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Home » UK MHRA expects to up-classify some AI device software
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UK MHRA expects to up-classify some AI device software

May 6, 2024
By Mark McCarty
The U.K. Medicines and Health Care Products Regulatory Agency (MHRA) is among the regulators across the globe that are scrambling to keep pace with artificial intelligence (AI) in medical devices, releasing an April 30, 2024, paper on its own approach. One of the key considerations in this paper is that MHRA expects to up-classify some AI-enabled device software functions in its ongoing regulatory revamp, a prediction that suggests a more stringent premarket path for these products in the years ahead.
BioWorld MedTech Regulatory Artificial intelligence Digital health MHRA

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