The guide elaborates on the provisions of the Executive Order on herbal medicines. In addition, the requirements for manufacture, quality, harmlessness, documentation of impact, labelling etc. are elaborated.
Any company manufacturing, importing, exporting, storing, procuring, distributing, dispensing, splitting or packaging medicinal products or intermediate products must obtain authorisation from the Danish Medicines Agency according to section 39(1) and (2) of the Danish Medicines Act (a section 39 authorisation).
Any company manufacturing, importing and distributing active substances (API) intended to be used in the manufacturing of marketed medicinal products for human use must register with the Danish Medicines Agency pursuant to section 50A(1) of the Danish Medicines Act (API registration).
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.
This guidance is aimed at consumers who use health apps and software that are medical devices. It offers guidance on how to tell if a health app is a medical device and how you should go about them.
There has been a large increase in the development of health apps for consumers and patient groups with all sorts of purposes and functionality. The purpose of an app could, for example, be to serve as an aid to monitor disease, health, exercise, lifestyle etc. The vast majority in this group of health apps are not medical devices and therefore are not CE marked.