The European Parliament has voted with a large majority to urge the European Commission to implement critical amendments to the EU Medical Device Regulation (MDR) by the first quarter of 2025. The drive for reform is intended to tackle pressing issues in the regulation, which has been criticised for its excessive bureaucracy and impact on patient care, jobs, and innovation in the medical device sector.
MEPs Dr Peter Liese (EPP) and Dr Angelika Niebler (EPP) have welcomed this step but expressed disappointment that a full overhaul of the regulation was not scheduled. The proposal for a complete revision was unsuccessful due to opposition from the Social Democrats, Liberals, and Greens, who felt the timeline was too ambitious. Despite this setback, MEP Liese urged the Commission to accelerate work on a comprehensive review, emphasising the urgency of the situation. MEP Niebler reiterated these concerns, emphasising the need for immediate reforms to simplify the certification process. "The current regulation is a threat to saving lives," she stated, emphasising the need for Europe to remain an attractive hub for medical device innovation.
The MDR, which introduced stricter certification requirements, has resulted in bottlenecks and product shortages, with some manufacturers even withdrawing products from the market. Industry leaders, including Pharma Deutschland and the Diagnostics Industry Association (VDGH), are calling for practical changes, such as faster certification processes, transparent costs, and the abolition of the mandatory five-year recertification cycle. These measures are regarded as vital to guaranteeing efficient, safe and innovative healthcare across Europe. Both the Parliament and industry stakeholders are now awaiting the new EU Health Commissioner's intervention to prevent further disruptions in healthcare supply.
