First four EUDAMED modules declared functional

On 27 November 2025, the EU published Commission Decision (EU) 2025/2371 in the EU Official Journal, declaring the first four modules of Eudamed (Actor, UDI/Device, Notified Bodies & Certificates and Market Surveillance) as functional. This marks the start of the different time periods before mandatory use of various elements that will start on 27 May 2026.

An updated overview of the timelines is available here. From this it appears that the timeline for the vigilance module has again been delayed and timeline for the clinical module remains unannounced, but is unlikely to be before late 2027.

The timelines for mandatory use of these first four modules are summarised below.

As a reminder, the Commission published a Q&A on the gradual roll-out of EUDAMED in November 2024, plus MDCG 2021-25 Rev. 1 was updated in October 2024, discussing the application of MDR requirements to ‘legacy’ devices.

There were also informational sessions on EUDAMED in 2025, in May (Stuttgart), October (Rome) and Brussels (December), at which several useful presentations and videos were made available.

Finally, for all EUDAMED related updates, the EUDAMED Information Centre website can be accessed from here.