Stage 1 Document and Record Request 第 1 阶段 文件和记录申请
EU MDR 欧盟 MDR
Subject: Submission of Documents for Stage 1 Audit under ISO 17021 Requirements 主题根据 ISO 17021 要求提交第 1 阶段审核文件
We acknowledge the requirement for a Stage 1 audit as part of our organization’s initial certification process, in accordance with ISO 17021. The Stage 1 audit is essential for evaluating the integration of standard and regulatory requirements within our Quality Management System (QMS) and for assessing the status of our organization and its devices across applicable regulatory jurisdictions. 我们承认，根据 ISO 17021 标准，第 1 阶段审核是我们组织初始认证过程的一部分。第 1 阶段审核对于评估我们的质量管理体系 (QMS) 中标准和监管要求的整合情况，以及评估我们的组织及其设备在适用监管辖区内的状况至关重要。
To support this process, we are submitting the requested documents for your review. These documents are controlled through our QMS and provide evidence that relevant requirements have been incorporated, with particular emphasis on compliance with the EU MDR and applicable national regulations. 为支持这一过程，我们提交所要求的文件供您审查。这些文件通过我们的质量管理体系进行控制，可证明相关要求已被纳入其中，并特别强调符合欧盟 MDR 和适用的国家法规。
We understand that additional or supplemental documentation may be requested to further demonstrate our readiness for certification. We are fully committed to providing any further information required to facilitate the audit process. 我们理解，为进一步证明我们已做好认证准备，可能会要求我们提供额外或补充文件。我们将全力提供所需的进一步信息，以促进审核过程。
Furthermore, we acknowledge that all actions and findings identified during the Stage 1 audit must be addressed and resolved prior to the Stage 2 audit. We are also aware that the Stage 2 audit must be conducted within six months of completing the Stage 1 audit. 此外，我们还认识到，在第 1 阶段审计期间发现的所有行动和结果都必须在第 2 阶段审计之前得到处理和解决。我们还知道，第 2 阶段审计必须在完成第 1 阶段审计后的六个月内进行。
Please do not hesitate to reach out if you require clarification or additional information regarding the submitted documents. 如果您需要对所提交的文件进行澄清或了解更多信息，请随时联系我们。
Thank you for your guidance and support throughout this certification process. 感谢您在整个认证过程中给予的指导和支持。
文件/记录申请 请注意：斜体字所列文件必须作为记录提供
Document / Record Request
Please note: documents listed in italics must be provided as records
Document / Record Request
Please note: documents listed in italics must be provided as records| Document / Record Request |
| :--- |
| Please note: documents listed in italics must be provided as records |
文件/记录参考（客户必须填写此部分）（文件编号、标题和修订版）
Document / Record Reference (Client MUST Complete This Section)
(Document #, Title and Revision)
Document / Record Reference (Client MUST Complete This Section)
(Document #, Title and Revision)| Document / Record Reference (Client MUST Complete This Section) |
| :--- |
| (Document #, Title and Revision) |
QMS Procedures and Documents 质量管理体系程序和文件
- List of all QMS Procedures, Processes, Work Instructions, etc. (Document #, Title and Revision) - 所有质量管理体系程序、流程、作业指导书等清单（文件编号、标题和修订版）
- 外部文件清单（ISO 标准、法规等）
- List of External Documents (ISO
Standards, Regulations, etc)
- List of External Documents (ISO
Standards, Regulations, etc)| - List of External Documents (ISO |
| :--- |
| Standards, Regulations, etc) |
- Quality Manual - 质量手册
- Quality Policy - 质量政策
- Quality Objectives - measurable - 质量目标--可衡量
- Validation of the application of computer software used in the quality management system - 对质量管理系统中使用的计算机软件的应用进行验证
- Control of Documents - 文件控制
- Control of Records - 记录控制
- Management Review - 管理审查
- Design Control - 设计控制
- Design Change Control - 设计变更控制
- Design transfer protocol - 设计传输协议
- DHR and DMF - 人力资源司和债务管理和金融司
- Purchasing - 采购
- Outsourcing - 外包
- Supplier control - 供应商控制
- Procedures and methods for the control of production - 控制生产的程序和方法
"Document / Record Request
Please note: documents listed in italics must be provided as records" "Document / Record Reference (Client MUST Complete This Section)
(Document #, Title and Revision)"
QMS Procedures and Documents - List of all QMS Procedures, Processes, Work Instructions, etc. (Document #, Title and Revision)
"- List of External Documents (ISO
Standards, Regulations, etc)"
- Quality Manual
- Quality Policy
- Quality Objectives - measurable
- Validation of the application of computer software used in the quality management system
- Control of Documents
- Control of Records
- Management Review
- Design Control
- Design Change Control
- Design transfer protocol
- DHR and DMF
- Purchasing
- Outsourcing
- Supplier control
- Procedures and methods for the control of production | | Document / Record Request <br> Please note: documents listed in italics must be provided as records | Document / Record Reference (Client MUST Complete This Section) <br> (Document #, Title and Revision) |
