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MHRA Says UK Approach To AI Regulation ‘Legislatively Light’, Unlike EU Proposals

 
• By Eliza Slawther

The UK’s medtech regulator is “going big on guidance” when it comes to artificial intelligence and software as a medical device, an expert from the agency has said, while legislation will be light in comparison to the EU’s planned AI Act.

Johan Ordish, MHRA, at ABHI regulatory conference 2022
Johan Ordish, MHRA, speaking at the ABHI regulatory conference 2022

“We do not intend to make a lot of changes for software and AI in legislation, because that isn’t the proper way to regulate [this technology]. It moves too fast and [legislation] is not flexible enough,” Johan Ordish, head of software and AI at the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), has said.

Instead, Ordish explained during a presentation at the Association of British HealthTech Industries (ABHI) regulatory conference in London, the MHRA...

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