NHS to get early access to MedTech ahead of regulatory approval

Manufacturers will be able to supply innovative medical devices to the NHS use before obtaining full regulatory approval, under new proposals.

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a statement of policy intent setting out plans to enable earlier access to medical technologies that address unmet clinical needs.

A new ‘Early Access’ service will be established to provide time-limited, conditional access to technologies ahead of full regulatory approval, where there is clear clinical need and evidence of benefit for patients.

According to the MHRA: “This will enable more patients to benefit from earlier access to innovative technologies in areas of unmet clinical need.

“This will be delivered through risk-proportionate regulation and ongoing support for innovators, reinforcing the UK’s role as a global leader in innovative technology.”

The Early Access service will initially focus on innovative diagnostic devices, particularly those supporting the NHS’s most urgent needs and financial sustainability in the NHS.

Learnings will be used from the Unmet Clinical Need Authorisation tool piloted in the Innovative Devices Access Pathway, and be shaped by stakeholder engagement with key sector representatives.

The new service aims to “to reduce unwarranted barriers to market entry, through faster, risk-proportionate, and predictable routes to regulatory approval,” MHRA said.

The measure forms part of the MHRA’s wider contribution to the government’s Life Sciences Sector Plan and the NHS 10 year health plan and supports the UK’s ambition to be a global leader in medical device innovation.

Other MHRA regulatory reforms include strengthened post-market surveillance and increased international collaboration.

A spokesperson for the Association of British HealthTech Industries (ABHI), told Digital Health News: “ABHI has long advocated for a regulatory system that is synonymous with innovation and early access, and is, therefore, very supportive of this initiative.

“Programmes enabling more rapid access for patients are consistent with the recently published Life Sciences Sector Plan and will do much to facilitate the three shifts outlined in the 10 year health plan.

“Early access schemes alongside robust post market surveillance can make the UK simultaneously one of the world’s most innovative, yet safest jurisdictions for the patients we serve.”

Dame Barbara Hakin, chair of the Health Tech Alliance and former deputy chief executive of NHS England, also welcomed the Early Access service.

“This means that some of the most innovative and game-changing medical devices, developed through significant investment and expertise, can reach patients more quickly where there is unmet clinical need.

“With the NHS facing unprecedented challenges, timely access to safe and effective technologies will be crucial in delivering on the ambitions of both the 10 year health plan and the Life Sciences Sector Plan.

“This move is a clear signal of intent to support the UK’s ambition to be a global leader in medical device innovation, and we look forward to working collaboratively to ensure these efforts translate into real progress for patients and innovators alike,” she said.

Meanwhile, the MHRA has begun recruiting for new digital and data roles at its newly launched Digital Hub in Leeds.