MHRA to be updating regulations for software and AI as a medical device

It was recently announced that the Medicines and Healthcare products Regulatory Agency (MHRA) will be updating the regulations regarding software and artificial intelligence (AI) as a medical device. 

Indeed, the MHRA has developed a work programme that will let people know about the changes and requirements about how software should be qualified and classified. This will aim to ensure that patients are properly protected as well as give manufacturers clear guidance to interpret requirements and tools to demonstrate their compliance.

Moreover, the programme wants to provide the assurance that the devices are safe and work as intended. It will then include 11 work packages across two workstreams, concerning the software as a medical device lifecycle and the challenges regarding device regulation. 

MHRA is hoping to deliver both workstreams between now and summer 2023, alongside NHSX, the National Institute for Health and Care Excellence, the Multi-Agency Advisory Service, and the devolved administrations.


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