Europe
As previously announced, as of 28 May 2026, the use of key modules of EUDAMED, the European database on medical devices, has become mandatory.
The following modules are now in scope:
- Actors (economic operator registration)
- UDI/Devices (device registration, excluding custom-made devices)
- Notified Bodies and Certificates (registration of certificates)
The Vigilance and Clinical Investigations / Performance Studies modules will follow at a later stage.
Key obligations:
- All manufacturers, authorised representatives, importers and producers of systems and procedure packs must be registered in the Actors module.
- Devices must be registered in the UDI/device module:
- Devices already placed on the market before 28 May 2026 must be registered by 27 November 2026.
- Devices placed on the market after 28 May 2026 must be registered in EUDAMED prior to market placement.
- National notification to the FAMHP for Class I medical devices and IVDs is no longer required; EUDAMED registration now fulfills this obligation.
For further information or support:
- EUDAMED registration: notifications.meddev@fagg-afmps.be
- MDR/IVDR questions: info.meddev@fagg-afmps.be
- EUDAMED page on the FAMHP website
- Access to EUDAMED