| :---: | :---: | :---: |
| QMS Procedures and Documents | - List of all QMS Procedures, Processes, Work Instructions, etc. (Document #, Title and Revision) | |
| | - List of External Documents (ISO <br> Standards, Regulations, etc) | |
| | - Quality Manual | |
| | - Quality Policy | |
| | - Quality Objectives - measurable | |
| | - Validation of the application of computer software used in the quality management system | |
| | - Control of Documents | |
| | - Control of Records | |
| | - Management Review | |
| | - Design Control | |
| | - Design Change Control | |
| | - Design transfer protocol | |
| | - DHR and DMF | |
| | - Purchasing | |
| | - Outsourcing | |
| | - Supplier control | |
| | - Procedures and methods for the control of production | |
Stage 1 Document and Record Request 第 1 阶段 文件和记录申请
EU MDR 欧盟 MDR
- Servicing (If applicable) - 维修（如适用）
- Validation of processes for production and service provision including validation of the application of computer software - 验证生产和提供服务的流程，包括验证计算机软件的应用
- Validation of Sterilization and sterile barrier systems (If applicable) - 灭菌和无菌屏障系统的验证（如适用）
- Product Release Procedures for Sterilized products - 灭菌产品的产品发布程序
- Product identification - 产品标识
- Traceability - 可追溯性
- Preserving the conformity of product - 保持产品的一致性
- Control of monitoring and measuring equipment including validation of the application of computer software - 监测和测量设备的控制，包括计算机软件应用的验证
- Feedback- including non-complaint - 反馈--包括非投诉
- Complaint handling - 投诉处理
- Reporting to regulatory authorities - 向监管机构报告
- Medical device registration procedure - 医疗器械注册程序
- PMS and vigilance - 经前综合症和警惕性
- Field action procedure (recall, FSCA/FSN) - 实地行动程序（召回、FSCA/FSN）
- Adverse event reporting - 不良事件报告
- Advisory notices - 咨询通知
- Internal Audits - 内部审计
- Monitoring and measurement of product - 产品的监测和测量
- Control of Non-Conforming Products - 不合格品控制
- Analysis of data - 数据分析
- Corrective / Preventive Actions - 纠正/预防措施
Internal Audit plan 内部审计计划
- Approved Internal Audit Plan - 批准的内部审计计划
Internal Audit report and related corrective actions 内部审计报告和相关纠正行动
(must have performed full internal audit prior to Stage 1 to the standards and regulations for which the company is applying), will review all documentation including findings.
- Internal audit records
(must have performed full internal audit prior to Stage 1 to the standards and regulations for which the company is applying), will review all documentation including findings.| - Internal audit records |
| :--- |
| (must have performed full internal audit prior to Stage 1 to the standards and regulations for which the company is applying), will review all documentation including findings. |
Last Management Review, including minutes and action items 上次管理评审，包括会议记录和行动项目
- Management review records (must have held a management review prior to Stage 1 audit which includes the status of the company's compliance to applied standards and/or regulations) - 管理审查记录（必须在第一阶段审计之前进行过管理审查，其中包括公司遵守适用标准和/或法规的情况）
Factory Layout (per site) 工厂布局（每个地点）
工厂布局 - 每种生产技术的生产面积
Factory Layout
- Production area per production technology
Factory Layout
- Production area per production technology| Factory Layout |
| :--- |
| - Production area per production technology |
- Servicing (If applicable)
- Validation of processes for production and service provision including validation of the application of computer software
- Validation of Sterilization and sterile barrier systems (If applicable)
- Product Release Procedures for Sterilized products
- Product identification
- Traceability
- Preserving the conformity of product
- Control of monitoring and measuring equipment including validation of the application of computer software
- Feedback- including non-complaint
- Complaint handling
- Reporting to regulatory authorities
- Medical device registration procedure
- PMS and vigilance
- Field action procedure (recall, FSCA/FSN)
- Adverse event reporting
- Advisory notices
- Internal Audits
- Monitoring and measurement of product
- Control of Non-Conforming Products
- Analysis of data
- Corrective / Preventive Actions
Internal Audit plan - Approved Internal Audit Plan
Internal Audit report and related corrective actions "- Internal audit records
(must have performed full internal audit prior to Stage 1 to the standards and regulations for which the company is applying), will review all documentation including findings."
