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If a Device Does Not Require DM, is it Acceptable to Only Have the UDI on the Package Label?

The Unique Device Identification (UDI) must always be carried on the product label - so it depends on whether the information on the device constitutes a label. The Direct Mark (DM) requirements only come into play if your device meets the criteria for direct marking.

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.


  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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