MHRA announces proposals to improve access to world’s best medical devices for patients and to boost economic growth in Britain’s med tech sector
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.
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.
Today’s 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.