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NEWS | Proposed framework for International Recognition of Medical Devices by MHRA

This statement describes the draft policy for recognition by the UK of international regulators’ approvals of medical devices. This statement and proposed framework applies to medical devices in Great Britain. For guidance on the regulation of devices in Northern Ireland, see Regulation of devices in Northern Ireland.

This statement describes the draft policy for recognition by the UK of international regulators’ approvals of medical devices. This statement and proposed framework applies to medical devices in Great Britain. For guidance on the regulation of devices in Northern Ireland, see Regulation of devices in Northern Ireland.
May 23, 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) has recently announced a proposed framework for international recognition of Medical Devices applicable in Great Britain.

This ‘Statement of policy intent’ describes how the UK Government intends to recognise regulatory approvals from Australia, Canada, the EU and the USA depending on the device type, its classification, and previous approval.

This transformative vision of the future regulatory framework for Medical Devices can mark a significant step forward by maintaining the priority on patient safety and allowing for optimisation of resources and a greater focus on innovation.

The proposed policy is still in draft, and the final version would be integral with the future core regulations which are aiming to be in force in 2025.

Read here the complete ‘Statement of policy intent’.

Contact us at medtech@asphalion.com to find out how we can support your journey through regulatory excellence for your Medical Devices.

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