Medical Device Traceability

Efficiently track and trace medical devices with image-based barcode readers

The United States Food and Drug Administration (FDA) Unique Device Identifier (UDI) mandate and the European Commission Medical Device and In Vitro Diagnostic Regulations (MDR/IVDR) require the use of UDI systems to provide a traceable trail of information about each medical device. All medical devices, cases, and pallets use a 1D or 2D code to simplify identification and data capture and must be read quickly and accurately for maximum efficiency and throughput.

After the marking or label printing process, codes can be low contrast or damaged, recessed, marked on shiny or white surfaces, or printed under shrink-wrap that makes them hard to track and trace. This can result in delayed production, costly reprints, and scrappage.

Cognex image-based barcode readers use patented decoding algorithms to quickly and reliably decipher codes on high-speed production lines, recessed parts, multiple sides of packages, at extreme angles, and from extended ranges. Cognex barcode readers decode even the most damaged, distorted, blurred, or low contrast barcodes, delivering industry-leading 99.9% read rates. With large depth-of-field and wide field-of-view coverage, Cognex barcode readers can even read multiple codes simultaneously on aggregated boxes or pallets. Fixed-mount and handheld barcode readers have the speed and accuracy to ensure medical devices of all shapes and sizes are properly scanned and can be easily identified and located in the event of a product recall.