Software and Artificial Intelligence (AI) as a Medical Device
Information for manufacturers, healthcare organisations and professionals, researchers, and patients & public on Software as a Medical Device (SaMD), including Artificial Intelligence as a Medical Device (AIaMD).
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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.
Last updated 25 October 2023 + show all updates
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Added the MHRA, FDA and Health Canada's 5 guiding principles for the use of PCCPs to the AI section.
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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.
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The report that was added to the Artificial Intelligence section has been temporarily removed for necessary corrections.
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A new report about an MHRA project from October 2021 to March 2022 was added to the Artificial Intelligence section.
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First published.