CE-IVD Technical File with Multiple IFUs

#1
Hi,
I am new to this forum, in fact this is my first post. I would greatly appreciate any input. Basically I just wanted to kindly ask whether CE-IVD certification for a medical device (not in contact with the patient) containing reagents for lab use, is possible for a product with multiple SKU's. More specifically it is a kit with multiple reagents in common between all the SKU's and different SKU's correspond to a single different reagent in the kit.
1. Can it be submitted to the NB in a single Technical File and a single IFU?
2. Can it be submitted to the NB in a single TF and multiple IFUs?

I hope my description is clear. Thank you very much in advance
 
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#3
Thank you very much for the reply. The indented use is the detection of mutations in specific regions of the human DNA. The regent (panel) that differs in each SKU is used to target a set of specific DNA sequences. If I understand your reply correctly, one TF can contain multiple IFUs as long as the intended use is the same? The need for multiple IFUs arises by the description for the sample collection as the specimens to be analyzed can come from different tissue material. Greatly appreciate your help.
 

chris1price

Trusted Information Resource
#4
Provided your IFU clearly identifies the different SKUs for each collection method, having one IFU should be ok. Similarly, one Technical File should be acceptable, provided the different SKUs, IFUs and methods are established.
 
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