UDI Labeling Compliance

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.

The FDA website has more information about the benefits of UDI labeling and a timetable for compliance dates. Also read our blog “4 Things You Should Know About UDI Compliance.”

Using UDIs

Each UDI consists of two numeric or alphanumeric parts:

  • The device identifier (DI) is assigned by one of three FDA-accredited issuing agencies and includes unique numbers indicating the manufacturer and the specific model or version of the device.
  • The production identifier (PI) includes information such as lot or batch number, serial number, and manufacture or expiration dates.

Regulations give manufacturers some flexibility when they choose how best to incorporate this information on their labels, as long as it is readable both by human eyes (in plain text) and by automatic identification and data capture (AIDC) technology. Several types of 1D and 2D barcodes or RFID tags are acceptable, depending on product type and package size.

Find UDI-Compliant Solution Options at Miles Data

Miles Data offers several solutions that can address your UDI labeling requirements:

  • Printers: We provide a wide range of printers that can produce the barcodes or RFID tags you need, providing crisp UDI labels that are durable and easily machine-readable. Our thermal transfer solutions offer the full breadth and depth of printing on a wide variety of specialized substrates. In addition, Miles Data provides full color on-demand label printing solutions from Epson for applications where the need for dynamic color is required or desired.
  • Software: Miles Data can advise you on the best enterprise labeling software to facilitate compliance with FDA standards, in addition to making label production and management easier. For example, our partner TEKLYNX offers TEKLYNX CENTRAL CFR, which is designed to facilitate FDA label compliance.
  • Labels and Tags: We carry a wide selection of labels, including custom media options, to fit UDI needs. In many cases, UDI labels must be able to withstand extreme environments. Our specialized labels can withstand sterilization, hold up against cleaning agents used in hospitals, last the life of product disposal, and meet UL standards.

Interested in learning more or have questions?