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Joint open letter: In anticipation of EUDAMED availability for mandatory use

Posted on 01.02.2024

The MDR and IVDR amendment proposal, adopted by the European Commission on 23 January 2024, would allow earlier mandatory use of individual modules of the of European medical devices database ‘EUDAMED’ ahead of the timelines currently published. Modules that are audited and declared functional can be gradually implemented as early as end of 2025.

In December 2023, MedTech Europe and five EU industry associations signed a joint open letter highlighting important preconditions that are needed before any EUDAMED modules would be made mandatory for use.

  1. The modules are fully developed, tested, audited and ready for practical implementation.
  2. EUDAMED enables the most efficient use of Notified Body and Manufacturer resources.
  3. Realistic and reliable implementation and transition timelines are provided.
  4. Redundancy in National Databases is eliminated.

Publicly available information for patients and healthcare professionals on medical devices is foreseen to be fully populated after the proposal will be adopted.

For more information, please contact Katalin Máté, Senior Expert In Vitro Diagnostics.