Connole Kieran, McDermott Olivia
College of Science and Engineering, University of Galway, Galway, Ireland.
Ther Innov Regul Sci. 2025 Jun 17. doi: 10.1007/s43441-025-00812-z.
In the past decade, additive manufacturing has been applied to mainstream medical devices, particularly in the orthopaedic sector across the hip, knee and shoulder segments for implants and instruments. The research aimed to determine the level of knowledge regarding the regulatory requirements for additive manufactured devices in the Irish Orthopedic medical device sector as well as the challenges faced by orthopedic medical devices manufacturers in interpreting and implementing the current regulatory guidance in the US and the EU. The findings were that there is a lack of knowledge regarding additive manufacturing across the orthopaedic medical device sector and education is required to address this knowledge gap. Furthermore, while the United States has produced specific additive manufacturing guidance, many of the respondents surveyed stated that further clarity is required in this document to remove ambiguity and unclear interpretations of the document. However, in the European Union, there is no support for the use of additive manufacturing as no specific guidance has been provided. This is the first study of its kind on awareness of additive manufacturing regulations. The output of this research is that the Irish orthopaedic medical device sector needs to educate and support its sector members in gaining experience with additive manufacturing in order to ensure that these devices can be commercialised in a timely fashion.
在过去十年中，增材制造已应用于主流医疗设备，尤其是在髋关节、膝关节和肩关节等骨科领域的植入物和器械方面。该研究旨在确定爱尔兰骨科医疗器械行业对增材制造设备监管要求的了解程度，以及骨科医疗器械制造商在解读和实施美国和欧盟现行监管指南时所面临的挑战。研究结果表明，骨科医疗器械行业对增材制造缺乏了解，需要开展教育以弥补这一知识差距。此外，虽然美国已出台了特定的增材制造指南，但许多接受调查的受访者表示，该文件需要进一步明确，以消除其中的模糊性和对文件的不明解读。然而，在欧盟，由于未提供具体指南，增材制造的使用得不到支持。这是同类关于增材制造法规认知的首次研究。本研究的成果是，爱尔兰骨科医疗器械行业需要对其行业成员进行教育并提供支持，以积累增材制造方面的经验，从而确保这些设备能够及时实现商业化。
