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Medical Device Regulation (MDR) booklet

This booklet offers a full overview of the EU Medical Device Regulation (MDR) and includes the latest M5 amendment.

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MDR booklet

What are the contents of the booklet?

The Regulation (EU) 2017/745 on medical devices (Medical Device Regulation – MDR) has been mandatory since May 26, 2021 and forms the main content of this booklet. Additionally, the booklet includes: 

  • a sampling plan for technical documentation
  • practical guidance for organizations
  • TÜV NORD diagrams illustrating the conformity assessment procedure.

Target audience for the MDR booklet

This booklet is particularly suitable for medical device manufacturers and healthcare professionals: In short, for anyone working with or affected by the MDR.

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