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ISO 13485
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Full text of EU MDR (Medical Device Regulation)
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 4
Chapter 4 –
Notified bodies
Article 35
–
Authorities responsible for notified bodies
Article 36
–
Requirements relating to notified bodies
Article 37
–
Subsidiaries and subcontracting
Article 38
–
Application by conformity assessment bodies for designation
Article 39
–
Assessment of the application
Article 40
–
Nomination of experts for joint assessment of applications for notification
Article 41
–
Language requirements
Article 42
–
Designation and notification procedure
Article 43
–
Identification number and list of notified bodies
Article 44
–
Monitoring and re-assessment of notified bodies
Article 45
–
Review of notified body assessment of technical documentation and clinical evaluation documentation
Article 46
–
Changes to designations and notifications
Article 47
–
Challenge to the competence of notified bodies
Article 48
–
Peer review and exchange of experience between authorities responsible for notified bodies
Article 49
–
Coordination of notified bodies
Article 50
–
List of standard fees
« Contents of EU MDR
Article 35 – Authorities... »
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