Mandatory use of the first four modules of EUDAMED New
The BASG has announced that the first four modules of the European Database on Medical Devices (EUDAMED) will be mandatory to use as from 28 May 2026.
This applies to the following modules:
- Actor registration
- UDI/Devices registration
- Notified Bodies & Certificates
- Market Surveillance (for competent authority use only)
A press release from the Directorate-General for Health and Food Safety of the European Commission was published on 27 November 2025:
“The Commission Decision (EU) 2025/2371 of 26 November 2025 on the notice regarding the functionality and the fulfilment of the functional specifications of certain electronic systems included in the European Database on Medical Devices declaring the functionality of the first four modules has been published in the Official Journal of the European Union (OJEU) of 27 November 2025.
In accordance with the transitional provisions set out in Regulation (EU) 2024/1860, this publication triggers a transition period of 6 months.”
Additional information on the phased implementation can be found in the Q&A on practical aspects related to the implementation of the gradual roll-out of Eudamed
