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Device details

  1. In this section provide the details of the device:

    • Device ID

    • Device name

    • Device trade name

    • EMDN nomenclature code

    • Nomenclature text/ Description of the device and its intended use – retrieved automatically based on the code selected

    • Risk class (choose from the list – only one option is possible)

    • Device description

    • Intended (clinical) purpose

    EUDAMED fields to complete regarding the device

  2. Reply Yes or No to the question Does the device contain or incorporate medicinal substance(s)?

    EUDAMED does the device contain or incorporate medicinal substance(s)? field

  3. If you reply Yes, you must provide the name of the medicinal substance.

    EUDAMED medical substance name(s) field displayed when yes option is selected in the does the device contain or incorporate medicinal substance(s)? field

  4. To add more medicinal substances click Add.

    EUDAMED add button

  5. Reply Yes or No to the question Does the device include human blood or plasma derivatives?

    EUDAMED does the device include human blood or plasma derivatives? field

  6. Reply Yes or No to the question Does the device incorporate, as an integral part, or is it manufactured using non-viable biological substances?

    If you reply Yes, you must complete the relevant value(s) for the field Please select the appropriate value(s).

    You can select several options.

    EUDAMED please select the appropriate value(s) field with check all and uncheck all options

  7. Reply Yes or No to the question Has the device been subject to scientific views/an opinion from an Expert Panel and/or EURL?

    EUDAMED has the device been subject to scientific views/an opinion from an expert panel and/or eurl? field