Core Legal Challenges for Medical 3D Printing in the EU

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Journal Title
Journal ISSN
Volume Title
A1 Alkuperäisartikkeli tieteellisessä aikakauslehdessä
Date
2024-06
Major/Subject
Mcode
Degree programme
Language
en
Pages
19
Series
Healthcare (Switzerland), Volume 12, issue 11
Abstract
3D printing has been adopted into routine use for certain medical applications, but more widespread usage has been hindered by, among other things, unclear legislation. We performed an analysis, using legal doctrinal study and legal informatics, of relevant EU legislation and case law in four issues relevant to medical 3D printing (excluding bioprinting or pharmacoprinting): pre-market approval, post-market liability, intellectual property rights, and data protection. Several gaps and uncertainties in the current legislation and interpretations were identified. In particular, we regard the current EU regulatory framework to be quite limiting and inflexible, exemplifying a cautionary approach common in EU law. Though the need to establish high safety standards in order to protect patients as a disadvantaged population is understood, both legal uncertainties and overregulation are seen as harmful to innovation. Hence, more adaptive legislation is called for to ensure continuous innovation efforts and enhanced patient outcomes.
Description
Publisher Copyright: © 2024 by the authors.
Keywords
3D printing, additive manufacturing, legal issues, legislation, medical, medicine, regulation
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Citation
Pettersson, A B V, Ballardini, R M, Mimler, M, Li, P, Salmi, M, Minssen, T, Gibson, I & Mäkitie, A 2024, ' Core Legal Challenges for Medical 3D Printing in the EU ', Healthcare (Switzerland), vol. 12, no. 11, 1114 . https://doi.org/10.3390/healthcare12111114