The Medicines and Healthcare products Regulatory Agency (MHRA) has announced important new steps to secure access for patients to the latest medical technologies available in Europe and other advanced countries.

As well as improving patient access to technologies, the proposals will boost medtech industrial growth by reducing duplicative regulatory costs faced by manufacturers and instead focuses on the domestic approvals route (UKCA) on first-in-market innovative technologies, including AI as a medical device.

The MHRA has now published the UK Government’s response to its public consultation on future routes to market for medical devices in Great Britain (GB), designed to modernise regulation and improve patient access to the latest innovative technologies, including assistive technologies.

In direct response to stakeholder feedback, the MHRA is also announcing its intention to consult later this year on the indefinite recognition of CE-marked medical devices.

In parallel, new international reliance routes will be introduced to allow swifter access to medical devices from trusted regulators in Australia, Canada, and the United States. This will allow eligible products to follow a streamlined pathway to market, helping bring the latest technologies to patients more quickly.

The MHRA will support removing the requirement for physical UKCA markings on products and packaging once unique device identification (UDI) requirements are in place. This will reduce barriers to entry to the market while strengthening traceability and safety monitoring.

The response to a fourth proposal, to extend four pieces of assimilated EU law, was published in February 2025 and has subsequently been actioned.

The MHRA’s proposals reflect the government’s ambitions in the UK’s Life Sciences Sector Plan and Industrial Strategy, and the 10 Year Health Plan for England, to reduce unwarranted barriers to market entry and to deliver transformative technologies to patients faster.

In addition, MHRA says its announcement forms part of its broader regulatory reform programme for medical devices that will see improvements in patient safety through its new post-market surveillance requirements, the creation of streamlined and risk-proportionate routes for faster market entry for products that have already undergone assessment in comparator regions, and a refocusing of the UKCA domestic pathway on innovative technologies including AI.

Lawrence Tallon, MHRA CEO, said: “Our focus is on ensuring that patients benefit from the earliest possible access to safe and effective medical technologies that meet their needs and deliver significant clinical benefit.

“By reducing regulatory duplication, improving traceability and aligning with international best practice, we are delivering on the Government’s promise to make this the best place in the world to market medical devices and a global leader in life sciences.”

The MHRA intends to notify the World Trade Organization (WHO) of these changes later this year and will continue engaging with international partners and industry to implement the reforms.

Responding to the MHRA’s announcement, William Lee, Head of Policy & Compliance at the British Healthcare Trades Association (BHTA) said: “Delivering on the Government’s goals for UK medical technology requires modern, fit-for-purpose UK regulations, and BHTA welcomes MHRA’s recent announcement.

“It sets out how MHRA plans to continue to uphold the highest standards and protect patient safety while ensuring the UK remains a world-leading destination for medtech companies. As outlined the NHS 10 Year Plan, the Life Sciences Sector Plan, and the overall UK Industrial Strategy, the UK’s medtech ambitions must be founded on a safe, nimble, and efficient regulatory framework – and BHTA and its members stand ready to help MHRA create just that.

“When it comes to making UK medical technology safe, affordable, and accessible, MHRA has listened to the concerns of industry and trade associations. This hasn’t always been easy in the last few years of uncertainty, and we applaud MHRA’s intentions to:

• “Consult in 2025 on indefinite recognition of CE-marked medical devices for the UK market, which will help SMEs especially.
• “Follow through on international reliance plans to allow swifter access to medical devices from trusted regulators in Australia, Canada, and the United States, which will help large companies and importers/exporters especially.
• “Simplify medtech packaging and labelling requirements, which will benefit companies of all sizes and types.”

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