Full text of EU MDR (Medical Device Regulation)

Here you can find the official text of the Regulation (EU) 2017/745 (Medical Device Regulation) arranged by chapters, sections, and articles. The Medical Device Regulation will become applicable in all member states on May 26, 2021 and applies to any company that manufactures, imports or distributes medical devices within those EU states. Read full MDR text below:

Chapter 1  –  Scope and definitions

Chapter 2  –  Making available on the market and putting into service of devices, obligations of economic operators, reprocessing, CE marking, free movement

Chapter 3  –  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  –  Notified bodies

Chapter 5  –  Classification and conformity assessment

Chapter 6  –  Clinical evaluation and clinical investigations

Chapter 7  –  Post-market surveillance, vigilance and market surveillance

Chapter 8  –  Cooperation between member states, medical device coordination group, expert laboratories, expert panels and device registers

Chapter 9  –  Confidentiality, data protection, funding and penalties

Chapter 10  –  Final provisions

Annexes

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