In brief
On 24 January 2022, the Decree of the Ministry of Health dated 10 November 2021 updating the National Classification of Medical Devices (NCD) was published in the Italian Official Gazette.
The update of the NCD, which groups medical devices into homogeneous categories of products intended to perform a similar diagnostic and/or therapeutic intervention, was justified by the need to include new technologies made available on the market, improve the description of individual classes of medical devices and ensure their adequacy, in accordance with the annual review process sets forth by the legislation establishing the CND.
Said update, which does not amend the original structure of the CND, resulted in (i) the introduction of 1600 new levels, representing internal branches within each Category, Group, or Type, based on the degree of details; (ii) the removal of 130 existing levels; and (iii) the modification of the description of 1700 levels.
The updated CND is available in the National Database on Medical Devices starting from 23 February 2022.
