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Case A: Device with a known UDI-DI/ EUDAMED ID

  1. If the device UDI-DI (or EUDAMED ID in the case of legacy devices) is known, answer Yes to the question Does the device have a UDI-DI/ EUDAMED ID that is known?:

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  2. Answer Yes or No to the question Is the device registered in EUDAMED UDI/Device module?:

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  3. If you answered Yes, start typing the UDI-DI/EUDAMED ID of the device and select the correct one:

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    The system will retrieve all the properties of the device:

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  4. Specify the device nomenclature from the dropdown list of EMDN codes that have been already assigned to the specific device (the system will auto-fill the Nomenclature text field below):

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  5. Describe the device and its intended purpose:

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  6. Answer if a scientific opinion has been requested or – for a companion diagnostic – if the Competent Authority or EMA have been consulted:

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