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 on first-in-market innovative technologies, including artificial intelligence (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 the United Kingdom, designed to modernize 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 U.S. 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 (UK Conformity Assessed) 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.
