UK – Notify MHRA about a clinical investigation for a medical device

How to notify MHRA of your intention to carry out a clinical investigation for a CE marking.

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

How to notify MHRA of your clinical investigation

You need to prepare your documents before you notify MHRA of a proposed clinical investigation.

A notification to MHRA will not be required for medical devices that are CE marked for the purpose under investigation…