Overview — The file concerns a forthcoming European Commission proposal for the revision of the Medical Devices Regulation. The procedure is in a pre-legislative phase, with the Commission currently finalising its draft. This analysis is based on the provided data regarding institutional handling and stakeholder outreach.
Institutional handling — The initiative is being prepared by the European Commission’s Directorate-General for Health and Food Safety (SANTE), under the responsibility of Commissioner Olivér Várhelyi. Within the Council of the EU, the Environment Council (ENV) configuration is identified as the relevant formation for handling this file.
Stakeholder reactions — There has been significant stakeholder engagement in the pre-proposal phase, with 75 documented meetings held between stakeholders and EU policymakers. These included 37 meetings with Members of the European Parliament, 20 with Commissioners, and 18 with European Commission staff. The outreach involved 32 distinct organisations, with the most active being MedTech Europe, COCIR, Zimmer Biomet Holdings, the European Coordination Committee of the Radiological, Electromedical and healthcare IT Industry, and Aboca S.p.a. Società Agricola.
On the core topic of medical devices, several industry stakeholders have expressed supportive positions focused on regulatory streamlining. COCIR explicitly advocates for maintaining regulatory exemptions under the RoHS (Restriction of Hazardous Substances) directive to avoid compliance costs and R&D losses. Similarly, Siemens Healthineers AG is advocating for adapting hazardous substance exemptions to reduce regulatory uncertainty. GE HealthCare Technologies Inc.'s position subtly favors reducing costs and red tape through the adaptation of such exemptions. Confindustria Dispositivi Medici advocates for 'more predictable regulatory pathways' and 'timely market entry,' which also aligns with reducing administrative burdens.
The stakeholder data also reveals positions on two ancillary policy areas, suggesting these topics may be contextually linked or discussed in parallel. On food labelling harmonisation at EU level, positions are mixed. Andries Olie, Senior Manager Nutrition, Health and Sustainability, subtly favors flexibility, while innocent drinks explicitly supports a harmonised front-of-pack nutrition label at EU level. Cosun Nutrition Center, part of Royal Cosun, criticises a harmonised front-of-pack system as difficult for consumers to understand, subtly supporting flexibility. On EU policy on novel foods, Cosun Nutrition Center explicitly criticises the current EU novel foods regulation as 'too long and too costly,' discouraging applications, indicating strong support for reform.