UK – Guidance : Software and AI as a Medical Device Change Programme

The Medicines and Healthcare products Regulatory Agency (MHRA) have embarked upon an ambitious programme of reform to ensure that medical device regulation is fit for purpose for software, including artificial intelligence (AI).

Software (and AI in particular) plays an increasingly prominent role in health systems, having a wide set of applications across health and social care. Many of these applications will be regulated as medical devices. It is increasingly important then that medical device regulation be fit for purpose, to ensure patients, public, and healthcare professionals are empowered with the best medical technology available.

This work programme will deliver bold change to provide a regulatory framework that provides a high degree of protection for patients and public, but also make sure that the UK is the home of responsible innovation for medical device software…