Core Legal Challenges for Medical 3D Printing in the EU

Ante Pettersson, Rosa Ballardini, Marc Mimler, Phoebe Li, Mika Salmi, Timo Minssen, Ian Gibson, Antti Mäkitie

Research output: Contribution to journalArticleScientificpeer-review

1 Citation (Scopus)

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 languageEnglish
Article number1114
JournalHealthcare
Volume12
Issue number11
DOIs
Publication statusPublished - 29 May 2024
MoEC publication typeA1 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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