This summer, the European Commission was expected to announce the functionality of five EUDAMED modules. With this announcement, Actor, UDI/Devices, notified body/certificates as well as market surveillance modules would have become mandatory six months afterwards, approximately by beginning of 2026. However, as of August 2025 no functionality notice was published and EUDAMED timeline was updated consequently.
EUDAMED timeline under revision
The latest EUDAMED timeline published by the European Commission – dated July 2025 – shows that the functionality note of five EUDAMED modules could come by end of September 2025. Nonetheless, it is important to stress out that this timeline is under revision and does not give precise or confirmed dates.
md_eudamed_roadmap_en(European Commission, 2025)
When can stakeholders expect EUDAMED to be mandatory?
As of August 2025, EUDAMED is not yet mandatory. EUDAMED will become mandatory six months after the functionality note of the modules. For instance, if the notice confirming the functionality of the device module is published on 1 October 2025, then the device registration obligation applies from 1 April 2026. In addition, last year EUDAMED Q&A clarifies that in case individual units/single products placed on the market before 1 April 2026 and other individual units/single products will also be placed on the market after that date, the device will have to be registered by 1 October 2026.
“Legacy devices” and “full MDR/IVDR compliant devices” – where individual (sales) unit are no longer placed on the market when the use of the device module becomes mandatory – do not need to be registered, unless a Post Market Surveillance and Vigilance (PMSV) action occurs.
When the placing on the market is done before the date of mandatory use and the device will still be place on the market after that date, manufacturers have 12 months to register their devices starting from the functionality note publication.
To never miss an update, check our MDlaw membership options. For any questions on EUDAMED or compliance of medical devices, contact MDlaw Team here or at mdlaw@obelis.net.
References:
European Commission (2025). EUDAMED – Overview. Retrieved on 26/08/2025.
European Commission (2024). Q&A gradual roll-out of EUDAMED. Retrieved on 26/08/2025.
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