Regulations that Govern the Labeling and Identification of Medical Devices
Each medical device must have a Unique Device Identifier (UDI) on all levels of packaging including shipping boxes or crates. For device that can be used multiple times, the UDI must also be directly marked on the device itself. UDIs enable healthcare providers to collect device performance data, accurately track hospital inventory, track devices in the event of a recall, and reduce the risk of unapproved or counterfeit devices.
Ever since the FDA published its final rule in 2013 for labeling medical devices, manufacturers have been challenged to find the right solutions that address their particular products and that keep them in UDI labeling compliance.