Start of the transition period: EUDAMED use becomes mandatory
Update Health Care & Life Sciences 11/2025
With Commission Decision (EU) 2025/2371 of 27 November 2025 (“Decision”), the European Commission initiates the six‑month transition period for the mandatory use of the first four EUDAMED modules. In order to ensure readiness for EUDAMED by the effective date of 28 May 2026, concerned economic operators should already undertake the necessary registrations in EUDAMED.
EUDAMED is the central European database for medical devices and in vitro diagnostic medical devices. It collects the essential information on medical devices pursuant to Regulation (EU) 2017/745 (“MDR”) as well as on in vitro diagnostic medical devices pursuant to Regulation (EU) 2017/746 (“IVDR”). As EUDAMED has not yet been fully operational, mandatory use was suspended until the formal confirmation of its functionality. In the meantime, the corresponding registration obligations were largely fulfilled via national registers.
With the Decision, the European Commission now confirms the functionality of the following modules:
- Electronic system on registration of manufacturers, authorised representatives and importers
- UDI database and electronic system for the registration of devices
- Electronic system on Notified Bodies and certificates of conformity
- Electronic system on market surveillance
With this confirmation, a six‑month transition period for the mandatory use of the respective modules is initiated. The concerned modules must be used mandatorily by 28 May 2026.
For the modules on clinical investigations and performance studies as well as vigilance and post‑market surveillance, the confirmation of functionality is still outstanding. Their use is therefore not yet mandatory. Instead, depending on applicability, national registers may be used.
