Medical device apps or not medical device apps
Apps may be categorized in three big sets: encyclopedic apps, health lifestyle apps and real medical devices apps.
Encyclopedic apps are not medical devices, neither for FDA nor for CE Mark. They often contain data or knowledge that can be found in books. They are most of time created by book editors which publish their books in electronic format.
Health lifestyle apps are made for people who are not physicians, for diet, life hygiene or general health condition. These are most of times not medical devices. The frontier between general health and medical devices is sometimes thin. They may fall into the regulations whereas it was not expected by their manufacturers.
Medical devices apps are those with an intended use, which is clearly in the scope of regulations. “Clearly” is not a clear criterion, you may object. That’s true, there is no clear boundary between general health apps and medical devices.