UK – MHRA announces a proposed framework for international recognition of medical devices

This initiative signals an important step towards a new regulatory framework for medical devices in Great Britain which protects public health, ensures access to MedTech innovations, and maintains an attractive market for industry

The Medicines and Healthcare products Regulatory Agency (MHRA) has today (21 May 2024) published a statement of policy intent for international recognition of medical devices.

The MHRA’s statement of policy intent describes how the UK Government intends to recognise regulatory approvals from Australia, Canada, the European Union and the United States of America depending on device type, class, and prior approval. The MHRA continues to review the list of comparable regulator countries and is in active discussions with the Pharmaceuticals and Medical Devices Agency (PMDA) to explore the recognition of medical device approvals from Japan…