Laser Marking of Medical Products for UDI Compliance

This technical report discusses the implementation of laser marking for medical products by Oertli Instrumente AG, a Swiss manufacturer specializing in ophthalmic surgery instruments. The report outlines the challenges faced in complying with the European UDI (Unique Device Identification) regulations, which mandate that medical devices be marked with a data matrix code for traceability. It details the collaboration between Oertli and TRUMPF, which provided laser marking technology and expertise. The report describes the initial feasibility studies, the adaptation of laser marking techniques to meet UDI specifications, and the development of software to facilitate marking on various surface types. The use of ultrashort pulse lasers for achieving high-contrast, corrosion-resistant markings is highlighted, showcasing the technical advancements made to ensure compliance with the new regulations. The report emphasizes the importance of these markings for patient safety and the proactive approach taken by Oertli in addressing regulatory challenges.