible for ensuring that the assessment of that application is conducted in accordance with the relevant procedures and for ensuring that the appropriate resources including personnel are utilised for each of the tasks of the assessment. The allocation of tasks required to be carried out as part of the conformity assessment and any changes subsequently made to this allocation shall be documented.
对于每份申请，公告机构应确定所需的资源，并确定一名个人负责确保按照相关程序对该申请进行评估，并确保为评估的每一项任务使用适当的资源，包括人员。作为合格评定的一部分，需要执行的任务的分配以及随后对这种分配所做的任何更改都应记录在案。
4.5. Conformity assessment activities
4.5. 合格评定活动
4.5.1. General 4.5.1. 常规
The notified body and its personnel shall carry out the conformity assessment activities with the highest degree of professional integrity and the requisite technical and scientific competence in the specific fields.
指定机构及其人员应以最高程度的专业操守和特定领域必要的技术和科学能力开展合格评定活动。
The notified body shall have expertise, facilities and documented procedures that are sufficient to effectively conduct the conformity assessment activities for which the notified body in question is designated, taking account of the relevant requirements set out in Annexes IX to XI, and in particular all of the following requirements:
公告机构应具备足以有效开展有关公告机构指定的合格评定活动的专业知识、设施和文件程序，同时考虑到附件九至十一中规定的相关要求，特别是以下所有要求：
适当地计划每个项目的实施，
确保评估小组的组成应具有与有关技术相关的足够经验，并具有持续的客观性和独立性，并规定评估小组成员在适当的时间间隔内轮换，
具体说明确定完成合格评定活动时限的理由，
评估制造商的技术文件和为满足附件I中规定的要求而采用的解决方案，
审查制造商与临床前方面评估相关的程序和文件，
审查制造商与临床评估相关的程序和文件，
解决制造商的风险管理过程与其对临床前和临床评估的评估和分析之间的接口，并评估它们与证明符合附件一中相关要求的相关性，
执行附件九第5.2至5.4节所述的具体程序，
对于 IIa 类或 IIb 类器械，请评估具有代表性的器械的技术文档，
计划并定期进行适当的监督审核和评估，进行或要求进行某些测试，以验证质量管理体系的正常运行，并进行突击现场审核，
与设备抽样有关，验证制造的设备是否符合技术文件;这些要求应在抽样前确定相关的抽样标准和测试程序，
评估和验证制造商是否符合相关附件。
The notified body shall, where relevant, take into consideration available CS, guidance and best practice documents and harmonised standards, even if the manufacturer does not claim to be in compliance.
在相关情况下，公告机构应考虑现有的CS、指南和最佳实践文件以及协调标准，即使制造商没有声称符合要求。
4.5.2. Quality management system auditing
4.5.2. 质量管理体系审核
As part of the assessment of the quality management system, a notified body shall prior to an audit and in accordance with its documented procedures:
作为质量管理体系评估的一部分，公告机构应在审核之前并按照其文件化程序：
评估根据相关合格评定附件提交的文件，并制定审核计划，明确确定证明制造商质量管理体系完全覆盖并确定其是否符合本法规要求所需的活动数量和顺序，
确定各个制造工厂之间的联系和责任分配，并确定制造商的相关供应商和/或分包商，并考虑是否需要对任何这些供应商或分包商或两者进行专门审核，
为审计方案中确定的每项审计明确界定审计的目标、标准和范围，并制定审计计划，充分解决和考虑所涉设备、技术和工艺的具体要求，
为IIa类和IIb类器械制定并更新一份抽样计划，以评估附件II和III中提到的技术文件，涵盖制造商申请所涵盖的此类器械的范围。►C1 该计划应确保在证书有效期内对证书所涵盖的所有设备进行抽样，并且
选择并指派具有适当资格和授权的人员进行个别审核。应明确界定和记录团队成员各自的角色、职责和权限。
Based on the audit programme it has drawn up, the notified body shall, in accordance with its documented procedures:
根据其制定的审计方案，公告机构应按照其书面程序：
审核制造商的质量管理体系，以验证质量管理体系是否确保所涵盖的器械符合本法规的相关规定，这些规定适用于从设计到最终质量控制再到持续监督的每个阶段的器械，并应确定是否满足本法规的要求，
根据相关技术文件，并确定制造商是否符合相关合格评定附件中提到的要求，审查和审核制造商的流程和子系统，特别是：
生产和过程控制，
购买控制，包括对购买设备的验证，
纠正和预防措施，包括上市后监督，以及
以及检讨及审核制造商所采纳的要求及规定，包括与履行附件I所载一般安全和性能要求有关的要求及规定。
文件的抽样方式应反映与设备的预期用途、制造技术的复杂性、生产的设备的范围和类别以及任何可用的上市后监督信息相关的风险，
如果审核计划尚未涵盖，则当成品设备的符合性受到供应商活动的重大影响时，特别是当制造商无法证明对其供应商的充分控制时，对制造商供应商场所的流程控制进行审核，
根据其抽样计划并考虑第 4.5.4 节对技术文档进行评估。和 4.5.5.用于临床前和临床评估，以及
公告机构应确保根据本条例的要求和相关标准，或MDCG制定或采用的最佳实践文件，对审计结果进行适当和一致的分类。
4.5.3. Product verification
4.5.3. 产品验证
Assessment of the technical documentation
技术文件评估
For assessment of the technical documentation conducted in accordance with Chapter II of Annex IX, notified bodies shall have sufficient expertise, facilities and documented procedures for:
为了评估根据附件九第二章进行的技术文件，公告机构应具备足够的专业知识、设施和文件化程序，以便：
分配具有适当资格和授权的人员来检查各个方面，例如设备的使用、生物相容性、临床评估、风险管理和灭菌，以及
评估外观设计是否符合本法规，并考虑第 4.5.4 节。至 4.5.6.这种评估应包括审查制造商对进货、进行和最终检查的执行情况及其结果。如果需要进一步的测试或其他证据来评估是否符合本法规的要求，则有关指定机构应对设备进行充分的物理或实验室测试，或要求制造商进行此类测试。
Type-examinations 型式检验
The notified body shall have documented procedures, sufficient expertise and facilities for the type-examination of devices in accordance with Annex X including the capacity to:
指定机构应具有根据附件X对器械进行型式检查的书面程序、足够的专业知识和设施，包括以下能力：
考虑到第 4.5.4 节，检查和评估技术文档。到 4.5.6.，并验证该类型是否按照该文档制造;
制定测试计划，确定需要由指定机构或其负责测试的所有相关和关键参数;
记录其选择这些参数的理由;
进行适当的检查和测试，以验证制造商采用的解决方案是否符合附件 I 中规定的一般安全和性能要求。这种检查和测试应包括所有必要的测试，以核实制造商实际上已经应用了它选择使用的相关标准;
与申请人商定，如果不由指定机构直接进行必要的测试，将在哪里进行;和
对测试结果承担全部责任。制造商提交的测试报告只有在合格评定机构出具资格且独立于制造商的情况下才应予以考虑。
Verification by examination and testing of every product
通过对每个产品的检查和测试进行验证
The notified body shall:
公告机构应：
have documented procedures, sufficient expertise and facilities for the verification by examination and testing of every product in accordance with Part B of Annex XI;
有文件化的程序、足够的专业知识和设施，以便根据附件十一的B部分对每一种产品进行检查和测试进行验证;
establish a test plan identifying all relevant and critical parameters which need to be tested by the notified body or under its responsibility in order to:
制定测试计划，确定需要由指定机构或其负责测试的所有相关和关键参数，以便：
对于 IIb 类器械，验证器械是否符合欧盟型式检验证书中描述的类型以及适用于这些器械的本法规的要求，
确认 IIa 类器械符合附件 II 和 III 中提及的技术文件以及适用于这些器械的本法规的要求;
document its rationale for the selection of the parameters referred to in point (b);
记录其选择（b）点所述参数的理由;
have documented procedures to carry out the appropriate assessments and tests in order to verify the conformity of the device with the requirements of this Regulation by examining and testing every product as specified in Section 15 of Annex XI;
有文件化程序进行适当的评估和测试，以便通过检查和测试附件 XI 第 15 节中规定的每种产品来验证设备是否符合本法规的要求;
have documented procedures providing for the reaching of an agreement with the applicant concerning when and where necessary tests that are not to be carried out by the notified body itself are to be performed; and
有文件化程序，规定与申请人就何时何地进行非指定机构本身进行的必要测试达成协议;和
assume full responsibility for test results in accordance with documented procedures; test reports submitted by the manufacturer shall only be taken into account if they have been issued by conformity assessment bodies which are competent and independent of the manufacturer.
按照书面程序对测试结果承担全部责任;制造商提交的测试报告只有在由合格评定机构出具资格且独立于制造商的情况下才应予考虑。
4.5.4. Pre-clinical evaluation assessment
4.5.4. 临床前评估评估
The notified body shall have documented procedures in place for the review of the manufacturer's procedures and documentation relating to the evaluation of pre-clinical aspects. The notified body shall examine, validate and verify that the manufacturer's procedures and documentation adequately address:
指定机构应制定书面程序，以审查制造商的程序和与临床前方面评估相关的文件。指定机构应检查、验证和验证制造商的程序和文件是否充分解决了以下问题：
the planning, conduct, assessment, reporting and, where appropriate, updating of the pre-clinical evaluation, in particular of
临床前评估的规划、实施、评估、报告和（如适用）更新，特别是
科学临床前文献检索，以及
临床前测试，例如实验室测试、模拟使用测试、计算机建模、动物模型的使用、
the nature and duration of body contact and the specific associated biological risks,
身体接触的性质和持续时间以及具体相关的生物风险，
the interface with the risk management process, and
与风险管理流程的接口，以及
the appraisal and analysis of the available pre-clinical data and its relevance with regard to demonstrating conformity with the relevant requirements in Annex I.
对现有临床前数据的评估和分析，以及其与证明符合附件I中相关要求的相关性。
The notified body's assessment of pre-clinical evaluation procedures and documentation shall address the results of literature searches and all validation, verification and testing performed and conclusions drawn, and shall typically include considering the use of alternative materials and substances and take account of the packaging, stability, including shelf life, of the finished device. Where no new testing has been undertaken by a manufacturer or where there are deviations from procedures, the notified body in question shall critically examine the justification presented by the manufacturer.
指定机构对临床前评估程序和文件的评估应涉及文献检索的结果以及执行的所有验证、验证和测试以及得出的结论，通常应包括考虑替代材料和物质的使用，并考虑成品器械的包装、稳定性，包括保质期。如果制造商没有进行新的测试或与程序有偏差，则有关公告机构应严格审查制造商提出的理由。
4.5.5. Clinical evaluation assessment
4.5.5. 临床评估评估
The notified body shall have documented procedures in place relating to the assessment of a manufacturer's procedures and documentation relating to clinical evaluation both for initial conformity assessment and on an ongoing basis. The notified body shall examine, validate and verify that manufacturers' procedures and documentation adequately address:
指定机构应制定与评估制造商程序相关的文件程序以及与临床评估相关的文件，用于初始合格评定和持续进行。指定机构应审查、验证和验证制造商的程序和文件是否充分解决了以下问题：
附件十四中提及的临床评估的规划、实施、评估、报告和更新，
上市后监督和PMCF，
与风险管理流程的接口，
对现有数据的评估和分析及其与证明符合附件一相关要求的相关性，以及
根据临床证据得出的结论和临床评价报告的起草。
These procedures referred to in the first paragraph shall take into consideration available CS, guidance and best practice documents.
第1款所述的这些程序应考虑到现有的CS、指南和最佳做法文件。
The notified body's assessment of clinical evaluations as referred to in Annex XIV shall cover:
附件十四中提及的指定机构对临床评估的评估应包括：
制造商指定的预期用途及其定义的设备声明，
临床评估的规划，
文献检索方法，
文献检索中的相关文献，
临床研究，
要求对其他器械的等效性有效性、等效性的证明、等效和类似器械的适用性和结论数据，
上市后监督和PMCF，
临床评价报告，以及
与不进行临床调查或 PMCF 有关的理由。
In relation to clinical data from clinical investigations included within the clinical evaluation, the notified body in question shall ensure that the conclusions drawn by the manufacturer are valid in the light of the approved clinical investigation plan.
对于临床评估中包含的临床研究的临床数据，相关公告机构应确保制造商得出的结论根据批准的临床研究计划是有效的。
The notified body shall ensure that the clinical evaluation adequately addresses the relevant safety and performance requirements provided for in Annex I, that it is appropriately aligned with the risk management requirements, that it is conducted in accordance with Annex XIV and that it is appropriately reflected in the information provided relating to the device.
指定机构应确保临床评估充分满足附件 I 中规定的相关安全和性能要求，适当符合风险管理要求，按照附件 XIV 进行，并适当反映在提供的与设备相关的信息中。
4.5.6. Specific Procedures
4.5.6. 具体程序
The notified body shall have documented procedures, sufficient expertise and facilities for the procedures referred to in Sections 5 and 6 of Annex IX, Section 6 of Annex X and Section 16 of Annex XI, for which they are designated.
指定机构应具有文件化程序、足够的专门知识和设施，以执行附件九第5节和第6节、附件十节第6节和附件十一第16节所述程序。
In the case of devices manufactured utilising tissues or cells of animal origin or their derivatives, such as from TSE susceptible species, as referred to in Regulation (EU) No 722/2012, the notified body shall have documented procedures in place that fulfil the requirements laid down in that Regulation, including for the preparation of a summary evaluation report for the relevant competent authority.
对于使用动物源性组织或细胞或其衍生物（例如来自TSE易感物种）制造的器械，如第722/2012号法规（EU）所述，公告机构应制定符合该法规规定要求的书面程序，包括为相关主管当局准备摘要评估报告。
4.6. Reporting 4.6. 报告
The notified body shall:
公告机构应：
确保合格评定的所有步骤都记录在案，以便评估的结论清晰明了，并证明符合本条例的要求，并能向本身不参与评估的人员（例如指定当局的人员）提供此类合规的客观证据，
确保足以提供可识别的审计跟踪的记录可用于质量管理体系审计，
在临床评价评估报告中明确记录其对临床评价的评估结论，以及
对于每个具体项目，提供一份详细的报告，该报告应以标准格式为基础，其中包含MDCG确定的最低限度的要素集。
The report of the notified body shall:
公告机构的报告应：
清楚地记录其评估结果，并从制造商是否符合本法规要求的验证中得出明确的结论，
提出建议，供指定机构进行最终审查和作出最终决定;该建议应由被通知机构的负责人员签署，并且
提供给有问题的制造商。
4.7. Final review 4.7. 最终审查
The notified body shall prior to making a final decision:
在作出最终决定之前，被通知机构应：
确保被指派对具体项目进行最终审查和决策的人员得到适当授权，并且与进行评估的人员不同，
验证决策所需的报告和证明文件，包括关于评估期间发现的不符合项的解决方案，在申请范围方面是否完整和充分，以及
验证是否存在任何未解决的不符合项，无法颁发证书。
4.8. Decisions and Certifications
4.8. 决定和认证
The notified body shall have documented procedures for decision-making including as regards the allocation of responsibilities for the issuance, suspension, restriction and withdrawal of certificates. Those procedures shall include the notification requirements laid down in Chapter V of this Regulation. The procedures shall allow the notified body in question to:
公告机构应有书面的决策程序，包括关于证书颁发、暂停、限制和撤销的责任分配。这些程序应包括本条例第五章规定的通知要求。这些程序应允许有关公告机构：
根据评估文件和现有补充信息，决定是否满足本法规的要求，
根据其对临床评估和风险管理的评估结果，决定上市后监测计划（包括PMCF计划）是否充分，
决定由最新临床评估的公告机构进一步审查的具体里程碑，
决定是否需要为认证定义特定条件或规定，
根据器械的新颖性、风险分类、临床评估和风险分析结论，决定认证期限不超过五年，
清楚地记录决策和批准步骤，包括负责人员的成员签名批准，
明确记录传达决定的责任和机制，特别是当证书的最终签署人与决策者或决策者不同或不符合第 3.2.7 节中规定的要求时，
（a） 按照附件十二规定的最低要求颁发一份或多份证书，有效期不超过五年，并应说明是否存在与认证有关的具体条件或限制，
仅为申请人签发一份或多份证书，不得签发涵盖多个实体的证书，以及
确保将评估结果和由此产生的决定通知制造商，并将其输入第57条所述的电子系统。
4.9. Changes and modifications
4.9. 变更和修改
The notified body shall have documented procedures and contractual arrangements with manufacturers in place relating to the manufacturers' information obligations and the assessment of changes to:
指定机构应与制造商就制造商的信息义务和评估以下变化进行书面程序和合同安排：
经批准的质量管理体系或体系或所涵盖的产品范围，
经批准的设备设计，
设备的预期用途或声明，
设备的批准类型，以及
掺入或用于制造设备并遵守第 4.5.6 节规定的特定程序的任何物质。
The procedures and contractual arrangements referred to in the first paragraph shall include measures for checking the significance of the changes referred to in the first paragraph.
