Overview
The legislative file 2025/0404(COD) concerns a Commission proposal for a Regulation aimed at simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, while also supporting the European Medicines Agency's role regarding expert panels. The proposal is in the preparatory phase in the European Parliament under the ordinary legislative procedure. The analysis is based on the Council preparatory document (ST 16919 2025 INIT), which provides a summary of the proposal's provisions and intended impacts.
Legislative timeline
The file is at an early stage, with the European Parliament in its preparatory phase for a first reading. Recent preparatory work includes the publication of several Commission staff working documents on 14 January 2026, which were transmitted to the Council. These documents consist of an evaluation and an executive summary of the targeted evaluation of the existing Medical Devices Regulation (EU) 2017/745, as well as a document on estimated cost savings accompanying the legislative proposal.
Institutional handling
The lead Directorate-General within the European Commission is DG Taxation and Customs Union (TAXUD), under the responsibility of Commissioner Olivér Várhelyi. In the Council of the EU, the dossier is being handled by the Economic and Financial Affairs Council configuration (ECOFIN).
Stakeholder reactions
There has been notable stakeholder engagement on this initiative, with a total of 16 documented meetings held between stakeholders and EU policymakers. Of these, 10 were with Members of the European Parliament, 4 with Commissioners, and 2 with European Commission staff. The engagement involved 11 distinct organisations, with the most active being Philips, MedTech Europe, Aboca S.p.a. Società Agricola, the Helsinki and Uusimaa Hospital District (HUS), and Alber & Geiger. On the core topic of medical devices, the position of Philips, as indicated from these engagements, is one of support, with the company showing a subtle preference for measures that reduce costs and administrative red tape.