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

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 MDR preparation and resource center
• On-site MDR training for medical device manufacturers
• European CE Mark consulting for IVD device manufacturers
• Webinar: Eudamed requirements under the MDR and IVDR

Related services for Europe:

• CE Mark Certification for Medical Devices
• Clinical Evaluation Reports (CER) for Medical Devices in Europe
• EU IVDR Gap Assessment and CE Transition for IVD Companies
• EU MDR compliance consulting for cosmetic and aesthetic products
• EU Medical Device Vigilance Reporting in Europe
• EU Post-Market Clinical Follow-up Studies (PMCF) for Medical Devices
• European Authorized Representative for Clinical Trials
• European Authorized Representative for Medical Device Companies
• European MDR 2017/745 Gap Assessment and CE Transition Strategy
• European Union Medical Device Classification
• In Vitro Diagnostics Regulation (EU IVDR) On-Site Training
• IVD Certification and Registration to Obtain CE Marking in Europe
• Medical Device and IVD Emergency Use Routes in Europe
• Medical Device Technical File and Design Dossier for EU CE Marking
• Switzerland Representative for Medical Device Companies
• UKRP and Brexit consulting for medical device companies