The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) aims to be recognized globally as a “home of responsible innovation” when it comes to regulating software and artificial intelligence (AI) when used as medical devices.
‘Project Glass Box’ - UK Reveals Roadmap For AI Medtech Regulation
The MHRA recently announced plans to review and reform how medical devices with AI or software components are to be regulated in the UK. Its new roadmap sheds light on how, exactly, it will deliver on these ambitions.
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The intricate assembly of medical devices, often involving over 1,000 globally sourced components, faces severe disruption due to new US tariffs. These barriers could halt production and devastate small and medium-sized enterprises (SMEs), MedTech Europe’s CEO, Oliver Bisazza, warns in an interview with Medtech Insight.
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Manufacturers of medical products would be foolish to think that recent upheavals at the US FDA will result in a lack of inspections in the coming years. A panel of experts discussed the current state of inspections during a webinar hosted by the Food and Drug Law Institute.
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Its move comes as the Swiss recognize the need to ensure adequate supplies on medical devices in its country.
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Back-to-back meetings at LSX? No time to attend the innovator showcase? Here is what you might have missed from medtech innovators at the LSX World Congress Europe on 29 April.
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Its move comes as the Swiss recognize the need to ensure adequate supplies on medical devices in its country.
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Back-to-back meetings at LSX? No time to attend the innovator showcase? Here is what you might have missed from medtech innovators at the LSX World Congress Europe on 29 April.
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Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.