MHRA announces plan to speed up access to innovative medical devices

The Medicines and Healthcare products Regulatory Agency (MHRA) has outlined proposals to accelerate patient access to promising new medical devices, as part of efforts to address unmet clinical needs within the NHS.

In a new statement of policy intent, the regulator has set out its initial thinking on an early access service that would enable time-limited, conditional access to innovative devices ahead of full regulatory approval.

The approach would apply where there is a clear clinical need and sufficient evidence of patient benefit, the MHRA said.

The move is part of a broader programme of regulatory reform being led by the MHRA, which also includes enhanced post-market surveillance and increased international collaboration.

The regulator said the initiative would also support the ambitions of the UK Government’s life sciences sector plan, aimed at strengthening the UK’s position as a leader in MedTech innovation.

In addition, the proposed policy reflects the 10-year health plan’s stated intention for the MHRA to adopt a more pro-innovation approach to regulation, while maintaining safety.

The scheme is aimed at supporting innovation, particularly among small and medium-sized manufacturers, by offering a defined route to NHS use for novel diagnostic technologies. Initial focus will be on devices aligned with the NHS’s most urgent priorities.

The announcement follows the publishing of proposals contained within the government’s 10-year health plan for the regulator to launch a joint process with the National Institute for Health and Care Excellence (NICE) by April 2026 to speed up medicine approval decisions and reduce administrative burdens.