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添加剂制造医疗器械监管审批的挑战:一个定量调查

Kieran Connole¹, Olivia McDermott²

¹College of Science and Engineering, University of Galway, Galway, Ireland.

Therapeutic innovation & regulatory science

|June 17, 2025

概括

在爱尔兰的骨科行业,关于增材制造 (AM) 规定存在知识差距. 需要教育和更明确的指导,以便及时商业化AM医疗器械.

科学领域:

医疗器械规则医疗器械规则
添加剂制造添加剂制造添加剂制造
整形技术整形技术

背景情况:

增材制造 (AM) 越来越多地用于骨科植入物和仪器.
爱尔兰的骨科行业面临着与AM监管合规性相关的挑战.
美国和欧盟现有的监管指南需要澄清和发展.

研究的目的:

评估爱尔兰骨科医疗器械行业对AM监管要求的了解.
确定解释和实施当前美国和欧盟对AM设备的监管指导的挑战.
为AM骨科器械的及时商业化提供见解.

主要方法:

对爱尔兰的骨科医疗器械制造商进行调查.
分析美国和欧盟当前的监管指导.
对知识差距和实施挑战的定性评估.

主要成果:

爱尔兰骨科行业内对AM法规的知识严重缺乏.
美国的指导要求进一步澄清以减少模两可.
欧盟目前缺乏具体的指导,阻碍了AM的采用.

结论:

教育和部门支持对于爱尔兰骨科行业采用AM至关重要.
在全球范围内,对AM医疗器械需要更明确,更具体的监管指导.
解决这些差距将促进创新骨科解决方案的及时商业化.

关键词:

通过3D打印打印3D打印.增材制造增材制造是一种增材制造.医疗器械医疗器械医疗器械整形医疗器械整形医疗器械

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