Artificial Intelligence in Medical Devices - The MHRA's Perspective

In 2024, the UK's MHRA (Medicines and Healthcare products Regulatory Agency), together with the US Food and Drug Administration (FDA) and Health Canada, published 10 guiding principles on "Good Machine Learning Practice" (GMLP). These have now been expanded.

The UK government has adopted a list, drawn up by doctors in the UK health system, which is intended to support the regulation of artificial intelligence (AI) in connection with medical devices. The proposals are to be incorporated into Phase 3 of the national "AI Airlock" system. This system was developed to proactively examine the regulatory challenges of AI-supported medical devices. The aim of Phase 3 is to develop regulatory guidance for AI-supported medical devices.

A total of 44 recommendations on the regulation of AI in healthcare, intended to support new technologies, have been published by the MHRA. The list of recommendations and the comments on them from the regulator's perspective are available for reference.

What happens next?

Consultations are planned, starting next year, on the qualification and classification of AI-supported medical devices. A roadmap with timelines and responsibilities for all 44 recommendations is planned for spring 2027. It is to be updated regularly thereafter. Although there is some overlap with the original 10 principles, the 44 recommendations go well beyond them, both in breadth and in depth. Considerations on the regulation of AI in healthcare are also set out in a comprehensive brochure (119 pages!), which was published very recently on the MHRA website.

Conclusion: Even though the UK is no longer part of the EU, its considerations on the regulation of AI-supported medical devices could also be of interest to the EU.