Does the UDI Extension for Some Implantable Devices Apply to Implants Distributed in Sterile Form?

The Unique Device Identification (UDI) extension for some implantable devices only applies to devices distributed that are intended to be taken out of their package and sterilized before use, for example sets, trays and caddies.  Implants that remain in their sterile packing (class II and II) until use still have their original compliance deadlines.

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.