Regulatory and standards development in medical additive manufacturing

Regulations and associated standards are crucial for any emerging technologies as it matures and gains broader acceptance. Additive manufacturing (AM) is one such emerging technology that revolutionizes the way we manufacture parts in a range of industries. The healthcare industry was one of the early adopters of AM technology, identifying its unique capabilities to allow mass device personalization and complex structures. Since health care is a highly regulated industry, the capability demonstration of AM technology alone is insufficient to provide confidence in the use of parts produced using this technology. The safety and efficacy of the parts made by AM are demonstrated and approved through a regulatory framework supported by robust standards. This article reviews the regulatory and standard development activities in AM applied to medical devices. The progress in developing the regulatory framework for additively manufactured medical devices across different geographic domains is discussed. In addition, standards gaps and published standards that apply to AM medical devices are highlighted. Graphical abstract