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General description

  1. Reply to the question Has the manufacturer obtained the views of the expert panel on the clinical investigation according to Art 61(2) of Regulation (EU) 2017/745? by selecting Yes or No from the drop-down list.

    EUDAMED has the manufacturer obtained the views of the expert panel on the clinical investigation according to art 61(2) of regulation (eu) 2017/745? field

  2. Add more countries of conduct, if relevant.

    EUDANED additional countries of conduct (worldwide) field

  3. You can add several countries. To do it click Add and select the country from the drop-down list.

    EUDAMED add button

  4. Select the type of design. At least one option must be selected.

    EUDAMED type of design field

  5. Reply Yes or No to the question First in human?

    EUDAMED first in human field

  6. Select the design methodology. At least one option must be selected.

    EUDAMED design methodology field with check all and uncheck all options

  7. If you select the option Other you will be required to provide further information.

    Select the development stage from the drop-down list. You can select only one option.

    EUDAMED development stage field