Eudamed actor: 59 Photos
FAQs
Per the EU Commission's document: “An actor is a natural or legal person (organisation) with a specific role that has to be registered in EUDAMED.” Actors include the Economic Operators discussed above. However, Actors also include Supervising Entities.
the European database for medical devices. EUDAMED is the European database for medical devices. It's a secure, web-based portal that acts as a central hive for the exchange of information between national competent authorities and the European Commission.);})();(function(){window.jsl.dh(LLXFZqXUBr3bkPIP6JfpMQ__24,
The implementation of EUDAMED in the context of the MDR has been delayed, with the new go-live date expected in Q2 2024. Mandatory use of the database will begin in Q4 2024 for actors registration, clinical investigations, performance studies, vigilance and post-market surveillance.
The new target date for EUDAMED full functionality is Q2 2027 (best case scenario). Once it is declared fully functional, this triggers transition periods until the mandatory use of its modules, now foreseen as being:
EUDAMED supports the transparency and traceability of medical devices, which is vital for ensuring public health and safety. The full EUDAMED system integrates six modules: Actor registration. Unique device identification (UDI) and device registration.