Medical device manufacturers, distributors, and end users are mindful of the September 24, 2023 deadline for complying with unique device identifier (UDI) system requirements for medical devices. The goal is straightforward—to adequately identify devices sold in the United States throughout their lifecycle, with the purpose of promoting safety—but implementation can be complex. Traceability is a key measure for ascertaining the provenance and ensuring the safety of any medical device, whether it is a simple bedpan or a lifesaving artificial heart.

However, implementing UDI identification is not as simple as just sticking a printed barcode on a package. The means and methods of creating a robust system for verifying UDI marking, and preferably automating these functions, often involve significant complexity. Verifying labels in-line as they are generated and off-line once they are in service are key aspects of a UDI system.

This white paper describes UDI labeling requirements and details best practices for how the medical device industry can ensure that marking methods are properly verifiable.

Topics include:

  • UDI system overview
  • Ensuring UDI compliance
  • UDI marking verification approaches
  • UDI verification application example

Download The White Paper

This white paper will discuss the basics of subtractive manufacturing with a focus on waterjet applications.