UDI requirements for specific device types

Some specific medical device types have their own UDI requirements or are not required to meet all UDI requirements due to the nature of the device. It is important to understand if the devices that you supply are required to meet UDI requirements.

For detailed information on UDI requirements for specific device types, see: Complying with the Unique Device Identification requirements for medical devices.

Reusable devices

If you design or intend for your device to be reprocessed for reuse, your device is a reusable device. Reusable devices are intended to:

• be used more than once on the same or different patients
• undergo high-level disinfection or sterilisation before each use.

Single use only devices are not reusable devices.

A manufacturer’s determination on whether a device is reusable will be considered as part of the application for inclusion submitted to us. You should reflect this in the instructions for use with any relevant information on appropriate processes for allowing reuse.

As a manufacturer, if you design or intend for your device to be a reusable device you must meet direct marking requirements.

Direct marking requirements specify that the manufacturer must ensure that the UDI of reusable devices is:

• directly marked on the device itself (unless exempt)
• readable after each reprocessing
• able to withstand reprocessing for the lifetime of the device.

Capital equipment

Capital equipment is not required to be directly marked. However, you must label these devices with a UDI.

Examples of capital equipment that will require a UDI label, but is not directly marked, include:

• MRI machines
• IV pumps
• IVD bench top instruments.

You are required to label capital equipment with a UDI (unless otherwise exempt); however, we do not use the term ‘direct marking’. Equipment that contains labelling on the device itself or has a UDI printed directly on the device as part of labelling is UDI compliant, however this is referred to as UDI labelled. You may choose to directly mark these devices.

Single use devices

A single use device is used on an individual patient during a single procedure and then discarded. It is not intended to be reprocessed for use on another patient.

You must meet UDI requirements for single use devices, where the devices are in scope of devices required to meet UDI requirements.

Single use devices packaged individually

If the device is intended for individual commercial distribution, you must meet UDI requirements for the individual device.

Single use devices packaged together

If you supply single use devices packaged together in a base package, and these devices are intended to be stored in the base package until removed for use, you are only required to apply the UDI to the base package. You are not required to apply the UDI to each individual internal packaging level, if any exist.

When the end user (for example, healthcare provider) is not expected to have access to the base package, the UDI Carrier should be on the individual device packaging.

All other levels of packaging must bear a Package DI, except logistics units.

Personalised medical devices (PMDs)

Medical devices that are designed and manufactured, or adapted or modified, to meet the needs of an individual are personalised medical devices (PMD).

We use 3 specific terms to describe personalised medical devices:

• patient-matched medical devices
• adaptable medical devices
• custom-made medical devices.

Patient-matched medical devices (PMMDs)

As a sponsor or manufacturer, you must meet UDI requirements for patient-matched medical devices (PMMDs) if:

• your PMMDs are included in the ARTG
• you manufacture more than 5 per financial year, and
• your PMMD is in scope of devices required to meet UDI requirements.

Adaptable medical devices

Adaptable medical devices are devices that are mass-produced and intended by the manufacturer to be assembled or adapted after supply. Adaptable medical devices must meet UDI requirements, where they are in scope of devices required to meet UDI requirements.

Custom-made medical devices

Custom-made medical devices are exempt from meeting UDI requirements.

Note that most of the devices that were previously supplied under the custom-made medical device exemption now meet the definition of PMMD. You must meet UDI requirements for PMMDs, unless otherwise exempt.

Dental sponsors and manufacturers

You must meet UDI requirements for any dental devices that:

• are in scope of devices required to meet UDI requirements
• are required to be included in the ARTG.

Dental practitioners

As a registered dental practitioner, you have responsibilities to act in accordance with The Dental Board of Australia’s standards, codes, and guidelines.

You must be aware of and comply with other laws and regulations, including regulatory responsibilities to the TGA when:

• importing dental devices (a sponsor)
• manufacturing dental devices away from chair-side (a manufacturer and a sponsor).

You must meet UDI requirements for dental devices where:

• you are the sponsor of the dental device, and
• the dental device is in scope of devices that must meet UDI requirements.

You do not need to meet UDI requirements if you buy:

• finished devices from an Australian-based sponsor
• materials and components to manufacture non-implantable dental medical devices from an Australian-based sponsor who has already met UDI requirements.

