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Title: Custom-made Implants and Additive Manufacturing in the International and European Medical Device Regulations
Authors: Monzón Verona, Mario Domingo 
Paz Hernández, Rubén 
Bordón Pérez, Pablo Rubén 
Donate González, Ricardo 
Garcia Montagut, Carlos Joshua 
Vega Rodríguez, Gisela Del Carmen 
UNESCO Clasification: 3313 Tecnología e ingeniería mecánicas
Issue Date: 2024
Project: Nuevos Scaffolds Piezoeléctricos de Compuestos Nanoestructurados Para la Regeneración Ósea Mediante Fabricación Aditiva 
Conference: 2nd International Conference on Cells and Extracellular Templates (CET 2023)
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.
Source: The Organizing Committee ofthe 2nd Intemational -Coi.lference on Cells and Extracellular Te~plates {CET 20~) / Round table: Sc ience, l ndustry and Politics - CHAIR : Prof. lulian Antoniac. Rome, Italy, from 7fh to 9th of ]une 2023
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