Software and artificial intelligence (AI) as a medical device
Information for manufacturers, healthcare professionals, researchers and patients on software as a medical device (SaMD) and AI as a medical device (AIaMD).
Documents
Details
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
Last updated 13 June 2024 + show all updates
-
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.
-
First published.