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Guidance: Software and Artificial Intelligence (AI) as a Medical Device

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Medicines Healthcare Products Regulatory Agency
July 26
16:01 2023
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Software and Artificial Intelligence (AI) as a Medical Device

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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.

Published 6 April 2023
Last updated 26 July 2023 +show all updates

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

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

  3. First published.

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