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Understanding UDI and identifiers

Learn about each type of identifier required under the Australian UDI framework

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A UDI identifies a specific model and production run of a medical device.

It has 2 parts:

  • UDI Device Identifier (UDI-DI)
  • UDI Production Identifier (UDI-PI).

The full UDI links a model to its production run and is used to trace the model of device down to the batch, lot or manufacturing date.

If a recall affects one production run, the UDI-DI identifies the model, and the UDI-PI identifies the affected batch.

Example of how a UDI-DI and UDI-PI form the full UDI

Example of how a UDI-DI and UDI-PI form the full UDI

Example of how a UDI-DI and UDI-PI form the full UDI

This diagram shows the structure of a Unique Device Identifier (UDI). 

The left orange box explains the UDI Device Identifier (UDI-DI) as the fixed part identifying the manufacturer and model, with an example: “(01) 0 931234567890 7.” 

The right purple box describes the UDI Production Identifier (UDI-PI) as the dynamic part containing production details:

  • Manufactured date: 25 December 2023
  • Expiration date: 25 December 2033
  • Lot or batch: B01
  • Serial number: S234

A barcode appears at the bottom, and the formula “UDI = UDI-DI + UDI-PI” is shown in the centre.

UDI-Device Identifier (UDI-DI)

The UDI-DI is a globally unique numeric or alphanumeric code that identifies the device model.

The UDI-DI must appear on the device label, packaging, and in some cases on the device itself. It is also submitted to the AusUDID as the ‘Primary DI’.

The image below shows the UDI-DI portion of a UDI.

Example of UDI-DI in a UDI Carrier

Example of UDI-DI in a UDI Carrier

Example of UDI-DI in a UDI Carrier

This image shows the barcode with the HRI portion of the UDI circled in red.

UDI-Device Identifier (UDI-DI) continued

The UDI-DI is used to:

  • search the AusUDID
  • identify models of device in regulatory events such as recalls and adverse events.

A TGA recognised Issuing Agency must issue the UDI-DI to ensure global uniqueness.

We accept the following identifiers as a UDI-DI:

  • GS1 Global Trade Item Number (GTIN)
  • Health Industry Bar Code - Universal Product Number (HIBC-UPN)
  • ICCBBA ISBT 128 Processor Product Identification Code (PPIC).

Each model of medical device must have a unique UDI-DI. If you supply multiple models under a single ARTG inclusion, you must allocate a different UDI-DI to each model. In this scenario, each UDI record will link to the same ARTG inclusion.

Sabrina the sponsor

Sabrina supplies 5 models of medical device under a single ARTG inclusion.

Sabrina must allocate a UDI-DI for each model. This means that Sabrina has 5 UDI-DIs linked to one ARTG.

Sabrina applies a full UDs, consisting of the UDI-DI and UDI-PI, to each corresponding model of medical device.

UDI-Production Identifier (UDI-PI)

The UDI-PI identifies production details such as batch, lot, software version or manufacturing date.

The UDI-PI must appear on the device label, packaging, and in some cases on the device itself. However, the UDI-PI is not stored in the AusUDID.

The image below shows the UDI-PI portion of the UDI.

Example of UDI-PI in a UDI Carrier

Example of UDI-PI in a UDI Carrier

Example of UDI-PI in a UDI Carrier

A bar code with the HRI portion of the UDI circled in red

UDI-Production Identifier (UDI-PI) continued

Production identifiers vary depending on your device type and labelling practices. There is no limit to the number of identifiers included in a UDI-PI.

As a manufacturer, you are responsible for determining which production identifiers to include based on device type and the information provided on the label. You should follow the specifications of your chosen Issuing Agency.

UDI-PI requirements:

  • If your label includes a lot number, serial number, software identification or expiry date, it must be included in the UDI-PI.
  • If your label includes a manufacturing date on the label, it does not need to be included in the UDI-PI. If the manufacturing date is the only production identifier on the label, it must be used as the UDI-PI.
  • If your device is an active implantable medical device, you must include the serial number in the UDI-PI.
  • If your device is any other implantable device, you must include the serial number or lot number in the UDI-PI.
  • If your device is software, the software version is considered to be the manufacturing control mechanism and must be included in the UDI-PI. Note that minor software revisions require a new UDI-PI, but not a new UDI-DI.
  • If your device contains a Donation Identification Number (DIN) or a division identifier, it must be included in the UDI-PI.

Your chosen Issuing Agency may have specific requirements for production identifiers. You are responsible for confirming whether your device requires any specific inclusions in the UDI-PI.

You must not remove other production information from the device label, even if it is also part of the UDI. This includes the expiry date, manufacturing date and lot number.

Primary DI

The Primary DI is not an additional identifier - it is synonymous with the UDI-DI. It is referred to as the Primary DI in the AusUDID, as it is the primary lookup value.

The Primary DI is the UDI-DI portion of the UDI applied to the lowest level of packaging of a device.

