UDI record concepts

UDI record states

UDI records have different states, depending on:

• whether the UDI record has been published
• whether a sponsor or manufacturer has published it
• whether it is still within the Grace Period.

Draft UDI record

A draft UDI record is only accessible to the sponsor or manufacturer organisation of the user who created it.

If a manufacturer has been linked to the draft UDI record, they can also view it.

It is not visible to other users of the Australian Unique Device Identification Database (AusUDID) and it has not been through the full suite of validation checks.

Any changes can be made to the draft UDI record.

Published UDI record

Once a UDI record has been validated, it can be published either:

• immediately, or
• at a specific date in the future.

UDI records published by manufacturers are only visible to logged in users such as sponsors, allowing them to link their Australian Register of Therapeutic Goods (ARTG) ID to the UDI record.

Note

To meet UDI requirements, the UDI record must be linked to an ARTG and be publicly available.

Published and publicly available UDI record

Once a UDI record has been published by a sponsor or a sponsor has linked their ARTG ID to a UDI record published by a manufacturer, it becomes published and publicly available.

These UDI records can be viewed by all users of the AusUDID.

UDI records in the Grace Period

The Grace Period is a set period of time in which the UDI record can be edited without the use of the corrections functionality.

During the Grace Period, UDI Triggers can be edited without triggering the need for a new UDI record.

The Grace Period starts when the UDI record is first published.

UDI records outside the Grace Period

Once the Grace Period ends, the rules for editing UDI records change.

Changes to UDI Trigger data elements will require assignment of a new UDI-DI and creation of a new UDI record.

Users can still correct genuine errors for UDI Triggers by using the corrections functionality.

UDI Triggers

Certain changes to a device or its UDI data elements mean that the device can no longer be unambiguously identified by its existing UDI. These changes are UDI Triggers.

When a UDI Trigger occurs, a new UDI-DI must be assigned and new UDI record created.

For more information on UDI Triggers, see Managing UDI Triggers.

UDI Trigger data elements

These data elements trigger the need for a new UDI-DI and UDI record when changed:

• Primary DI
• Primary DI Issuing Agency
• Device Count
• Direct Marked DI*
• Direct Marked DI Issuing Agency*
• Brand Name
• Model/Version
• Is the medical device software or does it incorporate software?
• Is the medical device a kit?
• MRI Safety Status*
• Intended for Single Use?
• Restricted Number of Reuses
• Device required to be labelled as containing natural rubber latex or dry natural rubber?
• Device Packaged as Sterile?
• Requires Sterilisation Prior To Use?
• Clinical Size* (recorded in the AusUDID in a combination of data elements: Clinical Type, Clinical Size Value, Clinical Size Unit of Measure, Clinical Size Type Text).

*The rules and requirements for these data elements varying depending on the value stored in the data element or a related data field.

For a full list of all Australian UDI data elements and their rules, see the Australian UDI Data Dictionary.

Grace Period

Grace Period length: 30 days

The Grace Period allows you fix errors in a UDI record, including correcting data in UDI Trigger fields.

The Grace Period will apply to each UDI record and begins once you first publish the UDI record. During the Grace Period, you can change all data elements without triggering the need for a new UDI-DI or UDI record.

Note

The length of the Grace Period is subject to change as we introduce UDI and the AusUDID.

Changing UDI records in the Grace Period

You can update or correct any data element during the Grace Period. UDI Trigger rules do not apply during the Grace Period.

Changing UDI records outside the Grace Period

You can correct data outside the Grace Period, but the actions required depends on whether the change is to a UDI Trigger data element.

You may update any non-UDI Trigger data elements at any time, including outside the Grace Period.

You may correct UDI Trigger data elements outside the Grace Period, but you must do so as a Correction and must provide a reason for the change. We may review your reasoning and the correction.

For more information on editing UDI records, see: Submitting UDI records using the AusUDID portal.

Note

Corrections can only be made to UDI Trigger data elements to fix errors. If the data element has changed, you must get a new UDI-DI and submit a new UDI record.

All 4 data submission methods will prevent you from changing UDI Trigger data elements outside of the Grace Period. You must either make the change as a correction or create a new UDI record.