Core Legal Challenges for Medical 3D Printing in the EU

Research output: Contribution to journal › Journal article › Research › peer-review

Standard

Core Legal Challenges for Medical 3D Printing in the EU. / Pettersson, Ante ; Ballardini, Rosa Maria ; Mimler, Marc; Li, Phoebe; Salmi, Mika; Minssen, Timo; Gibson, Ian; Mäkitie, Antti.

In: Healthcare, Vol. 12, No. 11, 29.05.2024, p. 1114.

Research output: Contribution to journal › Journal article › Research › peer-review

Harvard

Pettersson, A, Ballardini, RM, Mimler, M, Li, P, Salmi, M, Minssen, T, Gibson, I & Mäkitie, A 2024, 'Core Legal Challenges for Medical 3D Printing in the EU', Healthcare, vol. 12, no. 11, pp. 1114. https://doi.org/10.3390/healthcare12111114

APA

Pettersson, A., 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, 12(11), 1114. https://doi.org/10.3390/healthcare12111114

Vancouver

Pettersson A, Ballardini RM, Mimler M, Li P, Salmi M, Minssen T et al. Core Legal Challenges for Medical 3D Printing in the EU. Healthcare. 2024 May 29;12(11):1114. https://doi.org/10.3390/healthcare12111114

Author

Pettersson, Ante ; Ballardini, Rosa Maria ; Mimler, Marc ; Li, Phoebe ; Salmi, Mika ; Minssen, Timo ; Gibson, Ian ; Mäkitie, Antti. / Core Legal Challenges for Medical 3D Printing in the EU. In: Healthcare. 2024 ; Vol. 12, No. 11. pp. 1114.

Bibtex

@article{c2318c2554d74249876b25670a68b0b7,
title = "Core Legal Challenges for Medical 3D Printing in the EU",
abstract = "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.",
keywords = "Faculty of Law, 3 D printing, Additive manufacturing, Intellectual Property Law, Regulation, legislation, medicine, healthcare, medical",
author = "Ante Pettersson and Ballardini, {Rosa Maria} and Marc Mimler and Phoebe Li and Mika Salmi and Timo Minssen and Ian Gibson and Antti M{\"a}kitie",
year = "2024",
month = may,
day = "29",
doi = "https://doi.org/10.3390/healthcare12111114",
language = "English",
volume = "12",
pages = "1114",
journal = "Healthcare",
issn = "2227-9032",
publisher = "M D P I AG",
number = "11",

}

RIS

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 -

ID: 392717083