Comparison of the regulatory requirements for custom-made medical devices using 3D printing in Europe, the United States, and Australia

Abstract Additive manufacturing (AM) has continuously grown in recent decades. Enhanced quality, further development of technology, and fall in prices make AM applicable and capable for various industrial applications, also for the manufacture of medical devices. 3D printing offers the possibility for an unprecedented adaptation to the anatomy of each patient, generating medical devices on a case-by-case basis. In many jurisdictions, custom-made devices qualify for an exemption to pre-market approval standards. This regulation is called into question by new technologies, like AM. Therefore, this article compares the current regulatory requirements for custom-made devices in Europe, the United States, and Australia and discusses the impact on 3D printed devices. It concludes that not all jurisdictions have yet adjusted their regulatory framework for custom-made devices to technological advances. Remaining uncertainties must be eliminated in order to help manufacturers comply with the regulatory requirements, emphasizing key aspects of AM.