Software (including AI) plays an essential part in health and social care. In the UK, many of these products are regulated as medical devices (or as in vitro diagnostic medical devices (IVDs). This guidance provides access to important software group outputs that might be of assistance.
Updates to this page
Published 6 April 2023 Last updated 3 February 2025 +show all updates
Added link to guidance on digital mental health technology: qualification and classification.
Updated guidance to include reference to guiding principles on transparency for machine learning-enabled medical devices
Added links to Scotland and Northern Ireland incident reporting centres
Update to the digital mental health technology section.
Added the MHRA, FDA and Health Canada's 5 guiding principles for the use of PCCPs to the AI section.
Updated the Artificial Intelligence section with our new guidance page on guiding principles for the use of Predetermined Change Control Plans (PCCPs) for managing rapid product changes.
The report that was added to the Artificial Intelligence section has been temporarily removed for necessary corrections.
A new report about an MHRA project from October 2021 to March 2022 was added to the Artificial Intelligence section.
