Aug 03, 2021 Kelly Stanton

What Is the Unique Device Identification (UDI) System and Why Is it Important?

If you’re preparing to introduce a new medical device to market, labelers must first secure a unique device identifier. 

In case you’re unfamiliar, the unique device identifier is a numeric or logarithmic code that describes:

  • The device type (e.g., model number and version) and 
  • The production variables (e.g., serial number, production date, and expiration date).

Most governing bodies leverage the UDI to better assess the performance of new and existing medical devices. Similarly, healthcare practitioners rely on the UDI to produce high-quality health outcomes for patients.

So what’s at stake if you don’t receive UDI marks?

Quite a lot.

Failing to accurately identify, label, and report your medical device to Global Unique Device Identification Database (GUDID) may result in delayed product approval. It’s a serious roadblock that thousands of growing medical device startups and scale-ups need to hurdle on the path to rapid FDA approval.

What Is the Unique Device Identification System?

According to the U.S. Food and Drug Administration (FDA), the UDI system is used to “adequately identify medical devices sold in the United States from manufacturing through distribution to patient use.”

In 2009, Mercy Health and the California Department of Health Care Services launched a UDI pilot project to identify performance inconsistencies of coronary stents. More than 5,000 pharmacies, medical suppliers, and hospitals participated in this project, which made it a major step toward the development of a uniform product traceability system.

In this article, we’ve included a brief overview of the UDI format, as well as the key regulatory requirements medical device manufacturers must comply with to obtain a UDI and streamline the FDA approval process.

Overview of the Unique Identifier Format 

unique-identification-system

Image Source: The U.S. Food and Drug Administration (FDA)

The UDI is commonly referred to as a “barcode.” In the example above, notice how the UDI includes both a device identifier (DI) and a production identifier (PI). These values are used to describe the device and production environment.

All labelers are required to include both a plain-text and scannable version of the UDI. The latter must be supported by automatic identification and data capture (AIDC).

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Unique Device Identifier Requirements 

To obtain UDI marks, labelers and manufacturers have to work closely with an FDA-accredited issuing agency. One such agency is GS1, which is used in the United States, European Union, and Asia. 

GS1 enforces the following UDI regulatory requirements:

1. Basic UDI-DI

The basic UDI-DI regulatory requirement is a relatively new level of identification in the European Union. To fulfill this requirement, medical device labelers must first request a Global Model Number (GMN). The GMN is used to describe the product’s version or model based on attributes derived from FDA standards. 

The GMN includes three major components, including a GS1 company prefix, internal/model number, and check character pair. GS1 offers a simple GMN generator to quickly create or validate a GMN.

2. UDI-DI

To fulfill the regulatory requirements under UDI-DI, medical device labelers must request a Global Trade Item Number (GTIN) from GS1. 

GS1 describes the Global Trade Number as a “global supply chain solution used to identify any trade item that may be priced, or ordered, or involved at any point in the supply chain.”

unique-identification-system-UDI

Image Source: G1

3. UDI-PI

All regulatory requirements under UDI-PI are fulfilled by the GSI Application Identifier (AI), which includes four distinct production identifiers: expiration date, serial number, manufacture date, and expiration date. 

This information is then used to generate a simple prefix. GSI relies on this data to quickly identify and relay important performance information about the product.

Maintaining Product Records with a Quality Management System

Under 21 CFR Part 820, manufacturers need to maintain electronic records of all manufacturing activities (e.g., production data, batch numbers, and standard operating procedures). 

It’s a difficult undertaking — especially for early-growth companies.

Qualio has created an electronic quality management system (eQMS) designed specifically to help teams document and retrieve all the information needed to fulfill UDI requirements.

Additionally, powerful, audit-ready reporting capabilities give teams all the intelligence they need to streamline inspections. With Qualio, you can easily query important documentation in seconds, speeding up the process considerably.

 

Are you investing in your first quality management system?

Are you planning on migrating away from a paper-based or other legacy system? 

There’s a lot that can go wrong during the transition process. 

Fortunately, we’ve put together a guide to help you maximize the effectiveness of your system adoption and implementation activities.

Download: 12 Questions to Ask Before You Buy an eQMS.

In this guide, we dive deep into the questions you need to ask to find the right eQMS for your growing medical device company. 

This special resource has helped hundreds of quality teams identify and assess the performance of prospective systems — and we hope it’ll help your team do the same.

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Published by Kelly Stanton August 3, 2021