Hi Lutz,
Great question!
From how I understand the 2nd indent of rule 11 (and was told by others the same way), it only applies to devices that do monitoring. Most monitoring devices will fall under rule 10. The monitoring indent of rule 11 was mainly implemented to regulate software that does monitoring the same way as hardware devices. Does that make sense?
Whether the app you’re referring to would be classified according to the 1st (which would likely make it a IIa device) or 3rd indent of rule 11 though is an ongoing debate. I could imaging (and hope) that it falls under class I. The future will tell…
Best, Pascal