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).
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).
Hope this helps...
Best,
TWA