A key platform of the government's Life Sciences Sector Plan and the 10-Year Health Plan is for the UK to be a global leader in life sciences. Regulatory reform continues to be a key aspect of driving growth and promoting the UK as friendly environment for life science companies to operate in.
The roadmap for these reforms concerning to medical devices was published at the end of 2024. At the end of July, the Medicines and Healthcare products Regulatory Agency (MHRA) announced the next stage in the process – an early access service that will enable access to innovative medical devices that address unmet clinical needs and improve outcomes.
This builds on the MHRA's other regulatory reforms that seek to increase international cooperation and fast track access to new healthcare products, such as the international recognition framework for medicines that was introduced in 2024.
This new early access service for medical devices will enable:
- Conditional market access for innovative devices that address unmet clinical needs from the NHS or have the potential to significantly improve patient outcomes.
- Offer a bridging scheme to maintain patient access to devices where the clinical investigation has ended and the manufacturer is still awaiting regulatory approval.
The service will focus initially on innovative diagnostic devices, particularly those supporting the NHS's most urgent needs and financial sustainability in the NHS.
In welcome news for innovators, the MHRA service will also off structured regulatory support, including regulatory advice and the promise to set clear milestones and expectations throughout the approval process.
Further announcements can be expected from the MHRA in the near future as it continues to work with stakeholders to refine the early access service for implementation, as well as broader reforms that seeks to build on other government initiatives designed to improve MedTech adoption in the NHS.
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