The Medicines and Healthcare products Regulatory Agency (MHRA) has announced new measure to modernise and reduce regulations to improve patient access to innovative technologies.
The MHRA has now published the Government’s response to its public consultation on future routes to market for medical devices in Great Britain. As well as improving patient access to new technology, the proposals will boost medtech 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.
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’s commitments 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.
Minister of State for Science, Lord Patrick Vallance, said: “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 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’s promise to make this the best place in the world to market medical devices and a global leader in life sciences.”
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 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, was published in February 2025 and has subsequently been actioned.