As part of its initiative to speed up the rollout of innovative medical devices, the Medicines and Healthcare products Regulatory Agency (MHRA) will establish Early Access service to provide conditional access to promising technologies, ahead of full regulatory approval, where there is clear clinical need and supporting evidence of benefit for patients.
Designed to support innovators, the Early Access service aims to provide patients access to safe and effective medical devices.
The focus initially will be on innovative diagnostic devices, particularly those supporting the NHS’s most urgent needs.
The initiative is in line with a broader programme of regulatory reform, including strengthened post-market surveillance and increased international collaboration.
The MHRA will continue to work with industry, clinicians, NHS leaders and other partners to shape the pathway and support growth across the UK MedTech sector.
