Understanding Unique Device Identification

Unique Device Identification (UDI) refers to a system that is designed to mark the labels of medical devices used within the healthcare system. The U.S. FDA released a final ruling on the system in 2014. The system is intended to be fully implemented over the next several years.

Medical Device







What is UDI?

The UDI was designed to establish a unified, global system for the identification of all medical devices within the U.S. supply chain. According to the rule:

  • A unique identifier must be assigned to each model or version of a medical device by the manufacturer.
  • The UDI must be both human and machine readable.
  • A UDI must be clearly and legibly applied.
  • Depending upon the nature and purpose of the device, the UDI may also include the manufacturer’s lot/batch number, the product serial number, date of manufacture, expiration date and name and address of manufacturer, supplier or distributor.

What is the Purpose of the UDI Requirement?

After a number of years’ research, the FDA concluded that automatic identification technologies (AIDC) have a number of benefits within the healthcare industry. Such technology can help improve cost efficiency and patient safety.

What are the Benefits of UDI?

The UDI system has a number of benefits including:

  • helping to reduce the incidence of medical error
  • making medical devices safer for patients, caregivers and health professionals
  • faster and more accurate data collection in conjunction with the GUDID
  • faster device identification in the event of device recall

The full implementation of the UDI rule will take place over the next seven years. The timeline for a particular medical device will vary depending on the class of the medical device.

At Innovatum, we can help you with all you need to know about understanding unique device identification. We are proud of our state-of-the-art UDI management technology, which includes a GS1 certified label design and print engine. Contact us today to find out more about how we can help you with UDI compliance.