EUDAMED: As of May 28, 2026, the first four modules will become mandatory
With Decision No. 2371 of November 26, 2025, the European Commission confirmed the functionality of the first four modules of EUDAMED, the European database on medical devices.
The publication marks the start of a six-month transition period. This means that, as of May 28, 2026, the first four EUDAMED modules will be mandatory to use:
- Actor Registration;
- UDI/Devices registration;
- Notified Bodies & Certificates;
- Market Surveillance.
The decision represents a crucial moment for the full operation of the medical device traceability and surveillance system in the EU, with significant compliance implications for the entire supply chain.
Now, companies must:
- Verify the registration of all economic operators in the supply chain;
- Prepare UDI data for device registration according to class timelines;
- Update technical documentation to ensure compliance with EUDAMED requirements;
- Implement procedures for managing post-market surveillance information.
For more information, please see the decision of the European Commission, available at this link: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202502371
Tag:
Medical Devices