第1款所指的程序和合同安排应包括检查第1款所指变更重要性的措施。
In accordance with its documented procedures, the notified body in question shall:
根据其书面程序，有关公告机构应：
确保制造商提交第一段所述变更的事先批准计划以及与此类变更相关的信息，
评估拟议的变更，并验证在这些变更后，质量管理体系或设备或设备类型的设计是否仍然符合本法规的要求，以及
将其决定通知制造商，并提供报告或补充报告（如适用），其中应包含其评估的合理结论。
4.10. Surveillance activities and post-certification monitoring
4.10. 监督活动和认证后监督
The notified body shall have documented procedures:
指定机构应有记录在案的程序：
确定制造商的监督活动的方式和时间。这些程序应包括安排对制造商进行突击现场审核，并在适用的情况下对进行产品测试的分包商和供应商进行现场审核，并监测是否符合对制造商有约束力的与认证决定相关的任何条件，例如在规定的时间间隔内更新临床数据。
用于筛选与其指定范围相关的科学和临床数据来源以及上市后信息。在规划和开展监视活动时应考虑到此类信息，并且
审查他们根据第92条第（2）款有权访问的警戒数据，以估计其对现有证书有效性的影响（如果有的话）。评估结果和作出的任何决定均应详细记录在案。
The notified body in question shall, upon receipt of information about vigilance cases from a manufacturer or competent authorities, decide which of the following options to apply:
有关公告机构在收到制造商或主管当局关于警戒案件的信息后，应决定采用以下选项中的哪一种：
不以警戒案件明显与所授予的证书无关为由采取行动，
观察制造商和主管当局的活动以及制造商的调查结果，以确定所授予的认证是否存在风险或是否采取了适当的纠正措施，
执行非常监视措施，例如文件审查、短时间或突击审核和产品测试，其中所授予的认证可能面临风险，
增加监督审计的频率，
在对制造商进行下一次审核时审查特定产品或工艺，或
采取任何其他相关措施。
In relation to surveillance audits of manufacturers, the notified body shall have documented procedures to:
关于对制造商的监督审核，公告机构应有文件化程序，以便：
至少每年对制造商进行一次监督审核，该审核应根据第 4.5 节中的相关要求进行计划和进行，
确保充分评估制造商关于警戒、上市后监督和 PMCF 规定的文件和适用情况，
在审核期间，根据预定义的抽样标准和测试程序对设备进行抽样和技术文件，以确保制造商不断应用经批准的质量管理体系，
确保制造商遵守相关附件中规定的文件和信息义务，并确保其程序在实施质量管理体系时考虑到最佳实践，
确保制造商不会以误导性的方式使用质量管理体系或设备认证，
收集足够的信息以确定质量管理体系是否继续符合本法规的要求，
如果检测到不符合项，请要求制造商进行纠正、纠正措施，并在适用的情况下采取预防措施，以及
必要时，对相关证书施加具体限制，或暂停或撤销。
The notified body shall, if listed as part of the conditions for certification:
如果被列为认证条件的一部分，则公告机构应：
根据制造商的上市后监测、其 PMCF 以及与使用该设备治疗的疾病相关的临床文献或与类似设备相关的临床文献，对制造商最近更新的临床评估进行深入审查，
清楚地记录深入审查的结果，并向制造商提出任何具体问题或对其施加任何具体条件，以及
确保最近更新的临床评估适当反映在使用说明中，并在适用的情况下反映在安全性和性能摘要中。
4.11. Re-certification 4.11. 重新认证
The notified body shall have documented procedures in place relating to the re-certification reviews and the renewal of certificates. Re-certification of approved quality management systems or EU technical documentation assessment certificates or EU type-examination certificates shall occur at least every five years.
指定机构应制定与重新认证审查和证书续期有关的书面程序。经批准的质量管理体系或欧盟技术文献评估证书或欧盟型式检验证书的重新认证应至少每五年进行一次。
The notified body shall have documented procedures relating to renewals of EU technical documentation assessment certificates and EU type-examination certificates and those procedures shall require the manufacturer in question to submit a summary of changes and scientific findings for the device, including:
指定机构应具有与欧盟技术文件评估证书和欧盟型式检验证书更新相关的文件程序，这些程序应要求相关制造商提交设备的更改和科学发现摘要，包括：
all changes to the originally approved device, including changes not yet notified,
对最初批准的设备的所有更改，包括尚未通知的更改，
experience gained from post-market surveillance,
从上市后监督中获得的经验，
experience from risk management,
风险管理经验，
experience from updating the proof of compliance with the general safety and performance requirements set out in Annex I,
更新符合附件I中规定的一般安全和性能要求的证明的经验，
experience from reviews of the clinical evaluation, including the results of any clinical investigations and PMCF,
临床评估审查的经验，包括任何临床研究和 PMCF 的结果，
changes to the requirements, to components of the device or to the scientific or regulatory environment,
对要求、设备组件或科学或监管环境的更改，
changes to applied or new harmonised standards, CS or equivalent documents, and
对应用或新的协调标准、CS 或等效文件的更改，以及
changes in medical, scientific and technical knowledge, such as:
医学、科学和技术知识的变化，例如：
测试方法的变化，
关于材料和组件的新科学发现，包括关于其生物相容性的发现，
对可比设备的研究经验，
来自登记册和登记册的数据，
使用类似设备进行临床研究的经验。
The notified body shall have documented procedures to assess the information referred to in the second paragraph and shall pay particular attention to clinical data from post-market surveillance and PMCF activities undertaken since the previous certification or re-certification, including appropriate updates to manufacturers' clinical evaluation reports.
公告机构应有评估第二段所述信息的书面程序，并应特别注意自上次认证或重新认证以来开展的上市后监测和PMCF活动的临床数据，包括对制造商临床评估报告的适当更新。
For the decision on re-certification, the notified body in question shall use the same methods and principles as for the initial certification decision. If necessary, separate forms shall be established for re-certification taking into account the steps taken for certification such as application and application review.
对于重新认证的决定，有关公告机构应使用与初始认证决定相同的方法和原则。如有必要，应当考虑到为认证而采取的步骤，如申请和申请审查，为重新认证建立单独的表格。
ANNEX VIII 附件八
CLASSIFICATION RULES 分类规则
CHAPTER I 第一章
DEFINITIONS SPECIFIC TO CLASSIFICATION RULES
特定于分类规则的定义
1. DURATION OF USE
1. 使用期限
|
1.1. |
‘Transient’ means normally intended for continuous use for less than 60 minutes. |
|
1.2. |
‘Short term’ means normally intended for continuous use for between 60 minutes and 30 days. |
|
1.3. |
‘Long term’ means normally intended for continuous use for more than 30 days. |
2. INVASIVE AND ACTIVE DEVICES
2. 侵入性和主动设备
|
2.1. |
‘Body orifice’ means any natural opening in the body, as well as the external surface of the eyeball, or any permanent artificial opening, such as a stoma. |
|
2.2. |
‘Surgically invasive device’ means:
(a) （一）
an invasive device which penetrates inside the body through the surface of the body, including through mucous membranes of body orifices with the aid or in the context of a surgical operation; and
(b) （二）
a device which produces penetration other than through a body orifice. |
|
2.3. |
‘Reusable surgical instrument’ means an instrument intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection to an active device and which is intended by the manufacturer to be reused after appropriate procedures such as cleaning, disinfection and sterilisation have been carried out. |
|
2.4. |
‘Active therapeutic device’ means any active device used, whether alone or in combination with other devices, to support, modify, replace or restore biological functions or structures with a view to treatment or alleviation of an illness, injury or disability. |
|
2.5. |
‘Active device intended for diagnosis and monitoring’ means any active device used, whether alone or in combination with other devices, to supply information for detecting, diagnosing, monitoring or treating physiological conditions, states of health, illnesses or congenital deformities. |
|
2.6. |
‘Central circulatory system’ means the following blood vessels: arteriae pulmonales, aorta ascendens, arcus aortae, aorta descendens to the bifurcatio aortae, arteriae coronariae, arteria carotis communis, arteria carotis externa, arteria carotis interna, arteriae cerebrales, truncus brachiocephalicus, venae cordis, venae pulmonales, vena cava superior and vena cava inferior. |
|
2.7. |
‘Central nervous system’ means the brain, meninges and spinal cord. |
|
2.8. |
‘Injured skin or mucous membrane’ means an area of skin or a mucous membrane presenting a pathological change or change following disease or a wound. |
CHAPTER II 第二章
IMPLEMENTING RULES 实施细则
|
3.1. |
Application of the classification rules shall be governed by the intended purpose of the devices. |
|
3.2. |
If the device in question is intended to be used in combination with another device, the classification rules shall apply separately to each of the devices.
►C1
Accessories for a medical device shall be classified in their own right ◄ separately from the device with which they are used. |
|
3.3. |
Software, which drives a device or influences the use of a device, shall fall within the same class as the device. If the software is independent of any other device, it shall be classified in its own right. |
|
3.4. |
If the device is not intended to be used solely or principally in a specific part of the body, it shall be considered and classified on the basis of the most critical specified use. |
|
3.5. |
If several rules, or if, within the same rule, several sub-rules, apply to the same device based on the device's intended purpose, the strictest rule and sub-rule resulting in the higher classification shall apply. |
|
3.6. |
In calculating the duration referred to in Section 1, continuous use shall mean:
(a) （一）
the entire duration of use of the same device without regard to temporary interruption of use during a procedure or temporary removal for purposes such as cleaning or disinfection of the device. Whether the interruption of use or the removal is temporary shall be established in relation to the duration of the use prior to and after the period when the use is interrupted or the device removed; and
(b) （二）
the accumulated use of a device that is intended by the manufacturer to be replaced immediately with another of the same type. |
|
3.7. |
A device is considered to allow direct diagnosis when it provides the diagnosis of the disease or condition in question by itself or when it provides decisive information for the diagnosis. |
CHAPTER III 第三章
CLASSIFICATION RULES 分类规则
4. NON-INVASIVE DEVICES 4. 非侵入性设备
4.1. Rule 1 4.1. 规则 1
All non-invasive devices are classified as class I, unless one of the rules set out hereinafter applies.
所有非侵入性设备均被归类为 I 类，除非下文规定的规则之一适用。
4.2. Rule 2 4.2. 规则2
All non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases for the purpose of eventual infusion, administration or introduction into the body are classified as class IIa:
所有用于引导或储存血液、体液、细胞或组织、液体或气体以最终输注、施用或引入体内的非侵入性装置均归类为 IIa 类：
如果它们可能连接到 IIa 类、IIb 类或 III 类有源设备;或
如果它们旨在用于引导或储存血液或其他体液，或用于储存器官、器官的一部分或身体细胞和组织，但血袋除外;血袋被归类为IIb类。
In all other cases, such devices are classified as class I.
在所有其他情况下，此类设备被归类为 I 类。
4.3. Rule 3 4.3. 规则3
All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class IIb, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class IIa.
所有用于改变人体组织或细胞的生物或化学成分、血液、其他体液或用于植入或给药到体内的其他液体的非侵入性装置均被归类为 IIb 类，除非使用该装置的治疗包括过滤、离心或气体、热的交换，在这种情况下，它们被归类为 IIa 类。
All non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class III.
所有非侵入性器械均由拟在体外与人体细胞、组织或器官直接接触的物质或物质混合物组成，或在植入或施用到体内之前与人类胚胎一起体外使用，均被归类为III类。
4.4. Rule 4 4.4. 规则4
All non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
所有与受伤的皮肤或粘膜接触的非侵入性设备都分为：
I类，如果它们打算用作机械屏障，用于压缩或吸收渗出物;
IIb类，如果它们主要用于破坏真皮或粘膜的皮肤损伤，并且只能通过次要意图愈合;
IIa类，如果它们主要用于管理受伤皮肤或粘膜的微环境;和
在所有其他情况下，IIa级。
This rule applies also to the invasive devices that come into contact with injured mucous membrane.
该规则也适用于与受伤粘膜接触的侵入性装置。
5. INVASIVE DEVICES 5. 侵入性设备
5.1. Rule 5 5.1. 规则 5
All invasive devices with respect to body orifices, other than surgically invasive devices, which are not intended for connection to an active device or which are intended for connection to a class I active device are classified as:
除手术侵入性设备外，所有与身体孔口有关的侵入性设备，这些设备不用于连接到有源设备或用于连接到 I 类有源设备，均归类为：
I类，如果它们打算用于临时使用;
IIa类，如果它们打算短期使用，除非它们用于口腔直至咽部，在耳道直至鼓膜或鼻腔中，在这种情况下，它们被归类为I类;和
IIb类，如果它们打算长期使用，除非它们在口腔中远至咽部，在耳道中直到鼓膜或鼻腔中使用，并且不易被粘膜吸收，在这种情况下，它们被归类为IIa类。
All invasive devices with respect to body orifices, other than surgically invasive devices, intended for connection to a class IIa, class IIb or class III active device, are classified as class IIa.
除手术侵入性装置外，用于连接 IIa 类、IIb 类或 III 类有源装置的所有与体孔有关的侵入性装置均归类为 IIa 类。
5.2. Rule 6 5.2. 规则 6
All surgically invasive devices intended for transient use are classified as class IIa unless they:
所有用于短暂使用的手术侵入性器械均被归类为 IIa 类，除非它们：
专门用于通过与身体这些部位的直接接触来控制、诊断、监测或纠正心脏或中央循环系统的缺陷，在这种情况下，它们被归类为 III 类;
是可重复使用的手术器械，在这种情况下，它们被归类为 I 类;
专门用于与心脏或中枢循环系统或中枢神经系统直接接触，在这种情况下，它们被归类为 III 类;
旨在以电离辐射的形式提供能量，在这种情况下，它们被归类为 IIb 类;
具有生物学效应或全部或主要被吸收，在这种情况下，它们被归类为IIb类;或
旨在通过输送系统管理医药产品，如果考虑到应用方式，以具有潜在危险的方式对医药产品进行管理，在这种情况下，它们被归类为IIb类。
5.3. Rule 7 5.3. 规则 7
All surgically invasive devices intended for short-term use are classified as class IIa unless they:
所有用于短期使用的手术侵入性设备均被归类为 IIa 类，除非它们：
专门用于通过与身体这些部位的直接接触来控制、诊断、监测或纠正心脏或中央循环系统的缺陷，在这种情况下，它们被归类为 III 类;
专门用于与心脏或中枢循环系统或中枢神经系统直接接触，在这种情况下，它们被归类为 III 类;
旨在以电离辐射的形式提供能量，在这种情况下，它们被归类为 IIb 类;
具有生物效应或全部或主要被吸收，在这种情况下，它们被归类为III类;
旨在在体内发生化学变化，在这种情况下，它们被归类为 IIb 类，除非将设备放置在牙齿中;或
旨在管理药物，在这种情况下，它们被归类为 IIb 类。
5.4. Rule 8 5.4. 规则 8
All implantable devices and long-term surgically invasive devices are classified as class IIb unless they:
所有植入式器械和长期手术侵入性器械均被归类为 IIb 类，除非它们：
旨在放置在牙齿中，在这种情况下，它们被归类为 IIa 类;
旨在用于与心脏、中枢循环系统或中枢神经系统直接接触，在这种情况下，它们被归类为 III 类;
具有生物效应或全部或主要被吸收，在这种情况下，它们被归类为III类;
旨在在体内发生化学变化，在这种情况下，它们被归类为 III 类，除非这些装置被放置在牙齿中;
旨在管理医药产品，在这种情况下，它们被归类为第三类;
是有源植入式设备或其附件，在这种情况下，它们被归类为 III 类;
是乳房植入物或手术网片，在这种情况下，它们被归类为 III 类;
是完全或部分关节置换，在这种情况下，它们被归类为III类，但螺钉、楔子、板和器械等辅助部件除外;或
是椎间盘置换植入物或与脊柱接触的植入式装置，在这种情况下，它们被归类为 III 类，螺钉、楔块、钢板和器械等组件除外。
6. ACTIVE DEVICES 6. 有源设备
6.1. Rule 9 6.1. 规则 9
All active therapeutic devices intended to administer or exchange energy are classified as class IIa unless their characteristics are such that they may administer energy to or exchange energy with the human body in a potentially hazardous way, taking account of the nature, the density and site of application of the energy, in which case they are classified as class IIb.
