Prime Highlights
- Health industry groups are urging the European Commission to simplify the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), citing excessive paperwork and approval delays.
- Industry leaders argue that easing regulations will boost innovation, reduce costs, and improve patient access to safe and effective medical technologies.
Key Facts
- The MDR and IVDR came into effect in 2021 and 2022, and have since been criticized for creating high compliance costs and slowing down the introduction of new devices.
- In September 2025, the European Commission launched a public consultation to gather feedback on potential reforms to make the regulations more efficient without compromising safety.
Background
Health industry groups in Europe are urging the European Commission to make the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) easier to follow. The rules, in effect since 2021 and 2022, are seen as complicated and costly, especially for companies introducing new devices and diagnostic tools.
Groups like MedTech Europe and the European Federation of Pharmaceutical Industries and Associations (EFPIA) say the current system creates too much paperwork, delays product approvals, and makes it harder for smaller companies to meet all requirements. Another issue that companies encounter is collaboration with Notified Bodies, the agencies that check and approve medical devices.
The industry leaders propose reforms to minimize the irrelevant steps, enhance coordination between the regulators, and accelerate approvals. They also suggest that the recertification requirements of products that are low risk and already have a good safety track record should be made easier.
The delays in the existing regulations have impacted clinical trials and have slowed down the pace of launching new treatments. This can delay patients’ access to important medical devices and therapies. Industry groups say simpler rules will help European companies innovate more quickly and compete better globally.
In September 2025, a public consultation was initiated by the European Commission to hear feedback from companies, regulators, and medical organizations. The goal is to find practical ways to make the MDR and IVDR system simpler while keeping safety standards high.
Officials are expected to review the feedback and suggest changes later this year. Industry groups say updates to the rules will support innovation, reduce costs, and make sure patients can get safe, effective medical devices more quickly.
