On January 24, 2022, the Italian Official Journal published the Decree aiming to amend and update the Medical Device National Classification (CND). The CND groups the various types of medical devices and IVD medical devices into different categories.
Adaptation of the classification system
This major update was launched to adapt the classification system, which is jointly used as the European Medical Device Nomenclature (EMDN) as per Medical Device Regulation (MDR) and In Vitro Diagnostics Medical Device Regulation (IVDR), to include new technologies in the classification and improve the description of existing classes.
What is new?
In particular, the new 2021 version includes additional 1,600 new levels – 173 of which belong to the Medical Device Software class characterized by the suffix 92. Moreover, the update also led to the removal of 130 levels, and the modification of description of 1,700 existing entries.
Specifically, the revised Medical Device National Classification has been available since February 23, 2022. Indeed, the Italian Ministry of Health is asking manufacturers to verify the classification level within the system to ensure MDR- and IVDR-compliant devices are up-to-date with the latest version.
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References:
Ministero della Salute. (2022). Dispositivi medici, aggiornamento della Classificazione nazionale. Retrieved on 24 May 2022 from: https://www.salute.gov.it/portale/news/p3_2_1_1_1.jsp?lingua=italiano&menu=notizie&p=dalministero&id=5777
Ministero della Salute. (2022). Decreto 10 novembre 2021. Modifiche ed aggiornamenti alla classificazione nazionale dei dispositivi medici (CND), di cui al decreto 20 febbraio 2007. (22A00461). Retrieved on 24 May 2022 from: https://www.trovanorme.salute.gov.it/norme/dettaglioAtto?id=85314
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