Legal Framework for digital therapeutics (DTx) in the European Union

This paper examines the origins and limitations of EU medical device law. The main questions asked are whether EU medical device law defines the concept of medical purpose for software, whether the concept of medical purpose is understood as a medical service defined by national law, and whether it requires the involvement of medical professionals as users. Particular attention is paid to the aspect of Recital 8 of the Regulation (EU) 2017/745 on medical devices (MDR), alongside the general internal provisions of EU law and its sector-specific subsidiarity provisions. In practice, Member States have taken different legal approaches to address DTx-related challenges, creating legal uncertainty within the EU as to which DTx should be defined as a medical device.