MDR 2017 745

2017年5月5日，欧盟发布新版医疗器械法规MDR（EU 2017/745），以替代旧版医疗器械指令MDD（93/42/EEC）和有源植入医疗器械指令AIMDD（90/385/EEC），同年5月26日生效。

Regulation (EU) 2017/745

• CHAPTER I SCOPE AND DEFINITIONS 范围和定义
  • Article 1 Subject matter and scope
  • Article 2 Definitions
  • Article 3 Amendment of certain definitions
  • Article 4 Regulatory status of products
• CHAPTER II MAKING AVAILABLE ON THE MARKET AND PUTTING INTO SERVICE OF DEVICES, OBLIGATIONS OF ECONOMIC OPERATORS, REPROCESSING, CE MARKING, FREE MOVEMENT 器械上市和投入使用，经济运营商的职责， 在处理，CE标识，自由销售
  • 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 系统和手术包
  • Article 23 Parts and components
  • Article 24 Free movement
• CHAPTER III IDENTIFICATION AND TRACEABILITY OF DEVICES, REGISTRATION OF DEVICES AND OF ECONOMIC OPERATORS, SUMMARY OF SAFETY AND CLINICAL PERFORMANCE, EUROPEAN DATABASE ON MEDICAL DEVICES 器械的识别和追踪，经济运营商的注册，安全和临床性能总结，医疗器械欧盟数据库
  • Article 25 Identification within the supply chain
  • Article 26 Medical devices nomenclature
    • CND
  • Article 27 Unique Device Identification system
  • Article 28 UDI database
  • Article 29 Registration of devices
    • MDCG 2019-4
    • MDCG 2019-5
  • 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
    • MDCG 2019-9
  • Article 33 European database on medical devices
  • Article 34 Functionality of Eudamed
• CHAPTER IV NOTIFIED BODIES
  • Article 35 Authorities responsible for notified bodies
  • Article 36 Requirements relating to notified bodies
  • Article 37 Subsidiaries and subcontracting 分支机构和分包
  • Article 38 Application by conformity assessment bodies for designation 符合性评价机构的委任申请
  • Article 39 Assessment of the application
  • Article 40 Nomination of experts for joint assessment of applications for notification NB邀请专家一起评估申请
  • Article 41 Language requirements
  • Article 42 Designation and notification procedure 委任和公告流程
  • Article 43 Identification number and list of notified bodies 识别码和公告机构清单
  • 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 V CLASSIFICATION AND CONFORMITY ASSESSMENT
  • SECTION 1 Classification
    • Article 51 Classification of devices
  • SECTION 2 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 符合性评价程序的豁免
    • Article 60 Certificate of free sale
• CHAPTER VI 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 知情同意
  • Article 64 Clinical investigations on incapacitated subjects 针对无行为能力受试者的临床试验
  • Article 65 Clinical investigations on minors 未成年人的临床试验
  • Article 66 Clinical investigations on pregnant or breastfeeding women 孕妇和哺乳期妇女的临床试验
  • Article 67 Additional national measures
  • Article 68 Clinical investigations in emergency situations
  • Article 69 Damage compensation 损害赔偿
  • 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 临床试验的实质性修改
  • 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 临床试验结束，或暂时停止或提前终止的情况下，申办方需要提供的信息
  • 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 实施细则
  • Article 82 Requirements regarding other clinical investigations
• CHAPTER VII POST-MARKET SURVEILLANCE, VIGILANCE AND MARKET SURVEILLANCE
  • SECTION 1 Post-market surveillance
    • Article 83 Post-market surveillance system of the manufacturer
    • Article 84 Post-market surveillance plan
    • Article 85 Post-market surveillance report
    • Article 86 Periodic safety update report
  • SECTION 2 Vigilance
    • Article 87 Reporting of serious incidents and field safety corrective actions
    • Article 88 Trend reporting
    • Article 89 Analysis of serious incidents and field safety corrective actions
    • Article 90 Analysis of vigilance data
    • Article 91 Implementing acts
    • Article 92 Electronic system on vigilance and on post-market surveillance
  • SECTION 3 Market surveillance
    • Article 93 Market surveillance activities
    • Article 94 Evaluation of devices suspected of presenting an unacceptable risk or other non-compliance 对涉嫌不可接受风险或其他不合规器械的评估
