FOBA Laser Marking + Engraving: UDI Marking Regulation Update for Medical Devices

FOBA Laser Marking + Engraving, a specialist in laser marking and engraving solutions, has provided insights into the requirements for Unique Device Identification (UDI) marking on medical devices, instruments, and implants. The company organized a webinar in April 2020 to discuss the regulatory landscape and technical implementation of the UDI system.

The UDI system aims to enhance product traceability, combat counterfeiting, and improve patient safety. In the European Union, UDI is governed by the Medical Device Regulation (MDR), while the U.S. Food and Drug Administration (FDA) oversees it in the United States. Despite the U.S. already having the system in place, manufacturers have often faced challenges understanding the implementation of the MDR for the European market.

The webinar, hosted by Christian Söhner, Global Vertical Manager Medical at FOBA, covered the current status of UDI direct marking and provided an overview of the UDI system according to MDR and FDA. Attendees learned about the significance of the UDI code, technical implementation considerations, aspects of readability and code size, and how to achieve process reliability in direct marking.

Due to the COVID-19 pandemic, the official start date for the EU's UDI regulation was postponed from May 2020 to 2021. FOBA will continue to share expertise on laser marking solutions through webinars and other publications.