Medical devices: Actions to facilitate transition to stricter new European rules and avoid shortages

Following the meeting of Health Ministers (EPSCO) on 14 June 2022, the Medical Devices Coordination Body (MDCG), chaired by the Commission, approved a list of actions aimed at supporting the capacity of notified bodies and preparing manufacturers to facilitate the transition to the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation.

Health and Food Safety Commissioner Stella Kyriakidou said: “Our rules on medical devices ensure that patients in the EU have access to safe, life-saving medical devices. The measures we are announcing today aim to address the immediate challenges related to the availability of medical devices to patients in the EU. Through cooperation, we are committed to finding sustainable solutions to ensure the availability of these products at all times and to avoid shortcomings”.

Among the actions listed, the MCDG advises notified bodies to carry out hybrid audits, organize structured dialogues with manufacturers to make the conformity assessment process more efficient and provide support to SMEs and new applicants. Manufacturers are requested to make every effort to comply with the new regulatory requirements in a timely manner. MDCG will continue to monitor the availability of medical devices. The Commission will report to the Council in December 2022. The list of actions is available here. More information on medical device regulations is available here.

Nikos Andritsos

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