Chris Whitehouse, a political consultant and expert on medical technology policy and regulation at Whitehouse Communications, an advisor to MedTech suppliers, chair of the Urology Trade Association, and governor of the Anscombe Bioethics Centre, showcases a new pan-EU consultation on the effectiveness of EU regulations on medical devices.
The European Commission has launched a new consultation on the effectiveness of EU regulations on medical devices and in vitro diagnostic medical devices.
The regulations, specifically Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), aim to ensure the safety and effectiveness of medical devices, protect patient safety, and support innovation in the sector.
The evaluation seeks to assess whether the current rules are achieving their objectives and to identify any areas for improvement. Key aspects under review include the capacity of notified bodies, the length and cost of conformity assessments, and the impact of stricter requirements on pre-market clinical data.
The evaluation is very much a “blank sheet of paper” review, with respondents able to address any and all points that they wish to record with the Commission.
The feedback from this evaluation will help the Commission determine if changes are needed to enhance the regulatory framework, ensuring it remains robust, transparent, and sustainable while continuing to support innovation and high safety standards.
The MedTech sector should engage with this consultation to ensure that its outcome boosts opportunities and minimises unintentional regulatory threats. The consultation closes on 21st March 2025.
The Author used AI in preparing this article. Comments upon or questions about this article can be addressed to chris.whitehouse@whitehousecomms.com.
