Search results with tag "Eudamed"
ACTOR MODULE FAQs - European Commission
ec.europa.euEUDAMED will normally trigger a duplicate warning for first the requester and next for the potential AR verifier and CA assessor. The CA will have to look into these requests as they might contain differences on different fields not shown in the list. EUDAMED does not perform any assessment, The CA is
Guide to Using EUDAMED - European Commission
ec.europa.eu2 – REQUEST ACCESS AS A USER OF A REGISTERED ECONOMIC OPERATOR If your organisation is already registered as an actor in EUDAMED, you can request access as a user of that actor. Once one of the administrators in your actor (an LAA or LUA) has approved your request, your account will be granted the required user profile for that actor.
Global Medical Device Nomenclature (GMDN)
www.who.intGlobal acceptance? GHTF (now IMDRF) proposes GMDN for UDI EC proposes GMDN for the EUDAMED (market surveillance database) EUCOMED supports the use of GMDN in meeting the needs of European manufacturers EC has translated the GMDN into 20 languages WHO & MSF use GMDN in guidance for developing countries