IVDR Medical device software

[Tiffany88]

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?

 

[yodon]

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?

 

[Tiffany88]

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?

The software is a stand alone app that uses in vitro input, but this in vitro product is not ours

 

[yodon]

You still need to describe what the software does in order to determine if it qualifies as a medical device.

 

[mihzago]

as yodon said there's not enough detail, but if your software meets the definition and uses IVD source then it would qualify as a IVD MDSW.

take a look at this guidance https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_2021_mdsw_en.pdf

 

[Tiffany88]

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]

as yodon said there's not enough detail, but if your software meets the definition and uses IVD source then it would qualify as a IVD MDSW.

take a look at this guidance https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_2021_mdsw_en.pdf

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]

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.

 

[yodon]

If the software is making a diagnosis, it's absolutely going to be considered a medical device.