On 27 November 2025, the Official Journal of the EU released Commission Decision (EU) 2025/2371. With this announcement, ‘Actors’, ‘UDI and devices’, ‘Notified bodies and certificates’, and ‘Market surveillance’ modules become officially functional and mandatory in six months, on 28 May 2026.
EUDAMED registration becomes mandatory
EUDAMED registration becomes mandatory on 28 May 2026 for all actors and for all devices placed on the Union market as of 28 May 2026.
- All actors shall be registered by 28 May 2026. These include manufacturers, authorised representative, importers, system and procedure pack producers, and sponsors.
- For devices placed on the market before 28 May 2026 and that will continue being placed on the market as of 28 May 2026, EUDAMED becomes mandatory on 28 November 2026.
Manufacturers of custom-made devices have to register as actors only when manufacturing Class III implantable medical devices in order to allow the notified body to register the corresponding certificate. Additionally, all manufacturers of custom-made devices have to register as actors only when they need to submit information about vigilance or PMS-related activities.
Next steps: EUDAMED registrations
As first step, manufacturers of medical devices and IVDs must register as actors. When based outside of the Union market, the European authorised representative verifies the registration. Once registered as as actor, the manufacturer can proceed with the device registrations.
Registration of legacy devices
When the equivalent of a legacy device becomes a compliant Regulation, a new Regulation Device shall be registered in EUDAMED. EUDAMED will allow linking of the Regulation Device with the Legacy Device and perform this linking automatically where the same UDI-DI has been assigned to both the Legacy Device and the Regulation Device.
Some tools to support manufacturers with the actor and devices registrations include:
- Gradual roll out of EUDAMED
- Infographic: Actor roles and Actor ID/SRN
- Infographic: Actor registration request process
- Infographic – Legacy device identifiers
- EUDAMED Information Centre, which includes all relevant user guides
Do you have any questions on EUDAMED? Contact us here or at mdlaw@obelis.net.
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