Last Management Review, including minutes and action items - Management review records (must have held a management review prior to Stage 1 audit which includes the status of the company's compliance to applied standards and/or regulations)
Factory Layout (per site) "Factory Layout
- Production area per production technology" | | - Servicing (If applicable) | |
| :---: | :---: | :---: |
| | - Validation of processes for production and service provision including validation of the application of computer software | |
| | - Validation of Sterilization and sterile barrier systems (If applicable) | |
| | - Product Release Procedures for Sterilized products | |
| | - Product identification | |
| | - Traceability | |
| | - Preserving the conformity of product | |
| | - Control of monitoring and measuring equipment including validation of the application of computer software | |
| | - Feedback- including non-complaint | |
| | - Complaint handling | |
| | - Reporting to regulatory authorities | |
| | - Medical device registration procedure | |
| | - PMS and vigilance | |
| | - Field action procedure (recall, FSCA/FSN) | |
| | - Adverse event reporting | |
| | - Advisory notices | |
| | - Internal Audits | |
| | - Monitoring and measurement of product | |
| | - Control of Non-Conforming Products | |
| | - Analysis of data | |
| | - Corrective / Preventive Actions | |
| Internal Audit plan | - Approved Internal Audit Plan | |
| Internal Audit report and related corrective actions | - Internal audit records <br> (must have performed full internal audit prior to Stage 1 to the standards and regulations for which the company is applying), will review all documentation including findings. | |
| Last Management Review, including minutes and action items | - Management review records (must have held a management review prior to Stage 1 audit which includes the status of the company's compliance to applied standards and/or regulations) | |
| Factory Layout (per site) | Factory Layout <br> - Production area per production technology | |
Stage 1 Document and Record Request 第 1 阶段 文件和记录申请
EU MDR 欧盟 MDR
- 仓库 - 物料流
- Warehouse(s)
- Material Flow
- Warehouse(s)
- Material Flow| - Warehouse(s) |
| :--- |
| - Material Flow |
Operational details 运行细节
- 组织结构图 请确保标明负责监管合规的人员
- Organization Charts
Please ensure this identifies the Person responsible for regulatory compliance
- Organization Charts
Please ensure this identifies the Person responsible for regulatory compliance| - Organization Charts |
| :--- |
| Please ensure this identifies the Person responsible for regulatory compliance |
Suppliers 供应商
- 经批准的供应商名单（确定关键供应商） - 2. 与任何欧盟进口商签订的协议副本
- 1. Approved Supplier List (Identify Critical Suppliers)
- 2. Copy of the Agreement with any importers into the EU
- 1. Approved Supplier List (Identify Critical Suppliers)
- 2. Copy of the Agreement with any importers into the EU| - 1. Approved Supplier List (Identify Critical Suppliers) |
| :--- |
| - 2. Copy of the Agreement with any importers into the EU |
Training 培训
- 对相关人员进行了 MDR 方面的培训 - 请说出相关文件的名称
- Trained the relevant staff in terms of MDR
- Please name the relevant documents
- Trained the relevant staff in terms of MDR
- Please name the relevant documents| - Trained the relevant staff in terms of MDR |
| :--- |
| - Please name the relevant documents |
"- Warehouse(s)
- Material Flow"
Operational details "- Organization Charts
Please ensure this identifies the Person responsible for regulatory compliance"
Suppliers "- 1. Approved Supplier List (Identify Critical Suppliers)
- 2. Copy of the Agreement with any importers into the EU"
Training "- Trained the relevant staff in terms of MDR
- Please name the relevant documents" | | - Warehouse(s) <br> - Material Flow | |
| :---: | :---: | :---: |
| Operational details | - Organization Charts <br> Please ensure this identifies the Person responsible for regulatory compliance | |
| Suppliers | - 1. Approved Supplier List (Identify Critical Suppliers) <br> - 2. Copy of the Agreement with any importers into the EU | |
