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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.
Original language | English |
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Article number | 1114 |
Journal | Healthcare |
Volume | 12 |
Issue number | 11 |
DOIs | |
Publication status | Published - 29 May 2024 |
MoEC publication type | A1 Journal article-refereed |
Keywords
- 3D printing
- additive manufacturing
- legal issues
- legislation
- medical
- medicine
- regulation
Field of science
- Law
- Mechanical engineering
- Medical engineering
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- 1 Active
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VBM 2: Bio-oils based polymeric composites; value chain from synthesis to additive manufacturing
Ballardini, R. (Principal Investigator), Vesala, J. (Other), Salami, E. (Other), Kaunisvaara, M. (Other) & Casi, C. (Other)
01.09.2022 → 31.08.2025
Project: Co-funded project