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Comparator

  1. Click Comparator from the left menu.

  2. Indicate if there is at least one Comparator that is a medical device and if there is at least one Comparator other than a medical device, by selecting Yes or No.

    EUDAMED is there at least one comparator that is a medical device? and is there at least one comparator other than a medical device fields

  3. If you reply Yes to the first question, a new sub-section will appear for you to choose the type of Comparator device, which depends on the legislation selected in the first step.

    EUDAMED kind of comparator field

  4. If you reply Yes to the second question, the system will display a list for you to choose the type of Comparator. You can select more than one option.

    EUDAMED type of comparator(s) other than device when yes option is selected in the is there at least one comparator other than a medical device field

  5. The following Comparators require further information:

    • Medical device

    • IVD medical device

    • IVD medical device according to Art 5(5) of the IVDR

  6. To fill in the information of the above Comparators, follow the explanation presented in the chapter Investigational/Study device(s).

    Note

    For each Comparator device, the system generates a new sub-section under the Language-specific Comparator device(s) information header of the National Information section with the same identifier as the Comparator.

  7. Below you can find a summary table where you can check the data you need to provide depending on certain conditions.

    Do I need to provide the following data?

    The medical device Comparator is not CE marked - CI/PS only, option not applicable for PMCF/PMPF

    The medical device Comparator is CE marked but is not registered in EUDAMED

    The medical device Comparator is registered in EUDAMED

     

    CI/PS

    PMCF/PMPF

    UDI-DI / EUDAMED ID

    Yes

    Yes

    UDI-DI - not registered in EUDAMED

    Yes

    Issuing entity

    Yes

    I confirm that the CE-marked device will be used outside the scope of its CE mark

    Yes (PMCF/PMPF)

    Yes

    Will the CE-marked Comparator medical device be used in the clinical investigation/performance study within the scope of its CE mark?

    Yes (CI/PS)

    Yes

    Investigational/Study device details

    Device ID (like Model number / Version)

    Yes

    Yes

    Device name

    Yes

    Yes

    Device trade name

    Yes

    Yes

    EMDN nomenclature code and nomenclature text

    Risk Class

    Yes

    Yes

    Device description

    Yes

    Yes

    Yes

    Yes

    Intended (clinical) purpose

    Yes

    Yes

    Yes

    Yes

    Does the device contain or incorporate medicinal substance(s)?

    Yes

    Yes

    Does the device include human blood or plasma derivatives?

    Yes

    Yes

    Does the device incorporate, as an integral part, or is it manufactured using non-viable biological substances?

    Yes

    Yes

    Has the device been subject to scientific views/an opinion from an Expert Panel and/or EURL?

    Yes

    Yes

    Manufacturer of the investigational/study device

    Is the manufacturer the same as the sponsor?

    Yes

    Yes

    Is the manufacturer registered in EUDAMED

    Yes

    Yes

    Manufacturer Actor ID / SRN or Manufacturer details

    Yes

    Yes