MDCG: MDR Transitional regime

The MDCG published on Friday a guidance document, where it further clarified Article 120 (2), (3) of the MDR – Transitional provisions.

These provisions allow under certain conditions to place a device on the market after the MDR application date with a Certificate, issued under the ''old'' Directives, to remain valid until 27 May 2024 at the latest.

Among the requirements to benefit from the transitional regime, it is required that ''the notified body that issued the certificate – under a valid designation – continues to be responsible for the . . .