MedTech Dive September 20, 2021
Dive Brief:
- The U.K.’s Medicines and Healthcare products Regulatory Agency is overhauling its regulations applying to software and artificial intelligence as a medical device.
- MHRA has developed a Software and AI as a Medical Device Change Programme it contends will provide a regulatory framework that will ensure “the U.K. is the home of responsible innovation.” The U.K. device regulator is seeking changes across the software as a medical device lifecycle, from qualification to classification to pre- and post-market requirements.
- The overhaul comes as the FDA issued its own action plan in January for establishing a regulatory approach to such software. Bradley Merrill Thompson, attorney at the law firm Epstein Becker Green, contends that MHRA is a “small step”...
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