The UK Medicines and Healthcare products Regulatory Agency (MHRA) has today 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 are intended to boost medical technology (MedTech) industrial growth by reducing duplicative regulatory costs faced by manufacturers and instead focus the domestic approvals route (UK Conformity Assessed [UKCA]) on first-in-market innovative technologies, including artificial intelligence (AI) as a medical device.
The MHRA has now published the government’s response to its public consultation on future routes to market for medical devices in the UK, which are designed to modernise regulation and improve patient access to the latest innovative technologies.
In direct response to stakeholder feedback, the MHRA has also announced 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 USA. This will allow eligible products to follow a streamlined pathway to market, helping bring the latest technologies to patients more quickly, the MHRA claims in a press release.
The MHRA will support removing the requirement for physical UKCA markings on products and packaging once unique device identification (UDI) requirements are in place, and states that this will reduce barriers to market entry while strengthening traceability and safety monitoring.
These measures are said to reflect the government’s commitments within the UK’s Life Sciences Sector Plan and Industrial Strategy, and the 10-Year Health Plan for England, to reduce unwarranted barriers to entering the market and to deliver transformative technologies to patients more quickly.
According to the MHRA, today’s announcement forms part of a broader regulatory reform programme for medical devices that will see improvements in patient safety through 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.
Wes Streeting, UK secretary of state for health and social care, 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 [National Health Service] 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.”
Patrick Vallance, minister of state for science, added: “The MHRA’s new international reliance routes are excellent news for patients, who will now gain rapid access to new medical devices which have been approved as safe by our trusted regulatory partners. This is precisely the sort of streamlining of red tape that the Life Sciences Sector Plan calls for. By making quick, informed, sensible decisions enabled by international reliance, the MHRA will be able to better target its resources, focusing on regulatory activity and scientific advice that will advance the development of innovative new medical products—ultimately helping patients, and supporting MedTech businesses to grow.”
Lawrence Tallon, MHRA chief executive officer, commented: “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.”
Tom Clutton-Brock, professor of anaesthesia and intensive care medicine at the University of Birmingham (Birmingham, UK), and chair of the Interim Devices Working Group—an expert advisory committee to the MHRA—noted: “The proposed changes to the regulations represent the most significant advances since their original introduction. When enacted, we will lead the world in streamlining medical device approvals.
“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. 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 and published its response. Simplification for low-risk devices and the carefully controlled reliance and recognition of regulatory approval from other countries will support safe innovation. This will benefit patients, clinicians and our MedTech and HealthTech industries.”
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.
The MHRA’s 2024 public consultation on medical device regulation focused on the following areas: international reliance, UKCA marking, and the regulation of in-vitro diagnostic (IVD) devices.
Measures being taken forward by the MHRA include:
- International reliance routes will allow certain devices that have approvals or certifications from trusted regulators in Australia (Therapeutic Goods Administration [TGA]), Canada (Health Canada), and the USA (Food and Drug Administration [FDA]), to follow a streamlined pathway to the UK market. This includes specific software and implantable devices that meet UK equivalence criteria.
- The government will consult later this year on proposals to indefinitely recognise CE-marked medical devices, which continue to be recognised in the UK under existing transitional arrangements until 30 June 2028 or 2030, depending on the device classification and legislation complied with.
- Physical UKCA marking requirements will be removed once UDI is in place, which aims to reduce burdens on manufacturers while improving traceability and post-market surveillance.
- Class B IVD devices will be subject to a more risk-proportionate approach, requiring manufacturers to self-declare conformity with the Medical Devices Regulations 2002 and hold ISO 13485 quality management system certification before placing products on the UK market.
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 release concludes.
