The targeted revision of the MDR and IVDR is a welcome step toward a more workable medical technology framework. It would replace rigid certification cycles with risk-based reviews and make certain post-certification changes easier to manage. By recognising real-world evidence and creating clearer routes for breakthrough devices, the proposal would strengthen Europe’s position as a launch market for medical technologies.

Further changes would give companies greater certainty and better support innovation. Policymakers should clarify the rules for drug device combination products and ensure that reprocessing rules keep patient safety at the centre. Labelling changes should remain subject to appropriate oversight. Health institution exemptions should also be carefully balanced so they do not weaken patient safeguards or distort competition.

The MDR and IVDR must also align properly with wider EU legislation, including the AI Act and cybersecurity rules. Clearer timelines and a single reporting approach would help avoid duplication. A more flexible framework would make Europe a more attractive place to launch medical technologies and improve patient access across the EU.