MDR法规原文中英对照
MDR Regulation (EU) 2017/745
MDR Regulation (EU) 2017/745
MDR Regulation (EU) 2017/745
Chapter 1 (Art. 1 – 4) Scope and definitions
Article 1 – Subject matter and scope
Article 2 – Definitions
Article 3 – Amendment of certain definitions
Article 4 – Regulatory status of products
Chapter 2 (Art. 5 – 24)
Making available on the market and putting into service of devices, obligations of economic operators, reprocessing, CE marking, free movement
Article 5 – Placing on the market and putting into service
Article 6 – Distance sales
Article 7 – Claims
Article 8 – Use of harmonised standards
Article 9 – Common specifications
Article 10 – General obligations of manufacturers
Article 11 – Authorised representative
Article 12 – Change of authorised representative
Article 13 – General obligations of importers
Article 14 – General obligations of distributors
Article 15 – Person responsible for regulatory compliance
Article 16 – Cases in which obligations of manufacturers apply to importers, distributors or other persons
Article 17 – Single-use devices and their reprocessing
Article 18 – Implant card and information to be supplied to the patient with an implanted device
Article 19 – EU declaration of conformity
Article 20 – CE marking of conformity
Article 21 – Devices for special purposes
Article 22 – Systems and procedure packs
Article 23 – Parts and components
Article 24 – Free movement
Chapter 3 (Art. 25 – 34)
Identification and traceability of devices, registration of devices and of economic operators, summary of safety and clinical performance, European database on medical devices
Article 25 – Identification within the supply chain
Article 26 – Medical devices nomenclature
Article 27 – Unique Device Identification system
Article 28 – UDI database
Article 29 – Registration of devices
Article 30 – Electronic system for registration of economic operators
Article 31 – Registration of manufacturers, authorised representatives and importers
Article 32 – Summary of safety and clinical performance
Article 33 – European database on medical devices
Article 34 – Functionality of Eudamed
Chapter 4 (Art. 35 – 50) Notified bodies
Article 35 – Authorities responsible for notified bodies
Article 36 – Requirements relating to notified bodies
Article 37 – Subsidiaries and subcontracting
Article 38 – Application by conformity assessment bodies for designation
Article 39 – Assessment of the application
Article 40 – Nomination of experts for joint assessment of applications for notification
Article 41 – Language requirements
Article 42 – Designation and notification procedure
Article 43 – Identification number and list of notified bodies
Article 44 – Monitoring and re-assessment of notified bodies
Article 45 – Review of notified body assessment of technical documentation and clinical evaluation documentation
Article 46 – Changes to designations and notifications
Article 47 – Challenge to the competence of notified bodies
Article 48 – Peer review and exchange of experience between authorities responsible for notified bodies
Article 49 – Coordination of notified bodies
Article 50 – List of standard fees
Chapter 5 (Art. 51 – 60)Classification and conformity assessment
Section 1 (Art. 1) Classification
Article 51 – Classification of devices
Section 2 (Art. 1 – 9) Conformity assessment
