City Research Online

Core Legal Challenges for Medical 3D Printing in the EU

Petterson, A. B. V., Ballardini, R. M., Mimler, M. ORCID: 0000-0002-9457-2506 , Li, P., Salmi, M., Minssen, T., Gibson, I. & Mäkitie,, A. (2024). Core Legal Challenges for Medical 3D Printing in the EU. Healthcare, 12(11), article number 1114. doi: 10.3390/healthcare12111114


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.

Publication Type: Article
Additional Information: © 2024 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (
Publisher Keywords: additive manufacturing; 3D printing; legal issues; legislation; regulation; medical; medicine
Subjects: J Political Science > JN Political institutions (Europe)
K Law
Q Science > QA Mathematics > QA75 Electronic computers. Computer science
R Medicine > RA Public aspects of medicine > RA1001 Forensic Medicine. Medical jurisprudence. Legal medicine
R Medicine > RC Internal medicine
T Technology > TK Electrical engineering. Electronics Nuclear engineering
Departments: The City Law School
The City Law School > Academic Programmes
SWORD Depositor:
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