You can find more information about regulatory responsibilities for dental practitioners, including information on what makes a dental practitioner a sponsor at Guidance for dental practitioners.

Medical device and IVD device software

You are required to meet UDI requirements for medical devices and IVDs that are software or incorporate software unless they are exempt.

The table below summarises software types that must meet UDI requirements.

Software specific UDI labelling and data provision requirements depend on factors such as:

• the type of software
• whether it is a physical product
• whether you supply the software packaged or unpackaged.

You can learn more about specific requirements for software including UDI assignment and placement in Complying with the Unique Device Identification requirements for medical devices.

Devices principally sold in retail

If you principally sell your device in retail, you have reduced labelling requirements for these devices.

The determination for whether a device is principally sold in retail is the responsibility of the manufacturer. You may be required to justify this upon request.

If your device is supplied in both retail premises and healthcare settings, you must meet full UDI requirements where the device is predominantly supplied in healthcare settings.

UDI-DI and UDI-PI requirements for devices principally sold in retail

As a manufacturer, you must allocate and apply a UDI-DI to your devices in both machine readable and human readable forms. The UDI-DI can be applied in any non-HRI form recommended by your chosen Issuing Agency.

Devices principally sold in retail premises are exempt from using HRI and AIDC forms. You are not required to use HRI or AIDC forms. However, these devices must still meet reduced UDI labelling requirements.

You only need to apply the UDI-PI in non-HRI form. You may choose to apply the UDI-PI in machine readable form; however, this is on a voluntary basis.

The below table summarises the UDI-DI and UDI-PI requirements for devices principally sold in retail.

You must meet all UDI requirements for all other applicable levels of packaging. You are not required to meet UDI requirements for logistics units. This includes Shelf Ready Packaging (SRP) as advertising material.

You must also meet all other UDI requirements, including submitting UDI records for these devices to the AusUDID.

Refurbished devices, reprocessed single use devices, own brand or private labellers

UDI requirements for refurbished, reprocessed and relabelled devices depends on a range of factors, including:

• whether you are the original manufacturer of the device you are refurbishing or relabelling
• whether the device has undergone changes that have altered the intended purpose of the device
• whether the device that is being reprocessed is single use or reusable.

Note that reprocessing reusable devices in ways described in the manufacturer’s Instructions for Use does not make you the manufacturer. Reprocessing of reusable medical devices is part of the intended purpose for the medical device, and part of clinical practice. We do not regulate clinical practice.

For detailed guidance on UDI requirements for refurbished devices, reprocessed devices, own brand or private labellers, see Complying with the Unique Device Identification requirements for medical devices.

In vitro diagnostic (IVD) medical devices

As a manufacturer of IVDs, you must assign a UDI to each model of IVD unless exempt. In most scenarios, IVDs share the same UDI requirements with medical devices.

IVD kits

Although the term ‘kit’ has a specific meaning in the Australian legislation, some products that are regulated as medical devices include the word kit in their name and include at least one medical device. For example, SARS-CoV antigen test kits, which only contain medical devices (including IVD devices).

You must meet UDI requirements for IVD kits where they are in scope of devices required to meet UDI requirements.

You must also meet UDI requirements for components of the kit, if the component is:

• regulated as a medical device, and
• commercially available on its own.

If your IVD kit does not include any components that you must meet UDI requirements for, you only need to assign and apply the UDI to the IVD kit itself, where applicable.

If your IVD kit contains single use medical devices, these devices do not need a UDI where:

• the person(s) intending to use the device generally know the uses*
• the single use medical devices are not intended for individual use outside the context of the IVD kit, or
• the single use medical devices are Class I non-measuring non-sterile or Class Im (measuring).

However, you should provide a UDI for replacement parts of the IVD kit, regardless of whether they are single use or not. 

*You may be required to justify this on our request.

For more information on UDI requirements for IVD kits, see Complying with the Unique Device Identification requirements for medical devices.

Implantable devices

Because of the high risks with implantable devices, the UDI for an implantable device should be identifiable and able to be recorded before implantation. This can minimise the risks of misidentification of the implanted device.

