UK regulator to shift from one-off checks to continuous monitoring of AI medical devices
The UK’s Medicines and Healthcare products Regulatory Agency announced a new policy that will require continuous monitoring of AI‑driven medical devices, replacing the current one‑time review model.
The change follows 44 recommendations from the National Commission into the Regulation of AI in Healthcare, which the government accepted on 6 October. An implementation roadmap is expected in spring 2027.
The MHRA also opened applications for the third phase of its "AI Airlock" sandbox, aiming to test devices under the new agile framework and accelerate safe deployment.
Officials said the reforms will help patients benefit from trustworthy AI while keeping safeguards in step with rapid technological advances, though some AI industry groups have voiced concerns about the speed of regulation.
This writeup was produced by pharmadog from original reporting by Fierce Biotech.
Original headline: “UK unveils new policy to constantly monitor AI-based medical devices”
read at Fierce Biotech ↗
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