From 28 May 2026, the use of the first modules of EUDAMED, the European database on medical devices, has become mandatory.
The following modules are concerned.
- Actors: for the registration of economic operators.
- UDI/Devices: for the registration of devices, with the exception of custom-made devices.
- Notified Bodies and Certificates: for the registration of certificates.
The “Vigilance” and “Clinical Investigations and Performance Studies” modules will become applicable at a later stage.
Obligations applicable from 28 May 2026
- Module “actors”
From 28 May 2026 onwards, all manufacturers, authorised representatives, importers and producers of systems and procedure packs must be registered in the ‘Actors’ module of EUDAMED. - Module “UDI/devices”
An additional six-month period (from 28 May 2026 to 27 November 2026) is provided for the registration of devices in order to allow manufacturers to register all their relevant devices. This transitional period applies only to medical devices and in vitro diagnostic medical devices placed on the market before 28 May 2026.
Devices placed on the market from 28 May 2026 onwards must, however, be registered in EUDAMED before being placed on the market.
From 28 May 2026
From 28 May 2026, the notification to the FAMHP of the placing on the market of Class I medical devices and in vitro diagnostic medical devices is no longer applicable. The relevant obligations are now fulfilled through registration in EUDAMED.
More information
EUDAMED page on the FAMHP website
Access to EUDAMED