51茶馆

The 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 will boost med tech industrial growth by reducing duplicative regulatory costs faced by manufacturers and instead focuses the domestic approvals route (UKCA) on first-in-market innovative technologies, including AI as a medical device. 聽

The MHRA has now published the government鈥檚 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.

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.

These measures reflect the government鈥檚 commitments in the UK鈥檚 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.

Today鈥檚 announcement forms part of our broader regulatory reform programme for medical devices that will see improvements in patient safety through our 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.

Secretary of State for Health and Social Care, Wes Streeting MP, 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.

Minister of State for Science, Lord Patrick Vallance MP, said:

The MHRA鈥檚 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 鈥� ultimately helping patients, and supporting med tech businesses to grow.

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鈥檚 promise to make this the best place in the world to market medical devices and a global leader in life sciences.

Professor Tom Clutton-Brock, Professor of Anaesthesia & Intensive Care Medicine at the University of Birmingham and Chair of the Interim Devices Working Group (an expert advisory committee to the MHRA), said:

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.聽 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 of these changes later this year and will continue engaging with international partners and industry to implement the reforms.聽

Summary of the consultation response:

The MHRA鈥檚 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 include:

• International reliance routes will allow certain devices that have approvals or certifications from trusted regulators in Australia (TGA), Canada (Health Canada), and the United States (FDA) to follow a streamlined pathway to the GB market. This includes specific software and implantable devices that meet GB equivalence criteria.

• The government will consult later this year on proposals to indefinitely recognise CE marked medical devices, which continue to be recognised in GB 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 Unique Device Identification (UDI) is in place. This 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 GB market.

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

Support received following this announcement:

Peter Ellingworth, Chief Executive, Association of British HealthTech Industries (ABHI), said:

鈥淭his announcement marks a significant step towards a more agile, internationally aligned regulatory system. ABHI has consistently called for the indefinite recognition of CE-marking, and it is encouraging to see this, along with a number of other long-standing ABHI recommendations, reflected in government thinking. We particularly welcome the positive engagement with the new MHRA leadership and their commitment to reducing barriers to market entry and enabling faster, risk-proportionate, and predictable regulatory pathways.鈥�

Edmund Proffitt, Chief Executive, British Dental Industry Association (BDIA), said:

鈥淭he British Dental Industry Association welcomes the MHRA鈥檚 proposals to consult on swift and indefinite market access for medical devices bearing the CE mark. Such an approach could benefit patient outcomes and foster innovation, whilst giving manufacturers and suppliers the certainty and confidence they require going forward. By championing international reliance our regulator is leading the way in providing patients with safe, effective and innovative treatment solutions.鈥�

Prof Mike Messenger, Head of Regulatory Strategy, British In Vitro Diagnostic Association (BIVDA), said:

鈥淭oday鈥檚 response from the MHRA will be broadly welcomed by industry. Its excellent to see that the MHRA have listened to industry and are increasingly recognising the importance of the IVD industry and its global nature.鈥�

William Lee, Head of Policy & Compliance, British Healthcare Trades Association (BHTA) said:

鈥淒elivering on the Government鈥檚 goals for UK medical technology requires modern, fit-for-purpose UK regulations, and BHTA welcomes MHRA鈥檚 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 med tech companies. As outlined the NHS 10 Year Plan, the Life Sciences Sector Plan, and the overall UK Industrial Strategy, the UK鈥檚 med tech ambitions must be founded on a safe, nimble, and efficient regulatory framework 鈥� 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鈥檛 always been easy in the last few years of uncertainty, and we applaud MHRA鈥檚 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 med tech packaging and labelling requirements, which will benefit companies of all sizes and types.鈥�

Notes to Editors

• The consultation response is available here:
• The consultation, 鈥淔uture regulation of medical devices and IVDs 鈥� routes to market鈥�, ran from 30 November 2024 to 29 January 2025. It sought views on four legislative proposals to update the Medical Devices Regulations 2002 (as amended).
• These reforms are part of a broader programme to modernise medical device regulation in Great Britain following the UK鈥檚 departure from the European Union. They align with the ambitions of the Government鈥檚 Life Sciences Sector Plan and 10-Year Plan for the NHS in England.
• ISO 13485 is an internationally recognised standard that sets out requirements for a quality management system (QMS) specific to the medical device industry. It ensures that manufacturers demonstrate consistent design, development, production, and post-market support for medical devices.
• The MHRA will publish further information in due course about the next steps, including updates on the planned Pre-Market Statutory Instrument and a future consultation on the indefinite recognition of CE-marked devices.
• The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
• The MHRA is an executive agency of the Department of Health and Social Care.

For media enquiries, please contact the newscentre@mhra.gov.uk, or call on 020 3080 7651.