What is UDI (Unique Device Identification)?

Learn More About UDI Labelling for Medical Devices

The Unique Device Identification (UDI) system is a globally recognised framework designed to provide a unique identifier for medical devices, enhancing traceability and safety within healthcare. It has become a cornerstone of regulatory efforts in both the United States and Europe, ensuring that medical devices, especially those used in critical environments like hospitals, are clearly identified and tracked throughout their lifecycle. This article will explore the definition of UDI, the reasons for its introduction, and the regulatory frameworks governing its implementation in the US and Europe.

Definition of UDI: What is It?

UDI stands for Unique Device Identification, a system that assigns a unique numeric code to medical devices. This code is typically encoded in a barcode or Radio Frequency Identification (RFID) tag attached to the device or its packaging. The UDI system is designed to enhance the traceability and identification of medical devices, which is crucial in ensuring product safety and effective post-market surveillance.

The UDI consists of two parts:

  1. Device Identifier (UDI-DI): This is the static part of the code that identifies the device model and manufacturer. It remains the same for the lifetime of a product and cannot be reused once the product is discontinued.
  2. Production Identifier (UDI-PI): This is the variable part of the UDI, providing information specific to a particular batch or lot of devices, such as the manufacturing date, expiration date, and lot or serial numbers.

Together, these elements form a comprehensive identifier that allows healthcare professionals and regulatory authorities to trace devices efficiently, ensuring they are correctly used, maintained, and recalled if necessary.

Why Was UDI Introduced?

The primary goal of the UDI system is to improve patient safety. Before its introduction, the healthcare sector faced challenges in managing and tracking the vast array of medical devices, particularly during recalls or in identifying defective products. UDI provides a standardised approach that offers several benefits:

  • Enhanced Traceability: UDI ensures that each device can be tracked from manufacturing through to end-use, allowing for quicker identification of potential issues in the supply chain and reducing the risk of faulty devices being used.
  • Improved Transparency: By making device information more accessible through central databases, UDI increases visibility into the device lifecycle, providing manufacturers, regulators, and healthcare providers with greater insight into device performance.
  • Standardisation Across Regions: Prior to UDI, different regions had their own systems for managing medical device information, making it difficult to track products globally. The UDI framework aligns regulations across major markets, facilitating better coordination during international product recalls and ensuring consistency in device labelling.

These benefits are particularly valuable for complex medical devices, such as implantable devices or those used in life-saving procedures, where accurate information about the device is crucial.

Regulatory Requirements in the USA

In the United States, the UDI system is managed by the Food and Drug Administration (FDA) under the Global Unique Device Identification Database (GUDID). The system was introduced as part of the FDA’s initiative to increase medical device transparency and patient safety, especially after several high-profile product recalls exposed weaknesses in the industry’s ability to trace devices efficiently.

Key Requirements for UDI in the US:

  • Device Classes: The US requires UDI labelling on all Class III devices (the most critical, life-sustaining devices), Class II devices, and some Class I devices. However, Class I devices that are exempt from Good Manufacturing Practice (GMP) requirements, such as simple wound dressings, do not require UDIs.
  • Data Submission: Device manufacturers must submit specific product information to the GUDID database. This database, which is publicly accessible, stores all relevant details about the medical device, including the manufacturer, product model, and any production identifiers.
  • Labelling and Barcodes: UDI barcodes must be placed on the device itself or its packaging. The FDA mandates that both the UDI-DI and UDI-PI must be presented in both machine-readable (such as a barcode) and human-readable formats.

Additionally, the US system requires manufacturers to maintain a clear, non-reused system for UDIs. Barcodes or identifiers cannot be reassigned to different products after discontinuation, addressing issues in the past where barcodes were reused, causing confusion in tracking.

Regulatory Requirements in Europe

Europe’s approach to UDI is governed by the European Union Medical Device Regulation (EU MDR) and the In Vitro Diagnostic Regulation (IVDR). Similar to the FDA’s system, Europe’s UDI framework aims to ensure robust traceability of medical devices, from production to their use by patients and healthcare providers.

Key Requirements for UDI in Europe:

  • EUDAMED Database: The European system is centralised around the EUDAMED database, which holds all UDI information for medical devices marketed within the EU. EUDAMED mirrors the GUDID in the US, though the system is still being developed, with full functionality expected in the coming years.
  • Labelling: UDI labelling requirements in Europe apply to all devices, including Class I, II, and III, similar to the US system. Manufacturers must ensure that the UDI is affixed to the product or its packaging in both machine-readable and human-readable formats. Reusable devices, in particular, must have labels that withstand cleaning and sterilisation processes.
  • Distributor and Importer Responsibilities: In addition to manufacturers, European regulations place significant responsibility on distributors and importers. They must ensure that UDI is properly maintained throughout the supply chain, with all parties capable of scanning and managing device information accurately. This is particularly important in ensuring traceability across borders within the European Union.

In Europe, UDI also plays a critical role in post-market surveillance, as the system allows regulators to track adverse events and recalls more effectively. The introduction of UDI helps align the medical device industry with other sectors that have long used barcoding and traceability systems, such as pharmaceuticals.

Differences and Similarities Between US and EU Requirements

While the US and European systems share many common goals and processes, there are a few differences:

  • Database Structure: The US system relies on the GUDID, while Europe uses EUDAMED. Though both databases serve similar purposes, EUDAMED’s implementation has been slower, and its full functionality is still under development.
  • Global Nomenclature: In the US, the FDA uses Global Medical Device Nomenclature (GMDN) codes to classify devices, while Europe initially used a separate system (CND), although GMDN is becoming more widely adopted in Europe as well.
  • Product Exemptions: There are minor differences in which devices are exempt from UDI requirements. For example, some Class I devices in the US are exempt from UDI, while Europe has slightly broader labelling requirements for Class I products.

 

Conclusion

The UDI system represents a critical advancement in medical device regulation, improving transparency, traceability, and patient safety. By ensuring that every medical device is uniquely identified, UDI facilitates faster recalls, enhances supply chain management, and provides healthcare professionals with essential information. Both the US and European systems have adopted UDI frameworks, with some variations, but the overarching goals remain the same: to protect patients and ensure that the medical devices used in healthcare are safe, reliable, and traceable throughout their lifecycle.

As global adoption of UDI continues, it is likely that other countries will align their regulatory frameworks, furthering the international harmonisation of medical device regulations. For manufacturers, it is essential to understand and comply with these UDI regulations to avoid disruptions in market access and to contribute to the safety and effectiveness of the healthcare system.

 

Written by Educo Life Sciences Expert, Richard Young

Richard Young has over 25 years of experience in the medical device and IVD industry with products such as class 3 implants to electromedical infusion systems. Richard has extensive experience in regulatory affairs, GMP (quality), GLP (laboratory testing) and clinical affairs. Richard has held various positions within the industry such as QA/RA Manager and Director, Quality Assurance and Regulatory Compliance at various companies including Biomet, Plasma Surgical and Zimmer Limited.

This article was written using materials from the course, Labelling and UDI for Medical Devices and IVDs.

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