The introduction of the European Database on Medical Devices (EUDAMED) is a crucial milestone for the implementation of the MDR (EU Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation). As a central platform for the exchange of information and data, it is intended to significantly increase transparency, safety, and traceability of medical devices in the European market.
What is changing?
The use of the individual modules will become mandatory in stages. Yesterday, the Commission confirmed the full functionality of the first four modules in the Official Journal of the European Union (OJEU), marking the beginning of a 6-month transition period followed by an obligation to use the system. Consequently, the mandatory use of the modules "Actor Registration," "UDI/Device Registration," "Notified Bodies & Certificates," and "Market Surveillance" will commence in six months.
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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