REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance) CHAPTER I INTRODUCTORY PROVISIONS Section 1 Scope and definitions Article 1 Subject matter and scope Article 2 Definitions Section 2 Regulatory status of products and counselling Article 3 Regulatory status of products Article 4 Genetic information, counselling and informed consent CHAPTER II MAKING AVAILABLE ON THE MARKET AND PUTTING INTO SERVICE OF DEVICES, OBLIGATIONS OF ECONOMIC OPERATORS, 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 EU declaration of conformity Article 18 CE marking of conformity Article 19 Devices for special purposes Article 20 Parts and components Article 21 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 Article 22 Identification within the supply chain Article 23 Medical devices nomenclature Article 24 Unique Device Identification system Article 25 UDI database Article 26 Registration of devices Article 27 Electronic system for registration of economic operators Article 28 Registration of manufacturers, authorised representatives and importers Article 29 Summary of safety and performance Article 30 European database on medical devices CHAPTER IV NOTIFIED BODIES Article 31 Authorities responsible for notified bodies Article 32 Requirements relating to notified bodies Article 33 Subsidiaries and subcontracting Article 34 Application by conformity assessment bodies for designation Article 35 Assessment of the application Article 36 Nomination of experts for joint assessment of applications for notification Article 37 Language requirements Article 38 Designation and notification procedure Article 39 Identification number and list of notified bodies Article 40 Monitoring and re-assessment of notified bodies Article 41 Review of notified body assessment of technical documentation and performance evaluation documentation Article 42 Changes to designations and notifications Article 43 Challenge to the competence of notified bodies Article 44 Peer review and exchange of experience between authorities responsible for notified bodies Article 45 Coordination of notified bodies Article 46 List of standard fees CHAPTER V CLASSIFICATION AND CONFORMITY ASSESSMENT Section 1 Classification Article 47 Classification of devices Section 2 Conformity assessment Article 48 Conformity assessment procedures Article 49 Involvement of notified bodies in conformity assessment procedures Article 50 Mechanism for scrutiny of conformity assessments of class D devices Article 51 Certificates of conformity Article 52 Electronic system on notified bodies and on certificates of conformity Article 53 Voluntary change of notified body Article 54 Derogation from the conformity assessment procedures Article 55 Certificate of free sale CHAPTER VI CLINICAL EVIDENCE, PERFORMANCE EVALUATION AND PERFORMANCE STUDIES Article 56 Performance evaluation and clinical evidence Article 57 General requirements regarding performance studies Article 58 Additional requirements for certain performance studies Article 59 Informed consent Article 60 Performance studies on incapacitated subjects Article 61 Performance studies on minors Article 62 Performance studies on pregnant or breastfeeding women Article 63 Additional national measures Article 64 Performance studies in emergency situations Article 65 Damage compensation Article 66 Application for performance studies Article 67 Assessment by Member States Article 68 Conduct of a performance study Article 69 Electronic system on performance studies Article 70 Performance studies regarding devices bearing the CE marking Article 71 Substantial modifications to performance studies Article 72 Corrective measures to be taken by Member States and information exchange between Member States on performance studies Article 73 Information from the sponsor at the end of a performance study or in the event of a temporary halt or early termination Article 74 Coordinated assessment procedure for performance studies Article 75 Review of the coordinated assessment procedure Article 76 Recording and