The introduction of the European Database on Medical Devices (EUDAMED) marks a decisive milestone in the implementation of the MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation). As a central platform for information and data exchange, it is intended to significantly increase the transparency, safety, and traceability of medical devices on the European market.
What is changing?
Until now, usage has been voluntary—but the phased obligation for data entry is now beginning:
1. From January 2026: Mandatory use of the modules that are already functional, including:
- Registration of actors
- UDI/Device registration for devices newly placed on the market
2. From July 2026: Mandatory registration of all existing devices (Legacy Devices).
What does this mean for economic operators?
Manufacturers, Authorized Representatives, Importers, and Notified Bodies must effectively deposit, maintain, and keep up-to-date all relevant data in EUDAMED. Those who start too late risk delays in market launches or compliance violations.
Prepare now! The requirements affect not only labeling and UDI systems but, in particular, complex data management. Device data must be correct, complete, and up-to-date at all times to ensure unambiguous identification and seamless traceability throughout the entire product lifecycle.
Conclusion: Now is the right time to establish internal processes and prepare for the mandatory use of EUDAMED.
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