Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether he plans to prioritise the assessment of breakthrough implantable devices in the MHRA Early Access Service.

In July 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) published a statement of policy intent for the development and implementation of an Early Access Service for innovative medical devices. The statement of policy is available at the following link:

https://www.gov.uk/government/publications/statement-of-policy-intent-early-access-to-innovative-medical-devices/statement-of-policy-intent-early-access-to-innovative-medical-devices#next-steps

The service aims to speed up safe access to innovative medical devices for patients, supporting the Government’s Life Sciences Sector Plan. Implementing the Early Access Service will require new systems and processes to be established. The MHRA is currently investing in internal capability and working closely with stakeholders to support the establishment and implementation of the service. Further information on this work, including details of the products that will initially be in scope, will be provided later this year.