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Medical Device Regulation (MDR) booklet including M5

Get a concise overview of the EU Medical Device Regulation (MDR), including the latest Amendment M5. Our MDR booklet helps manufacturers, quality managers, and other stakeholders efficiently understand and implement regulatory requirements.

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TÜV NORD MDR Booklet M5

Contents of the MDR booklet including M5

The MDR booklet contains the consolidated version of Regulation (EU) 2017/745 on medical devices (Medical Device Regulation – MDR), which has been mandatory since 26 May 2021. The MDR replaces both the Medical Devices Directive 93/42/EEC (MDD) and the AIMDD 90/385/EEC.

This version includes all amendments up to and including Regulation (EU) 2024/1860 of the European Parliament and of the Council of 13 June 2024.

The booklet provides companies with a clear and well-structured foundation to ensure regulatory compliance.

Additionally, it includes:

  • TÜV NORD diagrams on the conformity assessment procedure
  • A sampling plan for technical documentation
  • Practical guidance for organizations affected by the MDR
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Who is the MDR booklet suitable for?

The MDR booklet is intended for anyone dealing with the EU Medical Device Regulation. It is particularly beneficial for medical device manufacturers, quality managers, consultants, and healthcare professionals.

What exactly changes with M5 amendment?

Regulation (EU) 2024/1860 introduces important updates to the MDR and IVDR. M5 is specifically aimed at strengthening supply security and accelerating the implementation of EUDAMED. The key changes are:

1. New reporting obligation for supply interruptions / end of supply

Starting January 10, 2025, manufacturers must report if the supply of a product is interrupted or discontinued and this could affect patient care or public health. Reports are to be submitted to national authorities and, if applicable, to affected healthcare institutions.

2. Gradual implementation of the EUDAMED modules

The EUDAMED database will be activated gradually as individual modules are completed. Manufacturers must register their data once the respective module becomes available. The first mandatory modules could be introduced from the end of 2025.

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