Unique Device Identification

Unique Device Identification (UDI) Legislation Illustrates the FDA's Focus on Product Safety

By 2020, virtually all medical devices on the U.S. market will be required to carry a unique device identifier (UDI) label as part of the FDA's unique device identification rule. A UDI is a distinct two-part numeric or alphanumeric bar code that includes a device identifier (DI), which is specific to the device model, and a production identifier (PI), which includes the production information for the specific device (lot/batch number, serial number and/or expiration date). The purpose of the system is to improve patient safety, discourage counterfeiting, and strengthen postmarket surveillance efforts like adverse event reporting. An enterprise quality management system (EQMS) can help you more easily manage the data, process and system changes UDI requires.

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Why You Need to Implement a Unique Device Identification System—and When

Congress directed the FDA to develop a global unique device identification system as part of the FDA Amendments Act of 2007. The UDI final rule was released in 2013. It mandates that labels and packaging of Class I, II and III medical devices include a unique device identifier in both human- and machine-readable formats. (Exceptions and special conditions are outlined on the FDA website.) Device manufacturers are also required to load the data on each device into the FDA's publicly accessible Global Unique Database (GUDID). Manufacturers that do not adhere to this regulation are subject to strict regulatory sanctions.

The FDA's proposed rollout of unique device identifiers is based on the risk. Class I includes devices with the lowest risk. Therefore, manufacturers of Class I devices will have more time to implement a UDI system. Compliance dates are listed on the FDA website. While the FDA is the first regulatory body to require a global unique device identification system, other countries are expected to follow. The European Commission, for example, has recommended that a UDI framework be implemented for devices sold in the European Union (EU).

An EQMS Makes It Easier to Implement and Maintain a Compliant UDI System

Because the Unique Device Identification rule impacts every facet of a manufacturers quality processes (documentation, training, adverse event reporting) and operations (R&D, quality assurance, packaging), device makers should avoid implementing UDI in a silo, independent of existing business systems and workflows. This will only add cost and complexity to an already complicated endeavor.

Conversely, managing UDI within the quality system, with the help of an EQMS, allows manufacturers to avoid the piecemeal approach to compliance that standalone solutions create. Other ways in which an EQMS helps facilitate compliance are:

  • Reduces time, effort and errors: While using disparate point solutions to manage UDI is not recommended, attempting to do it using a paper-based QMS is a huge, almost insurmountable, task. Manually collecting product data from various departments within the organization and entering it into the FDA's unique device identifier database requires significant time and effort. Automating the data collection process not only saves time but also reduces the risk of human error.
  • Simplifies change control: The unique device identification rule mandates that any changes to a device's packaging, labeling or the product itself, requires the manufacturer to resubmit new product records to the FDA. Implementing change manually can be a tedious endeavor, but an EQMS can streamline the entire change control process. Geographically dispersed employees or virtual teams can access documents, enter data and initiate changes from any location, allowing for faster turnaround.
  • Enables FDA 21 CFR Part II compliance: FDA 21 CFR Part 11 compliance is essential for regulated companies that wish to use electronic quality records and electronic signatures in place of paper-based and ink-based counterparts to maintain compliance. The UDI rule requires manufacturers to abide by FDA 21 CFR Part II when submitting unique device identifier information. Selecting an EQMS designed to address FDA 21 CFR Part II is the first step toward a compliant system.
  • Improves Product Safety: The main purpose of the unique device identification system is to improve product safety. Leveraging an EQMS to automate quality processes, particularly adverse event reporting, helps manufacturers produce and deliver higher quality devices to customers.

Why Choose MasterControl to Meet UDI Regulations

An EQMS can jumpstart your unique device identification system implementation efforts; however, not all enterprise systems are created equal. Few provide all of the tools and advanced features (e.g., document control, electronic signatures, tracking and trending analytics and adverse event reporting) necessary to manage your device from the point of manufacture, through the point of use, and beyond. MasterControl's EQMS connects all quality and other processes throughout the product's lifecycle under one scalable platform. Other attributes that set our company and solutions apart are:

  • Five of the largest regulatory agencies in the world use MasterControl including the industry's most recognized regulatory agency
  • Our solutions have been designed to meet FDA 21 CFR Part II compliance—and critical component of UDI
  • We are trusted by more than 1,000 regulated companies, including 572 life science companies, in 33 countries
  • We have a successful software implementation and validation track record as reflected by our 97 percent customer retention rate
  • In addition to our robust solutions, we provide consulting and training on a wide variety of regulations. Our experts can help you build a compliant unique device identification system and teach you how to submit product information into the FDA's unique device identifier database.

Learn More about How to Address UDI Using MasterControl

To learn more about how MasterControl can help you address your UDI needs contact a MasterControl representative.