TY - JOUR
T1 - Core Legal Challenges for Medical 3D Printing in the EU
AU - Pettersson, Ante
AU - Ballardini, Rosa Maria
AU - Mimler, Marc
AU - Li, Phoebe
AU - Salmi, Mika
AU - Minssen, Timo
AU - Gibson, Ian
AU - Mäkitie, Antti
PY - 2024/5/29
Y1 - 2024/5/29
N2 - 3D printing has been adopted into routine use for certain medical applications. Yet, more widespread usage has been hindered by, among other things, unclear legislation. Using legal doctrinal study and legal informatics, we analyzed relevant EU legislation and case law relating to four issues relevant to medical 3D printing (excluding bioprinting or pharma-coprinting): 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. Recognizing the need to establish high safety standards in order to protect patients, we identify both legal uncertainties and overly restrictive legislation as key factors harmful to innovation. Hence, more adaptive legislation is called for to ensure continuous innovation efforts and enhanced patient outcomes.
AB - 3D printing has been adopted into routine use for certain medical applications. Yet, more widespread usage has been hindered by, among other things, unclear legislation. Using legal doctrinal study and legal informatics, we analyzed relevant EU legislation and case law relating to four issues relevant to medical 3D printing (excluding bioprinting or pharma-coprinting): 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. Recognizing the need to establish high safety standards in order to protect patients, we identify both legal uncertainties and overly restrictive legislation as key factors harmful to innovation. Hence, more adaptive legislation is called for to ensure continuous innovation efforts and enhanced patient outcomes.
KW - Faculty of Law
KW - 3 D printing
KW - Additive manufacturing
KW - Intellectual Property Law
KW - Regulation
KW - legislation
KW - medicine
KW - healthcare
KW - medical
UR - https://www.mdpi.com/2227-9032/12/11/1114
U2 - https://doi.org/10.3390/healthcare12111114
DO - https://doi.org/10.3390/healthcare12111114
M3 - Journal article
VL - 12
SP - 1114
JO - Healthcare
JF - Healthcare
SN - 2227-9032
IS - 11
ER -