A novel approach for increasing the traceability of 3D printed medical products

Abstract

According to the European Medical Device Directive (MDR (EU) 2017/745), medical products of all risk classes are obliged to be labelled with Unique Device Identification Codes (UDI). In order to meet the requirements of the MDR, a novel method of identification for additively manufactured metallic products was developed at the Fraunhofer Institute for Machine Tools and Forming Technology (IWU). The method provides a product traceability within its production process and during the whole product lifespan, and also functions as a counterfeit protection. This paper shows the integration of a unique identification during an additive manufacturing process for a titanium part. The readout of the integrated identification was executed using ultrasonic and eddy current methods, as well as micro computed tomography. Obtained results are discussed in the paper.

Keywords

• mdr
• component identification
• traceability
• barcode
• laser beam melting
• powder bed fusion