Clinical investigations for medical devices

You may need to carry out a clinical investigation as part of the process to obtain a UKCA, CE or CE UKNI marking for your medical device. You must inform the MHRA if you are planning to do this at least 60 days before starting your investigation.

Does my study require a clinical investigation application?

For studies in Great Britain, please use this flow chart and accompanying guidance to determine if you need to submit an application to MHRA.  In August 2025, MHRA published updated versions of these documents.  Please review the latest available guidance and ensure you are aware of its contents with respect to clinical investigation applications from this date.

For studies in Northern Ireland or Great Britain and Northern Ireland, use the flow chart and accompanying guidance in the Northern Ireland section.

Note: a notification to the MHRA will not be required for medical devices that are UKCA, CE or CE UKNI marked for the purpose that is under investigation.

Applications under Annex XVI of the Medical Device Regulation (EU) 2017/745 (MDR) for devices with no intended medical purpose cannot be accepted in GB.

Special circumstances for healthcare establishments

You do not need to notify us of a clinical investigation if:

You may need to notify the MHRA of a clinical investigation if:

Read more about the Health Institution Exemption for general medical devices to find out whether an exemption applies to your study.

Please refer to the flow chart and accompanying guidance to help determine if you need to submit an application to MHRA.