The introduction of the European Database for Medical Devices (EUDAMED) is a key milestone in the implementation of the MDR (EU Medical Device Regulation) and IVDR (in vitro diagnostics). As a central platform for the exchange of information and data, it is intended to significantly increase the transparency, safety and traceability of medical devices on the European market
What is changing?
The use of the individual modules will gradually become mandatory.
Yesterday, the Commission confirmed the functionality of the first four modules in the Official Journal of the EU (OJEU), and a transitional period of 6 months will now begin with a subsequent obligation to use them. The mandatory use of the modules “Actor Registration”, “UDI/Device Registration”, “Notified Bodies & Certificates” and “Market Surveillance” will start in six months.
What does this mean for economic players?
In future, manufacturers, authorized representatives, importers and notified bodies must store and maintain all relevant data in EUDAMED and keep it up to date. If you start too late, you risk delays in the market launch or compliance violations.
Prepare now!
The requirements relate not only to coding and UDI systems, but also to complex data management in particular:
Product data must be correct, complete and up-to-date at all times – for clear identifiability and seamless traceability throughout the entire product life cycle.
Conclusion: Now is the right time to set up internal processes and prepare for the mandatory use of EUDAMED.
