UDI labelling requirements
Understand and apply the UDI labelling and packaging requirements to your medical devices.
The UDI Carrier is the means to convey the UDI in a label. The UDI Carrier contains 2 forms:
- Human Readable Interpretation (HRI)
- Automatic Identification Data Capture (AIDC).
This is to ensure the device can be both read by humans and machines.
The UDI Carrier must be on the label or on the device itself, and all applicable higher levels of packaging. This is to ensure that the device can be identified throughout the supply chain.
For detailed information about UDI labelling requirements, see Complying with the Unique Device Identification requirements for medical devices.
The UDI Carrier is not to replace any other existing labelling requirements that apply under the Therapeutic Goods Act or Medical Device Regulations.
Automatic Identification Data Capture (AIDC) technologies and machine-readable formats
We have not restricted the AIDC form to a specific symbology, noting that some symbologies may be more appropriate for specific settings or use.
- AIDC technology that you may use includes:
- linear barcodes (1D)
- data matrix barcodes (2D)
- smart cards, biometrics
- Radio Frequency Identification (RFID).
As a manufacturer, if you use RFID technology, you must comply with open and commercially acceptable, international standards such as ISO/IEC 17360:2023. You must also provide a linear, 2D barcode or another type of barcode on the label to maintain usability for systems with varying technological capabilities.
Each Issuing Agency has their own general technical specifications about UDI Carrier types, size, placement and quality. We recommend that manufacturers liaise with their chosen Issuing Agency to determine the preferred and most appropriate UDI Carrier for their devices.
Human Readable Interpretation (HRI)
The HRI is to be:
- a legible interpretation of the data characters encoded in the UDI Carrier
- usually presented next to or below the AIDC form of the UDI Carrier.
In the HRI portion of the UDI Carrier, the UDI should precede any non-UDI elements. You should order the HRI portion of the UDI to specify the UDI-DI first, followed by the UDI-PI.
If there are any non-UDI elements in the UDI Carrier, the non-UDI elements should follow the UDI-PI. The HRI data and the applicable data delimiters allow for UDI data to be accurately captured manually when the AIDC porting cannot be captured.
HRI data delimiters
The HRI portion of the UDI Carrier must include data delimiters. These may also be known as qualifiers or application identifiers. The purpose of data delimiters is to distinguish the information in the string of characters that follow the data delimiter.
Data delimiters are particularly important in case of damaged or unreadable AIDC forms. The HRI allows the encoded data to be accessed manually.
Data delimiters vary between Issuing Agencies. Your chosen Issuing Agency can help you with data delimiters and formats.
Non-HRI
Some device types, such as devices principally sold in retail, do not require the UDI in HRI form. Instead, non-HRI or plain text format is required.
UDI Carrier placement
As a manufacturer, it is your responsibility to place the UDI on the label, or on the device itself, and on all applicable higher levels of device packaging unless exempt. If your device is reusable and must meet UDI requirements, then your UDI must be directly marked on the device itself.
As a manufacturer, you are responsible for determining the most appropriate placement of the UDI Carrier. You should place the UDI Carrier in a way that the AIDC can be accessed during normal operation or storage.
Packaging levels
As well as the UDI Carrier on the device label or device itself and its packaging, you must apply a UDI to all applicable higher levels of packaging. This is to ensure that the device can be tracked and identified throughout the supply chain.
The UDI-DI assigned to the base package, or the lowest trade level, is known as the Primary DI. DIs assigned to higher levels of packaging are known as the Package DI(s).
As a manufacturer, you must assign a different Package DI to each level of packaging containing a quantity of medical devices. For example, a single device, carton or case. The Package DI(s) must be unique at all levels of packaging and must follow the rules of your chosen Issuing Agency.
You do not need to assign a Package DI to levels of packaging that are logistics units.
Base package
The base package is the lowest trade level of the device packaging. In some cases, the base package is the only device packaging. The base package may also be known as the base unit.
The UDI-DI that you apply to the base package is used as the Primary DI. The UDI-DI for the base package, or Primary DI, is the ‘key’ to the UDI record in the AusUDID. You must supply the Primary DI to the AusUDID.
If there is more than one unpackaged and unlabelled device in the base package, your device must also have a Unit of Use DI. You must supply the Unit of Use DI to the AusUDID.
The exception to this is that if there is more than one unpackaged device in the base package, but the devices are directly marked, your devices do not need a Unit of Use DI. However, you must provide the Direct Marking DI to the AusUDID.
