The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is updating regulations applying to software and artificial intelligence (AI) as a medical device.
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.
In the UK, 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).
MHRA Director of Devices Graeme Tunbridge commented:
“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.”