Jan 21, 2020
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:
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.
EMERGO SUMMARY OF KEY POINTS:
EMERGO BY UL SUMMARY OF KEY POINTS: