List of actions to support the capabilities of notified authorities (i.e. authorities designated by Member States to assess whether certain products comply with EU technical specifications), as well as the preparation of medical device manufacturers for the entry into force of the new of relevant Regulations, approved by the competent technocratic body of the Commission.
Explaining the decision, Health Commissioner Stella Kyriakidou pointed out that the relevant rules "ensure that patients in the European Union will have access to safe life-saving medical devices".
"The measures we are announcing today aim to address the short-term challenges associated with the availability of medical devices to patients in the EU," he noted.
"Through cooperation, we are committed to developing sustainable solutions to ensure these products are available at all times and to avoid shortages," he added.
The measures were approved by the Medical Devices Coordinating Body (MDCG), chaired by the Commission, following the meeting of the EU Council of Health Ministers held on June 14, and concern the transition to the Medical Devices Regulation and the Regulation for In Vitro Diagnostic Medical Devices.
Among other things, the Medical Devices Coordination Body recommends notified bodies to carry out hybrid audits, to conduct structured dialogues with manufacturers to improve the efficiency of the evaluation process, as well as to provide support to small and medium-sized enterprises and new applicants. At the same time, manufacturers are urged to make every effort to comply with the new requirements in time.
As reported, the Commission's coordinating body will continue to monitor the sector, and the Commission will report to the Council in December 2022.
KYPE