MedTech Europe backs EU device regulation overhaul but asks key changes
Posted on 05.05.2026
Brussels, 05 May 2026 – MedTech Europe published today its detailed position on the European Commission’s proposed revision of the Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), supporting the overall direction of the reform while calling for targeted changes to translate the framework into workable outcomes.
The industry association broadly welcomes the Commission’s push to optimise the regulatory system by reducing unpredictability and administrative duplication. Specific measures on open-ended certificates, streamlined change control and digitalised processes maintain high levels of patient safety while meaningfully cutting unnecessary red tape. The proposed chapter on international regulatory cooperation is also a timely step to reinforce global reliance on the CE mark.
However, in several areas, the legislative text as drafted does not yet fully deliver on the proposal’s own stated ambition. Without targeted safeguards, there is a risk that positive reforms will be diluted through inconsistent implementation, regulatory overlap or insufficient operational detail. MedTech Europe, therefore, identifies a focused set of areas requiring strengthening: innovation pathways need to be more effective, the integration of artificial intelligence requirements demands greater legal clarity, and performance study rules for in vitro diagnostics risk creating unnecessary process burdens. The association also cautions that the IVDR amendments have so far received insufficient attention given their importance to healthcare systems.
On one point, MedTech Europe urges co-legislators to fundamentally reconsider. The proposal to introduce a reusable-by-default presumption for single-use devices would add regulatory complexity without clear benefits for patients and would depart from established safety principles applied in regulatory systems worldwide.
“With this proposal, the EU has a real opportunity to correct course and restore confidence in its medical technology framework,” said Oliver Bisazza, CEO, MedTech Europe. “A simpler, more predictable system is a prerequisite for timely patient access and for keeping Europe an attractive place to innovate and invest.”
MedTech Europe calls on the European Parliament and the Council to move swiftly and to engage constructively with the detailed legislative amendments set out in the full position paper.
Read the 2‑page summary.