The Challenges in the Regulatory Approval of Additive-Manufactured Medical Devices: A Quantitative Survey.

Abstract

In the past decade, additive manufacturing has been applied to mainstream medical devices, particularly in the orthopaedic sector across the hip, knee and shoulder segments for implants and instruments. The research aimed to determine the level of knowledge regarding the regulatory requirements for additive manufactured devices in the Irish Orthopedic medical device sector as well as the challenges faced by orthopedic medical devices manufacturers in interpreting and implementing the current reg