As known, the Medical Device Regulation was enacted on publication in the OJLA Issue31499 of 02 June 2021. This Regulation imposes a change in various device classification rules, involving the redefinition of risk categorisations made for certain medical devices.

At the present, the Regulation requires a change of classification for devices which have been placed on the market based on conformity assessments directly held by their manufacturers without mediation or involvement of a notified body, and, which will have to be submitted to notified bodies due to the mentioned change in categorisation of risks.