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ISO 13485 for IVD (In-vitro Diagnostic Device) Manufacturers?

Watchcat

Trusted Information Resource
#1
I assume IVD manufacturers can get an ISO 13485 certificate if they are willing to pay for one. Is this a common practice? Does it serve a regulatory purpose?
 
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shimonv

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#2
I don't know enough about Pharma, but I'm sure you will run into conflicting and different requirements between ISO 13485 and the MOH requirements of the target market. It seems counterproductive.
 

Watchcat

Trusted Information Resource
#5
Thanks for the revision and for the reply to the question I meant to ask, but didn't. :rolleyes:

I was thinking it would be interesting to take all the COVID-19 tests that have been rubber-stamped through FDA and, instead of looking at what data might be available on their specificity and sensitivity (which I take as mere rumor, having not been reviewed by FDA), look at which companies have prior experience with ISO 13485. And then see how that plays out in terms of tests that prove to be reliable and those that do not.

That's a bit of a task, and IVDs are not my strong suit, so I didn't want to spend the time without some confirmation that an IVD company would typically pursue ISO 13485, if it was a legitimate IVD company and wasn't in a mad race to a finish line.
 

indubioush

Quite Involved in Discussions
#7
IVDs has a lot in common with medical devices. It makes prefect sense for IVD manufacturer to implement ISO 13485.
IVDs do not just have a lot in common with medical devices, they are medical devices. They must be compliant with ISO 13485 or equivalent regulation (for example 21CFR820 in the US).

Definition of medical device in ISO 13485 includes items "providing information by means of in vitro examination of specimens derived from the human body."
 

shimonv

Trusted Information Resource
#8
This is true in the US, but in the EU regulation there is a distinction between 'medical device' and ‘in vitro diagnostic medical device’.
 

indubioush

Quite Involved in Discussions
#9
Yes, but ISO 13485 has always been the harmonised standard for IVD manufacturer quality systems. I see why you are making the distinction though. Things are a bit up in the air regarding harmonised standards these days, and of course we have the MDR and IVDR.
 

twanmul

Involved In Discussions
#10
We have ISO 13485:2016 certification as an IVD manufacturer (we don't manufacture medical devices/active medical devices). The certification is useful, though not necessarily mandated. The registration process with distributors and/or economic operators with competent authorities is made a lot easier by having the certification (though isn't impossible without it).
 
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