所有用于管理或交换能量的活性治疗设备都被归类为IIa类，除非它们的特性是考虑到能量的性质、密度和应用地点，它们可能以潜在危险的方式向人体施用能量或与人体交换能量，在这种情况下，它们被归类为IIb类。
All active devices intended to control or monitor the performance of active therapeutic class IIb devices, or intended directly to influence the performance of such devices are classified as class IIb.
所有旨在控制或监测有源治疗IIb类设备性能的有源设备，或旨在直接影响此类设备性能的有源设备均被归类为IIb类。
All active devices intended to emit ionizing radiation for therapeutic purposes, including devices which control or monitor such devices, or which directly influence their performance, are classified as class IIb.
所有旨在为治疗目的发射电离辐射的有源设备，包括控制或监测此类设备或直接影响其性能的设备，均归类为 IIb 类。
All active devices that are intended for controlling, monitoring or directly influencing the performance of active implantable devices are classified as class III.
所有用于控制、监控或直接影响有源植入式设备性能的有源设备均被归类为 III 类。
6.2. Rule 10 6.2. 第10条
Active devices intended for diagnosis and monitoring are classified as class IIa:
用于诊断和监测的有源设备分为 IIa 类：
如果它们旨在提供将被人体吸收的能量，但用于照亮患者身体的装置除外，在可见光谱中，在这种情况下，它们被归类为 I 类;
如果它们旨在对放射性药物的体内分布进行成像;或
如果它们旨在允许直接诊断或监测重要的生理过程，除非它们专门用于监测重要的生理参数，并且这些参数的变化性质可能对患者造成直接危险，例如心脏功能、呼吸、中枢神经系统活动的变化， 或者它们旨在在患者处于直接危险的临床情况下进行诊断，在这种情况下，它们被归类为 IIb 类。
Active devices intended to emit ionizing radiation and intended for diagnostic or therapeutic radiology, including interventional radiology devices and devices which control or monitor such devices, or which directly influence their performance, are classified as class IIb.
用于发射电离辐射和用于诊断或治疗放射学的有源设备，包括介入放射学设备和控制或监测此类设备或直接影响其性能的设备，被归类为 IIb 类。
6.3. Rule 11 6.3. 第11条
Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa, except if such decisions have an impact that may cause:
旨在提供用于做出诊断或治疗目的决策的信息的软件被归类为 IIa 类，除非此类决策具有可能导致以下影响：
死亡或一个人的健康状况不可逆转地恶化，在这种情况下，它属于第三类;或
一个人的健康状况严重恶化或手术干预，在这种情况下，它被归类为IIb类。
Software intended to monitor physiological processes is classified as class IIa, except if it is intended for monitoring of vital physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient, in which case it is classified as class IIb.
用于监测生理过程的软件被归类为IIa类，除非它用于监测重要的生理参数，其中这些参数的变化性质可能对患者造成直接危险，在这种情况下，它被归类为IIb类。
All other software is classified as class I.
所有其他软件均归类为 I 类。
6.4. Rule 12 6.4. 第12条
All active devices intended to administer and/or remove medicinal products, body liquids or other substances to or from the body are classified as class IIa, unless this is done in a manner that is potentially hazardous, taking account of the nature of the substances involved, of the part of the body concerned and of the mode of application in which case they are classified as class IIb.
所有用于施用和/或将医药产品、体液或其他物质带入或移出人体的有源装置均被归类为 IIa 类，除非考虑到所涉及物质的性质、有关身体部位和应用方式，以具有潜在危险的方式进行，在这种情况下，它们被归类为 IIb 类。
6.5. Rule 13 6.5. 规则13
All other active devices are classified as class I.
所有其他有源设备均归类为 I 类。
7. SPECIAL RULES 7. 特殊规则
7.1. Rule 14 7.1. 规则 14
All devices incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product, as defined in point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma, as defined in point 10 of Article 1 of that Directive, and that has an action ancillary to that of the devices, are classified as class III.
所有器械，如果单独使用，可被视为第2001/83/EC号指令第1条第2款所定义的医药产品，包括该指令第1条第10款所定义的源自人血或人血浆的医药产品，并且具有与器械相关的作用， 被归类为III类。
7.2. Rule 15 7.2. 规则15
All devices used for contraception or prevention of the transmission of sexually transmitted diseases are classified as class IIb, unless they are implantable or long term invasive devices, in which case they are classified as class III.
所有用于避孕或预防性传播疾病传播的装置都被归类为IIb类，除非它们是植入式或长期侵入性装置，在这种情况下，它们被归类为III类。
7.3. Rule 16 7.3. 规则 16
All devices intended specifically to be used for disinfecting, cleaning, rinsing or, where appropriate, hydrating contact lenses are classified as class IIb.
所有专门用于消毒、清洁、冲洗或在适当情况下用于保湿隐形眼镜的设备均归类为 IIb 类。
All devices intended specifically to be used for disinfecting or sterilising medical devices are classified as class IIa, unless they are disinfecting solutions or washer-disinfectors intended specifically to be used for disinfecting invasive devices, as the end point of processing, in which case they are classified as class IIb.
所有专门用于对医疗器械进行消毒或灭菌的器械均被归类为IIa类，除非它们是专门用于对侵入性器械进行消毒的消毒液或清洗消毒器，作为处理的终点，在这种情况下，它们被归类为IIb类。
This rule does not apply to devices that are intended to clean devices other than contact lenses by means of physical action only.
此规则不适用于仅通过物理操作清洁隐形眼镜以外的设备。
7.4. Rule 17 7.4. 规则 17
Devices specifically intended for recording of diagnostic images generated by X-ray radiation are classified as class IIa.
专门用于记录 X 射线辐射产生的诊断图像的设备被归类为 IIa 类。
7.5. Rule 18 7.5. 规则 18
All devices manufactured utilising tissues or cells of human or animal origin, or their derivatives, which are non-viable or rendered non-viable, are classified as class III, unless such devices are manufactured utilising tissues or cells of animal origin, or their derivatives, which are non-viable or rendered non-viable and are devices intended to come into contact with intact skin only.
所有使用人类或动物来源的组织或细胞或其衍生物制造的器械，如果不可行或无法存活，则被归类为III类，除非此类器械是利用动物源性组织或细胞或其衍生物制造的，这些组织或细胞不可行或无法存活，并且是仅与完整皮肤接触的器械。
7.6. Rule 19 7.6. 规则 19
All devices incorporating or consisting of nanomaterial are classified as:
所有包含或由纳米材料组成的设备都分为：
III级，如果它们具有高或中等的内部暴露潜力;
IIb级，如果它们具有较低的内部暴露可能性;和
IIa级，如果它们具有可忽略不计的内部暴露潜力。
7.7. Rule 20 7.7. 规则20
All invasive devices with respect to body orifices, other than surgically invasive devices, which are intended to administer medicinal products by inhalation are classified as class IIa, unless their mode of action has an essential impact on the efficacy and safety of the administered medicinal product or they are intended to treat life-threatening conditions, in which case they are classified as class IIb.
除手术侵入性装置外，所有旨在通过吸入给药药品的侵入性装置均被归类为IIa类，除非其作用方式对所给药药品的功效和安全性有重要影响，或者它们旨在治疗危及生命的疾病，在这种情况下，它们被归类为IIb类。
7.8. Rule 21 7.8. 规则 21
Devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed in the human body are classified as:
由旨在通过体孔引入人体或应用于皮肤并被人体吸收或局部分散在人体中的物质或物质组合组成的装置分为：
III类，如果它们或其代谢产物被人体系统吸收以达到预期目的;
如果它们在胃或下消化道中达到预期目的，并且它们或其代谢产物被人体全身吸收，则为III类;
IIa类，如果它们应用于皮肤，或者如果它们应用于鼻腔或口腔，直至咽部，并在这些腔内达到其预期目的;和
在所有其他情况下，IIb 类。
7.9. Rule 22 7.9. 规则 22
Active therapeutic devices with an integrated or incorporated diagnostic function which significantly determines the patient management by the device, such as closed loop systems or automated external defibrillators, are classified as class III.
具有集成或合并诊断功能的有源治疗设备，可显着决定设备的患者管理，例如闭环系统或自动体外除颤器，被归类为 III 类。
ANNEX IX 附件九
CONFORMITY ASSESSMENT BASED ON A QUALITY MANAGEMENT SYSTEM AND ON ASSESSMENT OF TECHNICAL DOCUMENTATION
基于质量管理体系和技术文件评估的合格评定
CHAPTER I 第一章
QUALITY MANAGEMENT SYSTEM
质量管理体系
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1. |
The manufacturer shall establish, document and implement a quality management system as described in Article 10(9) and maintain its effectiveness throughout the life cycle of the devices concerned. The manufacturer shall ensure the application of the quality management system as specified in Section 2 and shall be subject to audit, as laid down in Sections 2.3 and 2.4, and to surveillance as specified in Section 3. |
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2. |
Quality management system assessment 质量管理体系评估
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3. |
Surveillance assessment 监测评估
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CHAPTER II 第二章
ASSESSMENT OF THE TECHNICAL DOCUMENTATION
技术文件评估
4. Assessment of the technical documentation applicable to class III devices and to the class IIb devices referred to in the second subparagraph of Article 52(4)
4. 评估适用于第52条第（4）款第2项所述III类器械和IIb类器械的技术文件
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4.1. |
In addition to the obligations laid down in Section 2, the manufacturer shall lodge with the notified body an application for assessment of the technical documentation relating to the device which it plans to place on the market or put into service and which is covered by the quality management system referred to in Section 2. |
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4.2. |
The application shall describe the design, manufacture and performance of the device in question. It shall include the technical documentation as referred to in Annexes II and III. |
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4.3. |
►C1
The notified body shall assess the technical documentation using staff with proven knowledge ◄ and experience regarding the technology concerned and its clinical application. The notified body may require the application to be completed by having further tests carried out or requesting further evidence to be provided to allow assessment of conformity with the relevant requirements of the Regulation. The notified body shall carry out adequate physical or laboratory tests in relation to the device or request the manufacturer to carry out such tests. |
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4.4. |
The notified body shall review the clinical evidence presented by the manufacturer in the clinical evaluation report and the related clinical evaluation that was conducted. The notified body shall employ device reviewers with sufficient clinical expertise and, if necessary, use external clinical experts with direct and current experience relating to the device in question or the clinical condition in which it is utilised, for the purposes of that review. |
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4.5. |
The notified body shall, in circumstances in which the clinical evidence is based partly or totally on data from devices which are claimed to be equivalent to the device under assessment, assess the suitability of using such data, taking into account factors such as new indications and innovation. The notified body shall clearly document its conclusions on the claimed equivalence, and on the relevance and adequacy of the data for demonstrating conformity. For any characteristic of the device claimed as innovative by the manufacturer or for new indications, the notified body shall assess to what extent specific claims are supported by specific pre-clinical and clinical data and risk analysis. |
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4.6. |
The notified body shall verify that the clinical evidence and the clinical evaluation are adequate and shall verify the conclusions drawn by the manufacturer on the conformity with the relevant general safety and performance requirements. That verification shall include consideration of the adequacy of the benefit-risk determination, the risk management, the instructions for use, the user training and the manufacturer's post-market surveillance plan, and include a review of the need for, and the adequacy of, the PMCF plan proposed, where applicable. |
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4.7. |
Based on its assessment of the clinical evidence, the notified body shall consider the clinical evaluation and the benefit-risk determination, and whether specific milestones need to be defined to allow the notified body to review updates to the clinical evidence that result from post-market surveillance and PMCF data. |
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4.8. |
The notified body shall clearly document the outcome of its assessment in the clinical evaluation assessment report. |
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4.9. |
The notified body shall provide the manufacturer with a report on the technical documentation assessment, including a clinical evaluation assessment report. If the device conforms to the relevant provisions of this Regulation, the notified body shall issue an EU technical documentation assessment certificate. The certificate shall contain the conclusions of the technical documentation assessment, the conditions of the certificate's validity, the data needed for identification of the approved design, and, where appropriate, a description of the intended purpose of the device. |
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4.10. |
Changes to the approved device shall require approval from the notified body which issued the EU technical documentation assessment certificate where such changes could affect the safety and performance of the device or the conditions prescribed for use of the device. Where the manufacturer plans to introduce any of the above-mentioned changes it shall inform the notified body which issued the EU technical documentation assessment certificate thereof. The notified body shall assess the planned changes and decide whether the planned changes require a new conformity assessment in accordance with Article 52 or whether they could be addressed by means of a supplement to the EU technical documentation assessment certificate. In the latter case, the notified body shall assess the changes, notify the manufacturer of its decision and, where the changes are approved, provide it with a supplement to the EU technical documentation assessment certificate. |
5. Specific additional procedures
5. 具体附加程序
5.1. Assessment procedure for certain class III and class IIb devices
5.1. 某些 III 类和 IIb 类设备的评估程序
For class III implantable devices, and for class IIb active devices intended to administer and/or remove a medicinal product as referred to in Section 6.4. of Annex VIII (Rule 12), the notified body shall, having verified the quality of clinical data supporting the clinical evaluation report of the manufacturer referred to in Article 61(12), prepare a clinical evaluation assessment report which sets out its conclusions concerning the clinical evidence provided by the manufacturer, in particular concerning the benefit-risk determination, the consistency of that evidence with the intended purpose, including the medical indication or indications and the PMCF plan referred to in Article 10(3) and Part B of Annex XIV.
对于 III 类植入式设备，以及用于管理和/或移除第 6.4 节中提及的药品的 IIb 类有源设备。附件八（规则12），公告机构应在核实支持第61条第（12）款所述制造商临床评估报告的临床数据质量后，编制一份临床评估评估报告，其中列出其关于制造商提供的临床证据的结论，特别是关于收益-风险确定的结论，该证据与预期目的的一致性， 包括附件十四第10条第（3）款和B部分所述的一个或多个医疗适应症和PMCF计划。
The notified body shall transmit its clinical evaluation assessment report, along with the manufacturer's clinical evaluation documentation, referred to in points (c) and (d) of Section 6.1 of Annex II, to the Commission.
指定机构应将其临床评估报告以及附件II第6.1节（c）和（d）点所述的制造商的临床评估文件转交委员会。
The Commission shall immediately transmit those documents to the relevant expert panel referred to in Article 106.
委员会应立即将这些文件转交第106条所述的有关专家小组。
The notified body may be requested to present its conclusions as referred to in point (a) to the expert panel concerned.
