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Case B: Device without a known UDI-DI/ EUDAMED ID

  1. If the device UDI-DI (or EUDAMED ID in the case of legacy devices) is not known, answer No to the question Does the device have a UDI-DI/ EUDAMED ID that is known?:

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  2. Answer Yes or No to the questions below and provide the applicable legislation:

    Q3_MIR_Step3_CaseB_2.png

    Note

    There will be some variation in the fields appearing next, depending on the legislation chosen.

    • For legacy devices (MDD, IVDD, AIMDD) not yet registered in EUDAMED, the system will display two additional fields, UDI-DI/EUDAMED ID Code and Issuing Entity:

      Q3_MIR_Step3_CaseB_2b.png

    • For regulation devices (IVDR, MDR) not yet registered in EUDAMED, the system will display six additional fields:

      Q3_MIR_Step3_CaseB_2c.png

  3. In the case of AIMDD and MDD, specify if the device is custom-made or not and continue with the following questions in a similar manner.

  4. Answer the question shown below with Yes for a legacy device or No for an old device:

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  5. Select the applicable Risk Class and Device type from the relevant drop-down lists:

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  6. Enter the Device model and Medical device name (brand/trade/proprietary or common name) and select the appropriate nomenclature for the device under Medical device terminology:

    MIR_medical_device_name.png

    In the case of GMDN, GIVD or Other nomenclature, you must type the device nomenclature code and provide a description in the text boxes provided:

    image33.png

    In the case of EMDN nomenclature, you must provide the appropriate code from the EMDN nomenclature dropdown list, for example:

    medical-device-name-change.png

    Tip

    Click on the blue question mark above for a link to the entire EMDN nomenclature via the pop-up window:

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    When you click on the code, the nomenclature description box is auto-filled with the selected code description:

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  7. Select Yes or No for the question regarding a scientific opinion. If you select Yes, the system will prompt you to provide the competent authority or EMA:

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  8. Provide the Catalogue/reference number:

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  9. Fill in the UDI Production Identifier section:

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  10. Fill in the Device dates section:

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  11. In the Certificate Identification section, click on the plus sign to add the Notified Body (NB) details and the NB certificate number:

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  12. Select the NB details from the dropdown list and type the certificate number (you can add more than one certificate by clicking on Add):

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  13. Specify if the device is implantable. If you select Yes, you need to provide more details in the new boxes appearing below:

    image43.png

  14. Under Market Distribution, select the country(-ies), in which the device is made available:

    MIR_Market_distribution_countries.png

  15. Provide any associated devices or device accessories:

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