| Training | - Trained the relevant staff in terms of MDR <br> - Please name the relevant documents | |
Information provided by the applicant / manufacturer *) 申请人/制造商提供的信息 *)
Evidence for implementation available in Document ID-# 实施证据见 ID-# 号文件
Evidence addressed on page # or section # 第 # 页或第 # 节涉及的证据
a) strategy for regulatory compliance a) 合规战略
b) identification of applicable general safety and performance requirements (GSPR) b) 确定适用的一般安全和性能要求（GSPR）
(c) responsibility of the management (c) 管理层的责任
(d) resource management, including selection and control of suppliers and sub-contractors (d) 资源管理，包括选择和控制供应商和分包商
(e) risk management as set out in in MDR Section 3 of Annex I (e) 附件 I《多边报告程序》第 3 部分规定的风险管理
(f) clinical evaluation in accordance with Article 61 and Annex XIV, including PMCF (f) 根据第 61 条和附件 XIV 进行临床评估，包括 PMCF
(g) product realisation, including planning, design, development, production and service provision (g) 产品实现，包括规划、设计、开发、生产和提供服务
(h) 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 (h) 核实根据第 27 条第(3)款对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
(i) setting-up, implementation and maintenance of a post-market surveillance system, in accordance with Article 83 (i) 根据第 83 条的规定，建立、实施和维护市场后监督制度
EU-MDR Article 10 (9) requirement Information provided by the applicant / manufacturer *)
Evidence for implementation available in Document ID-# Evidence addressed on page # or section #
a) strategy for regulatory compliance
b) identification of applicable general safety and performance requirements (GSPR)
(c) responsibility of the management
(d) resource management, including selection and control of suppliers and sub-contractors
(e) risk management as set out in in MDR Section 3 of Annex I
(f) clinical evaluation in accordance with Article 61 and Annex XIV, including PMCF
(g) product realisation, including planning, design, development, production and service provision
(h) 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
(i) setting-up, implementation and maintenance of a post-market surveillance system, in accordance with Article 83 | EU-MDR Article 10 (9) requirement | Information provided by the applicant / manufacturer *) | |
| :---: | :---: | :---: |
| | Evidence for implementation available in Document ID-# | Evidence addressed on page # or section # |
| a) strategy for regulatory compliance | | |
| b) identification of applicable general safety and performance requirements (GSPR) | | |
| (c) responsibility of the management | | |
| (d) resource management, including selection and control of suppliers and sub-contractors | | |
| (e) risk management as set out in in MDR Section 3 of Annex I | | |
| (f) clinical evaluation in accordance with Article 61 and Annex XIV, including PMCF | | |
| (g) product realisation, including planning, design, development, production and service provision | | |
| (h) 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 | | |
| (i) setting-up, implementation and maintenance of a post-market surveillance system, in accordance with Article 83 | | |
Stage 1 Document and Record Request 第 1 阶段 文件和记录申请
EU MDR 欧盟 MDR
(j) 处理与主管当局、通知机构、其他经济经营者、客户和/或其他利益相关者的沟 通
(j) handling communication with competent
authorities, notified bodies, other economic
operators, customers and/or other stakeholders
(j) handling communication with competent
authorities, notified bodies, other economic
operators, customers and/or other stakeholders| (j) handling communication with competent |
| :--- |
| authorities, notified bodies, other economic |
| operators, customers and/or other stakeholders |
(k) 在保持警惕的情况下报告严重事故和采取实地安全纠正行动的程序
(k) processes for reporting of serious incidents and
field safety corrective actions in the context of
vigilance
(k) processes for reporting of serious incidents and
field safety corrective actions in the context of
vigilance| (k) processes for reporting of serious incidents and |
| :--- |
| field safety corrective actions in the context of |
