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 have manufactured the medical device in-house for your own patients with no objective to place it on the market

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

- you want to provide a medical device to another organisation, that up until now has been manufactured in-house for patients, for data to support safety and performance of a commercial product

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.

Clinical investigation enquiries

For specific enquires relating to applications for clinical investigations, contact info@mhra.gov.uk and ensure you add ‘clinical investigation enquiry’ in the subject line.

Regulatory advice meetings

The MHRA clinical investigations team can offer a comprehensive device regulatory advice meeting.

We cannot review individual documents but we can provide guidance on navigating the regulatory landscape.

See our information on fees regarding the charges for a regulatory advice meeting

To request a regulatory advice meeting, contact the Head of Clinical Investigations mark.grumbridge@mhra.gov.uk.

See section 7 of our fees page.

A fee under the Medical Devices Regulations 2002:

(a) shall be payable when the notice to which it relates is given to the Secretary of State;

(b) shall accompany that notice when it is given.

The fees detailed on our fees page also cover applications for device studies in Northern Ireland

Payment for a clinical investigation

How to make a payment to MHRA.