The images below show how the UDI-DI and Primary DI are the same.

Example of UDI-DI matching a UDI record

Example of UDI-DI matching a UDI record

Example of UDI-DI in a UDI Carrier

A bar code with the HRI portion of the UDI circled in red.

Example of Primary DI in a UDI record matching UDI-DI

Example of Primary DI in a UDI record matching UDI-DI

Example of Primary DI in a UDI record matching UDI-DI

An image of a UDI record showing the UDI-DI as the Primary DI.

Direct Marking DI

Some devices are required to have the UDI directly marked onto the device itself. The UDI permanently marked on the device is referred to as the Direct Marking DI. The Direct Marking DI ensures reusable devices remain identifiable after it is removed from its packaging or the label is removed.

It may match or differ from the UDI-DI on the label.

Example:

A reusable surgical instrument must have the UDI directly marked onto the device itself. The UDI engraved, etched or marked onto the device is the Direct Marking DI. It may be the same as the UDI on the device label, or it may be different.

Example of a UDI Carrier directly marked on a device

Example of a UDI Carrier directly marked on a device

Example of a UDI Carrier directly marked on a device

This image is of a surgical scalpel with a close-up inset showing a Unique Device Identifier (UDI) marking. The inset displays a 2D DataMatrix barcode and text:

  • (01)00842768015588
    (10)123FOBA

The word “UDI” appears below the barcode.

Unit of Use DI

If a base package contains multiple instances of the same model of device and the devices are not individually labelled with a UDI, the devices must be allocated a Unit of Use DI. This identifier is virtual. It does not appear on the label, packaging, or the device but it must be provided in the UDI record in the AusUDID.

The image below shows how the Unit of Use DI is included in a UDI record.

Example of Unit of Use DI included in a UDI record

Example of Unit of Use DI included in a UDI record

Example of Unit of Use DI included in a UDI record

This image is of a UDI record showing the Unit of Use DI.

Unit of Use DI continued

The Unit of Use DI allows the use of the individual device to be associated with a patient.

Example:

A base package contains 10 syringes. The syringes are not individually labelled with a UDI. The base package is allocated a UDI-DI (Primary DI), and the syringes within the base package are allocated a Unit of Use DI.

Package DI

Package DI(s) are UDIs applied to packaging levels above the base package. They follow standard UDI requirements, and they are submitted to the AusUDID as Package DI(s).

Package DIs help find devices when multiple packaging levels exist between the device and the outer carton(s).

Example:

A base package contains one medical device. A box contains 5 base packages. A carton contains 5 boxes. A Package DI must be allocated to the box and the carton. If the carton is used for shipping purposes only, it is considered a logistics unit and is exempt from UDI requirements.

Secondary DI

You are not required to allocate more than one UDI-DI to a model of device. However, in some cases, devices may be allocated with a UDI-DI from more than one Issuing Agency. The Secondary DI enables identification of the device using any of these identifiers.

While the Primary UDI-DI is the only UDI-DI on the label, you may include the Secondary DI in your UDI record and support scenarios when the Secondary DI is used.

Example:

A device bears a HIBCC UDI-DI but is also supplied through GS1’s National Product Catalogue. Because of this, the device will also be allocated a GS1 UDI-DI. Both UDI-DIs can be submitted in the UDI record, with the UDI-DI on the label must be submitted as the Primary DI. If a hospital’s inventory management system refers to the GS1 allocated UDI-DI, the device can still be identified and located.

Previous DI

A Previous DI allows for the identification of a device that was assigned a new or substitute device identifier for reasons other than changes to the device physical specifications or new indications for use that changed the version or model.

When a device changes in a way that triggers a new UDI-DI, the Australian UDI requirements stipulate that you create a new UDI record. The Previous DI provides a means to link the 2 UDIs via 2 records in the AusUDID.

Example:

A device’s brand name changes, which is a UDI Trigger, and a new UDI-DI must be assigned to the device with the new brand name. A new UDI record must be created for the new UDI-DI and the Previous DI will allow linking of the 2 UDI records, showing the relationship between the different brand-named devices.

Summary of identifiers

The below table summarises the various identifiers, their use and whether they are included in the AusUDID.

Summary of identifiers
IdentifierPurposeRequired on label?Required in the AusUDID?
UDI-DIIdentifies device modelYesYes
UDI-PIIdentifies production run of the deviceYesNo
Direct Marking DIIdentifies reusable devices when separated from their packagingRequired on the device itselfYes
Unit of Use DIIdentifies devices at unit-of-use levelNoYes
Package DIIdentifies device at higher packaging levelsRequired on packagingYes
Secondary DIAdditional UDI-DINoOptional
Previous DILinks old and new UDI recordsNoOptional

Related links

UDI information for sponsors and manufacturers
Complying with the Unique Device Identification requirements for medical devices
Complying with the Unique Device Identification timeframes for medical devices
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