Many of FDA’s Unique Device Identification requirements have already phased in. The labels and packages of Class III and Class II medical devices, for instance, must now bear a UDI.
“But UDI is not over,” says Ardi Batmanghelidj, President and CEO of Innovatum, a software and regulatory consulting company specializing in life science labeling and Unique Device Identification (UDI) compliance. “In contrast, it is just beginning.
“Although many medical device manufacturers have complied, on-going maintenance for previously submitted UDI data will soon be enforced,” he tells PMP News. “And the regulatory requirements of UDI variants by regulatory bodies around the world will continue to make global UDI compliance a challenge for quite some time.”
Batmanghelidj explains 5 common UDI challenges and potential solutions.
Communication. One of the challenges arises from miscommunication of labeling data. “Most medical device manufacturers inexplicably approach UDI by separating it into two different projects that are managed by two different departments,” Batmanghelidj says. “The labeling team is responsible for UDI data on the label, and the UDI team is responsible for UDI data management and submissions. Yet, most of the data overlaps and must be kept in sync! Think of a row in an Excel spreadsheet that contains fields with labeling specific data for an item. Now think of adding additional columns to house regulatory data within that same row. Since some of the data within that row is placed upon sticky labels and some of that very same data is also being submitted to regulatory bodies, this data can be stored once and reused. This ensures data quality. The problem of having to prevent a likely mismatch between the information that is submitted and the information used on the label is now gone. With an extension to what is traditionally considered to be enterprise labeling software, it is now possible to bring these capabilities to life.”