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IVDR Medical device software

Tiffany88

Starting to get Involved
#1
Hello fellows!

I would like to ask you about the IVDR and the medical device software qualification. My question is, when an APP uses as input data from a RUO or laboratory reagents, not medical device certified (or IVD certified). Can this software be a medical device software in accordance with IVDR?
How can I validate this input?
 
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yodon

Staff member
Super Moderator
#2
I don't think you've provided enough information about what the software does. Is the software integral to the operation of your IVD device?
 

yodon

Staff member
Super Moderator
#4
You still need to describe what the software does in order to determine if it qualifies as a medical device.
 

Tiffany88

Starting to get Involved
#6
I'm sorry, seams I sent half of my message. I know this MDCG, thank you.

The software is intended to diagnosis using the in vitro data that came from RUO or laboratory use products.
 

Tiffany88

Starting to get Involved
#7

Tiffany88

Starting to get Involved
#8
You still need to describe what the software does in order to determine if it qualifies as a medical device.
I'm sorry, seams I sent half of my message.

The software is intended to diagnosis using the in vitro data that came from RUO or laboratory use products.
 
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