On September 8, 2025, the European Commissioned issued a “Call for Evidence” on the EU Medical Device Regulation 2017/745 (MDR) and the EU In Vitro Diagnostic Medical Device Regulation 2017/746 (IVDR).

The European Commission acknowledges that while the regulations have been in place for several years, implementation has been challenging. The higher demands of both the MDR and IVDR have also led to the risk of shortages and the disappearance of critical devices from the market. At the same time, the transitional periods have been extended several times.

Between December 2024 and March 2025, the European Commission conducted an evaluation of both regulations, and there have been multiple calls for a simplification of the framework.

The Call for Evidence notes that while the overall objectives of the MDR and IVDR are shared by most stakeholders, there are concerns about: sufficiently predictable timelines for certification,; diverging practices across the EU that are undermining the efficiency of obtaining CE marking,; and disproportionate costs relative to the risks presented by these devices.

In this context, the Commission is considering an initiative to simplify and streamline both regulations to: reduce the administrative burden; enhance the predictability and cost efficiency of certification; enable further digitalisation; streamline procedures; and better align the framework with other legislation.

This proposal will be widely welcomed. However, the proposed changes must be considered in the context of:

• The UK’s plans to broadly align medical and in vitro medical device law with the EU MDR and IVDR
• The new EU AI Act that imposes a dual layer of certification upon devices that are AI systems or have AI systems as safety components

This Call for Evidence allows stakeholders, both in the EU and beyond, to give submissions that will be considered when preparing changes to the regulations.

The Call for Evidence is open until 6 October, 2025. Feedback will be published on the website of the European Commission.

The McDermott Will & Schulte team are advising clients and stakeholders on a wide range of regulatory matters relating to the MDR and IVDR.

If you would like to contribute to this Call for Evidence, please access the link here or reach out to the authors for support on aspects to include in any submission.