MHRA to Fast-Track Overseas-Approved Devices into UK Market

The UK’s MHRA has unveiled new international reliance pathways that allow medical devices approved abroad, including those with CE and FDA certifications to enter the UK market more quickly.

Announced under the UK’s Life Sciences Vision, the policy is designed to streamline regulatory duplication while maintaining patient safety.

It’s especially relevant for devices driven by emerging technologies such as AI diagnostics, remote monitoring tools, and next-gen wearables.

Previously, even devices with proven international safety records faced long delays for UK approval.

Under the new framework, applications will be assessed more rapidly, relying on robust foreign evaluations where appropriate, with continued emphasis on post-market surveillance.

Industry leaders welcome the move, citing clearer market access, faster innovation cycles, and reduced administrative costs.

For patients, it promises more timely access to pioneering treatments and tools, bridging the gap between global R&D and local care.

UK patients and clinicians stand to benefit from swifter access to world-class medical devices, supporting innovation without compromising trust.