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

Author

Listed:
  • Joala Kätlin

    (Legal analyst, Ministry of Foreign Affairs of Estonia linkedin.com/in/katlinjoala)

  • Kerikmäe Tanel

    (Professor of European Legal Policy, Law & Technology, School of Business and Governance, Tallinn University of Technology (Estonia) and Senior Researcher at Faculty of Law, Palacký University Olomouc (Czech Republic).)

  • Hamuľák Ondrej

    (Senior Researcher at Faculty of Law, Palacký University Olomouc (Czech Republic) and Adjunct Professor in EU Strategic Legal Affairs, School of Business and Governance, Tallinn University of Technology (Estonia).)

  • Kocharyan Hovsep

    (PhD researcher at the Department of International and European Law, Faculty of Law, Palacký University Olomouc (Czech Republic).)

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.

Suggested Citation

  • Joala Kätlin & Kerikmäe Tanel & Hamuľák Ondrej & Kocharyan Hovsep, 2023. "Legal Framework for digital therapeutics (DTx) in the European Union," European Studies - The Review of European Law, Economics and Politics, Sciendo, vol. 10(2), pages 98-123.
    • Handle: RePEc:vrs:eurstu:v:10:y:2023:i:2:p:98-123:n:1005
    DOI: 10.2478/eustu-2023-0014
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