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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. )In Vitro Diagnostic Regulation – IVDR
- Recitals
CHAPTER I — INTRODUCTORY PROVISIONS- 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
- 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
- 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
- CHAPTER IX — CONFIDENTIALITY, DATA PROTECTION, FUNDING AND PENALTIES
- CHAPTER X — FINAL PROVISIONS
- Final
- ANNEXES
- ANNEX I — GENERAL SAFETY AND PERFORMANCE REQUIREMENTS
- 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
- 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
- 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
- ANNEX XIII — PERFORMANCE EVALUATION, PERFORMANCE STUDIES AND POST-MARKET PERFORMANCE FOLLOW-UP
- ANNEX XIV — INTERVENTIONAL CLINICAL PERFORMANCE STUDIES AND CERTAIN OTHER PERFORMANCE STUDIES
- ANNEX XV — CORRELATION TABLE