The European Commission adopted COM(2025) 1023 in Strasbourg on December 16, 2025. It amends Regulations (EU) 2017/745 and 2017/746 to reduce burden rather than replace the framework. The headline change removes the maximum validity period for certificates. Notified bodies would instead run periodic reviews proportionate to device risk, ending the five-year recertification cliff that has stranded products in queues.
Several changes read directly on small companies. Classification rules are adapted so that certain software, reusable surgical instruments and accessories to active implantable devices fall into lower classes, which for some patient self-management apps means no notified body at all. Notified body fees would drop 50 percent for micro manufacturers and orphan devices and 25 percent for small manufacturers. The requirement that a person responsible for regulatory compliance be permanently and continuously available would be relaxed for SMEs. PSUR frequency falls, and national authorities gain an ombudsperson role to settle manufacturer disputes with notified bodies within 90 days.
The proposal also defines orphan devices as those addressing conditions affecting no more than 12,000 EU patients a year, adds criteria for breakthrough designation, and enables priority and rolling review for both. Moving the MDR and IVDR from Section A to Section B of Annex I of the AI Act would pull some device software out of the high-risk classification that regime imposes.
MedTech Europe CEO Oliver Bisazza called it "a long-awaited and necessary step to fix parts of the EU regulatory system that are clearly not working." None of it is law. Parliament and Council still have to act, and a company planning a CE mark in 2026 works under the rules as written today.