| vigilance |
(I) 纠正和预防措施的管理及其有效性的核查
(I) management of corrective and preventive actions
and verification of their effectiveness
(I) management of corrective and preventive actions
and verification of their effectiveness| (I) management of corrective and preventive actions |
| :--- |
| and verification of their effectiveness |
(m) 监测和测量产出、分析数据和改进产品的程序
(m) processes for monitoring and measurement of
output, data analysis and product improvement
(m) processes for monitoring and measurement of
output, data analysis and product improvement| (m) processes for monitoring and measurement of |
| :--- |
| output, data analysis and product improvement |
"(j) handling communication with competent
authorities, notified bodies, other economic
operators, customers and/or other stakeholders"
"(k) processes for reporting of serious incidents and
field safety corrective actions in the context of
vigilance"
"(I) management of corrective and preventive actions
and verification of their effectiveness"
"(m) processes for monitoring and measurement of
output, data analysis and product improvement" | (j) handling communication with competent <br> authorities, notified bodies, other economic <br> operators, customers and/or other stakeholders | | |
| :--- | :--- | :--- |
| (k) processes for reporting of serious incidents and <br> field safety corrective actions in the context of <br> vigilance | | |
| (I) management of corrective and preventive actions <br> and verification of their effectiveness | | |
| (m) processes for monitoring and measurement of <br> output, data analysis and product improvement | | |
Requirement 要求
Evidence documents 证据文件
如果制造商未在成员国设立：第 11、12 条：授权代表 检查授权： - AR 永久保存一份最新的技术文件副本 - AR 主管当局的联系人/合作伙伴 - 如果制造商违反本条例规定的义务，AR 应终止授权，并立即通知当局（CA 和通知机构），包括原因。- 责任/保险 - AR变更协议 - AR合规责任人（第15条）
If a manufacturer is not established in a Member State:
Article 11, 12: Authorized Representative
Check mandate:
- AR keeps a current copy of the technical documentation permanent available
- AR contact person/cooperation partner for competent authority
- AR shall terminate mandate if the manufacturer acts contrary to his obligations under this Regulation and immediately inform authorities (CA and notified body) including reasons.
- Liability / insurance
- Agreement for change of AR
- Person responsible for regulatory compliance of AR (Article 15)
If a manufacturer is not established in a Member State:
Article 11, 12: Authorized Representative
Check mandate:
- AR keeps a current copy of the technical documentation permanent available
- AR contact person/cooperation partner for competent authority
- AR shall terminate mandate if the manufacturer acts contrary to his obligations under this Regulation and immediately inform authorities (CA and notified body) including reasons.
- Liability / insurance
- Agreement for change of AR
- Person responsible for regulatory compliance of AR (Article 15)| If a manufacturer is not established in a Member State: |
| :--- |
| Article 11, 12: Authorized Representative |
| Check mandate: |
| - AR keeps a current copy of the technical documentation permanent available |
| - AR contact person/cooperation partner for competent authority |
| - AR shall terminate mandate if the manufacturer acts contrary to his obligations under this Regulation and immediately inform authorities (CA and notified body) including reasons. |
| - Liability / insurance |
| - Agreement for change of AR |
| - Person responsible for regulatory compliance of AR (Article 15) |
Requirement Evidence documents
"If a manufacturer is not established in a Member State:
Article 11, 12: Authorized Representative
Check mandate:
- AR keeps a current copy of the technical documentation permanent available
- AR contact person/cooperation partner for competent authority
- AR shall terminate mandate if the manufacturer acts contrary to his obligations under this Regulation and immediately inform authorities (CA and notified body) including reasons.
