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Do we need to QA cert? We only plan to supply reagents

#1
Hi All, we are starting a Medical Diagnostics company in the New Year, we only plan to supply reagents.
My question is if we sell products as FFMU can we circumvent the need to comply with IVDR directive. We still intend to provide Certificates of Analysis and support for the products and Tech Files.
We won't be selling kits to end user so the labeler will have full responsibility for the product, my understanding is that they will also have to carry out QC on the final kitted products and thus they're ultimately responsible from a legal perspective.
 
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Ronen E

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Staff member
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#2
If you only supply bulk for further processing/repackaging, you are mostly exempt (your client will most likely pose on you requirements stemming from their regulatory responsibility).
If your product is final-packaged and labelled (i.e. ready for use IVDMD) you are responsible to an extent, even if you don't sell direct to end-users or your product is included (unaltered) in a kit.

It's unclear to me whether you are the manufacturer of the reagents or a distributor.
 

Lokus200

Starting to get Involved
#3
I would assume that your future clients will ask you to implement QMS as part of their supplier evaluation process.
 

Watchcat

Trusted Information Resource
#4
Define "need."

Do you have any interest in controlling and/or assuring the quality of the reagents you supply?
Do you have competitors with QA cert?
Are you required to have QA cert by law?

If the answer to all three of these questions is no, then you probably don't "need" QA cert.
 
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