Notify the MHRA about a Clinical Investigation for a Medical Device

On 25 May 2021 the MHRA updated the guidance on notifying the MHRA of a proposed clinical investigation for a medical device.

Sponsors may need to carry out a clinical investigation as part of the process to obtain a UKCA / CE / CE UKNI marking for the medical device. The sponsors must inform the MHRA if they are planning to do this at least 60 days before starting the investigation.

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.

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