On November 26, 2025, the EU Commission published its decision on the mandatory use of the following EUDAMED modules:
- Registration of economic operators
- UDI database and device registration
- Systems for notified bodies and certificates
- System for market surveillance
An independent audit confirmed in advance that the modules named are fully functional.
This started the six-month transition period up to mandatory use under the MDR/IVDR from May 28, 2026.
Read the EU Commission’s announcement here: The EUDAMED four first modules will be mandatory to use as from 28 May 2026