European Database on Medical Devices

European Database on Medical Devices

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European Database on Medical Devices
European Database on Medical Devices
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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).

Time Line

To stay up-to-date with EUDAMED development and timelines, please check the dedicated European Commission webpage.

The use of the EUDAMED certificate module by Notified Bodies becomes mandatory at the end of the transition period once EUDAMED is declared to be functional via the publication of a Commission notice in the OJEU. Notified Bodies will be required to submit information related to applications, certificates and their changes, PSUR evaluation reports, SS(C)Ps etc. Notified Bodies may choose to submit this information ahead of the mandated deadline as modules of EUDAMED become available for voluntary use.

We have updated some of our operating processes/procedures to remain compliant and to interact with EUDAMED, and we would like to share these changes with you.

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