Pettersson Ante B V, Ballardini Rosa Maria, Mimler Marc, Li Phoebe, Salmi Mika, Minssen Timo, Gibson Ian, Mäkitie Antti
Department of Otorhinolaryngology-Head and Neck Surgery, University of Helsinki and Helsinki University Hospital, FI-00029 HUS, Helsinki, Finland.
Department of Vascular Surgery, University of Helsinki and Helsinki University Hospital, 00100 Helsinki, Finland.
Healthcare (Basel). 2024 May 29;12(11):1114. doi: 10.3390/healthcare12111114.
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.
3D打印已在某些医疗应用中被常规使用,但除其他因素外,立法不明确阻碍了其更广泛的应用。我们运用法律教义学研究和法律信息学,对欧盟相关立法及判例法在与医疗3D打印(不包括生物打印或药物打印)相关的四个问题上进行了分析:上市前批准、上市后责任、知识产权和数据保护。我们发现了现行立法及解释中存在的一些差距和不确定性。特别是,我们认为当前的欧盟监管框架相当具有局限性且缺乏灵活性,这体现了欧盟法律中常见的谨慎态度。虽然理解为保护作为弱势群体的患者而建立高安全标准的必要性,但法律不确定性和过度监管都被视为对创新有害。因此,需要更具适应性的立法,以确保持续的创新努力并改善患者治疗效果。