Top 3 challenges with UDI Compliance for Medical Devices

by Craig Hodgson, on September 11, 2017

This month, Sept. 24th to be exact, is the FDA deadline for labelers of soft contact lenses to comply with the Unique Device Identification (UDI) system for class II and III soft contact lens devices. With this impending deadline, we thought it might be good to revisit three of the key challenges that all medical device manufacturers face in meeting UDI labeling requirements—and not just as it relates to FDA compliance, but global regulations, too.  

Of course, a number of the deadlines for UDI in the medical device sector have come and gone, but challenges remain. Adoption and effective usage of medical device labeling solutions are far from universal, and device-makers today face a variety of issues keeping them from sustaining long-term compliance while driving supply chain efficiency. It's important to note what these hurdles are and find ways around them.

1. A lack of standardized software
In August 2016, just over a month before the deadline passed for implementation of UDI requirements, Modern Healthcare reported more than 70 percent of device-makers did not possess a single, unified labeling solution for all their operations. Using a disorganized or patchwork labeling solution could keep organizations from comfortably meeting UDI standards.

2. Cost concerns
Manufacturers may be holding back their programs because of a worry about the immediate costs. Medical Device and Diagnostic Industry noted that the potential price tag attached to ensuring compliance has the ability to frighten company leaders. This is a fear they must overcome, however, as the news provider pointed out that the long-term price of noncompliance is larger.

3. Physical challenges
If the actual codes comprising a UDI system aren't up to standards, the whole project may be disappointing. Packaging Digest reported that printing and reading barcodes can prove problematic, especially because of the wide variability of devices that need codes applied to them. High-quality tech will be required to bridge this gap.

While the aforementioned issues are a persistent problem for many medical device manufacturers, these companies should resist the urge to put together slapdash or half-formed solutions. A much better approach is creating a fully formed and standardized program that will act as a long-term solution. Think of it as enterprise labeling best practices. Register for Loftware's webinar on this topic to learn more.

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Topics:Medical DevicesRegulatory