Is App that motivates patients to do therapy exercises a medical device?

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The MHRA (the UK’s medical devices regulatory authority) uses the following terms, used by manufacturers, as flags that a mobile app should be considered a Medical Device: calculates, converts, detects, diagnoses, measures, monitors. Further, the MHRA, in its guidance titled Medical device stand-alone software including apps (Aug 2014) stated: “apps with software that monitors a patient and collects information entered by the user, measured automatically by the app or collected by a point of care device may qualify as a medical device if the output affects the treatment of an individual”.

I would recommend formalising and documenting the app's Intended Use, as a basis for the determination whether or not it qualifies as a Medical Device. That documented intended use should form the basis for all labelling (packaging prints, manuals, promotional materials etc.), as well as for verbal promotion / marketing / sales pitch of the app (if any is planned).

Totally agree with Ronen. It is all about the intended use, so you need to determine if it really is about therapy, i.e. exercises prescribed to improve or prevent deterioration of a medical condition of a special patient or rather about general fitness exercises. Does the app determine an individual schedule or just send some nice reminders? Do risk management; if a problem with the app may compromise the results of the therapy because of a wrong or incomplete exercise regime, then you probably are better off to consider it a medical device...

Hope this helps...


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