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 appropriate surveillance activities with respect to all of the applicable requirements related to the devices it has certified and that it has the possibility to take any necessary measure in relation to those.”

In this respect, the MDCG stated that ‘’it needs to be ensured that Authorities responsible for notified bodies have the right to and do monitor those notified body’s activities to the extent appropriate and necessary’’.

The MDCG also clarified that the above transitional regime is not dependent on the fact whether ‘’the Notified Body applied to be designated under the MDR or not /or it has a still valid designation under the Directives’’.

Finally, it was noted that NANDO database – with regard to the Directives – will only be used for information purposes after the date of application of the MDR.

NANDO database will also contain a ‘’clear message that the Notified Body is not able to issue new Certificates but is only allowed to carry out surveillance activities for valid certificates in the transitional period, as established in Article 120 of the MDR’’

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