UK MHRA: Transforming the regulation of software and artificial intelligence 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.