Essentials of European Medical Device Regulatory Affairs

MDR 177 pages

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

47

MDR Annexes

48