UDI Labeling Compliance for Class II and Class III Medical Devices — New UDI Labeling Deadline Coming

NiceLabel PowerForms Suite 2016 edition
NiceLabel PowerForms Suite 2016 edition

It’s been roughly three years since the Final Rule for a Unique Device Identification labeling system was established. This rule established a system for labeling medical devices with a unique device identifier, or UDI. Under the system, not only must each medical device be labeled with its own UDI, that identifying information must be submitted by the labeler to the FDA’s Global Unique Device Identification Database (GUDID) barring any exemptions.

As with many regulations, the UDI system is complicated with various provisions taking effect at different times. Coming up on September 24, 2016, we will be three years post-Final Rule with a new UDI labeling rule taking effect.

What Does the New UDI Labeling Deadline Cover?

Up until now, for Class III devices intended to be used multiple times and reprocessed between uses had to have labels and packaging with UDI information. Effective September 24, 2016, these Class III devices will now need to have a permanent UDI on the devices itself.

This 2016 UDI deadline also impacts Class II medical devices which must be labeled and packaged with a UDI label and relevant information. The UDI must be submitted to the GUDID.

How Do You Print UDI Labels and Comply with UDI Labeling Rules?

Complying with FDA UDI labeling requirements is complex, because each individual Class II or Class III medical device needs to have its own unique device identifier. In addition to the unique identifier itself, the labels must include both machine readable and human readable UDIs. This means that not only will you need a label printer for printing your medical device UDI labels, you’ll need sophisticated label design software capable of:

  • Connecting to external databases
  • Working with variable data
  • Generating UDI barcodes

We recommend NiceLabel 2017 for this important UDI labeling job.

NiceLabel 2017 Software for UDI Compliance

NiceLabel 2017 comes in several editions including the entry level edition, NiceLabel 2017 Designer Express; the professional level edition, NiceLabel 2017 Designer Pro; the design and controlled print edition, NiceLabel 2017 PowerForms; and the managed design and controlled print edition, NiceLabel 2017 PowerForms Suite.

When it comes to UDI labeling compliance, we suggest using NiceLabel 2017 PowerForms Suite. This all-inclusive label management system includes all of the advanced, integrated features you need to standardize, centralize, and control label printing as well as meet all of your regulatory labeling compliance requirements.

NiceLabel 2017 PowerForms Suite integrates with SAP, Oracle, and other databases, making it possible to link your UDI label printing with your existing UDI compliance workflow. Its web printing system, PowerForms Web, allows for central deployment and business-wide scaling of print jobs. You can even extend PowerForms Web to third parties like vendors, suppliers, and manufacturers. With this solution, you maintain central control, while your UDI labels are printed at the source.

NiceLabel 2017 PowerForms Suite is an essential tool in UDI labeling compliance. Whether you’ve put off UDI labeling until the last minute or are looking for a more robust and intuitive UDI labeling system, DuraFast Label Company can help. Start by downloading a free 30-day trial version of NiceLabel 2017 or contact our office directly to discuss your UDI labeling needs. We can help with everything from UDI label design and control software to color and RFID label printers, laser marking systems, blank media, label printing supplies, and more. Business financing is available upon approved credit. Contact us today to learn more.