• Content Type

Regulation and official guidance

Software and artificial intelligence (AI) as a medical device


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

Key Information

Jurisdiction: UK - UK-wide

Date published: 25 Oct 2023

License: Open Government License (OGL)


Topic: Safety

Discussion forum

  • Author
  • Up

    Share your thoughts on this item here.

You must be logged in to contribute to the discussion