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CQC oversight of Medical device software?

Ben S UK

Starting to get Involved
#1
Hi All,

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?

Thanks
 
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dgrainger

Trusted Information Resource
#2
MHRA regulates manufacture/placing on the market/surveillance of medical devices in the UK - the software you describe is likely to be considered a medical device.
CQC regulates health and social care services in England - this included use of medical devices.
 

Ben S UK

Starting to get Involved
#3
Thanks for the reply.

I might not have been clear with my question.

I understand the role of the MHRA and CQC in the traditional sense.

But I was wondering whether some medical device apps (one's which offer diagnosis for example) that can be used by a consumer/patient without HCP supervision (i.e. downloaded via App store or Google Play) would also be considered a directly providing primary care.

In the CQC recent paper Clarification of Regulatory Methodology: PMS digital healthcare providers - March 2017 they defined digital healthcare providers as, "healthcare services that provide regulated activity by an online means. This involves transmitting information by text, sound, images or other digital forms for the prevention, diagnosis or treatment of disease..." This to me seems to suggest that a diagnosis app - intended for patient use - could potentially been seen to be providing digital healthcare. So the device manufacturer as well as being the legal manufacturer in the traditional MDD/IVDD sense could also be a primary care provider too??
 
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