- Liability / insurance
- Agreement for change of AR
- Person responsible for regulatory compliance of AR (Article 15)" | Requirement | Evidence documents |
| :---: | :---: |
| If a manufacturer is not established in a Member State: <br> Article 11, 12: Authorized Representative <br> Check mandate: <br> - AR keeps a current copy of the technical documentation permanent available <br> - AR contact person/cooperation partner for competent authority <br> - AR shall terminate mandate if the manufacturer acts contrary to his obligations under this Regulation and immediately inform authorities (CA and notified body) including reasons. <br> - Liability / insurance <br> - Agreement for change of AR <br> - Person responsible for regulatory compliance of AR (Article 15) | |
Article 10: Technical documentation 第 10 条：技术文件
Technical documentation according to annex II and III 附件二和附件三规定的技术文件
Retention period 10 years for non-implantable devices 非植入式设备的保存期为 10 年
Retention period 15 years for implants 植入物保存期 15 年
Procedure for UDI labeling including part B and C of Annex VI UDI 标签程序，包括附件 VI 的 B 部分和 C 部分
Single registration number 单一登记号
Article 13: Obligations of importers 第 13 条：进口商的义务
Check contracts between manufacturer and importers 检查制造商和进口商之间的合同
regarding the below obligations: 关于以下义务
Reasons to believe that device is not in conformity 认为设备不符合要求的理由
Labeling 标签
Verify Eudamed registration 验证 Eudamed 注册
Storage and transport 储存和运输
Register complaints, non conforming, recalls, withdrawals 登记投诉、不合格产品、召回和撤消
Stage 1 Document and Record Request 第 1 阶段 文件和记录申请
EU MDR 欧盟 MDR
Requirement 要求
Evidence documents 证据文件
- Obligation to inform manufacturer, authorized - 有义务通知制造商、授权
Article 14: Obligations of distributors 第 14 条：经销商的义务
Check contracts between manufacturer and distributors 检查制造商与分销商之间的合同
regarding the below obligations: 关于以下义务
- Check CE mark and DoC - 检查 CE 标志和 DoC
- Accompanying documents available - 随附文件
- UDI assigned - 分配的 UDI
Cooperate with competent authorities 与主管当局合作
Requirement Evidence documents
- Obligation to inform manufacturer, authorized
- quad Keepresentative, competent authority
- Cooperate with competent authorities
Article 14: Obligations of distributors
Check contracts between manufacturer and distributors
regarding the below obligations:
- Check CE mark and DoC
- Accompanying documents available
- UDI assigned
Cooperate with competent authorities | Requirement | Evidence documents |
| :--- | :--- |
| - Obligation to inform manufacturer, authorized | |
| - $\quad$ Keepresentative, competent authority | |
| - Cooperate with competent authorities | |
| Article 14: Obligations of distributors | |
| Check contracts between manufacturer and distributors | |
| regarding the below obligations: | |
| - Check CE mark and DoC | |
| - Accompanying documents available | |
| - UDI assigned | |
| Cooperate with competent authorities | |
Article 15: Person responsible for regulatory compliance (PRRC) 第 15 条：监管合规负责人（PRRC）
(for guidance see MDCG 2019-7) (指导意见见 MDCG 2019-7）
Appointment includes PRRC responsibilities (15.3) 任命包括 PRRC 职责（15.3）
sufficient qualification (15.1) 足够的资格（15.1）
Manufacturers Responsible Person (PRRC - 15.2) 制造商负责人（PRRC - 15.2）
a) PRRC needs to be an employee of the organization, a) PRRC 必须是组织的雇员、
b) Micro and small enterprises shall not be required to have the person responsible for regulatory compliance within their organization, but shall have such person permanently and continuously at their disposal b) 不要求微型和小型企业在其组织内配备负责监管合规的人员，但应长期、持续地 配备此类人员供其使用。
c) Organizations with more than one legal manufacturer under the parent company would need to ensure that each legal manufacturer has its own PRRC c) 母公司下有一个以上合法制造商的组织需要确保每个合法制造商都有自己的 PRRC
