Instrument and legal status
Jurisdiction: United Kingdom
Issuer: UK Government / MHRA
Publication date: 2026-10-06
状态： Government policy response / sectoral regulatory implementation — not enacted legislation
Reviewed: 2026-10-10
FACT — official development
On 6 October 2026 the government accepted all 44 recommendations of the National Commission into the Regulation of AI in Healthcare. MHRA opened AI Airlock Phase 3 applications, focusing on post-market surveillance and lifecycle oversight for AI-enabled medical devices. These are implementation commitments and sandbox activity, not a newly enacted law.
The response plans change-management draft guidance by December 2026, qualification/classification consultation in 2027 and a full implementation roadmap by Spring 2027. Airlock applications are rolling; apply before 31 October for the current review wave.
INTERPRETATION — governance relationship
This develops the UK’s sectoral medical-device governance and assurance model. Acceptance of recommendations is not their completed implementation or enactment as law.
IMPLICATION — enterprise relevance
Prepare lifecycle evidence and monitoring, assess sandbox eligibility and track future guidance alongside existing medical-device requirements. Participation is not product approval.