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

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 regulatory guidance in the US and the EU. The findings were that there is a lack of knowledge regarding additive manufacturing across the orthopaedic medical device sector and education is required to address this knowledge gap. Furthermore, while the United States has produced specific additive manufacturing guidance, many of the respondents surveyed stated that further clarity is required in this document to remove ambiguity and unclear interpretations of the document. However, in the European Union, there is no support for the use of additive manufacturing as no specific guidance has been provided. This is the first study of its kind on awareness of additive manufacturing regulations. The output of this research is that the Irish orthopaedic medical device sector needs to educate and support its sector members in gaining experience with additive manufacturing in order to ensure that these devices can be commercialised in a timely fashion.