可要求公告机构向有关专家小组提交（a）点所述的结论。
The expert panel shall decide, under the supervision of the Commission, on the basis of all of the following criteria:
专家小组应在委员会的监督下，根据以下所有标准作出决定：
the novelty of the device or of the related clinical procedure involved, and the possible major clinical or health impact thereof;
所涉及的器械或相关临床程序的新颖性，以及其可能对临床或健康产生的主要影响;
a significantly adverse change in the benefit-risk profile of a specific category or group of devices due to scientifically valid health concerns in respect of components or source material or in respect of the impact on health in the case of failure of the device;
由于对组件或源材料的科学有效的健康问题，或在设备故障的情况下对健康的影响，特定类别或一组器械的收益-风险状况发生重大不利变化;
a significantly increased rate of serious incidents reported in accordance with Article 87 in respect of a specific category or group of devices,
根据第87条报告的与特定类别或一组设备有关的严重事故发生率显著增加，
whether to provide a scientific opinion on the clinical evaluation assessment report of the notified body based on the clinical evidence provided by the manufacturer, in particular concerning the benefit-risk determination, the consistency of that evidence with the medical indication or indications and the PMCF plan. That scientific opinion shall be provided within a period of 60 days, starting on the day of receipt of the documents from the Commission as referred to in point (a). The reasons for the decision to provide a scientific opinion on the basis of the criteria in points (i), (ii) and (iii) shall be included in the scientific opinion. Where the information submitted is not sufficient for the expert panel to reach a conclusion, this shall be stated in the scientific opinion.
是否根据制造商提供的临床证据，特别是关于收益风险的确定、该证据与一个或多个医学适应症以及 PMCF 计划的一致性，对公告机构的临床评估评估报告提供科学意见。该科学意见应在收到（a）点所述委员会文件之日起60天内提出。根据第（i）、（ii）和（iii）点的标准决定提供科学意见的理由应包括在科学意见中。如果所提交的资料不足以使专家小组得出结论，则应在科学意见中说明。
The expert panel may decide, under the supervision of the Commission, on the basis of the criteria laid down in point (c) not to provide a scientific opinion, in which case it shall inform the notified body as soon as possible and in any event within 21 days of receipt of the documents as referred to in point (a) from the Commission. The expert panel shall within that time limit provide the notified body and the Commission with the reasons for its decision, whereupon the notified body may proceed with the certification procedure of that device.
专家小组可在委员会的监督下，根据（c）点规定的标准决定不提供科学意见，在这种情况下，专家小组应尽快通知指定机构，无论如何应在收到委员会（a）点所述文件后21天内通知通知机构。专家小组应在该时限内向公告机构和委员会提供其决定的理由，以便公告机构可以着手进行该装置的认证程序。
The expert panel shall within 21 days of receipt of the documents from the Commission notify the Commission, through Eudamed whether it intends to provide a scientific opinion, pursuant to point (c), or whether it intends not to provide a scientific opinion, pursuant to point (d).
专家小组应在收到委员会的文件后21天内，通过Eudamed通知委员会是否打算根据（c）点提供科学意见，或者是否打算不根据（d）点提供科学意见。
Where no opinion has been delivered within a period of 60 days, the notified body may proceed with the certification procedure of the device in question.
如果在60天内未提出意见，则指定机构可以继续进行有关设备的认证程序。
The notified body shall give due consideration to the views expressed in the scientific opinion of the expert panel. Where the expert panel finds that the level of clinical evidence is not sufficient or otherwise gives rise to serious concerns about the benefit-risk determination, the consistency of that evidence with the intended purpose, including the medical indication(s), and with the PMCF plan, the notified body shall, if necessary, advise the manufacturer to restrict the intended purpose of the device to certain groups of patients or certain medical indications and/or to impose a limit on the duration of validity of the certificate, to undertake specific PMCF studies, to adapt the instructions for use or the summary of safety and performance, or to impose other restrictions in its conformity assessment report, as appropriate. The notified body shall provide a full justification where it has not followed the advice of the expert panel in its conformity assessment report and the Commission shall without prejudice to Article 109 make both the scientific opinion of the expert panel and the written justification provided by the notified body publicly available via Eudamed.
指定机构应适当考虑专家小组的科学意见中表达的意见。如果专家小组发现临床证据水平不足或以其他方式引起对收益风险确定的严重关注，则该证据与预期目的（包括医学适应症）以及PMCF计划的一致性，则公告机构应在必要时建议制造商将设备的预期目的限制为某些患者群体或某些医学适应症和/或施加限制关于证书有效期，进行特定的PMCF研究，调整使用说明或安全和性能摘要，或酌情在其合格评定报告中施加其他限制。如果指定机构在其合格评定报告中未遵循专家组的建议，则应提供充分的理由，委员会应在不影响第109条的情况下，通过Eudamed公开专家组的科学意见和指定机构提供的书面理由。
The Commission, after consultation with the Member States and relevant scientific experts shall provide guidance for expert panels for consistent interpretation of the criteria in point (c) before
►M1
26 May 2021 ◄ .
委员会在与成员国和相关科学专家协商后，应为专家小组提供指导，以便在 ►M1 2021 年 5 月 26 日 ◄ 之前对 （c） 点中的标准进行一致的解释。
5.2. Procedure in the case of devices incorporating a medicinal substance
5.2. 含有药用物质的器械的程序
Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product within the meaning of point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma and that has an action ancillary to that of the device, the quality, safety and usefulness of the substance shall be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC.
如果器械包含的物质作为不可分割部分，如果单独使用，可被视为指令2001/83/EC第1条第2点所指的医药产品，包括源自人血液或人血浆的医药产品，并且具有与器械相关的作用， 该物质的质量、安全性和有用性应通过类比指令2001/83/EC附件I中规定的方法进行验证。
Before issuing an EU technical documentation assessment certificate, the notified body shall, having verified the usefulness of the substance as part of the device and taking account of the intended purpose of the device, seek a scientific opinion from one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or from the EMA, either of which to be referred to in this Section as ‘the medicinal products authority consulted’ depending on which has been consulted under this point, on the quality and safety of the substance including the benefit or risk of the incorporation of the substance into the device. Where the device incorporates a human blood or plasma derivative or a substance that, if used separately, may be considered to be a medicinal product falling exclusively within the scope of the Annex to Regulation (EC) No 726/2004, the notified body shall seek the opinion of the EMA.
在颁发欧盟技术文件评估证书之前，指定机构应在验证该物质作为设备一部分的有用性并考虑到设备的预期用途后，向成员国根据指令 2001/83/EC 指定的主管当局之一或 EMA 寻求科学意见， 在本节中，其中任何一种都应称为“咨询的医药产品主管部门”，具体取决于根据这一点咨询的药品主管部门，关于该物质的质量和安全性，包括将该物质掺入器械的益处或风险。如果器械含有人体血液或血浆衍生物，或如果单独使用，可被视为完全属于法规 （EC） 第 726/2004 号附件范围的医药产品的物质，则指定机构应征求 EMA 的意见。
When issuing its opinion, the medicinal products authority consulted shall take into account the manufacturing process and the data relating to the usefulness of incorporation of the substance into the device as determined by the notified body.
在发表意见时，所咨询的药品主管部门应考虑制造过程以及与指定机构确定的将该物质掺入器械的有用性有关的数据。
The medicinal products authority consulted shall provide its opinion to the notified body within 210 days of receipt of all the necessary documentation.
被咨询的药品主管部门应在收到所有必要文件后210天内向指定机构提供意见。
The scientific opinion of the medicinal products authority consulted, and any possible update of that opinion, shall be included in the documentation of the notified body concerning the device. The notified body shall give due consideration to the views expressed in the scientific opinion when making its decision. The notified body shall not deliver the certificate if the scientific opinion is unfavourable and shall convey its final decision to the medicinal products authority consulted.
所咨询的药品主管部门的科学意见，以及该意见的任何可能更新，应包含在有关该器械的公告机构的文件中。公告机构在作出决定时应适当考虑科学意见中表达的意见。如果科学意见不利，则公告机构不应提供证书，并应将其最终决定传达给所咨询的药品主管部门。
Before any change is made with respect to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the manufacturer shall inform the notified body of the changes. That notified body shall seek the opinion of the medicinal products authority consulted, in order to confirm that the quality and safety of the ancillary substance remain unchanged. The medicinal products authority consulted shall take into account the data relating to the usefulness of incorporation of the substance into the device as determined by the notified body, in order to ensure that the changes have no negative impact on the risk or benefit previously established concerning the incorporation of the substance into the device. The medicinal products authority consulted shall provide its opinion within 60 days after receipt of all the necessary documentation regarding the changes. The notified body shall not deliver the supplement to the EU technical documentation assessment certificate if the scientific opinion provided by the medicinal products authority consulted is unfavourable. The notified body shall convey its final decision to the medicinal products authority consulted.
在对器械中掺入的辅助物质进行任何更改之前，特别是与其制造过程相关的辅助物质，制造商应将更改通知机构。该公告机构应征求所咨询的药品主管部门的意见，以确认辅助物质的质量和安全性保持不变。所咨询的药品主管部门应考虑由指定机构确定的与将该物质掺入器械的有用性有关的数据，以确保这些变化不会对先前确定的有关将该物质掺入器械的风险或收益产生负面影响。所咨询的药品主管部门应在收到有关变更的所有必要文件后60天内提出意见。如果所咨询的医药产品主管部门提供的科学意见不利，则公告机构不得提供欧盟技术文献评估证书的补充。公告机构应将其最终决定传达给所咨询的药品主管部门。
Where the medicinal products authority consulted obtains information on the ancillary substance, which could have an impact on the risk or benefit previously established concerning the incorporation of the substance into the device, it shall advise the notified body as to whether this information has an impact on the risk or benefit previously established concerning the incorporation of the substance into the device. The notified body shall take that advice into account in reconsidering its assessment of the conformity assessment procedure.
如果所咨询的药品主管部门获得有关辅助物质的信息，而这些信息可能对先前确定的有关将该物质掺入器械的风险或利益产生影响，则应告知通知机构，该信息是否对先前确定的有关将该物质掺入器械的风险或益处产生影响。指定机构在重新考虑其对合格评定程序的评估时应考虑该建议。
5.3. Procedure in the case of devices manufactured utilising, or incorporating, tissues or cells of human or animal origin, or their derivatives, that are non-viable or rendered non-viable
5.3. 使用或结合人类或动物来源的组织或细胞或其衍生物制造的不可行或不可行设备的程序
5.3.1. Tissues or cells of human origin or their derivatives
5.3.1. 人源性组织或细胞或其衍生物
For devices manufactured utilising derivatives of tissues or cells of human origin that are covered by this Regulation in accordance with point (g) of Article 1(6) and for devices that incorporate, as an integral part, tissues or cells of human origin, or their derivatives, covered by Directive 2004/23/EC, that have an action ancillary to that of the device, the notified body shall, prior to issuing an EU technical documentation assessment certificate, seek a scientific opinion from one of the competent authorities designated by the Member States in accordance with Directive 2004/23/EC (‘human tissues and cells competent authority’) on the aspects relating to the donation, procurement and testing of tissues or cells of human origin or their derivatives. The notified body shall submit a summary of the preliminary conformity assessment which provides, among other things, information about the non-viability of the human tissues or cells in question, their donation, procurement and testing and the risk or benefit of the incorporation of the tissues or cells of human origin or their derivatives into the device.
对于根据第1条第（6）款（g）项使用本法规所涵盖的人类来源的组织或细胞的衍生物制造的器械，以及将指令2004/23/EC所涵盖的人源性组织或细胞或其衍生物作为组成部分的器械，其作用与器械的作用相辅相成， 在颁发欧盟技术文献评估证书之前，公告机构应就人类来源的组织或细胞或其衍生物的捐赠、采购和测试等方面向成员国指定的主管机构之一（“人体组织和细胞主管当局”）征求科学意见。指定机构应提交初步合格评定摘要，其中除其他外，提供有关有关人体组织或细胞的不可存活性、其捐赠、采购和测试以及将人类来源的组织或细胞或其衍生物纳入器械的风险或益处的信息。
Within 120 days of receipt of all the necessary documentation, the human tissues and cells competent authority shall provide to the notified body its opinion.
在收到所有必要文件后120天内，人体组织和细胞主管当局应向公告机构提供其意见。
The scientific opinion of the human tissues and cells competent authority, and any possible update, shall be included in the documentation of the notified body concerning the device. The notified body shall give due consideration to the views expressed in the scientific opinion of the human tissues and cells competent authority when making its decision. The notified body shall not deliver the certificate if that scientific opinion is unfavourable. It shall convey its final decision to the human tissues and cells competent authority concerned.
人体组织和细胞主管当局的科学意见以及任何可能的更新应包含在指定机构有关该设备的文件中。公告机构在作出决定时，应适当考虑人体组织和细胞主管当局的科学意见中表达的观点。如果该科学意见不利，则指定机构不得提供证书。委员会应将最后决定转达有关人体组织和细胞主管当局。
Before any change is made with respect to non-viable tissues or cells of human origin or their derivatives incorporated in a device, in particular relating to their donation, testing or procurement, the manufacturer shall inform the notified body of the intended changes. The notified body shall consult the authority that was involved in the initial consultation, in order to confirm that the quality and safety of the tissues or cells of human origin or their derivatives incorporated in the device are maintained. The human tissues and cells competent authority concerned shall take into account the data relating to the usefulness of incorporation of the tissues or cells of human origin or their derivatives into the device as determined by the notified body, in order to ensure that the changes have no negative impact on the established benefit-risk ratio of the addition of the tissues or cells of human origin or their derivatives in the device. It shall provide its opinion within 60 days of receipt of all the necessary documentation regarding the intended changes. The notified body shall not deliver a supplement to the EU technical documentation assessment certificate if the scientific opinion is unfavourable and shall convey its final decision to the human tissues and cells competent authority concerned.
在对非活的人类来源的组织或细胞或其衍生物进行任何更改之前，特别是与它们的捐赠、测试或采购有关，制造商应将预期的更改通知公告机构。公告机构应咨询参与初始咨询的主管部门，以确认器械中掺入的人源组织或细胞或其衍生物的质量和安全性得到维持。有关人体组织和细胞主管当局应考虑与指定机构确定的将人类来源的组织或细胞或其衍生物掺入器械的有用性有关的数据，以确保这些变化不会对在器械中添加人源性组织或细胞或其衍生物的既定利益风险比产生负面影响。它应在收到有关预期变更的所有必要文件后 60 天内提出意见。如果科学意见不利，则指定机构不得提供欧盟技术文献评估证书的补充，并应将其最终决定传达给有关人体组织和细胞主管当局。
5.3.2. Tissues or cells of animal origin or their derivatives
5.3.2. 动物源性组织或细胞或其衍生物
In the case of devices manufactured utilising animal tissue which is rendered non-viable or utilising non-viable products derived from animal tissue, as referred to in Regulation (EU) No 722/2012, the notified body shall apply the relevant requirements laid down in that Regulation.
对于使用动物组织制造的器械，如果该器械无法存活或使用来自动物组织的不可行产品，如法规 （EU） No 722/2012 所述，指定机构应适用该法规中规定的相关要求。
5.4. Procedure in the case of devices that are composed of substances or of combinations of substances that are absorbed by or locally dispersed in the human body
5.4. 由被人体吸收或局部分散的物质或物质组合组成的装置的程序
The quality and safety of devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by, or locally dispersed in, the human body, shall be verified where applicable and only in respect of the requirements not covered by this Regulation, in accordance with the relevant requirements laid down in Annex I to Directive 2001/83/EC for the evaluation of absorption, distribution, metabolism, excretion, local tolerance, toxicity, interaction with other devices, medicinal products or other substances and potential for adverse reactions.
