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Device information

  1. For MDR, specify whether it is a reprocessed single use device and whether it has an Intended purpose other than medical (Annex XVI):

    EUDAMED reprocessed single use device and intended purpose other than medical (annex xvi) fields in the deice information section

  2. If you select Yes for the Intended purpose other than medical (Annex XVI), possible options will appear. Select the relevant purpose(s):

    EUDAMED intended purpose other than medical (annex xvi) field

  3. Select Yes or No if the device was designed and manufactured by another legal or natural person.

    If Yes, there are two different ways to find the Product original manufacturer of the device:

    • Check the box I know the Actor ID/SRN, enter the Actor ID/SRN or name of the Product original manufacturer of the device and click Check registry:

      EUDAMED i know the actor id/srn checkbox and check registry button

      Note

      Please ensure to check the box I know the Actor ID/SRN in order to search for an existing registered Manufacturer Actor either by SRN or by name.

      Select the Actor from the list:

      EUDAMED list of registered actors

    • Enter the name of the Product original manufacturer organisation name and click on Check registry:

      EUDAMED product original manufacturer organisation name field and check registry button

      Select the Organisation name from the list:

      EUDAMED list of organisation names

      If the Organisation name is not in the list, click on Enter data manually and fill in the required fields with the details on the Product original manufacturer of the device:

      EUDAMED fields to complete when selecting enter data manually

  4. Select Yes or No to provide the Clinical Investigation reference for the current UDI-DI:

    EUDAMED clinical investigation toggle button to yes

  5. When registering under MDR, select Yes or No to complete information on tissues and cells, and information on substances:

    EUDAMED tissues and cells and information on substances fields

    If you answer Yes to Information on substances, enter the details:

    EUDAMED fields to complete when the answer to information to substances field is set to yes

    For IVDR, select Yes or No to complete information on tissues and cells, in addition you shall specify if the device is new:

    EUDAMED new device field

    Note

    A device shall be considered new if:

    • There has been no such device continuously available on the Union market during the previous three (3) years for the relevant analyte or other parameter.

    • The procedure involves analytical technology not continuously used in connection with a given analyte or other parameter on the Union market during the previous three (3) years.

  6. Choose a Member State in the drop-down list where the device is or has been first placed on the EU market, and click Save or Save & Next:

    EUDAMED member state where the device is or has been first placed on the eu market field

    Note

    The countries where the device is or is to be made available on the market are mandatory, to be provided when the device’s status is On the EU market and device’s risk class is not risk class I (MDR) and not risk class A (IVDR).