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Selected Legal Aspects of the Process of Developing and Introducing a New Technology for the Needs of Aesthetic Medicine in the Eu Based on the MDR Regulation Cover

Selected Legal Aspects of the Process of Developing and Introducing a New Technology for the Needs of Aesthetic Medicine in the Eu Based on the MDR Regulation

Polish Hyperbaric Research
Volume 90 (2025): Issue 1 (March 2025)
By: Łukasz Remigiusz Kodłubański  
Open Access
|Sep 2025

Authors

Łukasz Remigiusz Kodłubański

lukasz.kodlubanski@ug.edu.pl

Department of Human Rights and Intellectual Property Law, University of Gdańsk, Poland
DOI: https://doi.org/10.2478/phr-2025-0006 | Journal eISSN: 2084-0535 | Journal ISSN: 1734-7009
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Language: English
Page range: 95 - 110
Submitted on: Oct 17, 2024
Accepted on: Nov 25, 2024
Published on: Sep 22, 2025
Published by: Polish Hyperbaric Medicine and Technology Society
In partnership with: Paradigm Publishing Services
Publication frequency: 4 issues per year
Keywords:
article,
clinical trials,
certificate,
Eudamed,
classes,
classification rule,
commission,
doctor,
aesthetic medicine,
medical use,
clinical evaluation,
patient,
safety,
medical entity,
producer,
product,
recipe,
register,
registration,
EU regulation,
technology,
clinical evaluation,
requirements,
classification,
device,
MDR,
MDCG
Related subjects:
Engineering,
Introductions and overviews,
Engineering, other,
Bioengineering and biomedical engineering,
Bionanotechnology,
Medicine,
Clinical medicine,
Hygiene and environmental medicine,
Sports and recreation,
Sports and recreation, other

© 2025 Łukasz Remigiusz Kodłubański, published by Polish Hyperbaric Medicine and Technology Society
This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

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