On 27 November 2025, the Official Journal of the EU released Commission Decision (EU) 2025/2371. With this announcement, ‘Actors’, ‘UDI and devices’, ‘Notified bodies and…
Swissdamed device registration module is now available
In August 2025, Swissmedic announced the new UDI Devices module in Swissdamed is live. The registration is voluntary and will become mandatory only in July…
European Commission publishes Q&A on EUDAMED roll-out
On 21 November 2024, the European Commission released a Q&A document on the application of Regulation (EU) 2024/1860, addressing the gradual roll-out of EUDAMED. Article…
EUDAMED delay announced!
The European Commission has officially announced a delay in the full implementation of the EUDAMED database. As mentioned in a previous post, this delay will…