UK – 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…

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