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Latest / Health and life sciences

PolicyHealthGovernmentUKConfirmed

MHRA sets out how it will regulate AI medical devices under the UK white paper principles

See how this story connects

Source: GOV.UK: Impact of AI on the regulation of medical products

The MHRA published ‘Impact of AI on the regulation of medical products’ on 30 April 2024, its reply to a Secretary of State letter of 1 February 2024. It said the AI Airlock regulatory sandbox for AI medical devices would launch as a pilot in spring 2024, that predetermined change control plans would enter future UK device regulations on a non-mandatory basis initially, and that guidance on cyber security and on human factors for AI devices was due by spring 2025.

Why it matters

Companies selling AI medical devices in the UK learned which guidance and sandbox the MHRA planned, and that change-control plans would start as voluntary in UK law.

When
30 Apr 2024
ID
WTA-N-2024-0008
Who
MHRA

Summary by wheresthe.ai, from GOV.UK. Checked against the source on 9 Oct 2026.

Read the original at GOV.UK

Source copy: download the page as saved on 18 Oct 2026 (PDF). Document the source offers: document 1 (PDF). Also held by the Internet Archive.

Next stop on this Storyline: Led toUK accepts all 44 recommendations of doctor-led commission on regulating health AI

Cite this story

WTA-N-2024-0008: “MHRA sets out how it will regulate AI medical devices under the UK white paper principles.” wheresthe.ai, 30 Apr 2024. https://wheresthe.ai/d/gb-mhra-ai-regulation-approach-2024-04/ (source: GOV.UK: Impact of AI on the regulation of medical products).

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