AI Experts Tell UK MHRA How To Regulate AI Proportionately So Patients Benefit
UK policymakers will need to walk a fine line when developing regulation for AI as a medical device. An independent expert review sets out the need for carefully balanced rules that support innovation without allowing unsafe products to enter the market.
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Concerns are mounting over how the EU’s AI Act will impact the medtech sector. Now, a computer science expert has argued that the proposed regulation is fundamentally flawed in its approach, because it puts the focus on the AI product instead of its output.
The UK regulator is likely to establish mid-2024 as the new deadline for the standstill period during which CE-marked devices may access the UK market. Compulsory UKCA marking would accordingly also be delayed by a year.
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.