UDI Labeling Regulations Explained: How to Comply & Where to Start

UDI Labeling Regulations Explained: How to Comply & Where to Start

BY: JENNA WAGNER / DATE: 24/10/2024 / TOPICS: 医療機器, ヘルスケア, 製薬, REGULATORY COMPLIANCE, LABEL DESIGN

In today’s healthcare landscape, ensuring the safety of patients and maintaining an efficient supply chain is critical for medical device manufacturers. The Unique Device Identifier (UDI) system is a key component in achieving this. But what exactly is UDI labeling, why is it important, and how can manufacturers comply with its regulations?

This blog will guide you through UDI labeling regulations, breaking down the essentials for compliance. For a deeper dive into the specifics of medical device, pharmaceuticals, and healthcare labeling requirements and best practices, check out our eBook: Life Sciences Labeling & Compliance.

What is UDI labeling?

The UDI system final rule, established by the Food and Drug Administration (FDA), requires medical device labelers—typically, the manufacturer—to include a UDI on device labels and packages and submit device information to the Global Unique Device Identification Database (GUDID).

This helps adequately identify medical devices sold in the US from manufacturing through distribution to patient use. Medical devices range from medical gloves and tongue depressors to pacemakers and robotic surgical systems.

Why UDI matters

UDI labeling is not just about regulatory compliance—it’s about safety and efficiency.

• Patient safety: In the case of recalls or defects, UDI enables fast and accurate identification of affected devices, reducing the risk to patients.
• Supply chain efficiency: With clear identification, managing medical device inventories becomes much more efficient, reducing errors and waste.

UDI is part of a global push towards harmonizing medical device regulations, with standards adopted by the FDA and the European Medical Device Regulation (EU MDR).

What a UDI consists of

A UDI has two parts:

1. Device Identifier (DI): The DI is a fixed portion of the UDI that identifies the labeler and the specific version or model of a device. It doesn’t change and serves as the backbone of the device’s identification system. A Global Trade Item Number® (GTIN®) from GS1, an FDA-accredited issuing agency, could be used as a DI.
   
   
2. Production Identifier (PI): The PI is a variable portion that may include one or more of the following:
   
   

• Lot or batch number of the device
• Serial number of the device
• Expiration date of the device
• Date the device was manufactured
• Distinct identification code for tissue-based products

These pieces of information help track the device’s production and lifespan, making it easier to manage and recall devices when necessary.

Example of a GS1 easily readable plain-text UDI:

(01)51022222233336(11)141231(17)150707(10)A213B1(21)1234

How do I comply with UDI labeling requirements?

To comply with UDI labeling regulations, manufacturers must meet specific requirements in how the UDI is displayed on their devices and packaging. Here are the key requirements:

Human-readable and machine-readable formats

All UDIs must be displayed on labels and packages in both human-readable (plain text) and machine-readable formats. The machine-readable portion is typically encoded using automatic identification and data capture (AIDC) technology, such as barcodes or Radio Frequency Identification (RFID).

Standardized date formats

Any date on a device label, such as the expiration or manufacturing date, must follow a standardized format: YYYY-MM-DD. This ensures consistency and clarity across the global medical device market.

Example of a UDI-compliant label created in CODESOFT barcode label software.

Where do I get started with UDI labeling?

Compliance with UDI regulations can seem daunting, but by following a clear process, manufacturers can ensure they meet FDA requirements.

Step 1: Obtain a UDI from an FDA-accredited issuing agency

The first step in creating UDI labels is contacting an FDA-accredited issuing agency. The FDA has approved three issuing agencies to operate a system for assigning UDIs:

• GS1
• Health Industry Business Communications Council (HIBCC)
• International Council for Commonality in Blood Banking Automation (ICCBBA)

Labelers must contact one of the issuing agencies directly to use their system for issuing UDIs for their devices.

Step 2: Submit device information to GUDID

After obtaining the UDI, manufacturers must submit device information to GUDID. This database is publicly accessible and serves as a reference for healthcare professionals, regulators, and patients to identify medical devices.

GUDID only includes the DI part of the UDI, which is used to look up information about the device in the database. While GUDID doesn’t store PIs, it has flags to show which PI details are part of the UDI.

For more information on accessing GUDID, you can visit the FDA’s website.

Step 3: Evaluate your current labeling processes

Labeling software

Make sure your labeling software can support both human- and machine-readable formats. It should also handle various barcode types, such as GS1-128 or GS1 DataMatrix, and offer the flexibility to generate unique serial numbers or batch numbers for PIs.

If your labeling software doesn’t support these features and functionality, it’s time to upgrade. Solutions like CODESOFT RFID and barcode label design software offer dynamic label creation based on the device’s unique identifiers (DI, PI) and integrate easily with databases like Excel and Access or business systems like enterprise resource planning (ERP) systems and product lifecycle management (PLM) systems.

Download a free 30-day trial of CODESOFT and use these helpful video instructions:

• How to Leverage Variables in Your Counters to generate PIs like the lot or batch number and serial number of the device.
• How to Connect an Excel Spreadsheet or Access Database to pull in the DI and PIs like the expiration date or date the device was manufactured.
• How to generate a barcode using CODESOFT

During your trial, you can also access TEKLYNX Customer Support at +1 (414) 837-4800 or [email protected] if you have any questions.

Label printers

Your printer must also be capable of producing high-quality labels with readable barcodes to meet UDI standards. Choose a printer brand that’s compatible with your label software and offers reliable performance.

TEKLYNX has developed over 4,000 native label printer drivers for brands like Zebra, TSC, SATO, Epson, and Honeywell to provide the best overall quality for your barcode labeling needs. Learn about the benefits of using TEKLYNX printer drivers in our white paper.

Here's a quick compliance checklist now that you understand UDI labeling:

• Obtain a UDI from an FDA-accredited issuing agency.
• Submit the DI portion of the UDI to the GUDID.
• Update your labeling software to support UDI data and format requirements.
• Ensure your printers can handle the new labels.
• Train your team on the requirements to ensure proper labeling.

By following these steps, you can ensure your medical devices meet all UDI labeling requirements, keeping your products compliant and patients safe.

Beyond compliance: The real impact of UDI labeling

UDI labeling isn’t just about complying with FDA regulations—it’s about making healthcare safer and more efficient. From improved product traceability to streamlined recalls, the benefits of UDI labeling extend far beyond regulatory compliance.

If you’re looking for a labeling software provider to help with UDI compliance, consider TEKLYNX. Our solutions offer seamless integration with your existing systems, support for all UDI label formats, and reliable customer support. As Todd Engelken from QTS put it: “We have very high confidence in our compliance with UDI standards. I can absolutely say we made the right choice with TEKLYNX.”

With the right tools, knowledge and support, complying with UDI labeling regulations doesn’t have to be difficult. TEKYNX is here to help.

Get in touch

Or download a free 30-day trial of CODESOFT, which includes a UDI label sample.