由拟通过体孔引入人体或应用于皮肤并被人体吸收或局部分散在人体中的物质或物质组合组成的器械的质量和安全性应在适用时进行验证，并且仅针对本法规未涵盖的要求， 根据指令 2001/83/EC 附件 I 中规定的相关要求，用于评估吸收、分布、代谢、排泄、局部耐受性、毒性、与其他器械、药品或其他物质的相互作用以及不良反应的可能性。
In addition, for devices, or their products of metabolism, that are systemically absorbed by the human body in order to achieve their intended purpose, the notified body shall seek a scientific opinion from one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or from the EMA, either of which to be referred to in this Section as ‘the medicinal products authority consulted’ depending on which has been consulted under this point, on the compliance of the device with the relevant requirements laid down in Annex I to Directive 2001/83/EC.
此外，对于被人体系统吸收以达到其预期目的的器械或其代谢产物，公告机构应向成员国根据第 2001/83/EC 号指令指定的主管机构之一或 EMA 寻求科学意见，其中任何一个在本节中称为“咨询的药品主管部门”，具体取决于已咨询的机构在这一点上，关于设备是否符合指令 2001/83/EC 附件 I 中规定的相关要求。
The opinion of the medicinal products authority consulted shall be drawn up within 150 days of receipt of all the necessary documentation.
所咨询的药品主管部门的意见应在收到所有必要文件后150天内起草。
The scientific opinion of the medicinal products authority consulted, and any possible update, shall be included in the documentation of the notified body concerning the device. The notified body shall give due consideration to the views expressed in the scientific opinion when making its decision and shall convey its final decision to the medicinal products authority consulted.
所咨询的药品主管部门的科学意见以及任何可能的更新，都应包含在有关该器械的公告机构的文件中。公告机构在作出决定时应适当考虑科学意见中表达的意见，并应将其最终决定传达给所咨询的药品主管部门。
6. Batch verification in the case of devices incorporating, as an integral part, a medicinal substance which, if used separately, would be considered to be a medicinal product derived from human blood or human plasma as referred to in Article 1(8)
6. 如果器械将药用物质作为不可分割的一部分，如果单独使用，则被视为第1条第（8）款所述的源自人体血液或人体血浆的医药产品，则进行批次验证
Upon completing the manufacture of each batch of devices that incorporate, as an integral part, a medicinal substance which, if used separately, would be considered to be a medicinal product derived from human blood or human plasma as referred to in the first subparagraph of Article 1(8), the manufacturer shall inform the notified body of the release of the batch of devices and send it the official certificate concerning the release of the batch of human blood or plasma derivative used in the device, issued by a Member State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.
在完成每批器械的制造后，如果将药物作为不可分割的一部分，如果单独使用，将被视为第1条第（8）款第1项所述的源自人体血液或人体血浆的医药产品，制造商应将该批设备的放行情况通知公告机构，并向其发送有关该批产品放行的官方证书由成员国实验室或成员国根据指令 2001/83/EC 第 114（2） 条指定的实验室颁发的用于设备的人血或血浆衍生物。
CHAPTER III 第三章
ADMINISTRATIVE PROVISIONS
行政规定
|
7. |
The manufacturer or, where the manufacturer does not have a registered place of business in a Member State, its authorised representative shall, for a period ending no sooner than 10 years, and in the case of implantable devices no sooner than 15 years, after the last device has been placed on the market, keep at the disposal of the competent authorities:
—
the EU declaration of conformity,
欧盟符合性声明，
—
the documentation referred to in the fifth indent of Section 2.1 and in particular the data and records arising from the procedures referred to in point (c) of the second paragraph of Section 2.2,
第 2.1 节第五缩进中提及的文件，特别是第 2.2 节第 2.2 节 （c） 点所述程序产生的数据和记录，
—
information on the changes referred to in Section 2.4,
有关第 2.4 节中提及的更改的信息，
—
the documentation referred to in Section 4.2, and
第 4.2 节中提及的文档，以及
—
the decisions and reports from the notified body as referred to in this Annex.
本附件中提及的公告机构的决定和报告。 |
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8. |
Each Member State shall require that the documentation referred to in Section 7 is kept at the disposal of competent authorities for the period indicated in that Section in case a manufacturer, or its authorised representative, established within its territory goes bankrupt or ceases its business activity prior to the end of that period. |
ANNEX X 附件十
CONFORMITY ASSESSMENT BASED ON TYPE-EXAMINATION
基于型式检验的合格评定
|
1. |
EU type-examination is the procedure whereby a notified body ascertains and certifies that a device, including its technical documentation and relevant life cycle processes and a corresponding representative sample of the device production envisaged, fulfils the relevant provisions of this Regulation. |
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2. |
Application 应用 The manufacturer shall lodge an application for assessment with a notified body. The application shall include:
—
the name of the manufacturer and address of the registered place of business of the manufacturer and, if the application is lodged by the authorised representative, the name of the authorised representative and the address of its registered place of business,
制造商的名称和制造商的注册营业地点地址，如果申请是由授权代表提出的，则授权代表的名称及其注册营业地点的地址，
—
the technical documentation referred to in Annexes II and III. The applicant shall make a representative sample of the device production envisaged (‘type’) available to the notified body. The notified body may request other samples as necessary, and
附件二和附件三中提到的技术文件。申请人应向指定机构提供预期设备生产（“类型”）的代表性样品。如有必要，指定机构可以要求提供其他样品，并且
—
a written declaration that no application has been lodged with any other notified body for the same type, or information about any previous application for the same type that was refused by another notified body or was withdrawn by the manufacturer or its authorised representative before that other notified body made its final assessment.
一份书面声明，表明没有向任何其他指定机构提交过相同类型的申请，或有关其他指定机构拒绝或制造商或其授权代表在该其他指定机构进行最终评估之前撤回的相同类型的任何先前申请的信息。 |
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3. |
Assessment 评估 The notified body shall:
(a) （一）
examine the application by using staff with proven knowledge and experience regarding the technology concerned and its clinical application. The notified body may require the application to be completed by having further tests carried out or requesting further evidence to be provided to allow assessment of conformity with the relevant requirements of this Regulation. The notified body shall carry out adequate physical or laboratory tests in relation to the device or request the manufacturer to carry out such tests;
(b) （二）
examine and assess the technical documentation for conformity with the requirements of this Regulation that are applicable to the device and verify that the type has been manufactured in conformity with that documentation; it shall also record the items designed in conformity with the applicable standards referred to in Article 8 or with applicable CS, and record the items not designed on the basis of the relevant standards referred to in Article 8 or of the relevant CS;
(c) （三）
review the clinical evidence presented by the manufacturer in the clinical evaluation report in accordance with Section 4 of Annex XIV. The notified body shall employ device reviewers with sufficient clinical expertise and, if necessary, use external clinical experts with direct and current experience relating to the device in question or to the clinical condition in which it is utilised, for the purposes of that review;
(d) （四）
in circumstances in which the clinical evidence is based partly or totally on data from devices which are claimed to be similar or equivalent to the device under assessment, assess the suitability of using such data, taking into account factors such as new indications and innovation. The notified body shall clearly document its conclusions on the claimed equivalence, and on the relevance and adequacy of the data for demonstrating conformity;
(e) （五）
clearly document the outcome of its assessment in a pre-clinical and clinical evaluation assessment report as part of the EU type examination report referred to in point (i);
(f) （六）
carry out or arrange for the appropriate assessments and the physical or laboratory tests necessary to verify whether the solutions adopted by the manufacturer meet the general safety and performance requirements laid down in this Regulation, in the event that the standards referred to in Article 8 or the CS have not been applied. Where the device has to be connected to another device or devices in order to operate as intended, proof shall be provided that it conforms to the general safety and performance requirements when connected to any such device or devices having the characteristics specified by the manufacturer;
(g) （七）
carry out or arrange for the appropriate assessments and the physical or laboratory tests necessary to verify whether, in the event that the manufacturer has chosen to apply the relevant harmonised standards, those standards have actually been applied;
(h) （八）
agree with the applicant on the place where the necessary assessments and tests are to be carried out; and
(i) （一）
draw up an EU type-examination report on the results of the assessments and tests carried out under points (a) to (g). |
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4. |
Certificate 证书 If the type conforms to this Regulation, the notified body shall issue an EU type-examination certificate. The certificate shall contain the name and address of the manufacturer, the conclusions of the type examination assessment, the conditions of the certificate's validity and the data needed for identification of the type approved. The certificate shall be drawn up in accordance with Annex XII. The relevant parts of the documentation shall be annexed to the certificate and a copy kept by the notified body. |
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5. |
Changes to the type 对类型的更改
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6. |
Specific additional procedures 具体附加程序 Section 5 of Annex IX shall apply with the proviso that any reference to an EU technical documentation assessment certificate shall be understood as a reference to an EU type-examination certificate. |
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7. |
Administrative provisions 行政规定 The manufacturer or, where the manufacturer does not have a registered place of business in a Member State, its authorised representative shall, for a period ending no sooner than 10 years, and in the case of implantable devices no sooner than 15 years, after the last device has been placed on the market, keep at the disposal of the competent authorities:
—
the documentation referred to in the second indent of Section 2,
第 2 节第二缩进中提到的文档，
—
information on the changes referred to in Section 5, and
有关第 5 节中提及的更改的信息，以及
—
copies of EU type-examination certificates, scientific opinions and reports and their additions/supplements.
欧盟型式检验证书、科学意见和报告及其补充/补充的复印件。 Section 8 of Annex IX shall apply. |
ANNEX XI 附件十一
CONFORMITY ASSESSMENT BASED ON PRODUCT CONFORMITY VERIFICATION
基于产品合格评定的合格评定
|
1. |
The objective of the conformity assessment based on product conformity verification is to ensure that devices conform to the type for which an EU type-examination certificate has been issued, and that they meet the provisions of this Regulation which apply to them. |
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2. |
Where an EU type-examination certificate has been issued in accordance with Annex X, the manufacturer may either apply the procedure set out in Part A (production quality assurance) or the procedure set out in Part B (product verification) of this Annex. |
|
3. |
By way of derogation from Sections 1 and 2 above, the procedures in this Annex coupled with the drawing up of technical documentation as set out in Annexes II and III may also be applied by manufacturers of class IIa devices. |
PART A 第一部分
PRODUCTION QUALITY ASSURANCE
生产质量保证
|
4. |
The manufacturer shall ensure that the quality management system approved for the manufacture of the devices concerned is implemented, shall carry out a final verification, as specified in Section 6, and shall be subject to the surveillance referred to in Section 7. |
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5. |
When the manufacturer fulfils the obligations laid down in Section 4, it shall draw up and keep an EU declaration of conformity in accordance with Article 19 and Annex IV for the device covered by the conformity assessment procedure. By issuing an EU declaration of conformity, the manufacturer shall be deemed to ensure and to declare that the device concerned conforms to the type described in the EU type-examination certificate and meets the requirements of this Regulation which apply to the device. |
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6. |
Quality management system 质量管理体系
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|
7. |
Surveillance 监视 Section 3.1, the first, second and fourth indents of Section 3.2, Sections 3.3, 3.4, 3.6 and 3.7 of Annex IX shall apply. In the case of class III devices, surveillance shall also include a check that the quantities of produced or purchased raw material or crucial components approved for the type and correspond to the quantities of finished devices. |
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8. |
Batch verification in the case of devices incorporating, as an integral part, a medicinal substance which, if used separately, would be considered to be a medicinal product derived from human blood or human plasma referred to in Article 1(8). Upon completing the manufacture of each batch of devices that incorporate, as an integral part, a medicinal substance which, if used separately, would be considered to be a medicinal product derived from human blood or human plasma referred to in the first subparagraph of Article 1(8), the manufacturer shall inform the notified body of the release of the batch of devices and send it the official certificate concerning the release of the batch of human blood or plasma derivative used in the device, issued by a Member State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC. |
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9. |
Administrative provisions 行政规定 The manufacturer or, where the manufacturer does not have a registered place of business in a Member State, its authorised representative shall, for a period ending no sooner than 10 years, and in the case of implantable devices no sooner than 15 years, after the last device has been placed on the market, keep at the disposal of the competent authorities:
—
the EU declaration of conformity,
欧盟符合性声明，
—
the documentation referred to in the fifth indent of Section 2.1 of Annex IX,
附件 IX 第 2.1 节第五缩进中提及的文件，
—
the documentation referred to in the eighth indent of Section 2.1 of Annex IX, including the EU type-examination certificate referred to in Annex X,
附件 IX 第 2.1 节第 8 个缩进中提及的文件，包括附件 X 中提及的欧盟型式检验证书，
—
information on the changes referred to in Section 2.4 of Annex IX, and
关于附件九第2.4节所述变更的信息，以及
—
the decisions and reports from the notified body as referred to in Sections 2.3, 3.3 and 3.4 of Annex IX.
附件九第2.3、3.3和3.4节所述的公告机构的决定和报告。 Section 8 of Annex IX shall apply. |
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10. |
Application to class IIa devices 适用于 IIa 类设备
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PART B B部分
PRODUCT VERIFICATION 产品验证
|
11. |
Product verification shall be understood to be the procedure whereby after examination of every manufactured device, the manufacturer, by issuing an EU declaration of conformity in accordance with Article 19 and Annex IV, shall be deemed to ensure and to declare that the devices which have been subject to the procedure set out in Sections 14 and 15 conform to the type described in the EU type-examination certificate and meet the requirements of this Regulation which apply to them. |
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12. |
The manufacturer shall take all the measures necessary to ensure that the manufacturing process produces devices which conform to the type described in the EU type-examination certificate and to the requirements of the Regulation which apply to them. Prior to the start of manufacture, the manufacturer shall prepare documents defining the manufacturing process, in particular as regards sterilisation where necessary, together with all routine, pre-established procedures to be implemented to ensure homogeneous production and, where appropriate, conformity of the devices with the type described in the EU type-examination certificate and with the requirements of this Regulation which apply to them. In addition, for devices placed on the market in a sterile condition, and only for those aspects of the manufacturing process designed to secure and maintain sterility, the manufacturer shall apply the provisions of Sections 6 and 7. |
|
13. |
The manufacturer shall undertake to institute and keep up to date a post-market surveillance plan, including a PMCF plan, and the procedures ensuring compliance with the obligations of the manufacturer resulting from the provisions on vigilance and post-market surveillance system set out in Chapter VII. |
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14. |
The notified body shall carry out the appropriate examinations and tests in order to verify the conformity of the device with the requirements of the Regulation by examining and testing every product as specified in Section 15. The examinations and tests referred to in the first paragraph of this Section shall not apply to aspects of the manufacturing process designed to secure sterility. |
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15. |
Verification by examination and testing of every product 通过对每个产品的检查和测试进行验证
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|
16. |
Batch verification in the case of devices incorporating, as an integral part, a medicinal substance which, if used separately, would be considered to be a medicinal product derived from human blood or human plasma referred to in Article 1(8). Upon completing the manufacture of each batch of devices that incorporate, as an integral part, a medicinal substance which, if used separately, would be considered to be a medicinal product derived from human blood or human plasma referred to in the first subparagraph of Article 1(8), the manufacturer shall inform the notified body of the release of the batch of devices and send it the official certificate concerning the release of the batch of human blood or plasma derivative used in the device, issued by a Member State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC. |
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17. |
Administrative provisions 行政规定 The manufacturer or its authorised representative shall, for a period ending no sooner than 10 years, and in the case of implantable devices no sooner than 15 years, after the last device has been placed on the market, keep at the disposal of the competent authorities:
—
the EU declaration of conformity,
欧盟符合性声明，
—
the documentation referred to in Section 12,
第 12 节中提到的文件，
—
the certificate referred to in Section 15.2, and
第 15.2 节中提及的证书，以及
—
the EU type-examination certificate referred to in Annex X.
