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Submit normal update

You can submit a normal update to your application/notification when it has one of the following states:

  • Notified (published), Acknowledged, Started or Temporarily halted (PMCF/PMPF)

  • Validated (may start), Authorised, Started or Temporarily halted (CI/PS)

To do it, follow these steps:

  1. Click Create new version.

    EUDAMED create new version button

  2. A pop-up window will appear. Click Complete action to proceed.

    EUDAMED complete action button

  3. A new version of the application will be created as Draft. At this stage, you will be able to Edit the relevant information in the application.

    EUDAMED edit button

    Note

    You will not be able to change the value of the field CI/PS plan code. In the case of a coordinated assessment, the following fields cannot be edited either:

    a) the countries to which the coordinated assessment application has been submitted;

    b) the proposed coordinated Member State.

  4. When all appropriate updates have been registered, click Submit normal update.

    EUDAMED submit normal update button

  5. A pop-up window will appear for you to provide comments. Once you are done, click Complete action.

    EUDAMED complete action button

    Note

    Completing this action will generate a notification to the Competent Authority that a new version has been submitted.