Medical devices nomenclature in Eudamed

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Medical devices nomenclature in Eudamed

The Italian Ministry of Health, during the presentation of the new Governance of Medical Devices, has communicated that the European Medical Device Coordination Group (MDCG) has decided to use the system “Classificazione Nazionale dei Dispositivi medici” (CND), currently in use on the Italian territory, as nomenclature for medical devices to be used in the European database of medical devices, Eudamed.

The decision of the MDCG was taken on the basis of the requirements of the medical device nomenclature described in Article 26 and Article 23 of the European Medical Device Regulation MDR 2017/745 and of the European Regulation of in vitro Diagnostic Medical Devices IVDR 2017/746, respectively. In the Regulations, in fact, it is reported that to facilitate the functioning of Eudamed, the Commission ensures that an internationally recognized medical devices nomenclature is available free of charge to manufacturers and other natural or legal persons required by the Regulations to use that nomenclature. For this reason, the choice of the nomenclature fell on the Italian classification system, which is available free of charge as opposed to the Global Medical Device Nomenclature (GMDN), currently used worldwide as a nomenclature tool, which requires registration fee for the access.

To meet the MDR and IVDR requirements, MDCG will map Italian CND (Classificazione Nazionale dei Dispositivi medici) codes to GMDN codes to facilitate use by manufacturers and other entities using Eudamed. The correspondence between the nomenclatures will be visible to operators and incorporated in the future database. This will allow all operators registering their device to find CND nomenclature equivalent to a GMDN code.

http://www.salute.gov.it/portale/news/p3_2_1_1_1.jsp?lingua=italiano&menu=notizie&p=dalministero&id=3681

https://ec.europa.eu/docsroom/documents/34264?locale=en