EUDAMED Device Registration Transition Period Ends
November 28
Use of the EUDAMED Actor and UDI/Device modules is now mandatory for all devices on the market.
Background:
- The use of the above four modules was published in the Official Journal of the EU (OJEU) on November 26, 2025.
- As of May 28, 2026 the implementing act formally went into force. After this date, any device new to the European market must have been registered in the UDI/Device module prior to marketing. And any certificates issued on or after today must have been uploaded immediately into the Notified Body/Certificates module. Devices already on the market before this date had a transition period.
- As of November 28, 2026 the transition period for the UDI/Device module ended. All devices that were on the European market before May 28, 2026 must have been registered in EUDAMED by this date. If not, the device is out of MDR / IVDR compliance.
- Notified Bodies have a further transtion period, until May 28, 2027 to upload all certificates into the Notified Body/Certificates module.
For more detail, please read: EUDAMED Officially Published Today