Regulation and official guidance
Software and artificial intelligence (AI) as a medical device
Overview
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.
This content is available under the Open Government Licence v3.0
External Links
Key Information
Jurisdiction: UK - UK-wide
Name of organisation: Medicines and Healthcare products Regulatory Agency
Date published: 25 Oct 2023
License: Open Government License (OGL)
Categorisation
Topic: Safety
