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Use of EUDAMED Published in OJEU Today
26 November 2025
The use of the EUDAMED 1) Actor, 2) UDI/Device, 3) Notified Bodies/Certificates, and 4) Market Surveillance modules was published in the Official Journal of the EU (OJEU) on November 26, 2025.
- In six months from today (28 MAY 2026): the implementing act formally comes into force. All Actors must be registered in EUDAMED by this date. Actors requiring registration in EUDAMED are Manufacturers, System/Procedure Pack Producers, Importers, and Authorized Representatives. Further, any device new to the European market must be registered in the UDI/Device module prior to marketing. And any certificates issued on or after today must be uploaded (by the Notified Body) into the Notified Body/Certificates module. Devices already on the market before this date will have a transition period.
- In 12 months from today (28 NOVEMBER 2026): The transition period for the UDI/Device module ends. All devices that were on the European market before 28 MAY 2026 must be registered in EUDAMED by this date. If not, the device will be out of MDR / IVDR compliance.
- In 18 months from today (28 MAY 2027): The transition period for the Notified Bodies/Certificates module ends. Notified Bodies must upload all certificates by this date.
For more detail, please read: EUDAMED Officially Published Today