Does UDI apply to my device

Your device must meet UDI requirements

Based on your responses, you are required to meet UDI requirements for this device.  

UDI requirements include but are not limited to: 

• Allocating a UDI to your device per requirements of one of the 3 TGA recognised Issuing Agency
• Applying the UDI Carrier to your device label and packaging, and on the device itself if applicable
• Submitting a UDI record to the Australian UDI Database (AusUDID)
• Meeting any additional device-specific requirements
• Meeting all mandatory UDI requirements by the UDI compliance start date for your device. 

You can find out what you need to do to prepare for UDI requirements and the AusUDID here: Preparing for UDI and AusUDID Checklist.

You can find out when UDI requirements apply to your device by using our tool: ‘When do UDI requirements apply to my device?’  

Only certain Class 1 in vitro diagnostic (IVD) medical devices are required to meet UDI requirements. This depends on the GMDN Term for the IVD medical device. 

CT943 Instrument/analyser IVDs:

Manual, semi-automated or automated equipment or apparatus for processing, examining and/or providing information about a clinical specimen. 

CT944 Software IVDs:

Software for the collection, input, storage, retrieval, interpretation or reporting of digital data or other information. 

IVD medical devices are classified based on their intended purpose and the public health risk or personal risk that may arise from an incorrect result.

The higher the potential risk posed by an incorrect result, the higher the classification of the device.

UDI requirements apply to most IVD medical devices, but whether they apply depends on the device’s risk classification.

In house IVDs are pathology tests developed or modified within a laboratory or laboratory network to carry out testing on human samples. The results are intended to assist in clinical diagnosis or be used in making decisions concerning clinical management. 

IVDs that are developed in house but supplied* outside of the laboratory or laboratory network fall outside the definition of ‘in house IVD’. 

*Supplied in this context means supply of the actual device, not the testing service outside of the laboratory or laboratory network. 

Class I medical devices are further classified based on whether they are supplied sterile or non-sterile.

Medical devices are defined under section 41BD of the Therapeutic Goods Act 1989 and further informed by the Therapeutic Goods (Medical Devices - Specified Articles) Instrument 2020. 

In vitro diagnostic (IVD) medical devices are defined in the Therapeutic Goods (Medical Devices) Regulations 2002.

Medical devices are classified with regard to their intended purpose. In particular, the classification rules take into account:

• the degree of invasiveness in the human body
• the duration and location of use
• whether the device relies on a source of energy other than the body or gravity.

UDI requirements apply to most medical devices, but whether they apply depends on the device’s risk classification. 

To check if your device is appropriately classified, use our decision tool: ‘What classification is my medical device?’

UDI requirements do not apply to this device. 

Although compliance is not mandatory, you may choose to voluntarily comply with UDI requirements if your device is included on the ARTG as a medical device or IVD medical device.

If your device is not included in the ARTG or is included in the ARTG as an ‘other therapeutic good’ or a medicine, you cannot create a UDI record in the Australian UDI Database (AusUDID). However, you may still choose to apply a UDI to the device. 

You can learn more about UDI requirements here: Complying with the Unique Device Identification requirements for medical devices.

You can learn about UDI implementation timing here: Complying with the Unique Device Identification timeframes for medical devices.

Unique Device Identification (UDI) requirements only apply to certain medical devices and in vitro diagnostic (IVD) medical devices that are included in the Australian Register of Therapeutic Goods (ARTG).

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The Department of Health, Disability and Ageing has taken due care in preparing these materials but we do not guarantee, and assume no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in these materials. It should be noted that this is general information only.