Recent Updates

25th July 2025

Government response to the consultation on Medical Devices Regulations: Routes to market and in vitro diagnostic devices

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.

The consultation response sets out our response to the consultation proposals relating to international reliance, UKCA marking and the regulation of Class B in vitro diagnostic devices.

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.

Read the consultation response here

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.

Thank you,

The Medicines and Healthcare products Regulatory Agency