If you are a medical device manufacturer, your products must address global unique device identifier (UDI) requirements.

A UDI is a mark that identifies medical devices throughout the supply chain from manufacturing to distribution to patient use in order to ensure patient safety.

Many countries and regions have their own specific medical device UDI requirements, including Australia, Brazil, China, the European Union, Japan, Saudi Arabia, and the United States.

Per the U.S. FDA’s final rule, a UDI must:

According to Lena Cordie-Bancroft, BSI Sector Lead-Medical Devices, a UDI program should feature “a set of rules and standards for assigning the UDI and for the various data elements associated with the UDI that are required for the control of the database and that data.”

Common Medical Device UDI 483 Observations

In January 2022, Redica Systems Mark Agostino offered insights into UDI requirements during the webinar, “Unique Device Identification | Aligning to a Single Approach.” He identified the following seven common UDI-related 483 observations:

  1. Device History Record Does Not Refer to UDI Location
  2. Complaint Investigation Records Do Not Include UDI
  3. Illegible UDI Label
  4. UDI Not Carried Throughout Distribution
  5. No UDI Labeling Specifications
  6. No UDI Process Validation
  7. Failure to Maintain Records

[Related: For more on common UDI 483 observations, download a FREE one-page document featuring data from the Redica platform.]

UDI Form 483s analysis

Integrating UDI Requirements into a QMS

Also in the webinar, Agostino outlined the “functional areas” of a medical device quality management system (QMS) that need to account for UDI requirements.

  • Design and Development
  • Production
  • Postmarket Surveillance
  • Responsibilities of Economic Operators
  • Supply Chain
  • Documentation and Records

He explained that a quality management system must be agile enough to address some of the challenges involving UDI requirements, which include varying timelines and differing requirements among global regulatory agencies.

Additional UDI Resources

UDI Compliance for Medical Devices: Part I

UDI Compliance for Medical Devices: Part II

The 7 Most Common FDA 483 Observations Involving UDI

How Medical Device Manufacturers Can Integrate UDI into a QMS

EU MDR and Economic Operators for Medical Devices

Challenges to Integrating UDI into a QMS

Did you know that there were 24 primary issue FDA 483 observations involving the identification and traceability of medical devices over the past decade? Contact us to find out how we found this actionable intelligence?

Identification and Traceability
Redica Systems Enforcement Analytics | Medical Device Identification and Traceability 483 Observations

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