The MHRA has announced important new steps to ensure patients have access to the latest medical devices available in Europe and other advanced countries.
In addition to enhancing patient access to medical devices, the proposals will boost med tech industrial growth by reducing duplicative regulatory costs faced by manufacturers.
Instead, they will focus the domestic approvals route (UKCA) on first-in-market innovative technologies, including AI as a medical device.
The MHRA has now published the UK Government’s response to its public consultation on future routes to market for medical devices in Great Britain, designed to modernise regulation and improve patient access to the latest innovative technologies.
Minister of State for Science, Lord Patrick Vallance, stated: “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.
“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.”
Faster access to medical devices from trusted regulators
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.
Furthermore, new international reliance routes will be introduced to facilitate swifter access to medical devices from trusted regulators in Australia, Canada, and the United States.
This will enable eligible products to follow a streamlined pathway to market, thereby bringing 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 market entry while strengthening traceability and safety monitoring.
These measures reflect the government’s commitments in the UK’s Life Sciences Sector Plan and Industrial Strategy, as well as the 10 Year Health Plan for England, to reduce unwarranted barriers to market entry and deliver transformative technologies to patients more quickly.
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 medical 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 British market.
- 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.
- Physical UKCA marking requirements will be removed once Unique Device Identification (UDI) is in place.
- 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.
Supporting the government’s health policy reforms
These measures reflect the government’s commitments in the UK’s Life Sciences Sector Plan and Industrial Strategy, as well as the 10 Year Health Plan for England, to reduce unwarranted barriers to market entry and deliver transformative technologies to patients more quickly.
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.
“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,” explained Secretary of State for Health and Social Care Wes Streeting.
“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.”
