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医疗3D打印在欧盟的核心法律挑战

Ante B V Pettersson1,2, Rosa Maria Ballardini3, Marc Mimler4

  • 1Department of Otorhinolaryngology-Head and Neck Surgery, University of Helsinki and Helsinki University Hospital, FI-00029 HUS, Helsinki, Finland.

Healthcare (Basel, Switzerland)
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概括

不明确的立法阻碍了医疗3D打印的采用. 分析显示,欧盟法规不灵活,创造了法律不确定性,尽管有患者安全需求,但杀了创新. 适应性法律对于进步至关重要.

关键词:
通过3D打印打印3D打印.添加剂制造 添加剂制造 添加剂制造法律问题 法律问题在法律上,立法就是立法.医疗 医疗 医疗 医疗医学 医学 医学 医学 医学监管 监管 监管 监管 监管 监管

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科学领域:

  • 医疗技术法 医疗技术法 法律
  • 监管科学 监管科学

背景情况:

  • 3D打印越来越多地用于医学,但其更广泛的采用面临监管障碍.
  • 现有立法对医疗3D打印的实施提出了挑战.

研究的目的:

  • 分析影响医疗3D打印的欧盟 (EU) 立法和判例.
  • 确定关键领域的法律空白和不确定性:市场前批准,市场后责任,知识产权和数据保护.

主要方法:

  • 使用了法律教义研究和法律信息学.
  • 分析重点是欧盟立法和有关医疗3D打印 (不包括生物打印/药品打印) 的相关判例.

主要成果:

  • 在当前的欧盟监管框架中发现了重大差距和不确定性.
  • 欧盟现有的监管方法具有限制性,不灵活,过于谨慎的特点.
  • 发现法律模两可和过度监管都阻碍了医疗3D打印领域的创新.

结论:

  • 目前欧盟对医疗3D打印的监管框架需要调整.
  • 需要更灵活,更适应的立法来促进创新和改善患者的治疗结果.
  • 平衡患者安全与持续创新的需求是必不可少的.