Brussels, 29 August 2022
Following the meeting of health ministers (EPSCO) on 14 June 2022, the Medical Devices Coordination Group (MDCG), chaired by the Commission, agreed a list of actions to support the capacity of Notified Bodies and preparing manufacturers to facilitate the transition to the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR).
Stella Kyriakides, Commissioner for Health and Food Safety, said:
“Our rules on medical devices ensure that EU patients 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 for EU patients. By working together, we are committed to finding sustainable solutions to ensure their availability at all times and avoid shortages as a priority.”
Among the actions listed, the MDCG advises Notified Bodies to use hybrid audits, organize structured dialogues with manufacturers to improve the efficiency of the conformity assessment process, and provide support to small and medium-sized enterprises (SMEs) and new applicants. Manufacturers are urged to make every effort to comply with the new regulatory requirements in a timely manner.
The MDCG will continue to monitor the availability of medical devices. The Commission will report to the Council in December 2022. The list of actions can be found here. More information on medical device regulations is available here.
(Roughly translated from French using Google Translate)