Medical device regulation efforts for mHealth apps -- An experience report of Corona Check and Corona Health (2104.13635v1)

Abstract: Within the healthcare environment, mobile health (mHealth) applications (apps) are more and more important. The number of new mHealth apps has risen steadily in the last years. Especially the Covid-19 pandemic has led to an enormous amount of app releases. Notably, in most countries, mHealth applications have to be already compliant with several regulatory aspects in order to be declared to be a 'medical app'. However, the latest applicable medical device regulation (MDR) does not comment in more detail on the topic of the requirements for mHealth applications. When developing a medical app, it is essential that all contributors in an interdisciplinary team - especially the software engineers - are aware of the specific regulatory requirements beforehand. The development process, however, should not be stalled too long due to the integration of the MDR. Therefore, a developing framework, which includes these aspects, is required, to enable a smooth development process. The paper at hand introduces the creation of such a framework on the basis of the Corona Health and Corona Check apps. The relevant regulatory guidelines are listed and summarized to a guidance for medical app developments. In particular, the important stages and faced challenges emerged during the entire development process are highlighted.