UDI Compliance: How Do I Know if My Kit Can Take Advantage of the Convenience Kit Exception?

If you place a UDI on a kit, you do not need to place a UDI on the components in it. However, the manufacturer still needs to have traceability of the components in the kit with the UDI. If there is a problem, the company must know which devices are inside the kit, so it knows which kits to recall. Although this is a UDI exception, medical device manufacturers still need to maintain control, visibility and traceability of the components with the UDI on the kit.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.