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Guidance

Medical devices: software and artificial intelligence (AI)

Information for manufacturers, healthcare professionals, researchers and patients on software as a medical device and AI as a medical device.

Updates to this page

From:
Medicines and Healthcare products Regulatory Agency
Published:
6 April 2023
Last updated:
3 February 2025
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  1. Added link to guidance on digital mental health technology: qualification and classification.

  2. Updated guidance to include reference to guiding principles on transparency for machine learning-enabled medical devices

  3. Added links to Scotland and Northern Ireland incident reporting centres

  4. Update to the digital mental health technology section.

  5. Added the MHRA, FDA and Health Canada's 5 guiding principles for the use of PCCPs to the AI section.

  6. 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.

  7. The report that was added to the Artificial Intelligence section has been temporarily removed for necessary corrections.

  8. A new report about an MHRA project from October 2021 to March 2022 was added to the Artificial Intelligence section.

  9. First published.

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Software and artificial intelligence (AI) as a medical device

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Software and AI play 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 explains how the Software Group work to ensure the safety of the software and technology that meets a clinical need in the UK.

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