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EUDAMED

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Updated:

Changes

  • : Updated with mandatory use, as well as updated structure
  • : Added information statating that EUDAMED will be mandatory from May 28, 2026.

The European Database on Medical Devices (EUDAMED) is one of the key aspects of the new regulations for medical devices.

What is EUDAMED?

EUDAMED will provide an overview of the lifecycle of medical devices available on the market in the EU. The purpose is to increase transparency, including providing better access to information for the general public and healthcare professionals, as well as improving collaboration between different EU countries.

EUDAMED will consist of the following six modules:

  1. Actor Registration
  2. Product Registration and Unique Device Identification (UDI)
  3. Notified Bodies and Certificates
  4. Clinical Trials and Performance Studies
  5. Post-Market Surveillance
  6. Market Surveillance

EUDAMED - Public

EUDAMED - For actors

When will Eudamed become mandatory?

"Eudamed is being launched gradually, and the first four modules for the registration of actors, devices, and certificates, as well as the market surveillance module, are already mandatory to use.

The vigilance module will be the next module to become mandatory after this, but no date has yet been set for its mandatory use. Preliminary information indicates that it will be implemented in the second or third quarter of 2027.

As for the module for clinical trials and performance studies, we currently do not know when it will be ready.

The introduction of Eudamed requires extensive preparations. For more information about the progress of the project and how you, as an actor, can prepare, please refer to the EUDAMED Information Center.

NoMA will provide updates as further information becomes available.