MHRA Proposes Streamlined Market Access for Medical Devices in the UK

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has introduced new proposals to accelerate access to medical devices and reduce regulatory burdens. Central to these plans is the indefinite acceptance of EU CE-marked devices and the introduction of international recognition routes, which would allow approval of devices already cleared by trusted regulators like the FDA and Canada’s MDD.

These measures aim to cut duplicative regulatory costs for manufacturers while fast-tracking innovative devices into the UK market. According to MHRA experts, this will support patient care, reduce bureaucracy, and enable quicker adoption of beneficial technologies in the NHS.

The proposals complement recent post-market surveillance (PMS) rules introduced in June 2025, requiring manufacturers to actively monitor safety and performance of UKCA- and CE-marked devices. Together with a planned £29 billion NHS funding increase, these reforms signal a major move toward a modernised, innovation-friendly UK health system.

27-07-2025