January 21, 2021
The European Commission has clarified requirements pertaining to nomenclature medical device manufacturers will use to enter their product information into the forthcoming Eudamed database.
To this end, the EC has issued two recent guidance documents:
- One document covering the European Medical Device Nomenclature (EMDN), to be used by manufacturers once Eudamed goes fully online
- Another guidance provides background information on Italy’s Classificazone Nazionale dei Dispositivi Medici (CND) nomenclature, which as Emergo by UL previously reported will be used as the basis for the EMDN
European Commissioners plan to map CND nomenclature to Global Medical Device Nomenclature (GMDN) codes in order to fully meet requirements laid out in the Medical Devices Directive (MDR) and In-vitro Medical Devices Directive (IVDR), as well as to a planned international medical device nomenclature under development by the World Health Organization (WHO).
The EC nomenclature clarifications come two years ahead of the planned launch of Eudamed for both medical devices and IVDs, set for May 2022.
Learn more about Eudamed, MDR and IVDR compliance at Emergo by UL:
- European CE Mark consulting for IVD device manufacturers