With the introduction of the medical device regulation (MDR), there is a lot of ambiguity about which risk-class specific software is. And developing a medical device is linked to a lot of work and cost. Thus, I am wondering whether my app is even a medical device according to the MDR. Or, if it is, how I can adapt it to not be a medical device.
The basis: A physiotherapist can create a home exercise program for specific patients in the app and assign it to patients. The patients then get reminded to do the exercises and check whenever they have done them, which in turn gets visualized for the therapist via a calendar view.
Additional features (can be discussed in combination or separately from the basic functionality):
- The therapist can send customizable questionnaires to the patient and visualizes the results (without doing any inference/analysis on the data)
- The patient is guided through the process of setting treatment goals for themselves (SMART goals)
I think the main question here is, whether this "support" in daily life for the patient is considered treating a disease according to MDR article 2, section 1. Here is a nice summary of the definition of a medical device.
I am not expecting a complete and definite answer, but any thoughts from people with more regulatory experience are appreciated :)