<abstract xmlns="http://www.w3.org/1999/xhtml">

<p>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.</p>
</abstract>

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.

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

Tallinn University of Technology (Estonia) and Senior Researcher at Faculty of Law, Palacký University Olomouc

Palacký University Olomouc (Czech Republic) and Adjunct Professor in EU Strategic Legal Affairs, School of Business and Governance, Tallinn University of Technology

Department of International and European Law

Faculty of Law, Palacký University Olomouc

European Studies

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

{"article-title":"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...

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

Published Online: Jul 10, 2024

Page range: 98 - 123

DOI: https://doi.org/10.2478/eustu-2023-0014

Keywords
digital therapeutics, healthcare, medical device, public health, wellness application

© 2024 Verica Trstenjak., published by Sciendo

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

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

Published Online: Jul 10, 2024

Page range: 98 - 123

DOI: https://doi.org/10.2478/eustu-2023-0014

Keywordsdigital therapeutics, healthcare, medical device, public health, wellness application

© 2024 Verica Trstenjak., published by Sciendo

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

Keywords
digital therapeutics, healthcare, medical device, public health, wellness application