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Confirm Actor data accuracy

EUDAMED video icon VIDEO: Confirm actor data accuracy

Economic Operators registered in EUDAMED, are required by regulation MDR Article 31§5/ IVDR Article 28§5 to confirm their data accuracy.

This action can only be done by an LAAeither by creating a new version of the Actor or directly confirming the current data.

Method 1: Confirm the current data

To confirm your Actor data accuracy for the current version, on the homepage of EUDAMED click on Manage your actor data:

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  1. In the new window, click Actions on the side and then on Confirm data accuracy:

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  2. A pop-up message will appear asking you to confirm your actor data accuracy:

    EUDAMED warning message to confirm your actor data accuracy

  3. Click Yes to confirm or Cancel to go back.

  4. Once you have clicked Yes, you will notice the latest accuracy confirmation date has changed to the latest one:

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  5. Click View accuracy confirmation history to see the previous confirmation accuracy dates:

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Method 2: Create new version

  1. On the homepage of EUDAMED, click on Manage your actor data:

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  2. In the new window, click on Actions and then click on Create new version:

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  3. Once you are done updating the details of the new version, click on Register new version:

    EUDAMED register new version button when creating a new version of your actor data

  4. The pop-up message will ask you to confirm the new version. You can check the tick-box which will confirm the Actor data accuracy after clicking Confirm:

    EUDAMED warning message to confirm the actor data accuracy

  5. This can be seen in the Accuracy confirmation history part of My Actor data:

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    Note

    Note that the act of creating an Actor is not a confirmation of its data accuracy. If this action is performed right after the Actor is created, the accuracy confirmation date will also match the date the creation of the Actor took place.