Professor Laurent Castillo’s Perspective, Member of the European Parliament Committed to the MDR
Seance of wednesday 29 october 2025 (Disparition des implants articulaires du membre supérieur (hors épaule) consécutive à la réglementation européenne (MDR) sur les DMI.)
DOI number : 10.2699/qkqm-3615/emem.2025.44.08
Abstract
The revision of Regulation (EU) 2017/745 on medical devices (MDs) stems from the PIP breast implant scandal, which led to stricter legislation that has since become overly burdensome for manufacturers. Since 2021, 45% of medical devices have disappeared from the French market. While the current framework provides reassurance for patients, its cost and complexity penalize European SMEs.
In response, the European Parliament adopted a resolution on 23 October 2024, urging the European Commission to swiftly propose a revision of the legislation. The Commission, through O. Várhelyi, has launched a public consultation and a targeted evaluation. Several measures were already adopted in 2025, including the extension of electronic instructions for use, the creation of expert panels for orphan and pediatric MDs, and the exclusion of Chinese companies from certain markets. A comprehensive revision of the Regulation is expected before the end of 2025, supported by the upcoming Cypriot Presidency.
My objective is to ensure patient safety without hindering innovation or access to care. Reforming the system of Notified Bodies (NBs) is desirable, aiming for greater European harmonization and shared governance under the EMA’s coordination, to improve efficiency and coherence. In terms of simplification, the proposals include proportional requirements based on risk, streamlined certification rules for stable MDs, pre-certification dialogue, and fast-track procedures for innovative products.
Finally, at the international level, the EU should strengthen its competitiveness, join the MDSAP program, and protect itself against unfair practices, in order to maintain a European medical device market that is safe, agile, and attractive.
In response, the European Parliament adopted a resolution on 23 October 2024, urging the European Commission to swiftly propose a revision of the legislation. The Commission, through O. Várhelyi, has launched a public consultation and a targeted evaluation. Several measures were already adopted in 2025, including the extension of electronic instructions for use, the creation of expert panels for orphan and pediatric MDs, and the exclusion of Chinese companies from certain markets. A comprehensive revision of the Regulation is expected before the end of 2025, supported by the upcoming Cypriot Presidency.
My objective is to ensure patient safety without hindering innovation or access to care. Reforming the system of Notified Bodies (NBs) is desirable, aiming for greater European harmonization and shared governance under the EMA’s coordination, to improve efficiency and coherence. In terms of simplification, the proposals include proportional requirements based on risk, streamlined certification rules for stable MDs, pre-certification dialogue, and fast-track procedures for innovative products.
Finally, at the international level, the EU should strengthen its competitiveness, join the MDSAP program, and protect itself against unfair practices, in order to maintain a European medical device market that is safe, agile, and attractive.