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UDI Systems and Unique Device Identification

UDI Systems and Unique Device Identification assigns a unique identity to medical devices and displays this identity on the device or its packaging using methods such as labels, barcodes, or RFID. The UDI system enhances the security of medical devices, prevents counterfeiting, facilitates recall and reimbursement processes, and ensures supply chain control.

Components of UDI:

  • UDI-DI: UDI-DI is the device identifier that contains a unique code specific to the manufacturer and device. UDI-DI specifies the device's model, version, manufacturer's number, and reference number. UDI-DI also enables access to information about the device in the UDI database.
  • UDI-PI: UDI-PI is the production identifier that indicates the device's production unit or packaged devices. UDI-PI includes information such as serial number, lot number, expiration date, production date, and software version.
    • UDI-DI and UDI-PI together constitute the UDI.

    According to the UDI system, medical devices are classified into risk groups:

  • Medical devices are divided into four groups: class I (low risk), class IIa (low to moderate risk), class IIb (moderate to high risk), and class III (high risk). Different application dates and requirements have been set for each class. For example, the UDI system for class III medical devices came into effect on May 26, 2021, while class I medical devices were given until May 26, 2025.

    • To comply with the UDI system, medical device manufacturers need to follow these steps:

  • Learn the requirements and deadlines of the UDI system.

  • Classify their devices according to risk groups.

  • Select an organization that assigns UDIs.

  • Assign appropriate UDI-DI and UDI-PI to their devices.

  • Place the UDI on device labels or packaging in AIDC (Automatic Identification and Data Capture) or HRI (Human Readable Interpretation) format.

  • Provide basic data elements about the devices to the UDI database.

  • Register in the European Database on Medical Devices (EUDAMED).

    • Example of UDI:

    UDI Image
    × UDI Image

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    Keywords

    UDI (Unique Device Identifier) Medical Devices Unique Identifier Medical Device Safety Medical Device Tracking Barcode and QR Code GS1 Standards FDA Regulations Databases Patient Safety Health Institutions Fraud Prevention Supply Chain Management RFID Technology EUDAMED

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