How to Notify the MHRA about a Clinical Investigation for a Medical Device

On 19 May 2022 the UK MHRA updated the guidance on notifying the MHRA of the intention to conduct a clinical investigation for medical devices.

A notification to the MHRA will not be required for medical devices that are UKCA / CE / CE UKNI marked for the purpose that is under investigation. If possible, please provide the MHRA with advanced notice of the intention to submit a clinical investigation by emailing This email address is being protected from spambots. You need JavaScript enabled to view it. with some basic details about the investigational device, the intended population, the type of study, and estimated application date.

This guidance includes an updated Excel template, (MHRA Protocol Deviation Tracker) to use for tracking Study Deviations.

Read more online 
Copyright Widler & Schiemann AG 2020. All Rights Reserved. /