Legal Framework for digital therapeutics (DTx) in the European Union
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F61989592%3A15220%2F23%3A73625362" target="_blank" >RIV/61989592:15220/23:73625362 - isvavai.cz</a>
Result on the web
<a href="https://reference-global.com/article/10.2478/eustu-2023-0014" target="_blank" >https://reference-global.com/article/10.2478/eustu-2023-0014</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.2478/eustu-2023-0014" target="_blank" >10.2478/eustu-2023-0014</a>
Alternative languages
Result language
angličtina
Original language name
Legal Framework for digital therapeutics (DTx) in the European Union
Original language description
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.
Czech name
—
Czech description
—
Classification
Type
J<sub>SC</sub> - Article in a specialist periodical, which is included in the SCOPUS database
CEP classification
—
OECD FORD branch
50501 - Law
Result continuities
Project
<a href="/en/project/GA20-27227S" target="_blank" >GA20-27227S: The Advent, Pitfalls and Limits of Digital Sovereignty of the European Union</a><br>
Continuities
P - Projekt vyzkumu a vyvoje financovany z verejnych zdroju (s odkazem do CEP)
Others
Publication year
2023
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
European Studies – The Review of European Law, Economics and Politics
ISSN
1805-8809
e-ISSN
2464-6695
Volume of the periodical
10
Issue of the periodical within the volume
2
Country of publishing house
CZ - CZECH REPUBLIC
Number of pages
26
Pages from-to
98-123
UT code for WoS article
—
EID of the result in the Scopus database
2-s2.0-85199036061