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UDI-DI characteristics

  1. If applicable, specify clinical size for the UDI-DI and choose the dimension and the precision values in the drop-down lists below:

    Note

    When the selected Clinical size type has the option Other, users will be required to enter the Description of the Clinical size type and the language in which the description is given. The same applies for Measure unit.

    In case both the Clinical size and Measure unit have the option Other, the description for the two fields needs to be given in the same languages.

    EUDAMED clinical size information in the udi-di characteristics step of the registration of a basic udi-di together with the first udi-di

    You shall provide one of the following precision type:

    • Range – requires minimum and maximum values and the measure unit

    • Text – requires free text entry

    • Value – requires the size and the measuring unit

    You may add several clinical sizes by adding different types of dimension, but only one dimension for a given type.

  2. Specify if the device is labelled as single use.

    When device is not labelled as single use you will be asked to provide the number of reuses if applicable:

    • If the Maximum number of reuses is not applicable, then the device is considered as a non-Single Use Device and the device does not have a maximum number of reuses (infinite number of reuses)

    • If value provided is >=1, the device is considered as a non-Single use Device having a limited number of reuses (the value provided)

    EUDAMED labelled as single use field in the udi-di characteristics step when registering a basic udi-di together with the first udi-di

  3. Select Yes or No for each of the options below:

    EUDAMED details on the device in the udi-di characteristics step when registering a basic udi-di together with the first udi-di

    Containing latex is only for MDR, not applicable for IVDR.

  4. For MDR, if applicable, enter the CMR and/or Endocrine disruptor substances. When specifying CMR and/or Endocrine substances you have the option to provide the EC# or CAS#. If you do provide them, only the Name of substance is required (i.e. the language is no longer required):

    EUDAMED cmr/endocrine disruptor field in the udi-di characteristics step

  5. If applicable, the Storage/handling conditions; choose the correct information from the list and provide a description where relevant:

    EUDAMED storage/handling conditions in the udi-di characteristics step when registering a basic udi-di together with the first udi-di

    Note

    When the selected Storage/handling conditions type has the option Other, users will be required to enter the Description of the Storage/handling condition type and the language in which the description is given.

  6. Do the same for Critical warnings or contra-indications, and click Save or Save & Next:

    EUDAMED critical warning or contra-indications in the udi-di characteristics step when registering a basic udi-di together with the first udi-di

    Note

    When the selected Critical warning or contra-indications type has the option Other, users will be required to enter the Description of the Critical warning or contra-indications type and the language in which the description is given.