The following UDI requirements apply for implantable devices:

• all base packages of implantable devices need to be identified by checking the UDI before surgery and captured at the point of implantation
• the UDI must be in both HRI and AIDC formats
• the UDI-PI should include:
  • for an active implantable device, the serial number
  • for other implantable devices, the serial number or lot number per the manufacturer's quality management system.

Surgical Loan Kits (SLK)

Surgical loan kits (SLKs) are supplied on loan to Australian hospitals for use in a particular surgical procedure and generally comprise collections of reusable surgical instruments. They may also include implantable medical devices and other medical devices. All goods in a SLK are medical devices and each medical device in the SLK must be included in the ARTG.

SLKs are exempt from requiring a UDI at the kit-level. The item for transporting the devices in the kit (tray, tub or case) is considered a logistics unit which does not need a Package DI.

While the SLK is exempt at the kit level, your SLK components may require a UDI if in scope of devices that must meet UDI requirements.

If the component must meet UDI requirements, the UDI (UDI-DI and UDI-PI) for each component must be easily accessible at the point of care. This will allow the linking of the medical devices to their implantation or use on patients.

We acknowledge the global challenges to assigning UDI identification to devices in surgical loan kits, as typical UDI labelling methods are often not feasible. To reduce these challenges, we are not prescribing the method you use to provide the UDI. We aim to be consistent with the flexibility offered by other international regulators. This includes allowing provision methods such as stickers, tags, inventory sheets and data carrier strips.

System or Procedure Packs (SOPP)

You must assign a system or procedure pack (SOPP) a UDI if it contains one or more medical device in scope of the UDI requirements.

Your SOPP does not need a UDI on the pack if it only contains:

• medical devices that are Class I - with a measuring function, or
• medical devices that are Class I non-sterile.

However, the assembler or manufacturer of the SOPP may choose to apply a UDI to these SOPPs.

Any component of a SOPP that is a medical device that is in scope of UDI requirements must have a UDI unless the component is:

• not commercially available on its own
• an individual single-use disposable device where the person(s) using them generally know the uses; and are not intended for individual use outside the context of the SOPP. For example, an unpackaged sterile syringe in a sterile pack cannot be used for another procedure once removed from the pack
• exempt from UDI requirements.

Medical device components that you supply separately from the SOPP must be included in the ARTG and comply with UDI requirements, unless exempt.

Systems that are medical devices

A System is 2 or more goods that the manufacturer intends to be connected, used together or combined to achieve a specific medical purpose. The goods may be packaged together or packaged separately.

A System is not:

• a single item
• a collection of miscellaneous items that the manufacturer does not intend to be used together for a specific medical purpose
• bulk packs of one or more items
• a procedure pack (though a procedure pack can include a system in it).

As a manufacturer, you must allocate a UDI to the System that is a medical device in the same way as other medical devices.

As a sponsor, you must supply the UDI-DI and related data for the System to the AusUDID in the same way as other devices.

For information on configurable systems, see Complying with the Unique Device Identification requirements for medical devices.

Medical device accessories

An accessory is something that the manufacturer specifically intends to be used with a device. The accessory allows or helps the device to be used, in a way that the manufacturer of the device intended.

As a manufacturer, you must meet UDI requirements for accessories if your accessory (including components and sub-systems):

• is considered a medical device in its own right
• is commercially available
• has its own ARTG inclusion, and
• is in scope of devices required to meet UDI requirements.

You do not need to meet UDI requirements if your accessory:

• is supplied as part of a convenience, medical procedure, IVD kit or system that is a medical device that has its own UDI
• is exempt from inclusion in the ARTG, or
• is otherwise exempt from UDI requirements.

Spare or replacement parts

Spare parts

Though spare parts do not have a formal definition in Australian legislation, the term is taken to mean replacement components. These are not considered an accessory for a device, as they would not normally be supplied separately for use with the device.

You are only required to meet UDI requirements for spare parts where the part:

• is considered a medical device in its own right
• is commercially available
• has its own ARTG inclusion, and
• is in scope of devices required to meet UDI requirements.

Replacement consumables

Replacement consumable items that a manufacturer supplies separately to the original device are considered accessories.

Managing UDIs for spare or replacement parts

If you exchange a component of a device that is a device itself and has a UDI, you must continue to meet UDI requirements for the component, even when it is a replacement.