Please note this is an extract of the original bulletin.
Notify the MHRA about a clinical investigation for a medical device
Page summary:
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Change made:
Added Combined review of a CTIMP and Medical Device section and accompanying guidance Combined IMP Device guidance
Borderlines with medical devices and other products in Great Britain
Page summary:
Guidance on whether or not your product is a medical device.
Change made:
Updated ‘Borderlines with medical devices and other products in Great Britain’ guidance, as of March 2024.
