Overview
The NHS will soon allow manufacturers to provide innovative medical devices before they receive full regulatory approval, according to new proposals from the Medicines and Healthcare products Regulatory Agency (MHRA).
Key Details
- The MHRA has released a statement of policy intent outlining plans for earlier access to medical technologies that meet unmet clinical needs.
- A new Early Access service will be created to offer time-limited, conditional access to these technologies, provided there is a clear clinical need and evidence of patient benefit.
- This initiative aims to allow more patients to benefit from innovative technologies sooner.
Focus Areas
The initial focus of the Early Access service will be on:
- Innovative diagnostic devices.
- Technologies that address the NHS’s most urgent needs and financial sustainability.
Regulatory Approach
The MHRA emphasizes that this service will:
- Utilize risk-proportionate regulation.
- Provide ongoing support for innovators.
- Help the UK maintain its position as a leader in medical technology innovation.
Stakeholder Engagement
The development of this service will draw on insights from the Unmet Clinical Need Authorisation tool, which was piloted in the Innovative Devices Access Pathway. It will also involve engagement with key sector representatives.
Broader Impact
This initiative is part of the MHRA’s broader efforts to support the UK government’s Life Sciences Sector Plan and the NHS’s 10-year health plan. It aims to:
- Reduce barriers to market entry.
- Provide faster and more predictable routes to regulatory approval.
Industry Support
Industry representatives, including the Association of British HealthTech Industries (ABHI), have expressed strong support for this initiative, highlighting its alignment with the goals of the Life Sciences Sector Plan.
Expert Opinions
Dame Barbara Hakin, chair of the Health Tech Alliance, noted that this service will enable rapid access to innovative medical devices, which is crucial given the current challenges faced by the NHS.
Future Developments
The MHRA is also expanding its workforce by recruiting for new digital and data roles at its Digital Hub in Leeds.