Non-medical device software

Hello, we are a manufacturer and editor of class I software that will have to be in class IIa according to the regulation.
We are working on 2 projects with rehabilitation centers and hospitals, and we want to declare that the software under development is not a medical device, as it does not raise any alert and is used to collect and display the patient's vital parameters.
In your opinion how can it be declared as a diagnostic tool but not a medical device?
Thank you for your help,

When you say "diagnostic" then you're pretty much forcing it into a device category. Everything will come down to claims. I am pretty sure that even just collecting and displaying (some) vital parameters will push it into the device category (for example, the Owlet 'smart sock' was recalled because they marketed it as a commercial product but collection of blood oxygen levels put it into the device category, per the FDA). Not sure of your anticipated market, but if in the US, the FDA has a guidance on general wellness products that might help you see where the lines are drawn.

Thank you for your reply. The device is about to be launched on the European market.

In my opinion.... you'll need to classify it as a medical device. I used to work for a company that made devices including one that displayed information such as heart rate, SpO2 etc and we had to declare it as a medical device because it provides information about a patient's condition that can/will be used by a clinician to provide treatment. provide incorrect information about vital signs and the incorrect treatment could be given, which could harm the patient