Herbal medicinal products are medicinal products where the active ingredient consists exclusively of herbal substances or herbal preparations. Natural remedies are medicinal products where the active ingredient is of natural origin and consists of an animal part, a bacterial culture, a mineral or a salt.
The purpose of the guideline is to clarify the criteria for qualification of software and apps as medical devices and to highlight the legislative requirements that medical device manufacturers must fulfil.
The purpose of a device is determined by the manufacturer and not by virtue of how it is applied by the users. For example, an app intended to monitor the heart rate during exercise does not qualify as a medical device, not even if the user chooses to use the app for a medical purpose. In other words, it is the manufacturer who describes what the software/app is intended to be used for.