reporting of adverse events that occur during performance studies Article 77 Implementing acts CHAPTER VII POST-MARKET SURVEILLANCE, VIGILANCE AND MARKET SURVEILLANCE Section 1 Post-market surveillance Article 78 Post-market surveillance system of the manufacturer Article 79 Post-market surveillance plan Article 80 Post-market surveillance report Article 81 Periodic safety update report Section 2 Vigilance Article 82 Reporting of serious incidents and field safety corrective actions Article 83 Trend reporting Article 84 Analysis of serious incidents and field safety corrective actions Article 85 Analysis of vigilance data Article 86 Implementing acts Article 87 Electronic system on vigilance and post-market surveillance Section 3 Market surveillance Article 88 Market surveillance activities Article 89 Evaluation of devices suspected of presenting an unacceptable risk or other non-compliance Article 90 Procedure for dealing with devices presenting an unacceptable risk to health and safety Article 91 Procedure for evaluating national measures at Union level Article 92 Other non-compliance Article 93 Preventive health protection measures Article 94 Good administrative practice Article 95 Electronic system on market surveillance CHAPTER VIII COOPERATION BETWEEN MEMBER STATES, MEDICAL DEVICE COORDINATION GROUP, EU REFERENCE LABORATORIES AND DEVICE REGISTERS Article 96 Competent authorities Article 97 Cooperation Article 98 Medical Device Coordination Group Article 99 Tasks of the MDCG Article 100 The European Union reference laboratories Article 101 Device registers and databanks CHAPTER IX CONFIDENTIALITY, DATA PROTECTION, FUNDING AND PENALTIES Article 102 Confidentiality Article 103 Data protection Article 104 Levying of fees Article 105 Funding of activities related to designation and monitoring of notified bodies Article 106 Penalties CHAPTER X FINAL PROVISIONS Article 107 Committee procedure Article 108 Exercise of the delegation Article 109 Separate delegated acts for different delegated powers Article 110 Transitional provisions Article 111 Evaluation Article 112 Repeal Article 113 Entry into force and date of application ANNEXES ANNEX I GENERAL SAFETY AND PERFORMANCE REQUIREMENTS CHAPTER I GENERAL REQUIREMENTS CHAPTER II REQUIREMENTS REGARDING PERFORMANCE, DESIGN AND MANUFACTURE CHAPTER III REQUIREMENTS REGARDING INFORMATION SUPPLIED WITH THE DEVICE ANNEX II TECHNICAL DOCUMENTATION ANNEX III TECHNICAL DOCUMENTATION ON POST-MARKET SURVEILLANCE ANNEX IV EU DECLARATION OF CONFORMITY ANNEX V CE MARKING OF CONFORMITY ANNEX VI INFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF DEVICES AND ECONOMIC OPERATORS IN ACCORDANCE WITH ARTICLES 26(3) AND 28, CORE DATA ELEMENTS TO BE PROVIDED TO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN ACCORDANCE WITH ARTICLES 25 AND 26 AND THE UDI SYSTEM PART A INFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF DEVICES AND ECONOMIC OPERATORS IN ACCORDANCE WITH ARTICLES 26(3) AND 28 PART B CORE DATA ELEMENTS TO BE PROVIDED TO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN ACCORDANCE WITH ARTICLES 25 AND 26 PART C THE UDI SYSTEM ANNEX VII REQUIREMENTS TO BE MET BY NOTIFIED BODIES ANNEX VIII CLASSIFICATION RULES 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 ANNEX X CONFORMITY ASSESSMENT BASED ON TYPE-EXAMINATION ANNEX XI CONFORMITY ASSESSMENT BASED ON PRODUCTION QUALITY ASSURANCE ANNEX XII CERTIFICATES ISSUED BY A NOTIFIED BODY CHAPTER I GENERAL REQUIREMENTS CHAPTER II MINIMUM CONTENT OF THE CERTIFICATES ANNEX XIII PERFORMANCE EVALUATION, PERFORMANCE STUDIES AND POST-MARKET PERFORMANCE FOLLOW-UP PART A PERFORMANCE EVALUATION AND PERFORMANCE STUDIES PART B POST-MARKET PERFORMANCE FOLLOW-UP ANNEX XIV INTERVENTIONAL CLINICAL PERFORMANCE STUDIES AND CERTAIN OTHER PERFORMANCE STUDIES CHAPTER I DOCUMENTATION REGARDING THE APPLICATION FOR INTERVENTIONAL CLINICAL PERFORMANCE STUDIES AND OTHER PERFORMANCE STUDIES INVOLVING RISKS FOR THE SUBJECTS OF THE STUDIES CHAPTER II OTHER OBLIGATIONS OF THE SPONSOR ANNEX XV CORRELATION TABLE