European Database on Medical Devices

European Database on Medical Devices

Red Overlay
European Database on Medical Devices
European Database on Medical Devices
Red Overlay

What is EUDAMED?

The European Database on Medical Devices (EUDAMED) is the IT system developed by the European Commission as an integral part of MDR and IVDR implementation. It aims to enhance transparency about medical devices, including better access to information for the public and healthcare professionals, and enhancing coordination among EU member states. The system will provide a living picture of the lifecycle of medical devices available in the European Union.

The system integrates six modules to collate and process information on medical devices and manufacturers:

  1. Actor registration
  2. Unique Device Identification (UDI) and device registration
  3. Notified Bodies and certificates
  4. Clinical investigations and performance studies
  5. Vigilance and post-market surveillance
  6. Market surveillance

There is the EU guidance on practices in the transition to fully availability of EUDAMED for MDR and IVDR (MDCG 2021-1, MDCG 2022-12).


Eudamed timeline





Stay up to date with the latest updates from BSI