pharmaphorum May 1, 2024
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has said it will launch a pilot programme in the coming weeks to see how it can evolve the regulation of artificial intelligence as a medical device (AIaMD) technology.
The AI-Airlock regulatory sandbox will bring together the NHS, regulatory authorities, and approved bodies – organisations that have been designated by the MHRA to assess manufacturers and their medical devices – to “start to identify and address the novel regulatory challenges for AIaMD.”
It was first announced last year and will provide a regulator-monitored virtual area for developers to generate robust evidence for their advanced technologies, according to the agency, which says it will be ready sometime this spring.
The timeline is...
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