AusUDID data elements

For detailed information on all Australian UDI data elements, see: Australian UDI Data Dictionary.

The Australian UDI Data Dictionary explains every data element in the AusUDID.

It includes:

• data element names
• descriptions
• permitted values
• edit rules
• other useful metadata.

Mandatory, voluntary and conditionally mandatory data elements

AusUDID data elements fall into 3 groups.

Mandatory data elements must be included in every UDI record. Examples include:

• Primary DI
• Model/Version.

Optional data elements are optional but strongly recommended. Examples include:

• Catalogue Number
• Device Description.

Conditionally mandatory data elements are required only in certain situations. Examples include:

• if the Device Count is greater than one, you must provide either the Unit of Use DI or the Direct Marking DI
• if the device has higher levels of packaging, you must provide the Package DI(s)
• if the device requires sterilisation before to use, you must provide Sterilisation Methods.

The Australian UDI Data Dictionary describes which data elements are mandatory, optional and conditionally mandatory.

UDI Trigger and non-UDI Trigger data elements

AusUDID data elements are also grouped by whether changes require a new UDI-DI.

UDI Trigger data elements require a new UDI-DI and a new UDI record when changed. Examples include:

• Brand Name
• Device Count
• Model/Version

Non-UDI Trigger data elements can be edited at any time without requiring a new UDI-DI or a new UDI record. Examples include:

• Device Description
• Catalogue Number.

The Australian UDI Data Dictionary describes which data elements are UDI Triggers.

Device data elements and sponsor data elements

AusUDID data elements are also grouped by whether they are device-specific or sponsor-specific. This is important if:

• the manufacturer is contributing data
• the UDI record is linked to more than one sponsor.

Device data elements describe the device and the data for these data elements is usually provided by the manufacturer, either directly to the AusUDID or via the sponsor. Examples include:

• Sterilisation Methods
• Clinical Size information
• Storage and Handling information.

Manufacturers submitting data to AusUDID can only submit device data elements. They cannot submit sponsor data elements. They cannot link an ARTG to the UDI record.

Sponsor data elements relate only to the sponsor and can be added only by a sponsor. Examples include:

• ARTG ID
• Catalogue Number
• Sponsor Commercial Distribution End Date.

The AusUDID applies different rules to device and sponsor data elements when a device has multiple sponsors. For more information on managing UDI records with multiple sponsors, see: Managing UDI records with multiple sponsors.