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Medical Device Manufacturers: UDI Isn’t Going Away

If you work in the medical device manufacturing or healthcare industry, you’ll want to understand the issues behind the UDI task force. Take a few minutes and watch this video from GS1 called, “Standardization….Stat! Improving the Healthcare Supply Chain with Data Standards.”

Now you can see why a unique, global identifier is needed to ensure product/equipment traceability for electronic patient records, adverse event reporting, product recalls, and inventory management, and supply chain handling.

Will You Need To Comply or Will UDI Fade Away

Congress passed legislation in 2007 directing the FDA to develop regulations establishing a standard to identify medical device parts and equipment. This effort is known as Unique Device Identification (UDI.)

UDI Standard

The forces behind UDI are not going to back down.

UDI is being phased in over several years, but it isn’t likely to fade away. With rising healthcare costs and patient safety on the line, the UDI is the single point of reference that will identify the item and provide necessary information to trace it back to its origin from around the globe.

The time to get your compliance plan in place has arrived.

Do you have questions about where to start or what you need to do for UDI compliance? Want to get more out of your barcoding strategies? Give us a call and WincoID will help you with your labeling compliance. As label manufacturer, we can help you with getting just the right label for your application along with the barcoding equipment from printers, verifiers, barcode scanners, printing ribbons and software to ensure your compliance success.

Call David Holliday at 603-598-1553 or use our contact form.

Additional Reading Sources:

HIBCC Guidelines

GS1 logo The GS-1 explains more on the UDI in their White Paper, Global standards pave the way for Unique Device Identification (UDI).


HIBCCHIBCC Guideline: Understanding FDA’s Proposed UDI Requirement.

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