Notify the MHRA about a Clinical Investigation for a Medical Device

On 3 March 2021 the MHRA updated the guidance on how to notify the MHRA of a clinical investigation for a medical device.

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. Please provide as much notice as possible. An advanced notice is helpful to the MHRA, however is not a substitute for the formal clinical investigation notification.

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