EUDAMED implementation deadlines Commission Decision (EU) 2025/2371
In November 2025, the European Commission adopted Commission Decision (EU) 2025/2371, confirming that four EUDAMED modules are fully functional. This makes the MDR implementation deadlines legally binding. For medical device manufacturers, this means EUDAMED is no longer a preparatory exercise, but a concrete compliance requirement with fixed deadlines.
From 2026, the following EUDAMED modules will be mandatory:
- Actor Registration (SRN)
- UDI / Device Registration
- Notified Bodies & Certificates
- Market Surveillance
The Vigilance/PMS and Clinical Investigations modules are not yet included.
Key deadlines
- 28 May 2026 – Mandatory use of the four EUDAMED modules
- 28 November 2026 – UDI/device registration completed for devices already on the market
- 28 May 2027 – Registration of existing MDR/IVDR certificates by notified bodies
Start on time with:
• an EUDAMED gap analysis
• validation of UDI and device data before registration
This helps avoid last-minute corrections and audit discussions.