附件X中提及的欧盟型式检验证书。 Section 8 of Annex IX shall apply. |
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18. |
Application to class IIa devices 适用于 IIa 类设备
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ANNEX XII 附件十二
CERTIFICATES ISSUED BY A NOTIFIED BODY
由指定机构颁发的证书
CHAPTER I 第一章
GENERAL REQUIREMENTS 一般要求
1. Certificates shall be drawn up in one of the official languages of the Union.
一、证书应以本联盟官方语言之一拟制。
2. Each certificate shall refer to only one conformity assessment procedure.
2. 每份证书只能提及一个合格评定程序。
3. Certificates shall only be issued to one manufacturer. The name and address of the manufacturer included in the certificate shall be the same as that registered in the electronic system referred to in Article 30.
3. 证书只能发给一个制造商。证书中所列制造商的名称和地址应与第30条所述电子系统中登记的名称和地址相同。
4. The scope of the certificates shall unambiguously identify the device or devices covered:
4. 证书的范围应明确指出所涵盖的一个或多个设备：
EU technical documentation assessment certificates, EU type-examination certificates and EU product verification certificates shall include a clear identification, including the name, model and type, of the device or devices, the intended purpose, as included by the manufacturer in the instructions for use and in relation to which the device has been assessed in the conformity assessment procedure, risk classification and the Basic UDI-DI as referred to in Article 27(6);
欧盟技术文件评估证书、欧盟型式检验证书和欧盟产品验证证书应包括制造商在使用说明中包括的设备或设备的名称、型号和类型、预期用途以及与设备相关的明确标识，并在合格评定程序中评估了该设备， 第27条第（6）款所述的风险分类和基本UDI-DI;
EU quality management system certificates and EU quality assurance certificates shall include the identification of the devices or groups of devices, the risk classification, and, for class IIb devices, the intended purpose.
欧盟质量管理体系证书和欧盟质量保证证书应包括器械或器械组的标识、风险分类以及IIb类器械的预期用途。
5. The notified body shall be able to demonstrate on request, which (individual) devices are covered by the certificate. The notified body shall set up a system that enables the determination of the devices, including their classification, covered by the certificate.
5. 指定机构应能够根据要求证明证书涵盖哪些（单个）设备。指定机构应建立一个系统，以便确定证书所涵盖的器械，包括其分类。
6. Certificates shall contain, if applicable, a note that, for the placing on the market of the device or devices it covers, another certificate issued in accordance with this Regulation is required.
6. 如适用，证书应载有说明，说明要将其所涵盖的一个或多个器械投放市场，需要根据本条例签发的另一份证书。
7. EU quality management system certificates and EU quality assurance certificates for class I devices for which the involvement of a notified body is required pursuant to Article 52(7) shall include a statement that the audit by the notified body of the quality management system was limited to the aspects required under that paragraph.
7. 根据第52条第（7）款要求指定机构参与的I类器械的欧盟质量管理体系证书和欧盟质量保证证书应包括一份声明，说明指定机构对质量管理体系的审核仅限于该款要求的方面。
8. Where a certificate is supplemented, modified or re-issued, the new certificate shall contain a reference to the preceding certificate and its date of issue with identification of the changes.
8. 如果证书被补充、修改或重新签发，新证书应注明前一份证书及其签发日期，并注明更改。
CHAPTER II 第二章
MINIMUM CONTENT OF THE CERTIFICATES
证书的最低内容
name, address and identification number of the notified body;
指定机构的名称、地址和识别号码;
name and address of the manufacturer and, if applicable, of the authorised representative;
制造商的名称和地址，以及授权代表（如适用）的名称和地址;
unique number identifying the certificate;
标识证书的唯一编号;
if already issued, the SRN of the manufacturer referred to in to Article 31(2);
如果已经签发，则为第31条第（2）款所述制造商的SRN;
date of issue; 签发日期;
date of expiry; 到期日;
data needed for the unambiguous identification of the device or devices where applicable as specified in Section 4 of Part I;
如第一部分第 4 节所述，在适用的情况下明确识别设备所需的数据;
if applicable, reference to any previous certificate as specified in Section 8 of Chapter I;
如适用，参考第一章第8节规定的任何先前证书;
reference to this Regulation and the relevant Annex in accordance with which the conformity assessment has been carried out;
参考本法规和进行合格评定所依据的相关附件;
examinations and tests performed, e.g. reference to relevant CS, harmonised standards, test reports and audit report(s);
进行考试和测试，例如参考相关的CS、协调标准、测试报告和审核报告;
if applicable, reference to the relevant parts of the technical documentation or other certificates required for the placing on the market of the device or devices covered;
如果适用，请参阅将所涵盖的器械投放市场所需的技术文档或其他证书的相关部分;
if applicable, information about the surveillance by the notified body;
如适用，有关指定机构监督的信息;
conclusions of the notified body's conformity assessment with regard to the relevant Annex;
公告机构对相关附件的合格评定结论;
conditions for or limitations to the validity of the certificate;
证书有效期的条件或限制;
legally binding signature of the notified body in accordance with the applicable national law.
根据适用的国家法律，指定机构具有法律约束力的签名。
ANNEX XIII 附件十三
PROCEDURE FOR CUSTOM-MADE DEVICES
定制设备的程序
1. For custom-made devices, the manufacturer or its authorised representative shall draw up a statement containing all of the following information:
1. 对于定制设备，制造商或其授权代表应起草一份包含以下所有信息的声明：
制造商的名称和地址，以及所有生产基地的名称和地址，
如适用，授权代表的姓名和地址，
允许识别相关设备的数据，
该设备仅供特定患者或用户使用的声明，由姓名、首字母缩略词或数字代码标识，
开具处方的人的姓名，并凭借其专业资格获得国家法律的授权，并在适用的情况下，有关卫生机构的名称，
处方所指示的产品的具体特性，
一份声明，说明有关设备符合附件 I 中规定的一般安全和性能要求，并在适用的情况下指出哪些一般安全和性能要求尚未完全满足，以及理由，
在适用的情况下，表明设备包含或包含药用物质，包括人类血液或血浆衍生物，或人类来源的组织或细胞，或法规 （EU） No 722/2012 中提及的动物来源的组织或细胞。
2. The manufacturer shall undertake to keep available for the competent national authorities documentation that indicates its manufacturing site or sites and allows an understanding to be formed of the design, manufacture and performance of the device, including the expected performance, so as to allow assessment of conformity with the requirements of this Regulation.
2. 制造商应承诺向国家主管当局提供文件，说明其生产地点，并允许对设备的设计、制造和性能（包括预期性能）形成了解，以便评估是否符合本条例的要求。
3. The manufacturer shall take all the measures necessary to ensure that the manufacturing process produces devices which are manufactured in accordance with the documentation referred to in Section 2.
3. 制造商应采取一切必要措施，确保制造过程生产的设备按照第 2 节所述文件制造。
4. The statement referred to in the introductory part of Section 1 shall be kept for a period of at least 10 years after the device has been placed on the market. In the case of implantable devices, the period shall be at least 15 years.
4. 第 1 节引言部分所述的声明应在设备投放市场后至少保存 10 年。对于植入式器械，期限应至少为 15 年。
Section 8 of Annex IX shall apply.
适用附件九第8节。
5. The manufacturer shall review and document experience gained in the post-production phase, including from PMCF as referred to in Part B of Annex XIV, and implement appropriate means to apply any necessary corrective action, In that context, it shall report in accordance with Article 87(1) to the competent authorities any serious incidents or field safety corrective actions or both as soon as it learns of them.
5. 制造商应审查和记录在生产后阶段获得的经验，包括附件十四 B 部分所述的 PMCF 获得的经验，并采取适当措施采取任何必要的纠正措施，在这种情况下，制造商应根据第 87 条第 1 款的规定，在获悉任何严重事故或现场安全纠正措施或两者兼而有之后立即向主管当局报告。
ANNEX XIV 附件十四
CLINICAL EVALUATION AND POST-MARKET CLINICAL FOLLOW-UP
临床评估和上市后临床随访
PART A 第一部分
CLINICAL EVALUATION 临床评估
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1. |
To plan, continuously conduct and document a clinical evaluation, manufacturers shall:
(a) （一）
establish and update a clinical evaluation plan, which shall include at least:
—
an identification of the general safety and performance requirements that require support from relevant clinical data;
确定需要相关临床数据支持的一般安全性和性能要求;
—
a specification of the intended purpose of the device;
设备预期用途的规范;
—
a clear specification of intended target groups with clear indications and contra-indications;
明确规定目标群体，明确适应症和禁忌症;
—
a detailed description of intended clinical benefits to patients with relevant and specified clinical outcome parameters;
详细描述具有相关和特定临床结果参数的患者的预期临床益处;
—
a specification of methods to be used for examination of qualitative and quantitative aspects of clinical safety with clear reference to the determination of residual risks and side-effects;
用于检查临床安全性的定性和定量方面的方法规范，明确提及残留风险和副作用的确定;
—
an indicative list and specification of parameters to be used to determine, based on the state of the art in medicine, the acceptability of the benefit-risk ratio for the various indications and for the intended purpose or purposes of the device;
根据医学的最新技术水平，用于确定各种适应症和设备预期目的的收益风险比的可接受性，用于参数的指示性列表和规范;
—
an indication how benefit-risk issues relating to specific components such as use of pharmaceutical, non-viable animal or human tissues, are to be addressed; and
说明如何解决与特定成分（如使用药物、非活动物或人体组织）相关的利益-风险问题;和
—
a clinical development plan indicating progression from exploratory investigations, such as first-in-man studies, feasibility and pilot studies, to confirmatory investigations, such as pivotal clinical investigations, and a PMCF as referred to in Part B of this Annex with an indication of milestones and a description of potential acceptance criteria;
临床开发计划，说明从探索性研究（如首次人体研究、可行性和中试研究）到验证性研究（如关键临床研究）的进展，以及本附件 B 部分中提及的 PMCF，并说明里程碑和潜在验收标准的描述;
(b) （二）
identify available clinical data relevant to the device and its intended purpose and any gaps in clinical evidence through a systematic scientific literature review;
(c) （三）
appraise all relevant clinical data by evaluating their suitability for establishing the safety and performance of the device;
(d) （四）
generate, through properly designed clinical investigations in accordance with the clinical development plan, any new or additional clinical data necessary to address outstanding issues; and
(e) （五）
analyse all relevant clinical data in order to reach conclusions about the safety and clinical performance of the device including its clinical benefits. |
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2. |
The clinical evaluation shall be thorough and objective, and take into account both favourable and unfavourable data. Its depth and extent shall be proportionate and appropriate to the nature, classification, intended purpose and risks of the device in question, as well as to the manufacturer's claims in respect of the device. |
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3. |
A clinical evaluation may be based on clinical data relating to a device for which equivalence to the device in question can be demonstrated. The following technical, biological and clinical characteristics shall be taken into consideration for the demonstration of equivalence:
—
Technical: the device is of similar design; is used under similar conditions of use; has similar specifications and properties including physicochemical properties such as intensity of energy, tensile strength, viscosity, surface characteristics, wavelength and software algorithms; uses similar deployment methods, where relevant; has similar principles of operation and critical performance requirements;
技术：该设备具有类似的设计;在类似的使用条件下使用;具有相似的规格和性能，包括能量强度、拉伸强度、粘度、表面特性、波长和软件算法等理化性能;在相关的情况下使用类似的部署方法;具有相似的操作原理和关键性能要求;
—
Biological: the device uses the same materials or substances in contact with the same human tissues or body fluids for a similar kind and duration of contact and similar release characteristics of substances, including degradation products and leachables;
生物：该装置使用相同的材料或物质与相同的人体组织或体液接触，具有相似的种类和接触持续时间以及相似的物质释放特性，包括降解产物和可浸出物;
—
Clinical: the device is used for the same clinical condition or purpose, including similar severity and stage of disease, at the same site in the body, in a similar population, including as regards age, anatomy and physiology; has the same kind of user; has similar relevant critical performance in view of the expected clinical effect for a specific intended purpose.
临床：该设备用于相同的临床状况或目的，包括相似的严重程度和疾病阶段，在身体的同一部位，在相似的人群中，包括年龄、解剖学和生理学;具有相同类型的用户;鉴于特定预期目的的预期临床效果，具有类似的相关临界性能。 The characteristics listed in the first paragraph shall be similar to the extent that there would be no clinically significant difference in the safety and clinical performance of the device. Considerations of equivalence shall be based on proper scientific justification. It shall be clearly demonstrated that manufacturers have sufficient levels of access to the data relating to devices with which they are claiming equivalence in order to justify their claims of equivalence. |
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4. |
The results of the clinical evaluation and the clinical evidence on which it is based shall be documented in a clinical evaluation report which shall support the assessment of the conformity of the device. The clinical evidence together with non-clinical data generated from non-clinical testing methods and other relevant documentation shall allow the manufacturer to demonstrate conformity with the general safety and performance requirements and shall be part of the technical documentation for the device in question. Both favourable and unfavourable data considered in the clinical evaluation shall be included in the technical documentation. |
PART B B部分
POST-MARKET CLINICAL FOLLOW-UP
上市后临床随访
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5. |
PMCF shall be understood to be a continuous process that updates the clinical evaluation referred to in Article 61 and Part A of this Annex and shall be addressed in the manufacturer's post-market surveillance plan. When conducting PMCF, the manufacturer shall proactively collect and evaluate clinical data from the use in or on humans of a device which bears the CE marking and is placed on the market or put into service within its intended purpose as referred to in the relevant conformity assessment procedure, with the aim of confirming the safety and performance throughout the expected lifetime of the device, of ensuring the continued acceptability of identified risks and of detecting emerging risks on the basis of factual evidence. |
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6. |
PMCF shall be performed pursuant to a documented method laid down in a PMCF plan.
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|
7. |
The manufacturer shall analyse the findings of the PMCF and document the results in a PMCF evaluation report that shall be part of the clinical evaluation report and the technical documentation. |
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8. |
The conclusions of the PMCF evaluation report shall be taken into account for the clinical evaluation referred to in Article 61 and Part A of this Annex and in the risk management referred to in Section 3 of Annex I. If, through the PMCF, the need for preventive and/or corrective measures has been identified, the manufacturer shall implement them. |
ANNEX XV 附件十五
CLINICAL INVESTIGATIONS 临床检查
CHAPTER I 第一章
GENERAL REQUIREMENTS 一般要求
1. Ethical principles 1. 伦理原则
Each step in the clinical investigation, from the initial consideration of the need for and justification of the study to the publication of the results, shall be carried out in accordance with recognised ethical principles.
