Medical Device Identification refers to the process of uniquely identifying medical devices for various purposes such as tracking, regulatory compliance, quality control, and patient safety. Each medical device is assigned a unique identifier, often in the form of a barcode, serial number, or a combination of letters and numbers, distinguishing it from other devices.
Why is Medical Device Identification important?
Medical Device Identification is critical for ensuring the safety, quality, and effectiveness of medical devices throughout their lifecycle, from manufacturing to patient use. The FDA highlights that accurate device identification through systems like UDI helps improve patient safety by enabling more precise reporting, reviewing, and analysis of adverse event reports, and facilitating quicker identification and correction of problem devices.
What is UDI?
Unique Device Identification (UDI) is a system used in the medical device field to uniquely identify and trace medical devices throughout their distribution and use. It was introduced by regulatory authorities such as the U.S. Food and Drug Administration (FDA) and the European Commission to enhance patient safety, streamline device recalls, and improve post-market surveillance.
Benefits of Using UDI
- Support for value-based healthcare
- Facilitated medical device innovation
- Efficient inventory management
- Streamlined device recalls
- Improved post-market surveillance
- Enhanced patient safety
UDI Requirements by Region
Requirements in the United States
In the United States, the UDI system is regulated by the FDA. Key requirements include:
- Global Unique Device Identification Database (GUDID) Submission: All device identifiers must be submitted to the GUDID.
- Device Classification: Requirements vary based on the class of the device (Class I, II, or III).
- Labeling: Devices must be labeled with a UDI in human-readable and machine-readable formats (e.g., barcodes).
Requirements in the EU
In the European Union, UDI requirements are part of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR):
- Risk-Based UDI: Devices are classified by risk, and higher-risk devices have more stringent requirements.
- Labeling: UDIs must be placed on the device itself or its packaging.
- BUDI-DI and UDI-DI: Differences in the Basic UDI-DI (identifies the device model) and the UDI-DI (specific to a particular device).
Requirements in Japan
Japan’s Pharmaceutical and Medical Device Act (PMD Act) outlines UDI requirements:
- Registration: Devices must be registered in the Japanese UDI database.
- Labeling: UDIs must be included on the device label, packaging, and associated documentation.
Requirements in Australia
The Therapeutic Goods Administration (TGA) oversees UDI requirements in Australia:
- Inclusion on the Australian Register of Therapeutic Goods (ARTG): Devices must be listed with their UDI.
- Labeling: Devices must be labeled with UDIs in compliance with TGA guidelines.
Requirements in Canada
Health Canada mandates the following for UDI compliance:
- Database Submission: Devices must be registered in the Canadian UDI database.
- Labeling: UDIs are required on device labels and packaging.
Requirements in Other Regulatory Markets
- China: The National Medical Products Administration (NMPA) requires UDI for high-risk devices.
- Brazil: ANVISA mandates UDI for certain classes of medical devices.
- Saudi Arabia: The Saudi Food and Drug Authority (SFDA) requires UDI for imported and locally manufactured devices.
UDI Implementation Checklist and Timeline
The following checklist provides a comprehensive guide to UDI implementation:
- Create a UDI Environment: Assemble and train a multi-discipline team, create a customized plan for your product portfolio and deadlines, and update your systems.
- Choose an Issuing Agency: Select an agency based on your market and financial model. Consider agencies like GS1, HIBCC, ICCBBA, and IFA.
- Collect Data: Assign valid product identifiers, collect product attributes, enrich datasets, and assign data owners/stewards.
- Cleanse Data: Ensure information is accurate, up-to-date, and complete. Implement data versioning and change management controls.
- Comply with Requirements: Submit product UDI records to the Health Authority repository. Apply UDI to product labels and maintain ongoing updates.
Timeline Estimates:
- 2021 Oct 04: Start Voluntary UDI/Device Registration
- 2024 Q4: Start Mandatory UDI/Device Registration
- 2026 Q2: Deadline for Mandatory UDI/Device Registration
Application in Software as a Medical Device (SaMD)
SaMD includes a UDI in the labeling that comes with the SaMD.
About UDI Issuing Agencies
The Global Unique Device Identification Database (GUDID) is a publicly accessible database maintained by the U.S. Food and Drug Administration (FDA). It is a central repository of standardized device identification and attribute information for medical devices distributed in the United States.
FAQs on UDI
Who assigns UDIs?
Manufacturers are responsible for assigning UDIs to their medical devices before placing them on the market. Regulatory authorities may specify requirements and guidelines for UDI assignment and implementation.
What information is included in a UDI?
A UDI typically includes information such as the device’s name, model number, manufacturer, batch or serial number, manufacturing date, and expiration date. This information allows for accurate identification and tracking of the device.
Are all medical devices required to have UDIs?
Requirements for UDIs may vary by region and device class. Higher-risk devices are subject to more stringent UDI requirements in many jurisdictions, while certain exempt or custom devices may be subject to modified requirements.