MHRA Guidance Update: Notify MHRA about a clinical investigation for a medical device

The MHRA have published updated guidance on how to notify them if you intend to carry out clinical trials in order to obtain CE marking for a medical device. Device developers must inform the MHRA at least 60 days before the intended trial start date and have all required documentation prepared in advance.

Ideally the MHRA would like companies to provide advanced notice of the intention to submit a clinical investigation by emailing with details about the investigational device, the intended population, the type of study, and estimated application date. While advance notice is welcome, it is not a substitute for the formal notification.

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Published on 25. September 2018 in News UK