d) for manufacturers located outside the EU, it must be assumed that the PRRC should also be located outside the EU. d) 对于欧盟以外的制造商，必须假定 PRRC 也应位于欧盟以外。
e) for manufacturers located in the EU, it must be assumed that the PRRC should also be located in the EU e) 对于欧盟境内的制造商，必须假定 PRRC 也应位于欧盟境内
EU-Representative 欧盟代表
Responsible Person (PRRC - 15.6) 负责人（PRRC - 15.6）
a) Taking into account that the Authorized Representative is located in the EU, it must be assumed that any person to be permanently and continuously at its disposal should be also located in the EU a) 考虑到授权代表位于欧盟，必须假定任何长期和持续为其服务的人员也应位于欧盟
b) The person responsible for regulatory compliance for an authorized representative and for an ‘outside EU’ manufacturer cannot be the same person b) 授权代表和 "欧盟以外 "制造商的合规负责人不能是同一个人
quad\quad Shall be responsible for ensuring (15.3) quad\quad 应负责确保（15.3）
a) the conformity of the devices is appropriately checked a) 对设备的合格性进行适当检查
b) the technical documentation and the EU declaration of conformity b) 技术文件和欧盟合格声明
c) the post-market surveillance obligations c) 上市后的监督义务
d) the vigilance reporting obligations d) 警惕报告义务
e) for investigational devices, the statement is issued e) 对于研究用器械，则发布声明
Stage 1 Document and Record Request 第 1 阶段 文件和记录申请
EU MDR 欧盟 MDR
Requirement 要求
Evidence documents 证据文件
如果制造商处理系统和/或程序包：第 22 条：程序包--起草声明--兼容性--提供的信息--验证和确认--灭菌--无 CE 标志的部件 => 充当制造商--标签
If the manufacturer handles systems and/or procedure packs:
Article 22: Procedure packs
- draw up statement
- Compatibility
- Information supplied
- Verification and validation
- Sterilization
- Non CE-marked components => act as manufacturer
- Labeling
If the manufacturer handles systems and/or procedure packs:
Article 22: Procedure packs
- draw up statement
- Compatibility
- Information supplied
- Verification and validation
- Sterilization
- Non CE-marked components => act as manufacturer
- Labeling| If the manufacturer handles systems and/or procedure packs: |
| :--- |
| Article 22: Procedure packs |
| - draw up statement |
| - Compatibility |
| - Information supplied |
| - Verification and validation |
| - Sterilization |
| - Non CE-marked components => act as manufacturer |
| - Labeling |
If the manufacturer provides items intended to replace part or component of device:
Article 23: Parts and components items put on the market to replace are identical or similar parts or components of a device
If the manufacturer provides items intended to replace part or component of device:
Article 23: Parts and components items put on the market to replace are identical or similar parts or components of a device| If the manufacturer provides items intended to replace part or component of device: |
| :--- |
| Article 23: Parts and components items put on the market to replace are identical or similar parts or components of a device |
如果是植入式和 III 类设备：第 32 条：SSCP--编制程序（包括移交给通知机构）--提供SSCP模板
In case implantable and class III devices:
Article 32: SSCP
- Procedure for compiling (including transfer to notified body)
- Template SSCP available
In case implantable and class III devices:
Article 32: SSCP
- Procedure for compiling (including transfer to notified body)
- Template SSCP available| In case implantable and class III devices: |
| :--- |
| Article 32: SSCP |
| - Procedure for compiling (including transfer to notified body) |
| - Template SSCP available |
第 52 条第 20 款：CE 标志 - CE 标志的程序是否到位？
Article 52, 20: CE marking
- Procedure for CE marking in place?
Article 52, 20: CE marking
- Procedure for CE marking in place?| Article 52, 20: CE marking |
| :--- |
| - Procedure for CE marking in place? |
第 51、52 条：分类、CAP - 适用的分类规则 - CE 标志产品的更新列表 - MDR：定制设备？
Article 51, 52: Classification, CAP
- Classification rules applied
- updated List of CE marked products
- MDR: Custom made devices?
