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

Brussels, 18 December 2023 – Several Ministers of Health called for early mandatory availability of the European Medical Devices Database (EUDAMED) at the Employment, Social Policy, Health and Consumer Affairs Council meeting held on 30 November 2023.

The letter below, undersigned by six industry associations, including AESGP, highlights important preconditions that are needed before any modules of EUDAMED would be made mandatory:

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

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