FOI release

Yellow card reports on AI healthcare products

Case reference FOI2026/01080

Received 17 September 2026

Published 28 October 2026

Request

I am seeking information about safety incidents reported in connection with the use of AI products in healthcare. If possible, please could the MHRA provide answers to the following: 1. The number of safety incidents relating to i) SaMDs (Software as a Medical Device) and ii) AIaMDs (Artificial Intelligence as a Medical Device) reported to date through the MHRA's Yellow Card system. 2. A full list of all providers of SaMDs and AlaMDs the MHRA has registered in each of its risk based classification categories

Response

See attached

Documents

• FOI202601080 (redacted).pdf (1.2 MB)

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