Article 52 – Conformity assessment procedures
Article 53 – Involvement of notified bodies in conformity assessment procedures
Article 54 – Clinical evaluation consultation procedure for certain class III and class IIb devices
Article 55 – Mechanism for scrutiny of conformity assessments of certain class III and class IIb devices
Article 56 – Certificates of conformity
Article 57 – Electronic system on notified bodies and on certificates of conformity
Article 58 – Voluntary change of notified body
Article 59 – Derogation from the conformity assessment procedures
Article 60 – Certificate of free sale
医疗器械MDR 法规
MDR Regulation (EU) 2017/745
MDR Regulation (EU) 2017/745
第 1 章（第 1-4 条） 范围和定义
第 2 章（第 5-24 条）
在市场上提供并投入使用设备、经济运营商的义务、再加工、CE 标志、自由移动
第 16 条 – 制造商义务适用于进口商、分销商或其他人的情况
第 3 章（第 25-34 条）
设备的识别和可追溯性、设备和经济运营商的注册、安全性和临床性能总结、欧洲医疗设备数据库
第 4 章（第 35-50 条）公告机构
第 45 条 – 审查公告机构对技术文件和临床评估文件的评估
第 48 条 – 负责公告机构的机构之间的同行评审和经验交流
第 5 章（第 51-60 条） 分类和合格评定
第 55 条 – 某些 III 类和 IIb 类器械的合格评定审查机制
MDR Regulation (EU) 2017/745
MDR Regulation (EU) 2017/745
MDR Regulation (EU) 2017/745
Chapter 6 (Art. 61 – 82) Clinical evaluation and clinical investigations
Article 61 – Clinical evaluation
Article 62 – General requirements regarding clinical investigations conducted to demonstrate conformity of devices
Article 63 – Informed consent
Article 64 – Clinical investigations on incapacitated subjects
Article 65 – Clinical investigations on minors
Article 66 – Clinical investigations on pregnant or breastfeeding women
Article 67 – Additional national measures
Article 68 – Clinical investigations in emergency situations
Article 69 – Damage compensation
Article 70 – Application for clinical investigations
Article 71 – Assessment by Member States
Article 72 – Conduct of a clinical investigation
Article 73 – Electronic system on clinical investigations
Article 74 – Clinical investigations regarding devices bearing the CE marking
Article 75 – Substantial modifications to clinical investigations
Article 76 – Corrective measures to be taken by Member States and information exchange between Member States
Article 77 – Information from the sponsor at the end of a clinical investigation or in the event of a temporary halt or early termination
Article 78 – Coordinated assessment procedure for clinical investigations
Article 79 – Review of coordinated assessment procedure
Article 80 – Recording and reporting of adverse events that occur during clinical investigations
Article 81 – Implementing acts
Article 82 – Requirements regarding other clinical investigations
Chapter 7 (Art. 83 – 100)
Post-market surveillance, vigilance and market surveillance
Section 1 (Art. 1 – 4) Post-market surveillance
Section 2 (Art. 1 – 6) Vigilance
Section 3 (Art. 1 – 8) Market surveillance
Chapter 8 (Art. 101 – 108)
Cooperation between member states, medical device coordination group, expert laboratories, expert panels and device registers
Article 101 – Competent authorities
Article 102 – Cooperation
Article 103 – Medical Device Coordination Group
Article 104 – Support by the Commission
Article 105 – Tasks of the MDCG
Article 106 – Provision of scientific, technical and clinical opinions and advice
Article 107 – Conflict of interests
Article 108 – Device registers and databanks
Chapter 9 (Art. 109 – 113)
