Essentials of European Medical Device Regulatory Affairs - October 2019

MDR

Articles

Chapter

101 Recitals

I

1‐4

Scope and definitions

II

5‐24

Making available on the market and putting into service of device,  obligations of economic operators, reprocessing, CE marking and free  movement Identification and traceability of devices, registration of devices and of  economic operators, summary of safety and clinical performance,  European data base on medical devices.

25‐34

III

35‐50 51‐60 61‐82

IV

Notified bodies

V

Classification and conformity assessment

VI

Clinical evaluation and clinical investigation

83‐100 101‐108 109‐113 114‐123

VII

Postmarket surveillance vigilance and market surveillance

VIII

Cooperation between member states, medical device coordination group,  expert laboratories, expert panels and device registers

IX

Confidentiality, data protection, funding and penalties

X

Final provisions

43

MDR Annexes

Annex I

General safety and performance requirements  (GSPR) Technical documentation requirements Technical documentation on post market  surveillance (PMS)

Annex II  Annex III 

Annex IV  Annex V Annex VI  Annex VII  Annex VIII 

Declaration of conformity (DOC)

The CE Mark

Registration requirements and UDI

Notified Body requirements

Classification rules

44