New user but occasional browser.
(I used the search function and don't think this has been asked previously).
I'm wondering whether anyone is aware of the overlap between the CQC (in the UK) and the MHRA specifically when it comes to medical device software with a diagnostic function. Is there an official position on this or precedent?
My understanding is this. Software (Apps, web tool or otherwise) which has the function to diagnose falls under the scope of the MDD (and also the MDR) and needs to comply with associated requirements; legal manufacturer, CE marking, technical dossier, NB oversight etc etc.
However, I also understand that in the UK the oversight of primary healthcare providers lies with the CQC and they have their own requirements - which i'm less familiar with...
It occurred to me recently that some diagnostic devices (particularly those that bypass HCP) potentially could be providing primary care i.e an AI app which 'talks' to a user asking questions in order to provide a diagnosis or treatment recommendation. I know recently the CQC issued some guidance on digital healthcare providers in primary care and confirmed they have oversight. But i'm still unclear how this works in practice and what the actual delineation would look like between MHRA and CQC?