A clarion call for understanding regulatory processes for additive manufacturing in the health sector.

Introduction: As Additive Manufacturing (AM) in the health sector evolves to the point where products can be translated into the clinic, these manufactured goods need to be assessed by regulators in order for such products to be manufactured, sold, and used in accordance with the law. In this article, the authors argue that if AM products in the health sector are to be regulated in the near future, stakeholders involved in translational research need to understand the challenges faced by both regulators and industry. We portray different points of possible dissonance for AM medical products with existing regulatory frameworks. Hence, we advocate for stakeholders to proactively provide solutions for regulatory processes for products emerging from AM in the health sector.

Areas Covered: The publication discusses the need for clear definitions and standards to enable translation of AM research into the health sector. Key literature around legal and regulatory challenges applicable to this topic was synthesized.

Expert Opinion: We argue that stakeholders need to develop regulatory-rooted risk profiles of the respective AM medical products. The terminology must be defined clearly and used consistently. Standards need to be designed for the purpose of advancing regulatory processes.