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Full text of EU MDR (Medical Device Regulation)
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EU MDR Table of Contents
Chapter 1 (Art. 1 – 4)
Scope and definitions
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
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
Chapter 4 (Art. 35 – 50)
Notified bodies
Chapter 5 (Art. 51 – 60)
Classification and conformity assessment
Section 1 (Art. 51)
Classification
Section 2 (Art. 52 – 60)
Conformity assessment
Chapter 6 (Art. 61 – 82)
Clinical evaluation and clinical investigations
Chapter 7 (Art. 83 – 100)
Post-market surveillance, vigilance and market surveillance
Section 1 (Art. 83 – 86)
Post-market surveillance
Section 2 (Art. 87 – 92)
Vigilance
Section 3 (Art. 93 – 100)
Market surveillance
Chapter 8 (Art. 101 – 108)
Cooperation between member states, medical device coordination group, expert laboratories, expert panels and device registers
Chapter 9 (Art. 109 – 113)
Confidentiality, data protection, funding and penalties
Chapter 10 (Art. 114 – 123)
Final provisions
(Anx. 1 – 17)
Annexes
Source EUR-Lex:
https://eur-lex.europa.eu/
EU MDR
Chapter 6
Chapter 6 –
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
« Contents of EU MDR
Article 61 – Clinical ev... »
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