Regulatory Considerations for Devices Manufactured Using Additive Manufacturing Technologies

Abstract

This chapter reviews the regulatory framework for medical devices manufactured using additive manufacturing technologies in various countries and regions. The medical device regulations and guidelines published by these countries stipulate the specific regulatory requirements which medical device manufacturers must fulfil in order to bring their devices into the market. This chapter reviews the current regulations concerning, in particular, CE marking and US FDA regulation, and provides an overview of the Australian, Canadian, Brazilian and Japanese regulations. The review discusses routes of conformity for medical devices, device classification requirements and considerations when making changes to mass-produced medical devices. The methods which manufacturers can use to bring devices, such as custom-made medical devices, to the market will also be outlined. The review found that a regulatory framework currently exists to bring devices manufactured using additive manufacturing technologies to market. This framework, however, is more evolved in some countries in comparison to others, in particular, in relation to testing considerations for devices manufactured using such practices. Additionally, clarity would prove beneficial for manufacturers in relation to, for example, specific regulatory guidance documents from the regulatory authorities.