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Basic UDI-DI main information

  1. On the EUDAMED dashboard, click on Register a New System Procedure Pack:

    EUDAMED register a new system procedure pack link in the dashboard

  2. On the next page, specify the Issuing Entity and the Basic UDI-DI code:

    EUDAMED issuing entity and basic udi-di code fields in the basic udi-di main information page

    Note

    Only the applicable legislation MDR (Regulation (EU) 2017/745 on medical devices) is possible for system and procedure packs (selected by default).

    Important

    EUDAMED will validate the Basic UDI-DI code you insert based on the specific format provided by each Issuing Entity. Please ensure that you enter the correct code with the check digits.

    If the Basic UDI-DI code already exists in EUDAMED, the system will prevent you from saving – a Basic UDI-DI must be unique:

    EUDAMED error message if the basic udi-di code already exists in the basic udi-di main information page

  3. Choose if you are registering a system or procedure pack and click on Save & Next to save your registration as a draft and move on to the next steps:

    EUDAMED system of procedure pack type field in the basic udi-di main information page