The Unique Device Identifier (UDI) is a new set of labeling requirements mandated by the US Food & Drug Administration for most medical devices. The purpose of UDI labels is to identify a medical device throughout the entire arc of its distribution and use. This is intended to make the devices safer by helping doctors and patients identify the specific device and version of that device that they are using.
UDI guidelines were first published in 2013 and set a series of staggered deadlines:
- 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
Vivid Data Group can help you achieve total UDI compliance and labeling agility in the face of changing regulations.
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 production 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.
At Vivid Data Group, we want your labeling to be a non-issue. Contact Vivid Data Group or call 855-848-4332 to find out what we can do for yo