18 May 2023
The Department of Health & Social Care (DHSC) has provided an update on the Government’s plans to move to a system of Product Regulatory Equivalence (PRE) that would establish a new route to market for medical devices with certification from certain international regulators.
The Chancellor’s Spring Budget statement announced that from 2024, the MHRA “will move to a different model which will allow rapid, often near automatic sign-off for medicines and technologies already approved by trusted regulators in other parts of the world such as the United States, Europe or Japan.”
Although specific details of expected timelines for the introduction of any new route to market have not been shared, DHSC has advised that a public consultation on the broad principles of the system is currently being prepared and could be launched this summer.
The BDIA has engaged with the MHRA, DHSC and Office for Life Sciences on this work from an early stage and we will continue to share updates with members as they become available.