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

Medicines Healthcare Products Regulatory Agency

July 24
09:33 2023

Drift workshops, End of Project Report

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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.

Published 6 April 2023
Last updated 24 July 2023 +show all updates
  1. A new report about an MHRA project from October 2021 to March 2022 was added to the Artificial Intelligence section.

  2. First published.

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