The UK Medicines and Healthcare products Regulatory Agency (MHRA) has shared new proposals intended to improve access to the latest medical device technologies for UK patients.
Released following a UK Government consultation, the proposals include plans to introduce ‘indefinite recognition’ of medical devices that have received CE marking in the EU and establish ‘international reliance’ routes.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
The MHRA said the proposals will pave the way for the UK market introduction of medical devices that have already received regulatory approval from trusted authorities such as the US Food and Drug Administration (FDA) and Canada’s Medical Devices Directorate (MDD), thereby allowing eligible products to reach the UK market and patients more quickly.
According to the MHRA, the proposals will boost growth in the UK medical device sector by lowering manufacturers’ duplicative regulatory expenses.
Health secretary Wes Streeting said: “It makes perfect sense that medical devices approved for use on patients in a country whose safety regulations we trust can also be used here – without red tape or bureaucracy delaying devices which can benefit NHS patients now.”
Professor Tom Clutton-Brock, chair of the Interim Devices Working Group, an expert advisory committee to the MHRA, claimed that once the proposed regulatory reforms are enacted, the UK will “lead the world” in streamlining medical device approvals.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalData“The rapid advances in medical and healthcare technology make balancing the need for innovation against both short-term and long-term safety a real challenge,” Clutton-Brock said.
“After the EU exit there was a clear need to update our regulations to keep pace with other countries. After extensive consultation, the MHRA has listened carefully.”
The proposals follow the introduction of the MHRA’s new post-market surveillance (PMS) requirements for medical device in the UK, which took effect in June.
Applicable to all medical device manufacturers with UKCA- and CE-marked products placed on the UK market after 16 June 2025, the PMS requirements mandate that medical device manufacturers must ‘proactively track’ their products’ safety and performance.
Along with the new PMS requirements, the market access proposals resonate more broadly with the UK Government’s aims to modernise the UK National Health Service (NHS), following its recent announcement that the health service will receive a £29bn ($39.1bn) funding boost over the next three years to reach £226bn by 2029.
