Custom-made Implants and Additive Manufacturing in the International and European Medical Device Regulations

Abstract

The development and manufacturing of implants is under very restrictive regulations at international or national level. These regulations make sense if we see the fatal consequences of the failure of one implant: 62000 “adverse incidents”, related to medical devices between 2015 and 2018, were reported in the UK. On the other hand, Additive Manufacturing (AM) is a key process to manufacture custom-made implants and prosthesis. The objective of this paper is to understand how the different international regulations, and in particular de European Medical Device Regulation (MDR), deal with the AM custom-made implants for a specific patient and the exemption from the regulatory pathways. The main focus of this study is to see how the concept of custom- made is treated as opposed to mass-produced medical devices, key issue to simplify the process of approval. The conclusion of this analysis is that not all the international and national regulations follow the same directives and, in particular, the European one (MDR 2017/745) requires some clarification due to some confusing wording and no reference to AM or digital manufacturing in the definition of custom-made.