Transforming the regulation of software and artificial intelligence as a medical device



These measures demonstrate the UK’s commitment, after our exit from the European Union, to driving innovation in healthcare and improving patient outcomes.

The exciting and rapidly developing field of software and artificial intelligence (AI) as a medical device is playing an increasingly important role in healthcare systems. Applications of AI to be regulated as medical devices can range from screening to diagnosis, treatment and management of chronic diseases. Regulatory measures will be updated to better protect patient safety and take these technological advances into account.

The MHRA has developed an extensive program of work to inform regulatory changes, including key software reforms as a medical device lifecycle, from qualification and classification, to requirements that apply before and after marketing. This program will examine the challenges and opportunities posed by AI as a medical device, ensuring that these devices are properly highlighted and address issues of human interpretability (lack of transparency of AI) and ‘adaptability (recycling of AI models).

These bold reforms will ensure patient and public protection and provide manufacturers with clear guidance to interpret requirements as well as the tools to demonstrate compliance. The changes will transform medical device regulation as it applies to software and AI, providing a robust and dynamic regulatory system for the future.

Innovation Minister Lord Bethell said:

While the UK remains a premier destination for cutting edge healthcare, we are always on the lookout for new and innovative ways to improve the health and care system for NHS patients.

Software and artificial intelligence in medical devices have the potential to transform people’s lives, and these updated regulations will make a significant difference in the diagnosis and treatment of a variety of conditions.

I look forward to seeing the tangible impact these changes will have on improving patient safety and care for years to come.

MHRA Aircraft Director Graeme Tunbridge said:

Today’s announcement of a radical change in regulatory approach in this rapidly evolving field underpins MHRA’s commitment to supporting responsible innovation that champions patient safety. The reforms will build on broader changes in the regulation of medical devices already underway. We also launched our public consultation today on the legislative changes proposed in the Consultation on the Future Regulation of Medical Devices in the UK and we encourage all interested in these products and the way they are regulated to give their opinion. .

We will continue to evolve our regulations and directions to respond to this rapidly evolving field and conduct additional research on how best to deal with the challenges posed by artificial intelligence as a medical device.

In addition to our overhaul of the regulation of AI and software as a medical device, BEIS today announced that the MHRA is a recipient of a grant from the Regulatory Pioneers Fund.

The £ 194,000 grant supports the MHRA’s drive to become a world leader in regulating this field by conducting additional research on how adaptive AI algorithms in medical devices are ‘changing’ and how regulate their decisions.

The MHRA is supported in the implementation of this agenda for change through the support of the NHSX, partners such as NICE and the contribution of academic and industrial partners.


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