Confidentiality, data protection, funding and penalties
Article 109 – Confidentiality
Article 110 – Data protection
Article 111 – Levying of fees
Article 112 – Funding of activities related to designation and monitoring of notified bodies
Article 113 – Penalties
Chapter 10 (Art. 114 – 123) Final provisions
Article 114 – Committee procedure
Article 115 – Exercise of the delegation
Article 116 – Separate delegated acts for different delegated powers
Article 117 – Amendment to Directive 2001/83/EC
Article 118 – Amendment to Regulation (EC) No 178/2002
Article 119 – Amendment to Regulation (EC) No 1223/2009
Article 120 – Transitional provisions
Article 121 – Evaluation
Article 122 – Repeal
Article 123 – Entry into force and date of application
(Anx. 1 – 17) Annexes
Annex 1 – General safety and performance requirements
Annex 2 – Technical documentation
Annex 3 – Technical documentation on post-market surveillance
Annex 4 – EU declaration of conformity
Annex 5 – CE marking of conformity
Annex 6 – 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
Annex 7 – Requirements to be met by notified bodies
Annex 8 – Classification rules
Annex 9 – Conformity assessment based on a quality management system and assessment of the technical documentation
Annex 10 – Conformity assessment based on type examination
Annex 11 – Conformity assessment based on product conformity verification
Annex 12 – Certificates issued by a notified body
Annex 13 – Procedure for custom-made devices
Annex 14 – Clinical evaluation and post-market clinical follow-up
Annex 15 – Clinical investigations
Annex 16 – List of groups of products without an intended medical purpose referred to in Article 1(2)
Annex 17 – Correlation table
医疗器械MDR 法规
MDR Regulation (EU) 2017/745
MDR Regulation (EU) 2017/745
第 6 章（第 61-82 条） 临床评价和临床调查
第 62 条 – 有关为证明器械符合性而进行的临床调查的一般要求
第 63 条 – 知情同意
第 64 条 – 无行为能力受试者的临床研究
第 65 条 – 对未成年人的临床调查
第 66 条 – 孕妇或哺乳期妇女的临床调查
第 67 条 – 额外的国家措施
第 68 条 – 紧急情况下的临床调查
第 69 条 – 损害赔偿
第 70 条 – 临床研究申请
第 71 条 – 成员国的评估
第 72 条 – 进行临床调查
第 73 条 – 临床研究电子系统
第 74 条 – 关于带有 CE 标志的器械的临床研究
第 75 条 – 对临床研究的重大修改
第 76 条 – 成员国采取的纠正措施和成员国之间的信息交流
第 77 条 – 申办者在临床研究结束或暂停或提前终止时的信息
第 78 条 – 临床研究的协调评估程序
第 79 条 – 审查协调评估程序
第 80 条 – 记录和报告临床研究期间发生的不良事件
第 81 条 – 实施法案
第 82 条 – 关于其他临床研究的要求
第 7 章（第 83-100 条）
上市后监督、警戒和市场监督
第 1 条（第 1-4 条）上市后监督
第 2 节（第 1-6 条）警觉
第 3 节（第 1-8 条）市场监督
第 8 章（第 101-108 条）
成员国、医疗器械协调组、专家实验室、专家小组和器械注册机构之间的合作
第 101 条 – 主管当局
第 102 条 – 合作
第 103 条 – 医疗器械协调组
第 104 条 – 委员会的支持
第 105 条 – MDCG 的任务
第 106 条 – 提供科学、技术和临床意见和建议
第 107 条 – 利益冲突
第 108 条 – 设备注册和数据库
第 9 章（第 109-113 条）
保密、数据保护、资金和处罚
第 109 条 – 保密
第 110 条 – 数据保护
第 111 条 – 收费
第 112 条 – 与指定和监督指定机构有关的活动的资助
第 113 条 – 处罚
第 10 章（第 114-123 条） 最后条款
第 114 条 – 委员会程序
第 115 条 – 授权的行使
第 116 条 – 不同授权的单独授权行为
第 117 条 – 对 2001/83/EC 指令的修正
第 118 条 – (EC) No 178/2002 条例修正案
第 119 条 – 法规 (EC) No 1223/2009 修正案
第 120 条 – 过渡性规定
第 121 条 – 评估
第 122 条 – 废除
第 123 条 – 生效和适用日期
（附录 1 – 17） 附件
附件 1 – 一般安全和性能要求
附件 2 – 技术文件
附件 3 – 关于上市后监督的技术文件
附件 4 – 欧盟符合性声明
附件 5 – CE 符合性标志
附件 6 – 根据第 29(4) 条和第 31 条在设备和经济运营商注册时提交的信息；根据第 28 条和第 29 条，将与 UDI-DI 一起提供给 UDI 数据库的核心数据元素；以及 UDI 系统
附件 7 – 公告机构应满足的要求
附件 8 – 分类规则
附件 9 – 基于质量管理体系的符合性评估和技术文件评估
附件 10 – 基于型式检验的合格评定
附件 11 – 基于产品符合性验证的符合性评估
附件 12 – 公告机构颁发的证书
附件 13 – 定制设备的程序
附件 14 – 临床评价和上市后临床随访
附件 15 – 临床调查
附件 16 – 没有第 1(2) 条提及的预期医疗目的的产品组列表
附件 17 – 相关表