As applications of three-dimensional (3D) printed medical products are being translated into clinical practice, stakeholders are increasingly concerned about whether current regulatory frameworks are able to regulate such products. With more additive manufacturing (AM) and 3D printed medical products being brought into clinical use and the assumption that usage will be more widespread in the future, a (perceived) lack of or inadequacy of regulation by some stakeholders is often depicted as a hindrance to the comprehensive translation of AM and 3D printed medical products into clinical use. This article addresses this uncertainty by analyzing existing medical product regulations and their applicability to AM and 3D printed medical products to assess the degree of regulatory oversight they administer. It concludes that there are specific legal questions that need to be clarified, but the products are not expected to “disrupt” existing legal frameworks.

中文翻译：

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不确定但并非不受监管：从三维打印医疗产品看医疗产品监管

随着三维 (3D) 打印医疗产品的应用正在转化为临床实践，利益相关者越来越关注当前的监管框架是否能够监管此类产品。随着越来越多的增材制造 (AM) 和 3D 打印医疗产品被投入临床使用，并且假设未来使用会更加广泛，一些利益相关者（认为）缺乏或不充分的监管通常被描述为阻碍将 AM 和 3D 打印医疗产品全面转化为临床应用。本文通过分析现有医疗产品法规及其对 AM 和 3D 打印医疗产品的适用性来评估其管理的监管监督程度，从而解决了这种不确定性。