Eindhoven: Medical device makers from Eindhoven to Tuttlingen are watching the European Parliament’s Public Health Committee as it works through more than 130 proposed amendments to the Commission’s plan to simplify the medical devices regulation. The rapporteur published the draft report on 1 July 2026, and the committee held its first discussion on 14 July 2026, according to a legal analysis of the draft report.
The Commission proposed the targeted revision of the Medical Devices Regulation and the In Vitro Diagnostic Regulation on 16 December 2025. It wants rules proportionate to device risk, lighter reporting for manufacturers, tighter oversight of notified bodies through Joint Assessment Teams, and lower fees for micro and small companies. The proposal also limits how the AI legislation applies to medical devices.
Member states have not yet agreed their position. A Council progress report dated 5 June 2026 records no presidency compromise yet. It flags open questions on how the European Medicines Agency and the Medical Device Coordination Group share tasks, the conditions for expert panels, the cost of notified body oversight and the balance between pre-market and post-market requirements.
Parliament’s amendments pull in a different direction from the Commission on several points of the medical devices regulation. They add a category of “niche” devices for small patient groups where no suitable alternative exists, ask authorities for substantiated evidence before they challenge a device’s regulatory status, widen expert panel access in classification disputes and restore product liability provisions that the Commission wanted to remove. Members back more proportionality but disagree on how far simplification should go before patient safety suffers.
The medical devices regulation revision reaches beyond manufacturers. The Commission launched its targeted evaluation in 2024, after the rules became applicable in May 2021 for devices and May 2022 for diagnostics, and the revision aims to cut administrative burden and make certification more predictable. Parliament’s text also aligns conformity assessment timelines for companion diagnostics with medicines reviews and lets non-EU laboratories use health institution exemptions during clinical trials.
Timing matters for manufacturers. Current transition deadlines run to December 2027, 2028 or 2029 depending on device type, and the industry body MedTech Europe has asked for relief from recertification during the 2028 transition period, as Osborne Clarke reports. The Council document points to a Parliament vote in early 2027, while the rapporteur’s own schedule points to a plenary vote around the turn of the year.
Technical talks continue through autumn 2026, so the next test is whether the Council reaches a general approach before Parliament votes. Until then, the medical devices regulation revision stays a negotiation about how much risk-based simplification Europe will accept for devices that reach patients.
