European Commission launches targeted 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) and the In Vitro Diagnostic Medical Devices Regulation (IVDR) 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." (RELATED: EU Parliament passes resolution citing ‘urgent need’ for MDR/IVDR revision, Regulatory Focus 28 October 2024).

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 seeks input from a variety of stakeholders, including EU competent authorities, companies, consumer groups, and individuals. It includes targeted questions designed for various stakeholder groups, with some areas of overlap. Groups are asked to address whether they are addressing MDR or IVDR, with different questions presented specific to each regulation.

For example, companies, consumer groups, and EU health authorities are asked to what extent they agree that the extended transition periods of the regulation have addressed their concerns.

The groups were asked to evaluate how much they agree that the regulation has positively impacted patient health. They were also asked to determine whether they believe the MDR has ensured that the rules are applied fairly and impartially to all stakeholders before a device is launched on the market.

Yet EU health authorities were asked slightly different questions on whether they agree that cross-sector solutions exist for MDR. They were also asked to address whether a robust and transparent regulatory framework is in place to determine which legislation applies to a given product or type of product across the EU.

The consultation process will allow interested parties to comment in any of the 24 official EU languages. Additional consultations will be held with the Medical Device Coordination Group (MDCG) to enhance the consultation process. A stakeholder conference will also take place during the evaluation to further support these efforts.

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

Announcement; Call for evidence and link to survey

European Commission launches targeted consultation on MDR, IVDR

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