UDI labeling can identify medical devices through their distribution and use. The deadline for labeling Class 1 and unclassified devices is coming up.
Tim Kearns, Videojet Technologies
A Videojet Wolke m610 oem thermal inkjet printer [Image courtesy of Videojet]
Whether you are expanding the production of medical devices already subject to Unique Device Identification (UDI) requirements or finishing your plan to meet the FDA’s UDI requirements for Class I devices, you’ll want to attain high-resolution printing of variable codes on devices and their packaging. UDI paves the way for traceabilityTo improve medical device traceability, the FDA established the UDI system and implemented it in phases, beginning in 2014. While the agency delayed UDI compliance for Class I and unclassified devices until September 2022, full compliance for medical devices in Class II and III and implantable life-supportin…