EUDAMED has recently introduced new features to their system. The database is regularly subject to improvements and updates. In the latest release, EUDAMED has several new features. As of October 2025, some additions relevant for manufacturers of medical devices and IVDs and their EAR concern the new functions in the actor and UDI modules.
Actor module new functions
The main new addition to the Actor module concerns the possibility to change the VAT/EORI and or NTR (national trade register number). Once the actor submits the change request, the relevant Competent Authority will evaluate it and eventually updated. If the actor did not enter value for these fields, they can provide them via a new actor version.
UDI/Devices Module: notification to EAR
While until recently the authorised representative received a notification only for the actor registration, the EAR will not be informed when a the manufacturer submits or registers a new Basic UDI.
When is EUDAMED going to become mandatory?
EUDAMED will become mandatory six months after the functionality note of the modules. As of 16 October 2025, the Official Journal of the EU has not yet released the functionality note. However, stakeholders can expect the functionality note to be published very soon.
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.
Leave a Reply