23 Jan European Commission issues new guidance on nomenclature for Eudamed medical device database

Eudamed, the forthcoming medical device information database developed by the European Commission, already has a guide to clarify the nomenclature-related requirements to be met by manufacturers.

The guide consists of two documents:

A document covering the European Medical Device Nomenclature (EMDN), to be used by manufacturers once Eudamed is fully online.

This document is accompanied by a separate guide providing information on the nomenclature used in Italy’s Classificazone Nazionale dei Dispositivi Medici (CND), which will be used as the basis for the EMDN, as reported by the European Commission.

The CND nomenclature will be mapped to the Global Medical Device Nomenclature (GMDN) codes and thus meet the requirements set out in the Medical Devices Directive (MDR) and the In Vitro Medical Devices Directive (IVDR), as well as to an international medical device nomenclature scheme under development by the World Health Organisation (WHO).

The EC nomenclature clarifications come two years before the planned launch of Eudamed for medical devices and IVDs, scheduled for May 2022.

Source: https://ec.europa.eu/docsroom/documents/39009?locale=en