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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
Annexes
Annexes
Annex 1
–
General safety and performance requirements
Annex 2
–
Technical documentation
Annex 3
–
Technical documentation on post-market surveillance
Annex 4
–
EU declaration of conformity
Annex 5
–
CE marking of conformity
Annex 6
–
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
Annex 7
–
Requirements to be met by notified bodies
Annex 8
–
Classification rules
Annex 9
–
Conformity assessment based on a quality management system and assessment of the technical documentation
Annex 10
–
Conformity assessment based on type examination
Annex 11
–
Conformity assessment based on product conformity verification
Annex 12
–
Certificates issued by a notified body
Annex 13
–
Procedure for custom-made devices
Annex 14
–
Clinical evaluation and post-market clinical follow-up
Annex 15
–
Clinical investigations
Annex 16
–
List of groups of products without an intended medical purpose referred to in Article 1(2)
Annex 17
–
Correlation table
« Contents of EU MDR
Annex 1 – General safety... »
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