    • Article 95 Procedure for dealing with devices presenting an unacceptable risk to health and safety 对健康和安全带来不可接受风险的器械的处理程序
    • Article 96 Procedure for evaluating national measures at Union level 在欧盟层面评估国家措施的流程
    • Article 97 Other non-compliance
    • Article 98 Preventive health protection measures 预防性健康保护措施
    • Article 99 Good administrative practice
    • Article 100 Electronic system on market surveillance
• CHAPTER VIII COOPERATION BETWEEN MEMBER STATES, MEDICAL DEVICE COORDINATION GROUP, EXPERT LABORATORIES, EXPERT PANELS AND DEVICE REGISTERS .......的协助
  • 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 IX CONFIDENTIALITY, DATA PROTECTION, FUNDING AND PENALTIES 保密性，数据保护，资金来源和处罚
  • Article 109 Confidentiality 保密性
  • Article 110 Data protection
    • 项目管理
    • 项目团队建设
    • 客户关系管理
  • Article 111 Levying of fees 收费
  • Article 112 Funding of activities related to designation and monitoring of notified bodies
  • Article 113 Penalties 处罚
• CHAPTER X FINAL PROVISIONS 最终条款
  • 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 指令修订案
  • Article 118 Amendment to Regulation (EC) No 178/2002 指令修订案
  • Article 119 Amendment to Regulation (EC) No 1223/2009 指令修订案
  • Article 120 Transitional provisions 过渡条款
  • Article 121 Evaluation
  • Article 122 Repeal 废除
  • Article 123 Entry into force and date of application
• ANNEX XVII CORRELATION TABLE 对照表
• ANNEX XVI LIST OF GROUPS OF PRODUCTS WITHOUT AN INTENDED MEDICAL PURPOSE REFERRED TO IN ARTICLE 1(2) 无预期医疗目的的产品分组清单
• ANNEX XV CLINICAL INVESTIGATIONS
  • CHAPTER I GENERAL REQUIREMENTS
  • CHAPTER II DOCUMENTATION REGARDING THE APPLICATION FOR CLINICAL INVESTIGATION
  • CHAPTER III OTHER OBLIGATIONS OF THE SPONSOR 申办方的其他义务
• ANNEX XIV CLINICAL EVALUATION AND POST-MARKET CLINICAL FOLLOW-UP
  • PART A CLINICAL EVALUATION
    • MDCG 2020-5 等效性
  • PART B POST-MARKET CLINICAL FOLLOW-UP
    • MDCG 2020-7
    • MDCG 2020-8
• ANNEX XIII PROCEDURE FOR CUSTOM-MADE DEVICES
• ANNEX XII CERTIFICATES ISSUED BY A NOTIFIED BODY
  • CHAPTER I GENERAL REQUIREMENTS
  • CHAPTER II MINIMUM CONTENT OF THE CERTIFICATES 证书的必需内容
    • MDCG 2020-3
• ANNEX XI CONFORMITY ASSESSMENT BASED ON PRODUCT CONFORMITY VERIFICATION
  • PART A PRODUCTION QUALITY ASSURANCE 生产质量保证
  • PART B PRODUCT VERIFICATION 产品验证
• ANNEX X CONFORMITY ASSESSMENT BASED ON TYPE-EXAMINATION
• ANNEX IX CONFORMITY ASSESSMENT BASED ON A QUALITY MANAGEMENT SYSTEM AND ON ASSESSMENT OF TECHNICAL DOCUMENTATION
  • CHAPTER I QUALITY MANAGEMENT SYSTEM
  • CHAPTER II ASSESSMENT OF THE TECHNICAL DOCUMENTATION
  • CHAPTER III ADMINISTRATIVE PROVISIONS 行政管理规定
• ANNEX VIII CLASSIFICATION RULES
  • CHAPTER I DEFINITIONS SPECIFIC TO CLASSIFICATION RULES
  • CHAPTER II IMPLEMENTING RULES
  • CHAPTER III CLASSIFICATION RULES
    • NON-INVASIVE DEVICES非侵入器械: rule 1-4
    • INVASIVE DEVICES侵入器械：rule 5-8
    • ACTIVE DEVICES 有源器械：rule 9-13
    • SPECIAL RULES特殊规则：rule 14-22
• ANNEX VII REQUIREMENTS TO BE MET BY NOTIFIED BODIES
• ANNEX 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
  • PART A INFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF DEVICES AND ECONOMIC OPERATORS IN ACCORDANCE WITH ARTICLES 29(4) AND 31 器械注册和经济运营商注册所需的信息
  • PART B CORE DATA ELEMENTS TO BE PROVIDED TO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN ACCORDANCE WITH ARTICLES 28 AND 29 制造商应向UDI数据库提交的UDI-DI和其他相关信息
  • PART C THE UDI SYSTEM
• ANNEX V CE MARKING OF CONFORMITY
• ANNEX IV EU DECLARATION OF CONFORMITY
• ANNEX III TECHNICAL DOCUMENTATION ON POST-MARKET SURVEILLANCE
• ANNEX II TECHNICAL DOCUMENTATION
• ANNEX I GENERAL SAFETY AND PERFORMANCE REQUIREMENTS
  • CHAPTER I GENERAL REQUIREMENTS
  • CHAPTER II REQUIREMENTS REGARDING DESIGN AND MANUFACTURE 设计和生产要求
  • CHAPTER III REQUIREMENTS REGARDING THE INFORMATION SUPPLIED WITH THE DEVICE 器械随附信息的要求