Article from the UK Medicines and Healthcare products Regulatory Agency. 31st July 2025.
The UK medical devices market is a dynamic and innovation-driven sector. To ensure that innovative technologies reach patients quickly and safely, the MHRA is taking key actions aligned with the Government’s 10-year Health Plan for England and the Life Sciences Sector Plan. These strategies aim to drive health innovation, enable research and development, create an outstanding ecosystem for investment, and highlight the key importance of the MedTech sector in this.
Our ambition is to establish a regulatory regime that balances streamlined access through International Reliance with a refocused domestic UK Conformity Assessment (UKCA) route that enables innovation. We are transforming how the MHRA enables innovation through advice services, regulatory sandboxes, rapid approvals for clinical investigations, and the development of a service to facilitate earlier access to innovative technologies, as outlined in the Life Sciences Sector Plan.
The following Statement of Policy Intent sets out our initial thinking on an Early Access service which will be developed further over the coming months. It takes on learnings from the Unmet Clinical Need Authorisation (UCNA) tool piloted in the Innovative Devices Access Pathway (IDAP) and is shaped by stakeholder engagement with key sector representatives. The intent is to turn the UCNA tool into a business-as-usual Early Access service available to innovators outside of an innovation pathway such as IDAP. 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.
Read more here
The MHRA will work closely with key stakeholders across the life science ecosystem to refine the Early Access service for its implementation. We will also establish internal capability to deliver this service.
If you have general queries about this statement of policy intent, contact us at [email protected].