In brief

On 9 December 2022, the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) met to discuss a possible amendment to Art. 120 of Regulation 745/2017 (MDR), with the purposes of deferring the transitional periods provided therein.

Key takeaways

At the meeting, the European Commission proposed to extend the transitional provision of Art. 120, paragraph 3, of the MDR, with staggered deadlines based on the risk class of the medical device. This deadline may occur in the year 2027 for Class III and IIb devices and in the year 2028 for Class IIa and I devices. The Commission also proposed to extend the duration of validity of CE certificates issued according to the MDD and the AIMDD and removing the “sell-off” provision in Art. 120, paragraph 4 of the MDR to prevent safe devices already on the market from being rejected.

In this respect, the Commission clarified that the proposed extensions may be granted only to those medical devices that do not present unacceptable risks to public health and safety, that have not undergone significant changes in design or intended use, and for which manufacturers have already taken the necessary steps to initiate the certification process under the MDR.