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. Read more: https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices/statement-of-policy-intent-international-recognition-of-medical-devices

Updates to guidance – Information on how to notify the MHRA of your intention to carry out a clinical investigation for medical devices. https://www.gov.uk/guidance/notify-mhra-about-a-clinical-investigation-for-a-medical-device (updates include new guidance on early terminations and temporary halts).