Unique Device Identifier (UDI)

The Unique Device Identifier (UDI) system is a globally harmonized regulatory requirement established to provide a single, consistent mechanism for identifying and tracking medical devices throughout their entire life cycle, from manufacturing through distribution and patient use.

A Unique Device Identifier (UDI) is an identifier that adequately identifies a device through its distribution and use by meeting specific technical and regulatory requirements. The UDI is a combination of mandatory fixed information and conditional variable information, designed to ensure comprehensive traceability.

What You Need to Know About the UDI System

The UDI system is fundamental to modern quality management and regulatory compliance, particularly for medical devices, as it facilitates traceability, enhances post-market surveillance, and supports patient safety efforts.

Structure of the UDI

The UDI is composed of two primary segments:

Device Identifier (DI) - Mandatory

The mandatory, fixed portion of the UDI. It identifies the specific version or model of the device and the labeler.

Production Identifier (PI) - Conditional

The conditional, variable portion of the UDI. It identifies specific production characteristics, but is only included when present on the device label.

The Production Identifier (PI) may include the following characteristics, if present on the label:

• The lot or batch number within which the device was manufactured.
• The serial number of a specific device.
• The expiration date of a specific device.
• The date manufactured.
• For a Human Cell, Tissue, or Cellular and Tissue-Based Product (HCT/P) regulated as a device, the required distinct identification code.

UDI Labeling Requirements

The UDI must be presented on the device and/or its packaging in two mandatory forms:

• Easily readable plain-text.
• Automatic Identification and Data Capture (AIDC) technology, which means any technology that conveys the UDI in a form that can be entered into an electronic patient record or computer system via an automated process.

The label of every medical device and every device package must bear a UDI. If AIDC technology is not visibly obvious on the label or package, its presence must be disclosed.

Special Cases and Exemptions

• Stand-Alone Software: Software not distributed in packaged form (e.g., downloaded from a website) meets UDI requirements if it conveys the version number in its PI and displays the UDI in easily readable plain-text when started or via a menu command (e.g., an "About" command).
• UPC Codes for Class I Devices: A Class I device bearing a Universal Product Code (UPC) is generally considered to have met all UDI labeling requirements, and the UPC serves as the required UDI. A UPC is the product identifier for an item sold at retail in the U.S..
• General Exceptions: Exemptions exist for certain products, including individual single-use devices distributed in a multipack (which must have a UDI on the outer package), devices for research/teaching, custom devices, and investigational devices.
• Combination Products: A device packaged within a combination product or convenience kit may be exempt from bearing its own UDI, provided the label of the combination product or kit bears a UDI.
• Direct Marking: Devices that are intended to be used more than once and reprocessed before each use must bear a permanent marking providing the UDI on the device itself.

The Global Unique Device Identification Database (GUDID)

The GUDID is the central database serving as a repository of information designed to facilitate the identification of medical devices throughout their distribution and use.

• Data Submission: The labeler must provide identification information (DI) for each version or model required to bear a UDI no later than the date the label must bear the UDI.
• Information Required: Submissions must include details like the labeler's name and contact information, the device identifier, the proprietary name, model number, total number of units per package, and the FDA premarket submission number or listing number.
• Corrections: If FDA finds submitted information appears incorrect or misleading, the labeler must provide corrected information or a satisfactory explanation within 30 days.

Importance and Integration within Quality Systems

The UDI and the UDI system are critical requirements linked across multiple regulatory domains:

Post-Market Surveillance (PMS):

UDI is used in post-market data analysis. For manufacturers operating under the QMSR, the documented quality management system must include a system to assign UDI in accordance with the requirements of part 830 of this chapter.

Medical Device Reporting (MDR):

MDR reports submitted by user facilities and importers must include the UDI that appears on the device label or package, if reasonably known.

Medical Device Tracking:

The manufacturer of a tracked device must be able to provide the FDA with the UDI and other identifying information (like lot or serial number) for each tracked device distributed.

Recalls and Corrections:

UDI is specifically required in reports of device corrections and removals to uniquely identify the device involved in the action. UDI traceability is essential for executing adverse events, field safety corrective actions, or product withdrawals.

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