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Device information

Click on Device information from the menu on the left:

MTR_Step3_Device_info.png

Select the type of the device scope:

MTR_Step3_1.png

Depending on the device scope type selected, the process will vary slightly, as shown in detail in each of the four options below.

  • Steps for Category/Type/Group from Medical device nomenclature (EMDN):

    MTR_Step3_2.png

    1. Select the applicable legislation and risk class:

      MTR_Step3_3.png

    2. Enter the device nomenclature code:

      MTR_Step3_4.png

      To add more nomenclature codes, click on the Add button.

    3. Select the Notified Body ID number:

      MTR_Step3_5.png

  • Steps for Basic UDI-DI(s)/EUDAMED DI(s):

    MTR_Step3_6.png

    1. Enter the Basic UDI-DI/EUDAMED DI:

      basic-udi-device-information.png

    2. Select the Notified Body ID number:

      MTR_Step3_8.png

  • Steps for UDI-DI(s)/EUDAMED ID(s):

    MTR_Step3_9.png

    1. Click on the plus sign next to Device identifier to select the applicable legislation.

      • If the legislation selected is AIMDD, MDD or IVDD, the system will display the following mandatory question:

        MTR_Step3_10.png

        If you answer Yes, provide the device identifier:

        MTR_Step3_11_YES.png

        If you answer No, provide the device information:

        MTR_Step3_11b_NO.png

      • If the legislation selected is MDR/IVDR, enter the UDI-DI/EUDAMED ID:

        MTR_Step3_12.png

    2. Select the Notified Body ID number:

      MTR_Step3_13.png

  • Steps for UDI-DI and UDI-PI(s) / EUDAMED ID(s) / Device name and Lot/Batch Number(s):

    mtr-step3-case-d.png

    1. Click on the plus sign next to Device identifier to select the applicable legislation.

      • If the legislation selected is AIMDD, MDD or IVDD the system will display the following mandatory question:

        MTR_Step3_10.png

        If you answer Yes, provide the device identifier:

        MTR_Step3_11_YES.png

        If you answer No, provide the device information:

        MTR_Step3_11b_NO.png

      • If the legislation selected is MDR/IVDR enter the UDI-DI/EUDAMED ID:

        MTR_Step3_11_YES.png

    2. Enter the Production Identifiers either manually (up to 5 entries) or click Browse to upload a file:

      MTR_Step3_14.png
      MTR_Step3_15.png

    3. Select the Notified Body ID number:

      MTR_Step3_13.png