The MHRA has announced important new steps which aims 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 aim to 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.
The MHRA has now published the 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.
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.
The announcement forms part of the agency’s 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.
Summary of the consultation response:
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.
