The MDR and IVDR reform now moving through the Council would change how almost every medical device and diagnostic test reaches the EU market. The Commission published its simplification proposal on 16 December 2025, and in the week of 26 October 2026 Council officials in the pharmaceuticals and medical devices working party examine the role of expert panels and the link with the AI Act.
The debate has moved beyond whether to simplify. Member states and the European Parliament now have to decide how much relief for manufacturers is safe for patients.
What the MDR and IVDR reform changes
The proposal amends Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostics. Its most discussed change removes the five-year maximum validity of certificates. Notified bodies would instead use risk-based recertification and periodic reviews that match the device’s risk, with surveillance audits possible remotely and, where no safety concerns exist, only every two years.
The text also reshapes classification. Under a revised Rule 11, much medical software would fall into Class I rather than Class IIa, which would remove the need for a notified body for those products. A new criterion for serious or critical situations could still push a device into Class IIa, IIb or III, and commentators warn that this wording leaves considerable room for interpretation.
Smaller manufacturers and notified body timelines
Cost relief for smaller firms is central to the case for the MDR and IVDR reform. Notified body fees would fall by 50% for micro manufacturers, 25% for small manufacturers and 50% for orphan devices. Orphan devices would cover conditions affecting no more than 12,000 people per year in the EU. Relabelling or repackaging would no longer need a new certificate.
Speed matters as much as cost. A draft implementing regulation published on 12 December 2025 would cap conformity assessment at 255 days, or 165 days when quality system audits and product verification run in parallel. Certificate reissuance would take no more than 15 days. Firms that waited more than a year for certification will judge the MDR and IVDR reform against those limits.
Expert panels and the AI Act link
The proposal gives expert panels a larger role. They would help decide regulatory status and classification, give early scientific and clinical advice to manufacturers in certain cases, and designate breakthrough and orphan devices. If no member state raises a substantiated objection, classification disputes would be settled within 90 days.
The interaction with the AI Act is the most technical question in the Council talks. By moving software to lower classes and shifting the medical device regulations to Section B of Annex I of Regulation (EU) 2024/1689, the proposal could mean that many devices that use artificial intelligence would no longer count as high-risk under the AI Act. Supporters see less duplication, while patient groups ask who will check algorithm performance if one of the two regimes steps back.
The patient safety trade-off
Safety campaigners criticise two points of the MDR and IVDR reform. Longer reporting windows would give manufacturers 30 days instead of 15 to notify non-critical serious incidents, and lighter recertification rests on the quality of post-market data. If surveillance is thin, longer certificates could hide problems that the old five-year cycle would have caught.
Supporters of the MDR and IVDR reform answer that the existing cycle created bottlenecks without proving it improved safety. The Commission’s public consultation drew 584 responses and its call for evidence 441, which shows how divided stakeholders remain. Hospitals want predictable supply, manufacturers want speed, and notified bodies want clear workloads.
What happens next
Most simplifications would apply six months after entry into force, while rules on reprocessing single-use devices would wait five years. The Commission expects the co-legislators to finish the MDR and IVDR reform in 2027, although the text will change along the way. Council presidencies will try to settle the AI Act link early, because other chapters depend on it.
The MDR and IVDR reform is therefore a test of whether the EU can cut compliance costs without weakening trust in the CE mark. The answer will depend less on headline measures than on the detail of risk-based review and expert panel advice.
