EUDAMED mandatory from 28 May 2026
8 May 2026
From 28 May 2026, four modules of the European Database on Medical Devices (EUDAMED) will become mandatory for the registration of medical devices.
The already published modules have been available on a voluntary basis. By Commission Implementing Decision (EU) 2025/2371 of 27 November 2025, four of the six modules were declared fully functional and will therefore have to be used.
Following the release of this decision, a six‑month transition period began, ending  on 28 May 2026 and applying to the following modules:
- Actor registration
- Unique Device Identification (UDI)/device registration
- Notified bodies and certificates
- Market surveillance
Until that date, the DMIDS (German Medical Devices Information and Database System) will continue to be used for registering medical devices. The mandatory use of the four EUDAMED modules, effective May 28, 2026, will have the following implications for the DMIDS product modules in Germany:Â
- May 28, 2026: Data entry deactivation for new products.
- After November 28, 2026, data entry deactivation for product changes and withdrawals.
- The product databases will be frozen as of November 28, 2026.
- They will subsequently be available as archival data for public search purposes.
Read more information in German at BfArm:Â
More information is available on the European Commission’s website. Please feel free to reach out to our expert team. They will be happy to answer with your questions.