临床研究的每一步，从最初考虑研究的必要性和合理性到结果的公布，都应按照公认的伦理原则进行。
2. Methods 2. 方法
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2.1. |
Clinical investigations shall be performed on the basis of an appropriate plan of investigation reflecting the latest scientific and technical knowledge and defined in such a way as to confirm or refute the manufacturer's claims regarding the safety, performance and aspects relating to benefit-risk of devices as referred to in Article 62(1); the clinical investigations shall include an adequate number of observations to guarantee the scientific validity of the conclusions. The rationale for the design and chosen statistical methodology shall be presented as further described in Section 3.6 of Chapter II of this Annex. |
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2.2. |
The procedures used to perform the clinical investigation shall be appropriate to the device under investigation. |
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2.3. |
The research methodologies used to perform the clinical investigation shall be appropriate to the device under investigation. |
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2.4. |
Clinical investigations shall be performed in accordance with the clinical investigation plan by a sufficient number of intended users and in a clinical environment that is representative of the intended normal conditions of use of the device in the target patient population. Clinical investigations shall be in line with the clinical evaluation plan as referred to in Part A of Annex XIV. |
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2.5. |
All the appropriate technical and functional features of the device, in particular those involving safety and performance, and their expected clinical outcomes shall be appropriately addressed in the investigational design. A list of the technical and functional features of the device and the related expected clinical outcomes shall be provided. |
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2.6. |
The endpoints of the clinical investigation shall address the intended purpose, clinical benefits, performance and safety of the device. The endpoints shall be determined and assessed using scientifically valid methodologies. The primary endpoint shall be appropriate to the device and clinically relevant. |
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2.7. |
Investigators shall have access to the technical and clinical data regarding the device. Personnel involved in the conduct of an investigation shall be adequately instructed and trained in the proper use of the investigational device, and as regards the clinical investigation plan and good clinical practice. This training shall be verified and where necessary arranged by the sponsor and documented appropriately. |
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2.8. |
The clinical investigation report, signed by the investigator, shall contain a critical evaluation of all the data collected during the clinical investigation, and shall include any negative findings. |
CHAPTER II 第二章
DOCUMENTATION REGARDING THE APPLICATION FOR CLINICAL INVESTIGATION
关于临床研究申请的文件
For investigational devices covered by Article 62, the sponsor shall draw up and submit the application in accordance with Article 70 accompanied by the following documents:
对于第62条所涵盖的研究设备，申办者应根据第70条起草并提交申请，并附上以下文件：
1. Application form 1. 申请表
The application form shall be duly filled in, containing information regarding:
申请表应填写妥当，并包含以下信息：
name, address and contact details of the sponsor and, if applicable, name, address and contact details of its contact person or legal representative in accordance with Article 62(2) established in the Union;
根据本联盟第62条第（2）款的规定，保荐人的姓名、地址和联系方式，以及其联系人或法定代表人的姓名、地址和联系方式（如适用）;
if different from those in Section 1.1, name, address and contact details of the manufacturer of the device intended for clinical investigation and, if applicable, of its authorised representative;
如果与第 1.1 节中的规定不同，则提供用于临床研究的器械制造商的名称、地址和联系方式，以及其授权代表（如适用）的名称、地址和联系方式;
title of the clinical investigation;
临床研究的标题;
status of the clinical investigation application (i.e. first submission, resubmission, significant amendment);
临床研究申请的状态（即首次提交、重新提交、重大修改）;
details and/or reference to the clinical evaluation plan;
详细资料及/或临床评估计划的参考资料;
If the application is a resubmission with regard to a device for which an application has been already submitted, the date or dates and reference number or numbers of the earlier application or in the case of significant amendment, reference to the original application. The sponsor shall identify all of the changes from the previous application together with a rationale for those changes, in particular, whether any changes have been made to address conclusions of previous competent authority or ethics committee reviews;
如果申请是针对已经提交申请的器械的重新提交，则提供在先申请的日期和参考编号，或者在重大修改的情况下，参考原始申请。申办者应确定与先前申请相比的所有更改以及这些更改的理由，特别是是否进行了任何更改以解决先前主管当局或伦理委员会审查的结论;
if the application is submitted in parallel with an application for a clinical trial in accordance with Regulation (EU) No 536/2014, reference to the official registration number of the clinical trial;
如果申请与根据法规（EU）No 536/2014的临床试验申请同时提交，则参考临床试验的正式注册号;
identification of the Member States and third countries in which the clinical investigation is to be conducted as part of a multicentre or multinational study at the time of application;
在申请时确定将作为多中心或多国研究的一部分进行临床研究的成员国和第三国;
a brief description of the investigational device, its classification and other information necessary for the identification of the device and device type;
研究设备的简要描述、其分类以及识别设备和设备类型所需的其他信息;
information as to whether the device incorporates a medicinal substance, including a human blood or plasma derivative or whether it is manufactured utilising non-viable tissues or cells of human or animal origin, or their derivatives;
关于该器械是否含有药用物质，包括人类血液或血浆衍生物，或者是否利用人类或动物来源的非活组织或细胞或其衍生物制造的信息;
summary of the clinical investigation plan including the objective or objectives of the clinical investigation, the number and gender of subjects, criteria for subject selection, whether there are subjects under 18 years of age, design of the investigation such as controlled and/or randomised studies, planned dates of commencement and of completion of the clinical investigation;
临床研究计划摘要，包括临床研究的目的、受试者的数量和性别、受试者选择的标准、是否有 18 岁以下的受试者、调查设计（例如对照和/或随机研究）、计划开始和完成临床研究的日期;
if applicable, information regarding a comparator device, its classification and other information necessary for the identification of the comparator device;
如适用，有关比较器件的信息、其分类以及识别比较器器件所需的其他信息;
evidence from the sponsor that the clinical investigator and the investigational site are capable of conducting the clinical investigation in accordance with the clinical investigation plan;
申办者提供的证据，证明临床研究者和研究中心有能力按照临床调查计划进行临床调查;
details of the anticipated start date and duration of the investigation;
调查的预计开始日期和持续时间的详情;
details to identify the notified body, if already involved at the stage of application for a clinical investigation;
如果在临床研究申请阶段已经涉及，则识别指定机构的详细信息;
confirmation that the sponsor is aware that the competent authority may contact the ethics committee that is assessing or has assessed the application; and
确认申办者知道主管当局可以联系正在评估或已经评估申请的伦理委员会;和
the statement referred to in Section 4.1.
第 4.1 节中提及的声明。
2. Investigator's Brochure
2. 研究者手册
The investigator's brochure (IB) shall contain the clinical and non-clinical information on the investigational device that is relevant for the investigation and available at the time of application. Any updates to the IB or other relevant information that is newly available shall be brought to the attention of the investigators in a timely manner. The IB shall be clearly identified and contain in particular the following information:
研究者手册 （IB） 应包含与研究相关且在申请时可用的研究设备的临床和非临床信息。IB的任何更新或新获得的其他相关信息应及时提请调查人员注意。国际局应明确标识，并特别包含以下信息：
Identification and description of the device, including information on the intended purpose, the risk classification and applicable classification rule pursuant to Annex VIII, design and manufacturing of the device and reference to previous and similar generations of the device.
器械的标识和描述，包括有关预期用途的信息、根据附件 VIII 的风险分类和适用的分类规则、器械的设计和制造以及对器械前几代和类似型号的参考。
Manufacturer's instructions for installation, maintenance, maintaining hygiene standards and for use, including storage and handling requirements, as well as, to the extent that such information is available, information to be placed on the label, and instructions for use to be provided with the device when placed on the market. In addition, information relating to any relevant training required.
制造商的安装、维护、保持卫生标准和使用说明，包括储存和处理要求，以及在此类信息可用的情况下，应贴在标签上的信息，以及在投放市场时随设备提供的使用说明。此外，还需要与任何相关培训有关的信息。
Pre-clinical evaluation based on relevant pre-clinical testing and experimental data, in particular regarding in-design calculations, in vitro tests, ex vivo tests, animal tests, mechanical or electrical tests, reliability tests, sterilisation validation, software verification and validation, performance tests, evaluation of biocompatibility and biological safety, as applicable.
基于相关临床前测试和实验数据的临床前评估，特别是关于设计计算、体外测试、离体测试、动物测试、机械或电气测试、可靠性测试、灭菌验证、软件验证和确认、性能测试、生物相容性和生物安全性评估（如适用）。
Existing clinical data, in particular:
现有临床数据，特别是：
来自与设备和/或等效或类似设备的安全性、性能、对患者的临床益处、设计特征和预期目的相关的相关科学文献;
与同一制造商的同等或类似器械的安全性、性能、对患者的临床益处、设计特征和预期目的相关的其他相关临床数据，包括上市时间长短和对性能、临床益处和安全相关问题的审查以及采取的任何纠正措施。
Summary of the benefit-risk analysis and the risk management, including information regarding known or foreseeable risks, any undesirable side-effects, contraindications and warnings.
收益风险分析和风险管理摘要，包括有关已知或可预见风险、任何不良副作用、禁忌症和警告的信息。
In the case of devices that incorporate a medicinal substance, including a human blood or plasma derivative or devices manufactured utilising non-viable tissues or cells of human or animal origin, or their derivatives, detailed information on the medicinal substance or on the tissues, cells or their derivatives, and on the compliance with the relevant general safety and performance requirements and the specific risk management in relation to the substance or tissues, cells or their derivatives, as well as evidence for the added value of incorporation of such constituents in relation to the clinical benefit and/or safety of the device.
对于含有药用物质的器械，包括人类血液或血浆衍生物，或利用人类或动物来源的非活组织或细胞或其衍生物制造的器械，关于药用物质或组织、细胞或其衍生物的详细信息，以及关于遵守相关的一般安全和性能要求以及与该物质或组织有关的特定风险管理的信息， 细胞或其衍生物，以及与器械的临床益处和/或安全性相关的掺入此类成分的附加值的证据。
A list detailing the fulfilment of the relevant general safety and performance requirements set out in Annex I, including the standards and CS applied, in full or in part, as well as a description of the solutions for fulfilling the relevant general safety and performance requirements, in so far as those standards and CS have not or have only been partly fulfilled or are lacking.
详细说明满足附件一中规定的相关一般安全和性能要求的清单，包括全部或部分应用的标准和CS，以及满足相关一般安全和性能要求的解决方案的描述，只要这些标准和CS尚未或仅部分满足或缺乏。
A detailed description of the clinical procedures and diagnostic tests used in the course of the clinical investigation and in particular information on any deviation from normal clinical practice.
对临床调查过程中使用的临床程序和诊断测试的详细说明，特别是有关偏离正常临床实践的信息。
3. Clinical Investigation Plan
3. 临床研究计划
The clinical investigation plan (CIP) shall set out the rationale, objectives, design methodology, monitoring, conduct, record-keeping and the method of analysis for the clinical investigation. It shall contain in particular the information as laid down in this Annex. If part of this information is submitted in a separate document, it shall be referenced in the CIP.
临床研究计划（CIP）应规定临床研究的基本原理、目标、设计方法、监测、实施、记录保存和分析方法。它应特别载有本附件所载的资料。如果该信息的一部分在单独的文件中提交，则应在CIP中引用。
3.1. General 3.1. 概述
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3.1.1. |
Single identification number of the clinical investigation, as referred to in Article 70(1). |
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3.1.2. |
Identification of the sponsor — name, address and contact details of the sponsor and, where applicable, the name, address and contact details of the sponsor's contact person or legal representative in accordance with Article 62(2) established in the Union. |
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3.1.3. |
Information on the principal investigator at each investigational site, the coordinating investigator for the investigation, the address details for each investigational site and the emergency contact details for the principal investigator at each site. The roles, responsibilities and qualifications of the various kinds of investigators shall be specified in the CIP. |
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3.1.4. |
A brief description of how the clinical investigation is financed and a brief description of the agreement between the sponsor and the site. |
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3.1.5. |
Overall synopsis of the clinical investigation, in an official Union language determined by the Member State concerned. |
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3.2. |
Identification and description of the device, including its intended purpose, its manufacturer, its traceability, the target population, materials coming into contact with the human body, the medical or surgical procedures involved in its use and the necessary training and experience for its use, background literature review, the current state of the art in clinical care in the relevant field of application and the proposed benefits of the new device. |
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3.3. |
Risks and clinical benefits of the device to be examined, with justification of the corresponding expected clinical outcomes in the clinical investigation plan. |
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3.4. |
Description of the relevance of the clinical investigation in the context of the state of the art of clinical practice. |
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3.5. |
Objectives and hypotheses of the clinical investigation. |
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3.6. |
Design of the clinical investigation with evidence of its scientific robustness and validity.
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3.7. |
Statistical considerations, with justification, including a power calculation for the sample size, if applicable. |
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3.8. |
Data management. 数据管理。 |
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3.9. |
Information about any amendments to the CIP. |
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3.10. |
Policy regarding follow-up and management of any deviations from the CIP at the investigational site and clear prohibition of use of waivers from the CIP. |
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3.11. |
Accountability regarding the device, in particular control of access to the device, follow-up in relation to the device used in the clinical investigation and the return of unused, expired or malfunctioning devices. |
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3.12. |
Statement of compliance with the recognised ethical principles for medical research involving humans, and the principles of good clinical practice in the field of clinical investigations of devices, as well as with the applicable regulatory requirements. |
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3.13. |
Description of the Informed consent process. |
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3.14. |
Safety reporting, including definitions of adverse events and serious adverse events, device deficiencies, procedures and timelines for reporting. |
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3.15. |
Criteria and procedures for follow-up of subjects following the end, temporary halt or early termination of an investigation, for follow-up of subjects who have withdrawn their consent and procedures for subjects lost to follow-up. Such procedures shall for implantable devices, cover as a minimum traceability. |
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3.16. |
A description of the arrangements for taking care of the subjects after their participation in the clinical investigation has ended, where such additional care is necessary because of the subjects' participation in the clinical investigation and where it differs from that normally expected for the medical condition in question. |
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3.17. |
Policy as regards the establishment of the clinical investigation report and publication of results in accordance with the legal requirements and the ethical principles referred to in Section 1 of Chapter I. |
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3.18. |
List of the technical and functional features of the device, with specific mention of those covered by the investigation. |
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3.19. |
Bibliography. 书目。 |
4. Other information 4. 其他信息
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4.1. |
A signed statement by the natural or legal person responsible for the manufacture of the investigational device that the device in question conforms to the general safety and performance requirements apart from the aspects covered by the clinical investigation and that, with regard to those aspects, every precaution has been taken to protect the health and safety of the subject. |
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4.2. |
Where applicable according to national law, copy of the opinion or opinions of the ethics committee or committees concerned. Where according to national law the opinion or opinions of the ethics committee or committees is not required at the time of the submission of the application, a copy of the opinion or opinions shall be submitted as soon as available. |
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4.3. |
Proof of insurance cover or indemnification of subjects in case of injury, pursuant to Article 69 and the corresponding national law. |
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4.4. |
Documents to be used to obtain informed consent, including the patient information sheet and the informed consent document. |
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4.5. |
Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data, in particular:
—
organisational and technical arrangements that will be implemented to avoid unauthorised access, disclosure, dissemination, alteration or loss of information and personal data processed;
为避免未经授权的访问、披露、传播、更改或丢失所处理的信息和个人数据而实施的组织和技术安排;
—
a description of measures that will be implemented to ensure confidentiality of records and personal data of subjects; and
描述为确保受试者的记录和个人数据的机密性而将采取的措施;和
—
a description of measures that will be implemented in case of a data security breach in order to mitigate the possible adverse effects.
描述在发生数据安全漏洞时将采取的措施，以减轻可能的不利影响。 |
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4.6. |
Full details of the available technical documentation, for example detailed risk analysis/management documentation or specific test reports, shall, upon request, be submitted to the competent authority reviewing an application. |
CHAPTER III 第三章
OTHER OBLIGATIONS OF THE SPONSOR
保荐人的其他义务
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1. |
The sponsor shall undertake to keep available for the competent national authorities any documentation necessary to provide evidence for the documentation referred to in Chapter II of this Annex. If the sponsor is not the natural or legal person responsible for the manufacture of the investigational device, that obligation may be fulfilled by that person on behalf of the sponsor. |
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2. |
The Sponsor shall have an agreement in place to ensure that any serious adverse events or any other event as referred to in Article 80(2) are reported by the investigator or investigators to the sponsor in a timely manner. |
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3. |
The documentation mentioned in this Annex shall be kept for a period of at least 10 years after the clinical investigation with the device in question has ended, or, in the event that the device is subsequently placed on the market, at least 10 years after the last device has been placed on the market. In the case of implantable devices, the period shall be at least 15 years. Each Member State shall require that this documentation is kept at the disposal of the competent authorities for the period referred to in the first subparagraph in case the sponsor, or its contact person or legal representative as referred to in Article 62(2) established within its territory, goes bankrupt or ceases its activity prior to the end of this period. |
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4. |
The Sponsor shall appoint a monitor that is independent from the investigational site to ensure that the investigation is conducted in accordance with the CIP, the principles of good clinical practice and this Regulation. |
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5. |
The Sponsor shall complete the follow-up of investigation subjects. |
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6. |
The Sponsor shall provide evidence that the investigation is being conducted in line with good clinical practice, for instance through internal or external inspection. |
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7. |
The Sponsor shall prepare a clinical investigation report which includes at least the following:
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Cover/introductory page or pages indicating the title of the investigation, the investigational device, the single identification number, the CIP number and the details with signatures of the coordinating investigators and the principal investigators from each investigational site.
