Practical regulatory guidance for researchers manufacturing customized 3D (three-dimensional) - printed medical devices.

INTRODUCTION: Often used interchangeably with 'additive manufacturing,' 3D printing involves creating a three-dimensional (3D) object from a digital model, by building successive layers of raw material.By adding material to only where it is needed, 3D printing has the potential to save considerable resources compared to 'subtractive manufacturing' which involves removing the excessive materials to make the necessary part.In addition to cost-savings, 3D printing offers flexibility in design and the possibility of personalizing a 3D-printed object to a patient's anatomy. Some of the potential applications of personalized 3D-printed devices include custom-made surgical instruments, guides, and implants. AREAS COVERED: The UK Medical Device Regulations (MDR) 2002, UK Medical Device Amendment Regulations (MDAR) 2026 (draft), the EU Medical Device Regulation (MDR) 2017/745, and Federal Food, Drug, and Cosmetic Act provide comprehensive guidance and regulations for medical devices However, there is currently a knowledge gap, where researchers of 3D-printed customized medical devices lack complete understanding of the need for regulation, and step-by-step guidance specific to the field. This article provides practical guidance for researchers manufacturing customized 3D-printed medical devices. EXPERT OPINION: Artificial intelligence (AI) is likely to be a major aid for researchers and device manufacturers for completing applications in different jurisdictions.