For Class II DPM That Are Due In 2018, Would The Labeling (Carton, Etc) Used For This Product Need To Be Compliant In 2016 Or Would It Be On The Same Timeline As DPM – 2018?

The labeling UDI requirements are independent of the DM requirements. Therefore all Class II items, whether DM is required or not, must have their labels compliant by Sep. 24, 2016. The DM 'label' is not required to be compliant until Sep. 24, 2018 to allow additional time for implementation.

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.