The European Commission has announced an important milestone in the implementation of EUDAMED, the European Database on Medical Devices.
Following the publication of Commission Decision (EU) 2025/2371 in the Official Journal of the European Union on 27 November 2025, the functionality of the first four EUDAMED modules has been formally declared. In line with the transitional provisions under Regulation (EU) 2024/1860, this publication triggers a six-month transition period.
As a result, from 28 May 2026, the use of the following EUDAMED modules will become mandatory:
- Actor registration
- UDI/Devices registration
- Notified Bodies & Certificates
- Market Surveillance
This development represents a major step toward strengthening transparency, traceability, regulatory oversight, and post-market monitoring across the European medical device sector.
Stakeholders, including manufacturers, notified bodies, competent authorities, and other actors involved in the medical device regulatory framework, are encouraged to prepare for the mandatory use of these modules ahead of the implementation date.
Read more via the European Commission announcement: https://health.ec.europa.eu/latest-updates/eudamed-four-first-modules-will-be-mandatory-use-28-may-2026-2025-11-27_en
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