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Within the healthcare environment, mobile health (mHealth) applications(apps) are more and more important. The number of new mHealth apps has risensteadily in the last years. Especially the Covid-19 pandemic has led to anenormous amount of app releases. Notably, in most countries, mHealthapplications have to be already compliant with several regulatory aspects inorder to be declared to be a 'medical app'. However, the latest applicablemedical device regulation (MDR) does not comment in more detail on the topic ofthe requirements for mHealth applications. When developing a medical app, it isessential that all contributors in an interdisciplinary team - especially thesoftware engineers - are aware of the specific regulatory requirementsbeforehand. The development process, however, should not be stalled too longdue to the integration of the MDR. Therefore, a developing framework, whichincludes these aspects, is required, to enable a smooth development process.The paper at hand introduces the creation of such a framework on the basis ofthe Corona Health and Corona Check apps. The relevant regulatory guidelines arelisted and summarized to a guidance for medical app developments. Inparticular, the important stages and faced challenges emerged during the entiredevelopment process are highlighted.

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