UDI deadline

The Class II UDI deadline is past. Enterprise labeling is the future.

Susan Gosnell Medical Devices

Last month, the UDI deadline for Class II devices came and went and many medical device manufacturers breathed a collective sigh of relief.  Others are taking advantage of the extension for convenience kits and repackaged single-use devices, or still working to get their labeling and data organized for GUDID submission.

Last week, at the Medical Device Labeling Conference in Phoenix, Arizona, medical device manufacturers, the FDA, academia and representatives from standards committees came together and shifted focus from meeting UDI requirements to topics like translation and localization, 3rd party supplier labeling and how to get the most out of a corporate labeling team.

A popular topic of discussion was enterprise labeling. Medical device manufacturers are keen to understand how enterprise labeling systems can streamline their supply chain and improve productivity, but the thought of a complex implementation has them nervous. How can they reap the benefits of this kind of system while keeping the budget and deployment schedule in check?

UDI labeling implementation tips

One company shared their implementation story and lessons learned on meeting the UDI deadline. They suggested a few tips that I thought were noteworthy:

  • Know what’s important to your company regarding enterprise labeling
  • Get corporate buy-in
  • Analyze the current situation and determine core labeling needs
  • Understand how existing business systems impact decisions
  • Determine a business systems owner
  • Be ready to blend manufacturing needs, IT constraints and labeling requirements

If you want to learn more about how an enterprise labeling system can drive print productivity, download NiceLabel’s enterprise white paper.  For those still working on UDI compliance, check out NiceLabel’s UDI Guide.

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