Unique Device Identifier (UDI) Labels
Following the Regulations
Medical device manufacturers face increased government regulation and scrutiny. The FDA’s UDI or Unique Device Identifier requirements are now the law for many medical devices in the US, and similar requirements are on the way in the EU and elsewhere. Achieving UDI label compliance is essential.
Vivid Data Group offers convenient, cost-effective UDI label and Life Sciences/Pharmaceutical label solutions. Our goal is to ensure complete UDI compliance while streamlining your labeling process and reducing your total labeling costs. Our premier product, Vivid Solutions for UDI offers next-generation label lifecycle management. With NiceLabel for example, or other label design software applications, business users can design, review, approve and control label data from a simple web application.
Key benefits include:
- Fast, efficient label creation
- Fully automated HIBCC and GS1 barcode creation
- Compliance approval
- Simplified, secure label printing
- Complete audit trail
- Full revision history
- Optimized for FDA 21 CFR Part 11 and EU GMP Annex 11 compliance
Most importantly, we offer a label management system that can adapt quickly to future changes in UDI label regulations.
The 3 Biggest Challenges to UDI Compliance
A Smooth Label Change Management Process
For most medical device companies, the simple logistics of globally pushing out new labels present the largest barrier—and cost—to UDI compliance. With Vivid Solutions for UDI, Vivid Data Group gives you the power of a centralized database so you can create, edit and control label data in minutes. With secure browser-based access and intuitive collaboration tools, you can deploy approved, error-free label changes across your organization in less than a day.
Even the best label management system is no use if the implementation is months away. Vivid Data solutions for UDI is designed for same-day implementation and we offer the support to make it hassle-free. We streamline setup time in several ways:
- Prebuilt connectors to pull data from SAP and Oracle sources
- Web services to integrate NiceLabel with other database connections
- Guided “single source of truth” implementation
You can begin printing new UDI compliant labels within 24 hours of downloading the software.
We make audit preparation automatic—with no need to archive physical paperwork or store copies of labels in separate folders. All label transactions and changes are automatically recorded, sorted and ready for inclusion in FDA audit reports.
Don’t Miss UDI Compliance Deadlines
The FDA’s original UDI rules called for a three-stage rollout, applying UDI requirements to the most urgent categories of medical devices first. The original deadlines were:
- September 24, 2014: Class III devices must carry UDI info on labels & packaging
- September 24, 2016: Class II devices must carry UDI info on labels & packaging
- September 24, 2018: Class I devices must carry UDI info on labels & packaging
- September 24, 2020: Class I devices, and devices that have not been classified into class I, class II, or class III that are required to be labeled with a UDI, must a bear UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use.
Class II and III deadlines have now passed and nearly all devices in these categories must bear UDI-compliant labels. Some manufacturers are letting out a sigh of relief, knowing that their new labels are compliant, while others scramble to change labels and remain competitive. For many, the Class I deadline remains a source of worry.
Your business should not be hobbled by labeling requirements. The technology exists to make UDI label changes easy, cost-effective, and uniform across your enterprise—with a complete audit trail in place. Don’t let labeling changes disrupt your business.