Mobile applications on smartphones or tablet PCs are already part of everyday life for many people today. They help patients to use therapies, allow them to deal with their illness in a self-determined manner, support disease management, and reach not only a young, predominantly healthy target group, but also older and chronically ill patients in particular.
This whitepaper summarizes the essential aspects of the topic of "Medical Software and Apps" and takes a look at the legal framework based on the European Medical Device Regulation (EU) 2017/745, or MDR for Medical Device Regulation (German: Medizinprodukteverordnung). Using concrete examples, we discussed the question "Medical Device – yes or no?" and explain, among other things, what a risk analysis looks like, which steps a software goes through in the course of its life cycle, which standards are relevant and when it is a so called "Digitale Gesundheitsanwendung (for short: DiGA). Finally, we will use best practice examples to present what needs to be considered when planning and implementing software projects.