Secondary and tertiary packages
The levels of packaging above the base package are known as ‘Secondary’ and ‘Tertiary’ packages.
Secondary packages contain a set number of base packages of a device.
Tertiary packages contain a set number of secondary packages of a device.
Example of packaging configuration
The image below shows a base package that contains a single syringe with a UDI-DI for the base package of 12345678900001.
The secondary package is a carton containing 4 base packages of the syringe. The UDI-DI for the secondary package level is 12345678900002.
The tertiary package is a case containing 4 cartons that each contain 4 base packages of the syringe. The UDI-DI for the tertiary level of packaging is 12345678900003.
This demonstrates each level of packaging having a different UDI-DI.
Logistics units
Logistics units are levels of packaging that are traced in a controlled process specific to logistics system. Because of this, logistics units are not required to have a Package DI.
Forms of higher levels of packaging that are logistics units and do not require a Package DI include:
- shipping units
- Shelf Ready Packaging (SRP) as advertising material
- cartons used for shipping purposes only
- shipping invoices
- any other form of shipper.
Direct marking
Direct marking is the permanent marking of a UDI onto a device itself that can withstand normal usage and cleaning for the lifetime of the device.
Direct marking supports identification of reusable medical devices, when the device is no longer accompanied by its label or package that bears the UDI.
As a manufacturer, you must directly mark the full UDI in a way that cannot be removed from the device itself if your device is:
- intended to be reusable, and
- reprocessed between use on different patients.
We do not specify how you directly mark your device. There are many options available for the direct marking of devices. Your chosen Issuing Agency can give you recommendations on aspects of direct marking such as:
- substrate requirements
- dimensions
- quality
- placement
- suitable methods.
As a manufacturer, you are responsible for:
- determining the method of direct marking
- ensuring the direct marking can withstand the normal usage and cleaning procedures for the lifetime of the device.
Direct marking exemptions
Direct marking exemptions apply for:
- devices that are reprocessed between uses on the same patient*
- implantable devices
- devices where any type of direct marking would interfere with the safety or performance or effectiveness of the device
- devices where it is not technically feasible to directly mark the device.
*Note that if the device is subsequently reprocessed for use on another patient, the direct marking exemption does not apply.
When a medical device is exempt from direct marking, the UDI must be on the next level of packaging.
Unit of Use (UoU)
The Unit of Use Device Identifier (UoU DI) is a virtual identifier assigned to an individual medical device when:
- you supply more than one device in a base package, making the device count in the base package greater than one, and
- you have not labelled or directly marked the individual devices inside the base package.
The purpose of the Unit of Use is to associate the use of a device to or on a patient when a base package contains more than one device.
The Unit of Use DI is not considered the Primary DI, as it does not replace the UDI-DI for the base package. The base package remains the lowest trade level even when UoU is required. The UoU DI does not replace the Primary DI. However, the Unit of Use DI allows distinction between the individual device and the grouping at the base package level. In healthcare, there may be clinical reasons why the tracking of individual items may be necessary.
Each device within the base package shares the same Unit of Use DI. You are not required to allocate a different UoU DI to each individual item within the base package.
UDI Triggers
The overarching determinant in a UDI Trigger scenario is whether the device must be identified as different from previous iterations of the device.
Certain changes to medical devices or their UDI data elements mean that the device can no longer be identified by its existing UDI, as it is considered a new model of medical device. Because of this, when these changes occur the device requires a new UDI-DI and UDI record.
Changes to a device that mean that the device requires a new UDI-DI and UDI record include:
- changes to the safety of a device
- changes to the performance of a device
- changes to the intended purpose of a device
- changes to indications for use of the device
- changes to a UDI Trigger data element.
Further information on UDI Triggers can be found at Complying with the Unique Device Identification requirements for medical devices.
European Union (EU) or United States (US) UDI compliant labels
We accept UDI Carriers that meet the UDI requirements of the EU or US, if:
- the UDI-DI has been issued by one of our recognised Issuing Agencies
- the label complies with the existing regulatory and labelling requirements for Australia.
You can supply devices in Australia that have US or EU UDI compliant labels even if they are exempt from Australian UDI requirements. We recommend that you supply this data to the AusUDID to minimise confusion for the end users.
As an Australian manufacturer that exports to the USA or Europe, you can use the US or EU UDI compliant UDI Carrier in Australia.
The manufacturer must give their reasoning for not meeting the direct marking requirements, when requested by the TGA.