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In Vitro Diagnostic Medical Devices Regulation

Regulation (EU) 2017/746 on in vitro diagnostic medical devices
32017R0746 · official text on EUR-Lex

Articles

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