Managing UDI Triggers

The purpose of UDI is to identify and track devices down to the model and production run. As such, it is important to allocate a new UDI-DI to a device when key information about the original device changes in such a way that it should be identified differently from the previous iteration of the device.

The UDI-DI may change due to:

• changes to the safety or performance of a device
• changes to a UDI Trigger data element in the AusUDID
• changes that your chosen Issuing Agency determines will require a new UDI.

Not all changes to safety or performance will require a new UDI-DI. Changes to safety or performance of a device are likely only a UDI Trigger where:

• the changes result in clinical change
• the changes result in a new major version number for software
• the changes result in a new model or version.

While the UDI-PI will change with each production run, as this is not a change to a UDI-DI it does not need to be recorded in the AusUDID.

UDI Triggers

When certain changes to a device or its UDI data elements mean that the device can no longer be unambiguously identified by its existing UDI, it is considered a new model of medical device. When these attributes of the device change, a new UDI-DI must be assigned and new UDI record created.

UDI Trigger data elements

A UDI Trigger data element is a specific attribute in the UDI database that, when changed, requires assignment of a new UDI-DI because the change could affect device identification or traceability of the device. These are:

• Primary DI
• Primary DI Issuing Agency
• Device Count
• Direct Marked DI*
• Direct Marked DI Issuing Agency*
• Brand Name
• Model or 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 UDI data elements and details regarding when UDI Trigger rules apply, see the Australian UDI Data Dictionary.

Please note that the UDI Trigger data elements listed above apply to the Australian implementation of UDI. Other jurisdictions may include these data elements as well as additional requirements. As the manufacturer, you are responsible for ensuring UDI compliance in other jurisdictions where applicable.

As a manufacturer, you are responsible for determining whether changes to the device are UDI Triggers. Note that the AusUDID is designed to indicate which data elements are UDI Trigger data elements, recognise changes to UDI Trigger data elements and will enforce the creation of a new UDI record when you change the value of a UDI Trigger data element.

Changes to device information

If a change to the device information impacts the clinical characteristics, safety, or performance of the device, then the UDI Trigger rules are likely to apply, and a new UDI-DI required. If the change does not affect the clinical characteristics, safety, or performance of the device a new UDI may not be required.

This includes changes to Software as a Medical Device (SaMD). If SaMD undergoes a major software change, such as modified algorithms, added functionality or new user interface, and results in a new ‘major’ software version, this will be considered a UDI Trigger. The new UDI-DI is required to reflect the changed model of the device, enabling it to be distinguished from the previous model of device.

While the AusUDID will allow the linking of this new UDI record to the same ARTG inclusion, you are responsible for ensuring any changes are considered within the full context of other regulatory obligations.

Mac the manufacturer

Mac manufactures a device that monitors heart rate. He updates the software so it now can monitor heartrate and diagnose arrhythmias. This represents a change both to software functionality and intended purpose. As a result, a new UDI-DI must be allocated.

Managing UDI Triggers

As a manufacturer, you are responsible for:

• allocating a new UDI-DI to your changed device(s)
• labelling your changed device(s) with the new UDI-DI
• allocating new Package DIs for any higher levels of packaging
• meeting all other UDI requirements for your changed device(s)
• notifying your sponsor(s) of the new UDI-DI
• meeting any other applicable obligations.

As a sponsor, you are responsible for:

• creating a new UDI record for the new UDI-DI for the changed device
• including the Previous DI in the new UDI record of the changed device, if possible
• meeting any other applicable obligations.

Daniel the manufacturer

Daniel manufactures local anaesthesia needles under the brand name ‘ABC Needles’. He changes the brand name to ‘XYZ Needles’. Changing the brand name is a UDI Trigger, and therefore he must allocate a new UDI-DI to these local anaesthesia needles.

In this scenario:

• Daniel allocates a new UDI-DI for ‘XYZ Needles’
• the existing UDI record for ‘ABC Needles’ remains in the AusUDID indefinitely and Daniel does not update this UDI record to display the new UDI-DI
• Daniel creates a new UDI record for ‘XYZ Needles’ in the AusUDID
• the new UDI record may include the UDI-DI for ‘ABC Needles’ as a Previous DI.

Daniel’s new local anaesthesia needles are supplied with 10 in a base package and are not individually labelled with a UDI. Daniel must also allocate a new Unit of Use DI.

Daniel’s new local anaesthesia needles are supplied with higher levels of packaging. Daniel must allocate a new Package DI for every higher level of packaging.

There are circumstances, outside the requirements of the TGA and UDI Triggers, where a new UDI-DI is assigned to a device. For example, when a device has new supply chain requirements. As the sponsor, you must ensure a UDI record is created for these UDI-DIs if they will be supplied in Australia.