Notify the MHRA about a Clinical Investigation for a Medical Device

11 May 2023 – the UK MHRA published updated guidance on notifying the MHRA of a clinical investigation for a medical device.

A clinical investigation needs to be carried out as part of the process to obtain a UKCA / CE / CE UKNI marking for a medical device. The MHRA should be informed at least 60 days before starting the investigation. Validation Checklist text and accompanying document have been added.

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