Unique Device Identification: Are You Ready?

In less than a year, class III medical devices will need to have a Unique Device Identification (UDI) on them. The deadline means manufacturers of class III devices will soon need to comply with the FDA’s new UDI rule.  Deadlines for class II and class I devises take effect on a progressive basis over the next five years.

The UDI regulations will impact many aspects of medical device businesses.  Companies will be required to integrate the UDI into their information systems, submit product information to the Global Unique Identification Database (GUDID), and train employees.

For many medical device companies, developing solutions to comply with UDI requirements is complicated. For example, some of the world’s largest medical device companies have more than one thousand devices and sometimes dozens of versions of each one.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of 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 Life Sciences 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 database. Also, USDM experts ensure that all changes and enhancements are implemented under the governing GMP regulations, under change control and validated prior to release for production.