Europe
The European Commission has confirmed the full functionality of the first four modules of EUDAMED, the EU database for medical devices.
Starting May 28, 2026, the use of these modules becomes mandatory:
- Actors: Registration of economic operators.
- UDI/Devices: Registration of devices, excluding custom-made devices.
- Notified Bodies and Certificates: Registration of notified bodies and certificates.
- Market Surveillance: Coordination of market surveillance activities among authorities.
The remaining modules—Vigilance and Clinical Investigations and Performance Studies—will be implemented later.
Source: EUDAMED: details of obligations from 28 May 2026 | FAMHP