Software and AI as a medical device has an increasingly prominent role within health systems
The Medicines and Healthcare products Regulatory Agency (MHRA) is updating regulations applying to software and AI as a medical device. These changes aim to drive innovation in healthcare and improve patient outcomes.
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 protect patient safety and take account of 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. The 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).
The reforms aim to 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 government says that 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.
The MHRA has also launched a consultation on the future regulation of medical devices in the UK, which ends on 25 November 2021.