The Medicines and Healthcare products Regulatory Agency (MHRA) is
updating regulations applying to software and artificial
intelligence (AI) as a medical device.
These measures demonstrate the UK’s commitment, following our
exit from the European Union, to drive innovation in healthcare
and improve patient outcomes.
The exciting and fast developing field of software and artificial
intelligence (AI) as a medical device has an increasingly
prominent role within health systems. Applications of AI to be
regulated as medical devices can range from screening, to
diagnosis, to treatment, and to management of chronic conditions.
Regulatory measures will be updated to further protect patient
safety and take account of these technological advances.
The MHRA has developed an extensive work
programme to inform regulatory changes including key reforms
across the software as a medical device lifecycle, from
qualification to classification, to requirements that apply pre
and post-market. This programme will consider challenges and
opportunities posed by AI as a medical device, ensuring these
devices are appropriately evidenced and address issues of human
interpretability (lack of transparency of AI) and adaptivity
(retraining of AI models).
These bold reforms will ensure that patients and public are
protected and provide manufacturers with clear guidance to
interpret requirements as well as the tools to demonstrate
conformity. The changes will transform medical device regulation
as it applies to software and AI, providing a regulatory system
that is robust and dynamic for the future.
Minister for Innovation said:
While the UK remains a leading destination for cutting-edge
healthcare, we are always searching for new and innovative ways
we can improve the health and care system for NHS patients.
Software and artificial intelligence in medical devices offer 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 Director of Devices Graeme Tunbridge said:
Today’s announcement of an exciting step change in the regulatory
approach in this fast moving area underpins the MHRA’s commitment
to support responsible innovation that champions patient safety.
Reforms will build on wider changes to medical device regulation
already underway. We have also today launched our public
consultation on proposed legislative changes in the Consultation on the future
regulation of medical devices in the United Kingdom and we
are encouraging everyone with an interest in these products and
the way they are regulated to contribute their views.
We will continue to evolve our regulations and guidance to
respond to this fast-paced field and carry out further research
into how best to manage the challenges posed by artificial
intelligence as a medical device.
In addition to our overhaul of the regulations for AI and
software as a medical device, today BEIS announced that
the MHRA are recipients of a grant from the Regulatory Pioneers
Fund.
The grant for £194,000 supports the MHRA’s drive to become a
global leader in regulating this field by carrying out further
research into how adaptive AI algorithms in medical devices
‘change’ and how to regulate their decisions.
The MHRA is supported in bringing forward this programme of
change thanks to support from NHSX, partners such as NICE, and
input from academic and industry partners.