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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 2
Chapter 2 –
Making available on the market and putting into service of devices, obligations of economic operators, reprocessing, 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
–
Single-use devices and their reprocessing
Article 18
–
Implant card and information to be supplied to the patient with an implanted device
Article 19
–
EU declaration of conformity
Article 20
–
CE marking of conformity
Article 21
–
Devices for special purposes
Article 22
–
Systems and procedure packs
Article 23
–
Parts and components
Article 24
–
Free movement
« Contents of EU MDR
Article 5 – Placing on t... »
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