Commission launches public consultation on MDR/IVDR

The European Commission has launched a public consultation seeking stakeholder input on the effectiveness of the EU Medical Devices Regulation (MDR, 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (IVDR, 2017/746) in a targeted evaluation.

An announcement stated that the evaluation will help the Commission “take stock” and assess the effectiveness, efficiency, and proportionality of the regulations, as the EU looks to revisit aspects of the regulation after years of challenges and delays in transitioning to the regulations. Stakeholder input will be considered as this initiative is further developed and refined.

The call for feedback aligns with the European Parliament’s joint resolution, which was passed in October and calls upon the Commission to propose changes to the regulation and to conduct an impact assessment on the regulations by the end of Q1 2025. The resolution cited an “urgent need” to revise the regulations “to resolve issues of divergent interpretation and of practical application to streamline the regulatory process, improve transparency, and eliminate unnecessary administrative work for notified bodies and manufacturers, particularly SMEs, without compromising patient safety.”

In its announcement of the targeted evaluation, the Commission emphasized the considerable challenges encountered by various parties in transitioning to the new rules. While MDR and IVDR both require an evaluation by May 2027, the Commission said it has decided to shift the evaluation forward, with a planned completion date in Q4 2025.

The consultation and call for evidence will be open until 21 March 2025.