The Medicines and Healthcare Products Regulatory Agency (MHRA) is looking to change its regulations of artificial intelligence (AI) and software as a medical device. Following Brexit, the MHRA is looking to exercise its newfound freedoms to change the UK’s medical regulations for software and AI without the need to accommodate EU rules.

Under the new policies, set out in the MHRA’s Software and AI as a Medical Device Change Programme, the regulator is proposing reforms that will impact the sector in terms of qualification and classification as well as pre and post-market requirements.

The changes “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)”, the MHRA has said.

The regulator adds that reforms will seek to ensure the protection of patients, as well as clear guidelines for manufacturers, while providing a “robust and dynamic” regulatory framework for the future.

Graeme Tunbridge, the MHRA’s Director of Devices, 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.”

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