The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has announced new measures to improve patient access to advanced medical devices in Europe and other regions.
The initiative aims to modernise regulations, facilitating quicker access to innovative technologies, including AI as a medical device, and boosting growth in Britain’s med tech sector.
The government has published its response to a public consultation on future market routes for medical devices in Great Britain.
The proposals aim to reduce duplicative regulatory costs for manufacturers, focusing the UKCA approval route on first-in-market innovative technologies.
MHRA CEO Lawrence Tallon 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.”
In response to stakeholder feedback, the MHRA plans to consult on the indefinite recognition of CE-marked medical devices later this year.
The move could streamline market entry, allowing patients quicker access to the latest technologies.
New international reliance routes will be introduced, enabling swifter access to medical devices from trusted regulators in Australia, Canada, and the US.
It will streamline the pathway for eligible products, expediting their availability to patients.
The MHRA will support the removal of physical UKCA markings on products and packaging once unique device identification (UDI) requirements are established.
It aims to lower market entry barriers while enhancing traceability and safety monitoring.
The measures align with the UK’s Life Sciences Sector Plan, Industrial Strategy, and the 10-Year Health Plan for England, which aim to minimise market entry barriers.
The announcement is part of a broader regulatory reform programme for medical devices.
UK Secretary of State for Health and Social Care Wes Streeting said: “Our 10-Year Health Plan will seize the opportunities provided by new technology, medicines and innovation to deliver better care for patients, whether these originate at home or abroad.
“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.
“We will look around the world to bring the best life-saving devices to Britain quickly and safely and build a modern health service that is fit for the future.”
