EU: First Four EUDAMED Modules Mandatory from 28 May 2026
With Commission Decision (EU) 2025/2371, the European Commission has formally declared that the first four EUDAMED modules meet the required functional specifications. Publication in the OJEU on 27 November 2025 activates the six-month transition period foreseen in Regulation (EU) 2024/1860.
As a result, the following EUDAMED modules will become mandatory as of 28 May 2026:
- Actor Registration
- UDI / Device Registration
- Notified Bodies & Certificates
- Market Surveillance
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