Europe – European Commission issues new guidance on Eudamed medical device database nomenclature

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…