Simply put, a UDI is a unique device identification. This system was created and is regulated by the FDA (U.S. Food and Drug Administration), and is designed to identify medical devices and their distribution/use through a label/packaging and/or device identifier that is readable by both humans and machines.
What is considered a medical device? Syringes, knee prostheses, dental floss, elastic bandages, pacemakers, cochlear implants, surgical sutures, and examination gloves are medical devices, some of which may come as a surprise. Of course there are many other medical devices, defined by the FDA as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: recognized in the official National Formulary, or the U.S. Pharmacopoeia, or any supplement to them.”
UDI codes must be provided on every medical device subject to regulation, including on the device, label, and package. These codes are required to appear in a plain text form which is readable by humans, as well as machine-readable form. For example, a linear bar code commonly used to provide a UDI code is the GS1-128 which provides the bar code (readable by machine), and includes a numbered code beneath the bars/lines that is readable by humans. A UDI code includes both a device identifier and production identifier. UDI codes are also commonly captured using GS1 DataMatrix codes.
As of this year, UDI marking is required to be present on packaging and labels of devices used to sustain life as well as supporting/implantable devices. This marking must also be present on the same devices mentioned above which are reusable. By 2016, it will be required that a permanent UDI marking is present on both labels and packaging of Class II devices, as well as reusable Class III devices. Class II devices are devices considered the highest risk and therefore subject to the highest level of regulatory control by the FDA.
At REA JET, we understand the importance of choosing the right coding and marking equipment for application of codes on glass, plastic, paperboard, specialty medical packaging and other materials. Learn more about our industrial printing equipment and the many options we offer to a wide array of industries today!