封面/介绍页或多页，注明调查标题、研究设备、单一识别号、CIP 编号以及每个调查地点的协调调查员和主要调查员签名的详细信息。
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Details of the author and date of the report.
报告作者的详细情况和日期。
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A summary of the investigation covering the title, purpose of the investigation, description of the investigation, investigational design and methods used, the results of the investigation and conclusion of the investigation. The completion date of the investigation, and in particular details of early termination, temporary halts or suspensions of investigations.
调查摘要，包括标题、调查目的、调查描述、调查设计和使用的方法、调查结果和调查结论。调查的完成日期，特别是提前终止、暂时停止或暂停调查的细节。
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Investigational device description, in particular clearly defined intended purpose.
研究设备描述，特别是明确定义的预期目的。
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A summary of the clinical investigation plan covering objectives, design, ethical aspects, monitoring and quality measures, selection criteria, target patient populations, sample size, treatment schedules, follow-up duration, concomitant treatments, statistical plan, including hypothesis, sample size calculation and analysis methods, as well as a justification.
临床研究计划的摘要，包括目标、设计、伦理方面、监测和质量措施、选择标准、目标患者群体、样本量、治疗方案、随访时间、伴随治疗、统计计划，包括假设、样本量计算和分析方法，以及理由。
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Results of the clinical investigation covering, with rationale and justification, subject demographics, analysis of results related to chosen endpoints, details of subgroup analysis, as well as compliance with the CIP, and covering follow-up of missing data and of patients withdrawing from the clinical investigation, or lost to follow-up.
临床研究结果包括受试者人口统计学、与所选终点相关的结果分析、亚组分析的细节以及对 CIP 的依从性，并涵盖缺失数据的随访和退出临床研究的患者，或失访。
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Summary of serious adverse events, adverse device effects, device deficiencies and any relevant corrective actions.
严重不良事件、设备不良影响、设备缺陷和任何相关纠正措施的摘要。
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Discussion and overall conclusions covering safety and performance results, assessment of risks and clinical benefits, discussion of clinical relevance in accordance with clinical state of the art, any specific precautions for specific patient populations, implications for the investigational device, limitations of the investigation.
讨论和总体结论，涵盖安全性和性能结果、风险和临床益处评估、根据临床最新技术讨论临床相关性、针对特定患者群体的任何特定预防措施、对研究设备的影响、研究的局限性。 |
ANNEX XVI 附件十六
LIST OF GROUPS OF PRODUCTS WITHOUT AN INTENDED MEDICAL PURPOSE REFERRED TO IN ARTICLE 1(2)
第1条第（2）款所指的不具有预期医疗目的的产品组清单
1. Contact lenses or other items intended to be introduced into or onto the eye.
1. 隐形眼镜或其他打算引入眼睛或进入眼睛的物品。
2. Products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of modifying the anatomy or fixation of body parts with the exception of tattooing products and piercings.
2. 旨在通过手术侵入性手段全部或部分引入人体的产品，以改变身体部位的解剖结构或固定，但纹身产品和穿孔除外。
3. Substances, combinations of substances, or items intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction, excluding those for tattooing.
3. 拟通过皮下、粘膜下或皮内注射或其他方式引入面部或其他真皮或粘膜填充的物质、物质组合或物品，不包括用于纹身的物质。
4. Equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty.
4. 用于减少、去除或破坏脂肪组织的设备，例如吸脂、溶脂或脂肪成形术的设备。
5. High intensity electromagnetic radiation (e.g. infra-red, visible light and ultra-violet) emitting equipment intended for use on the human body, including coherent and non-coherent sources, monochromatic and broad spectrum, such as lasers and intense pulsed light equipment, for skin resurfacing, tattoo or hair removal or other skin treatment.
5. 用于人体的高强度电磁辐射（如红外线、可见光和紫外线）发射设备，包括相干和非相干光源、单色和广谱，如激光和强脉冲光设备，用于换肤、纹身或脱毛或其他皮肤治疗。
6. Equipment intended for brain stimulation that apply electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain.
6. 用于脑刺激的设备，施加穿透颅骨的电流或磁场或电磁场以改变大脑中的神经元活动。
ANNEX XVII 附件十七
CORRELATION TABLE 关联表
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Council Directive 90/385/EEC |
Council Directive 93/42/EEC |
This Regulation 本规定 |
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Article 1(1) 第1条第（1）款 |
Article 1(1) 第1条第（1）款 |
Article 1(1) 第1条第（1）款 |
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Article 1(2) 第1条第（2）款 |
Article 1(2) 第1条第（2）款 |
Article 2 第2条 |
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Article 1(3) 第1条第（3）款 |
Article 1(3) first subparagraph |
Article 1(9) first subparagraph |
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— |
Article 1(3) second subparagraph |
Article 1(9) second subparagraph |
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Article 1(4) and (4a) 第1条第（4）款和第（4a）款 |
Article 1(4) and (4a) 第1条第（4）款和第（4a）款 |
Article 1(8) first subparagraph |
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Article 1(5) 第1条第（5）款 |
Article 1(7) 第1条第（7）款 |
Article 1(11) 第1条第（11）款 |
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Article 1(6) 第1条第（6）款 |
Article 1(5) 第1条第（5）款 |
Article 1(6) 第1条第（6）款 |
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— |
Article 1(6) 第1条第（6）款 |
— |
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— |
Article 1(8) 第1条第（8）款 |
Article 1(13) 第1条第（13）款 |
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Article 2 第2条 |
Article 2 第2条 |
Article 5(1) 第5条第（1）款 |
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Article 3 first paragraph |
Article 3 first paragraph |
Article 5(2) 第5条第（2）款 |
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Article 3 second paragraph |
Article 3 second paragraph |
Article 1(12) 第1条第（12）款 |
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Article 4(1) 第4条第（1）款 |
Article 4(1) 第4条第（1）款 |
Article 24 第24条 |
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Article 4(2) 第4条第（2）款 |
Article 4(2) 第4条第（2）款 |
Article 21(1) and (2) 第21条第（1）款和第（2）款 |
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Article 4(3) 第4条第（3）款 |
Article 4(3) 第4条第（3）款 |
Article 21(3) 第21条第（3）款 |
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Article 4(4) 第4条第（4）款 |
Article 4(4) 第4条第（4）款 |
Article 10(11) 第10条第（11）款 |
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Article 4(5)(a) 第4条第（5）款（a）项 |
Article 4(5) first subparagraph |
Article 20(6) 第20条第（6）款 |
|
Article 4(5)(b) 第4条第（5）款（b）项 |
Article 4(5) second subparagraph |
— |
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Article 5(1) 第5条第（1）款 |
Article 5(1) 第5条第（1）款 |
Article 8(1) 第8条第（1）款 |
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Article 5(2) 第5条第（2）款 |
Article 5(2) 第5条第（2）款 |
Article 8(2) 第8条第（2）款 |
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Article 6(1) 第6条第（1）款 |
Articles 5(3) and 6 |
— |
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Article 6(2) 第6条第（2）款 |
Article 7(1) 第7条第（1）款 |
Article 114 第一百一十四条 |
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Article 7 第7条 |
Article 8 第8条 |
Articles 94 to 97 |
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— |
Article 9 第9条 |
Article 51 第五十一条 |
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Article 8(1) 第8条第（1）款 |
Article 10(1) 第10条第（1）款 |
Articles 87(1) and 89 (2) |
|
Article 8(2) 第8条第（2）款 |
Article 10(2) 第10条第（2）款 |
Article 87(10) and Article 87(11) first subparagraph |
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Article 8(3) 第8条第（3）款 |
Article 10(3) 第10条第（3）款 |
Article 89(7) 第89条第（7）款 |
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Article 8(4) 第8条第（4）款 |
Article 10(4) 第10条第（4）款 |
Article 91 第九十一条 |
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Article 9(1) 第9条第（1）款 |
Article 11(1) 第11条第（1）款 |
Article 52(3) 第52条第（3）款 |
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— |
Article 11(2) 第11条第（2）款 |
Article 52(6) 第52条第（6）款 |
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— |
Article 11(3) 第11条第（3）款 |
Article 52(4) and (5) 第52条第（4）款和第（5）款 |
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— |
Article 11(4) 第11条第（4）款 |
— |
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— |
Article 11(5) 第11条第（5）款 |
Article 52(7) 第52条第（7）款 |
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Article 9(2) 第9条第（2）款 |
Article 11 (6) 第11条第6款 |
Article 52(8) 第52条第（8）款 |
|
Article 9(3) 第9条第（3）款 |
Article 11(8) 第11条第（8）款 |
Article 11(3) 第11条第（3）款 |
|
Article 9(4) 第9条第（4）款 |
Article 11(12) 第11条第（12）款 |
Article 52(12) 第52条第（12）款 |
|
Article 9(5) 第9条第（5）款 |
Article 11(7) 第11条第（7）款 |
— |
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Article 9(6) 第9条第（6）款 |
Article 11(9) 第11条第（9）款 |
Article 53(1) 第53条第（1）款 |
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Article 9(7) 第9条第（7）款 |
Article 11(10) 第11条第（10）款 |
Article 53(4) 第53条第（4）款 |
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Article 9(8) 第9条第（8）款 |
Article 11(11) 第11条第（11）款 |
Article 56(2) 第56条第（2）款 |
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Article 9(9) 第9条第（9）款 |
Article 11(13) 第11条第（13）款 |
Article 59 第五十九条 |
|
Article 9(10) 第9条第（10）款 |
Article 11(14) 第11条第（14）款 |
Article 4(5) and Article 122 third paragraph |
|
— |
Article 12 第12条 |
Article 22 第22条 |
|
— |
Article 12a 第12a条 |
Article 17 第17条 |
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Article 9a(1) first indent |
Article 13(1)(c) 第13条第（1）款（c）项 |
— |
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Article 9a(1) second indent |
Article 13(1)(d) 第13条第（1）款（d）项 |
Article 4(1) 第4条第（1）款 |
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— |
Article 13(1)(a) 第13条第（1）款（a）项 |
Article 51(3)(a) and Article 51(6) |
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— |
Article 13(1)(b) 第13条第（1）款（b）项 |
Article 51(3)(b) and Article 51(6) |
|
Article 10 第10条 |
Article 15 第15条 |
Articles 62 to 82 |
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Article 10a(1), second sentence of Article 10a(2) and Article 10a(3) |
Article 14(1), second sentence of Article 14(2) and Article 14(3) |
Articles 29(4), 30 and 31 |
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Article 10a(2), first sentence |
Article 14(2) first sentence |
Article 11(1) 第11条第（1）款 |
|
Article 10b 第10b条 |
Article 14a 第14a条 |
Articles 33 and 34 |
|
Article 10c 第10c条 |
Article 14b 第14b条 |
Article 98 第九十八条 |
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Article 11(1) 第11条第（1）款 |
Article 16(1) 第16条第（1）款 |
Articles 42 and 43 |
|
Article 11(2) 第11条第（2）款 |
Article 16(2) 第16条第（2）款 |
Article 36 第三十六条 |
|
Article 11(3) 第11条第（3）款 |
Article 16(3) 第16条第（3）款 |
Article 46(4) 第46条第（4）款 |
|
Article 11(4) 第11条第（4）款 |
Article 16(4) 第16条第（4）款 |
— |
|
Article 11(5) 第11条第（5）款 |
Article 16(5) 第16条第（5）款 |
Article 56(5) 第56条第5款 |
|
Article 11(6) 第11条第（6）款 |
Article 16(6) 第16条第（6）款 |
Article 56(4) 第56条第（4）款 |
|
Article 11(7) 第11条第（7）款 |
Article 16(7) 第16条第（7）款 |
Articles 38(2) and 44(2) |
|
Article 12 第12条 |
Article 17 第17条 |
Article 20 第20条 |
|
Article 13 第13条 |
Article 18 第18条 |
Articles 94 to 97 |
|
Article 14 第14条 |
Article 19 第19条 |
Article 99 第九十九条 |
|
Article 15 第15条 |
Article 20 第20条 |
Article 109 第一百零九条 |
|
Article 15a 第15a条 |
Article 20a 第20a条 |
Article 102 第一百零二条 |
|
Article 16 第16条 |
Article 22 第22条 |
— |
|
Article 17 第17条 |
Article 23 第23条 |
— |
|
— |
Article 21 第21条 |
— |
(
1
) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).
（1） 2004年3月31日欧洲议会和理事会第726/2004号条例（EC），规定了欧洲人用和兽用药品的授权和监督以及建立欧洲药品管理局的程序（OJ L 136,2004年4月30日，第1页）。
(
2
) Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (OJ L 157, 9.6.2006, p. 24).
（2） 2006年5月17日欧洲议会和理事会关于机械的第2006/42/EC号指令，并修订了第95/16/EC号指令（OJ L 157,2006年6月9日，第24页）。
(
3
) Commission Recommendation 2003/361/ΕC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36).
（3） 委员会2003年5月6日关于微型、小型和中型企业定义的第2003/361/ΕC号建议（官方公报L 124,2003年5月20日，第36页）。
(
4
) Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p. 1).
（4） 2014 年 4 月 16 日欧洲议会和理事会关于人用医药临床试验的第 536/2014 号条例 （EU） 并废除指令 2001/20/EC（OJ L 158,2014 年 5 月 27 日，第 1 页）。
(
*1
) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).’.
(*1 )2017 年 4 月 5 日欧洲议会和理事会关于医疗器械的条例 （EU） 2017/745，修订了指令 2001/83/EC、法规 （EC） No 178/2002 和法规 （EC） No 1223/2009，并废除了理事会指令 90/385/EEC 和 93/42/EEC（OJ L 117,2017 年 5 月 5 日，第 1 页）。
(
*2
) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).’.
(*2 )2017 年 4 月 5 日欧洲议会和理事会关于医疗器械的条例 （EU） 2017/745，修订了指令 2001/83/EC、法规 （EC） No 178/2002 和法规 （EC） No 1223/2009，并废除了理事会指令 90/385/EEC 和 93/42/EEC（OJ L 117,2017 年 5 月 5 日，第 1 页）。
(
5
) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 ( OJ L 353, 31.12.2008, p. 1).
（5） 2008 年 12 月 16 日欧洲议会和理事会关于物质和混合物的分类、标签和包装的第 1272/2008 号条例 （EC），修订和废除第 67/548/EEC 和 1999/45/EC 号指令，并修订第 1907/2006 号条例 （EC） （OJ L 353,2008 年 12 月 31 日，第 1 页）。
(
6
) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ L 396, 30.12.2006, p. 1).
（6） 2006 年 12 月 18 日欧洲议会和理事会关于化学品注册、评估、授权和限制 （REACH） 的第 1907/2006 号条例 （EC） （OJ L 396,2006 年 12 月 30 日，第 1 页）。
(
7
) Regulation (EU) No 528/2012 of the European Parliament and the Council of 22 May 2012 concerning the making available on the market of and use of biocidal products (OJ L 167, 27.6.2012, p. 1).
（7） 2012 年 5 月 22 日欧洲议会和理事会关于在市场上提供和使用生物杀灭剂产品的第 528/2012 号条例 （EU） （OJ L 167,2012 年 6 月 27 日，第 1 页）。
(
8
) Council Directive 80/181/EEC of 20 December 1979 on the approximation of the laws of the Member States relating to units of measurement and on the repeal of Directive 71/354/EEC (OJ L 39, 15.2.1980, p. 40).
（8） 1979年12月20日理事会第80/181/EEC号指令，关于近似成员国有关计量单位的法律和关于废除第71/354/EEC号指令（OJ L 39,1980年2月15日，第40页）。
(
9
) Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (OJ L 50, 20.2.2004, p. 44).
（9） 2004年2月11日欧洲议会和理事会第2004/10/EC号指令，关于协调有关应用良好实验室规范原则的法律、法规和行政规定，并核查其化学物质测试申请（OJ L 50,2004年2月20日，第44页）。