During the meeting of health ministers in Brussels on Tuesday 14 March, the Commissioner for Health and Food Safety, Stella Kyriakides, welcomed the rapid adoption of transitional arrangements to avoid shortages of medical devices (see EUROPE 13136/32).
Swedish Minister for Health Acko Ankarberg Johansson announced that the legislation would be signed on Wednesday 15 March and published in the Official Journal of the EU.
Ms Kyriakides asked Member States to consider the medium and long term. She called for an increase in the number of notified bodies and offered the Commission’s support so that by the beginning of 2024 there would be as many notified bodies as possible. The Commissioner also recommended that Member States streamline their administrative procedures.
In addition, Ms Kyriakides called for tailor-made solutions, especially for so-called orphan devices. She welcomed the ongoing work in the Medical Devices Coordination Group.
The Commissioner stressed the need to support small and medium-sized enterprises in the sector and innovation. She indicated that the EU4Health programme would be mobilised in this context.
Finally, she announced that the Commission would draw up a wide-ranging evaluation of the new medical devices legislation by 2027, to identify areas for improvement.
Link to the Commission’s framework note: https://aeur.eu/f/5rs (Original version in French by Émilie Vanderhulst)