Do Medical Device Parts Need a UDI?

A commercially distributed part of a medical device does need a Unique Device Identifier (UDI).  Parts for medical devices used for repairs that are not commercially distributed do not need a UDI.

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.