Article 51, 52: Classification, CAP
- Classification rules applied
- updated List of CE marked products
- MDR: Custom made devices?| Article 51, 52: Classification, CAP |
| :--- |
| - Classification rules applied |
| - updated List of CE marked products |
| - MDR: Custom made devices? |
Clinical evaluation according to Part A of annex XIV process in place / updated to generate and assess clinical data
- Clinical evaluation plan (CEP)
- Identification of pertinent data
- Appraisal of pertinent data
- Analysis of clinical data
- Clinical data report including PMS / PMCF plan
Article 61: Clinical evaluation
Clinical evaluation according to Part A of annex XIV process in place / updated to generate and assess clinical data
- Clinical evaluation plan (CEP)
- Identification of pertinent data
- Appraisal of pertinent data
- Analysis of clinical data
- Clinical data report including PMS / PMCF plan| Article 61: Clinical evaluation |
| :--- |
| Clinical evaluation according to Part A of annex XIV process in place / updated to generate and assess clinical data |
| - Clinical evaluation plan (CEP) |
| - Identification of pertinent data |
| - Appraisal of pertinent data |
| - Analysis of clinical data |
| - Clinical data report including PMS / PMCF plan |
Article 62 to 82: clinical investigation Procedure for clinical investigations 第 62 至 82 条：临床研究 临床研究的程序
- quad\quad Procedure for post market surveillance (article 83 )
- Plan for Post market surveillance (article 84)
- Class I device:Template for surveillance report (article 85)
Article 83 to 86: Post market surveillance system
- quad Procedure for post market surveillance (article 83 )
- Plan for Post market surveillance (article 84)
- Class I device:Template for surveillance report (article 85)| Article 83 to 86: Post market surveillance system |
| :--- |
| - $\quad$ Procedure for post market surveillance (article 83 ) |
| - Plan for Post market surveillance (article 84) |
| - Class I device:Template for surveillance report (article 85) |
Requirement Evidence documents
"If the manufacturer handles systems and/or procedure packs:
Article 22: Procedure packs
- draw up statement
- Compatibility
- Information supplied
- Verification and validation
- Sterilization
- Non CE-marked components => act as manufacturer
- Labeling"
"If the manufacturer provides items intended to replace part or component of device:
Article 23: Parts and components items put on the market to replace are identical or similar parts or components of a device"
"In case implantable and class III devices:
Article 32: SSCP
- Procedure for compiling (including transfer to notified body)
- Template SSCP available"
"Article 52, 20: CE marking
- Procedure for CE marking in place?"
"Article 51, 52: Classification, CAP
- Classification rules applied
- updated List of CE marked products
- MDR: Custom made devices?"
"Article 61: Clinical evaluation
Clinical evaluation according to Part A of annex XIV process in place / updated to generate and assess clinical data
- Clinical evaluation plan (CEP)
- Identification of pertinent data
- Appraisal of pertinent data
- Analysis of clinical data
- Clinical data report including PMS / PMCF plan"
Article 62 to 82: clinical investigation Procedure for clinical investigations
"Article 83 to 86: Post market surveillance system
- quad Procedure for post market surveillance (article 83 )
- Plan for Post market surveillance (article 84)
- Class I device:Template for surveillance report (article 85)" | Requirement | Evidence documents |
| :---: | :---: |
| If the manufacturer handles systems and/or procedure packs: <br> Article 22: Procedure packs <br> - draw up statement <br> - Compatibility <br> - Information supplied <br> - Verification and validation <br> - Sterilization <br> - Non CE-marked components => act as manufacturer <br> - Labeling | |
| If the manufacturer provides items intended to replace part or component of device: <br> Article 23: Parts and components items put on the market to replace are identical or similar parts or components of a device | |
| In case implantable and class III devices: <br> Article 32: SSCP <br> - Procedure for compiling (including transfer to notified body) <br> - Template SSCP available | |
| Article 52, 20: CE marking <br> - Procedure for CE marking in place? | |
| Article 51, 52: Classification, CAP <br> - Classification rules applied <br> - updated List of CE marked products <br> - MDR: Custom made devices? | |
| Article 61: Clinical evaluation <br> Clinical evaluation according to Part A of annex XIV process in place / updated to generate and assess clinical data <br> - Clinical evaluation plan (CEP) <br> - Identification of pertinent data <br> - Appraisal of pertinent data <br> - Analysis of clinical data <br> - Clinical data report including PMS / PMCF plan | |
| Article 62 to 82: clinical investigation Procedure for clinical investigations | |
| Article 83 to 86: Post market surveillance system <br> - $\quad$ Procedure for post market surveillance (article 83 ) <br> - Plan for Post market surveillance (article 84) <br> - Class I device:Template for surveillance report (article 85) | |
Stage 1 Document and Record Request 第 1 阶段 文件和记录申请
- Class IIa, IIb and III device:
Periodic safety update report (article 86)
- Update of technical documentation
- Implantable and class III:
Upload to Eudamed / Notified Body| - Class IIa, IIb and III device: |
| :--- |
| Periodic safety update report (article 86) |
| - Update of technical documentation |
| - Implantable and class III: |
| Upload to Eudamed / Notified Body |