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

How UDI Labeling Works

Every medical device must carry a unique UDI code similar to a serial number. These codes are issued by specific agencies accredited by the FDA. Generally, new versions of any medical device must carry a new UDI so that the different versions can be told apart, even if they are substantively similar. As the UDI deadlines pass, virtually all medical devices in the US must carry them.

UDI regulations include rules about the UDI code itself and its labeling:

The UDI Code: This is a numeric or alphanumeric code unique to each medical device. The code consists of two parts. The first part is mandatory and is known as the DI (“device identifier”). The second part is conditional and can carry a variety of product information, such as the lot or batch number, the device’s expiration date, its date of manufacture, or more.
UDI Labeling: The UDI must be printed in both an “automatic identification and data capture” form (typically a barcode) and in human-readable text. It must appear both on the product packaging and on the product’s label. Additionally, for most devices, the UDI must be imprinted on the device itself, although this is part of the device itself and does not affect label printing.

Vivid Data Group Makes UDI Label Compliance Easy

Our goal is to make UDI adoption not only painless but cost-effective and agile. The entire medical device industry faces rapidly changing labeling requirements, with substantial variation from country to country. Often, the same device must be shipped with different labeling requirements for use in the European Union, the United States, Canada, and around the world. We build agility into all of our medical device labeling solutions, allowing you to continue to see ROI no matter what new requirements are passed.

Features of our solutions include:

Lightning-fast label changes. Use one central database to manage your labels across your entire organization. Quickly compare and update label templates and deploy new label versions overnight.
Rapid implementation. We help you maximize your time to value by making our solutions easy to implement, intuitive to use, and fully connectable to your ERP or other business systems. You can begin printing UDI-compliant labels immediately.
Audit-ready. Every label you’ve printed is tracked and ready for audit by the FDA.

The 3 Biggest Challenges to UDI Compliance

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.

Compliant Labeling That Transforms Your Business

Medical device manufacturers are facing increasing regulatory pressure. The FDA’s UDI requirements are well underway in the U.S., and the European Union Medical Device Regulation (EU MDR) is quickly taking shape with similar directives.

NiceLabel offers a next-generation label management system that enables UDI-compliant labeling and empowers medical device manufacturers (MDMs) to digitally transform their business. By undergoing this transformation, MDMs are able to increase agility while reducing operational costs.

Most importantly, we offer a label management system that can adapt quickly to future UDI label regulations. changes. Learn how digitally transforming your business can give you a competitive advantage in a challenging marketplace.

Setup Time

Even the best label management system is no use if the implementation is months away. Vivid Data solutions for UDI are 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.

Audit Preparation

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, which required UDI requirements to be applied 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.