On 8 September 2025, the European Commission published a call for evidence on "the targeted revision of the EU rules for medical devices and in vitro diagnostics". This is part of the Commission's on-going "targeted evaluation" of the Medical Devices Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR), with the aim of identifying methods to tackle critical issues experienced throughout the industry caused by the regulations.
Background
As discussed in our previous blog, towards the end of 2024, the Commission launched a public consultation, framed as a "targeted evaluation", on the MDR and IVDR. The focus of this was to identify problems with the legal framework. This was launched in part due to the European Parliament adopting a resolution on the urgent need to revise the MDR and the IVDR, as set out in our previous blog.
The consultation ended on 21 March 2025 and feedback provided the European Commission with the opportunity to reconsider objectives, understand the needs and difficulties of the industry, and reflect upon realistic targets for all stakeholders.
Feedback from the consultation identified issues such as a lack of predictable timelines for CE mark certification, divergent practices across the EU and disproportionate requirements compared to the risks presented by devices. This has led to inefficiency, high costs and unnecessary burdens, affecting market access and the overall competitiveness of the EU's medical device market. These are already well-known problems with the current regime and the reason why so many stakeholders have called for action to be taken.
Current call for evidence
The current call for evidence follows on from the consultation, with the aim of gathering input from stakeholders to address the problems identified during the consultation in a "targeted way".
The call for evidence sets out that the aim is to amend the current regulations through simplifying and streamlining the framework, making it "more cost-efficient and proportionate", while maintaining patient safety and public health. This will be in line with the Commission's Better Regulation guidelines. In particular, it sets out that the initiative aims to:
- reduce administrative burden including reporting obligations
- enhance the predictability and cost-efficiency of the certification processes of notified bodies;
- make conformity assessment requirements more proportionate, especially for low- and medium- risk devices and those that cater to special patient needs
- enable further digitalisation
- streamline procedures including those on governance
- enable the EU medical device sector to benefit from international cooperation including reliance, where appropriate
- better align the regulatory framework with other relevant legislation
The call for evidence is clear that this is not another public consultation, but a mechanism through which the Commission intends to collect the views and insights of stakeholders to support its proposed reforms. Feedback will be taken into account as the Commission "further develops and fine-tunes this initiative".
Timing
Stakeholders are invited to submit their responses by 6 October 2025. Feedback received will be made publicly available.
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