Classifying Software - Insulin Calculator

[QA-Man]

The examples you give would appear to be devices as they have a therapeutic purpose.
They would be classified by implementing rule 2.3:

2.3. Software, which drives a device or influences the use of a device, falls automatically in the same class.

I disagree. The calculators in the examples I gave do not drive a device or influence the use of a device no more than a pen or piece of paper used to do a hand calculation.

In fact, both of the calculators I posted links to are used widely across the EEA as non-devices.

 

[missjenny]

Thank you for the thoughtful discussion.

This is another reason why I was having trouble deciding whether it was a Class IIa device or a Class IIb device. I wasn't quite convinced that a bolus calculator app that is independent of insulin pumps and pens could be seen as "insulin dosage planning" software or that it is directly driving or influencing them as the users themselves can decide to not follow the recommended dosage.

However, it does seem like it is a medical device. Just not sure which. And if it is indeed a medical device, then it means I have to find clinical evidence for it which I am quite unfamiliar with as I have only dealt with IVDs in the past. I'm not sure there are much evidence out there for calculators.

 

[alexoptimistic]

Did anyone found a correct answer for this? An insulin calculator is included in which risk class and which rule applies? I found out one app that is 2B.
Thank you.

 

[Ronen E]

Did anyone found a correct answer for this? An insulin calculator is included in which risk class and which rule applies? I found out one app that is 2B.
Thank you.

It depends on the specific device's characteristics.
What's your opinion? Did you go through the classification rules - MDR Annex VIII?