Starting today, the first four modules of EUDAMED, the European Database on Medical Devices, become mandatory for all relevant economic operators and competent authorities across the EU.
This milestone was set in motion by Commission Decision (EU) 2025/2371 of 26 November 2025, which declared the functionality of the first four modules and triggered a six-month transition period under Regulation (EU) 2024/1860. That window closes today.
The four modules now subject to mandatory use are:
- Actor Registration — all manufacturers, authorized representatives, importers, and other relevant actors must be registered
- UDI/Device Registration — unique device identifiers and device data must be submitted and maintained
- Notified Bodies and Certificates — certificates issued by notified bodies are now tracked through the system
- Market Surveillance — national authorities use this module to coordinate and record surveillance activities
For manufacturers and other stakeholders who have been operating in voluntary mode or relying on transitional arrangements, today marks a hard deadline. Non-compliance is no longer a grey area.
If your organization has not yet completed registration or ensured your device data is up to date in EUDAMED, this is the moment to prioritize it. The remaining modules, covering post-market surveillance and vigilance, are expected to follow on a separate timeline once their functionality is formally declared.