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 :)

  • What’s an MDR and where does this law exist?
    – Dale M
    Oct 14, 2022 at 12:25
  • @DaleM: Medical Devices Regulation is the EU regulation, which covers hardware and software used for diagnosis and treatment of medical conditions.
    – MSalters
    Oct 14, 2022 at 12:34
  • @MSalters: But note that every western-world jurisdiction has a Medical Devices regulation (or more than one), even if "Medical Devices Regulation" is not its exact title.
    – Ben Voigt
    Oct 14, 2022 at 14:46
  • The "gdpr" tag is a hint that this is the EU MDR. While they're entirely different Regulations, the app will likely need to conform to both
    – MSalters
    Oct 17, 2022 at 7:58


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