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  • European UDI requirements

    Compliance time

    The European UDI compliance schedule is shown in the figure below. According to the difference in risk levels, the compliance schedules also vary, covering all products under the MDR and IVDR.

    The EUDAMED database contains several modules, one of which is the UDI module.

     Implementation of UDI (Unique Device Identification)

    1. The UDI shall be located on the device itself or its package, and the higher-level package shall have its own UDI.

    2. Transport containers shall be exempt from the requirements of Section 3.1. For example, UDI is not required on logistics equipment; when a medical service organization orders multiple devices using UDI or single device model, and the manufacturer places these devices in a container for transportation or protection of individually packaged devices, UDI shall not be required on the container (logistics equipment).

    3. UDI shall consist of two parts: UDI - DI and UDI - PI.

    4. UDI - DI is unique on all levels of device package.

    5. If the lot number, serial number, software identification or expiration date appears on the label, it will be part of UDI - PI. If the production date is also marked on the label, it is not necessary to include the production date in UDI - PI. If there is only the production date on the label, it shall be used as UDI - PI.

    6. Each component that is considered a device and can be purchased on the market shall have its own UDI, unless such a component is part of a configurable device sold under a separate UDI.

    7. The system and program package described in Article 22 shall be allocated and shall bear its own UDI. (Traceability)

    8. The manufacturer shall assign UDI to the device according to the following coding standards.

    9. When it is possible to cause misidentification of the device and/or its traceability is not clear, especially when any of the following changes in the UDI database elements requires a new UDI - DI, the new UDI - DI shall be provided.

    10. The manufacturer repackaging and/or reinstalling the device shall use its own labels and keep the UDI records of the original equipment manufacturer (OEM).

     UDI database declaration information

    The core data elements and UDI - DI provided for the UDI database in accordance with Articles 28 and 29: the manufacturer shall provide UDI - DI and the following information related to the manufacturer and device for the UDI database:

    1. The configured number of each program package;

    2. The basic UDI - DI and additional UDI-D as described in Article 29;

    3. The method to control the device production (expiration date or production date, lot number or lots, and serial number);

    4. If applicable, the “UDI - DI” user (when the UDI “user” is not labeled for the device, the DI “user” shall be specified to link the use of the device to the patient);

    5. The manufacturer’s name and address (as indicated on the label);

    6. The SRN issued in accordance with Article 31(2);

    7. If applicable, the name and address of the authorized representative (as indicated on the label);

    8. The medical device naming regulations stipulated in Article 26;

    9. The risk level of the device;

    10. If applicable, the trade name or brand name;

    11. If applicable, the model, reference number or catalog number of the device;

    12. If applicable, the clinical dimensions (including volume, length, specification, and diameter);

    13. The additional product description (optional);

    14. If applicable, the storage and/or handling conditions (as indicated on the label or in the instructions for use);

    15. If applicable, the additional trade name of the device;

    16. Marking as a disposable device (yes/no);

    17. If applicable, the maximum number of reuses;

    18. Marking as a sterile device (yes/no);

    19. Disinfection before use (yes/no);

    20. Marking as latex-containing (yes/no);

    21. If applicable, the information marked in accordance with Section 10.4.5, Annex I;

    22. The URL of additional information, such as electronic instructions (optional);

    23. The important warnings or contraindications (if applicable);

    24. The device status (commercially available, commercially unavailable, recalled, on-site safety corrective actions activated)