When does UDI apply to my device

This device must meet UDI requirements from 1 July 2029*, if the device is still in sponsor control on or after 1 July 2029. 

This device is exempt from Direct Marking requirements for the lifetime of the device.

Learn more about existing devices here: Complying with the Unique Device Identification timeframes for medical devices

*If a device eligible a transitional arrangement becomes UDI compliant before the transitional compliance date, it must meet Australia's UDI requirements from the date it becomes UDI compliant. 
If you relabel your medical device or IVD after the UDI compliance start date passes, you must meet UDI requirements for this newly labelled device. 
Relabelling your device after the UDI compliance start date does not impact the exemption from Direct Marking requirements. Your device remains exempt from Direct Marking requirements for the lifetime of the device.

This device is considered an ‘Existing Device’ as it was manufactured prior to the UDI compliance start date for its device risk classification.

It is exempt from UDI requirements for the lifetime of the device.

This device is eligible for the EU IVDD to EU IVDR transitional arrangements. This device must meet UDI requirements from 1 January 2030*.

If this device requires Direct Marking, it must be Directly Marked from 1 July 2030.

*If a device eligible a transitional arrangement becomes UDI compliant before the transitional compliance date, it must meet Australia's UDI requirements from the date it becomes UDI compliant. 
For example, if a device transitions to from EU IVDD to EU IVDR after the standard UDI compliance date but before the EU IVDD to EU IVDR transitional arrangements end, the device must meet Australian UDI requirements from the date it has transitioned.

This device is eligible for the EU IVDD to EU IVDR transitional arrangements. This device must meet UDI requirements from 1 January 2029*.

If this device requires Direct Marking, it must be Directly Marked from 1 July 2029.

*If a device eligible a transitional arrangement becomes UDI compliant before the transitional compliance date, it must meet Australia's UDI requirements from the date it becomes UDI compliant. 
For example, if a device transitions to from EU IVDD to EU IVDR after the standard UDI compliance date but before the EU IVDD to EU IVDR transitional arrangements end, the device must meet Australian UDI requirements from the date it has transitioned.

This device is eligible for the EU MDD to EU MDR transitional arrangements. This device must meet UDI requirements from 1 January 2029*.

If this device requires Direct Marking, it must be Directly Marked from 1 January 2029.

*If a device eligible a transitional arrangement becomes UDI compliant before the transitional compliance date, it must meet Australia's UDI requirements from the date it becomes UDI compliant. 
For example, if a device transitions to from EU MDD to EU MDR after the standard UDI compliance date but before the EU MDD to EU MDR transitional arrangements end, the device must meet Australian UDI requirements from the date it has transitioned.

This device is eligible for the EU MDD to EU MDR transitional arrangements. This device must meet UDI requirements from 1 January 2028*.

If this device requires Direct Marking, it must be Directly Marked from 1 January 2028.

*If a device eligible a transitional arrangement becomes UDI compliant before the transitional compliance date, it must meet Australia's UDI requirements from the date it becomes UDI compliant. 
For example, if a device transitions to from EU MDD to EU MDR after the standard UDI compliance date but before the EU MDD to EU MDR transitional arrangements end, the device must meet Australian UDI requirements from the date it has transitioned.

This device is eligible for the EU MDD to EU MDR transitional arrangements. This device must meet UDI requirements from 1 January 2028*.

Direct Marking is not applicable to implantable devices.

*If a device eligible a transitional arrangement becomes UDI compliant before the transitional compliance date, it must meet Australia's UDI requirements from the date it becomes UDI compliant. 
For example, if a device transitions to from EU MDD to EU MDR after the standard UDI compliance date but before the EU MDD to EU MDR transitional arrangements end, the device must meet Australian UDI requirements from the date it has transitioned.

This device must meet UDI requirements from 1 July 2029. It is not eligible for any transitional arrangements.

If this device requires Direct Marking, it must be Directly Marked from 1 July 2030.

This device must meet UDI requirements from 1 July 2028. It is not eligible for any transitional arrangements.

If this device requires Direct Marking, it must be Directly Marked from 1 July 2029.

This device must meet UDI requirements from 1 July 2028. It is not eligible for any transitional arrangements.

If this device requires Direct Marking, it must be Directly Marked from 1 January 2029.

This device must meet UDI requirements from 1 July 2027. It is not eligible for any transitional arrangements.

If this device requires Direct Marking, it must be Directly Marked from 1 January 2029.

This device must meet UDI requirements from 1 July 2026. It is not eligible for any transitional arrangements.

If this device requires Direct Marking, it must be Directly Marked from 1 January 2029.

This device must meet UDI requirements from 1 July 2026. It is not eligible for any transitional arrangements.

If this device requires Direct Marking, it must be Directly Marked from 1 January 2028.

Many in vitro diagnostic (IVD) medical devices are already UDI compliant because they are also supplied in countries that have implemented UDI requirements, such as the United States.

UDI compliant means that the device bears a UDI Carrier that includes a UDI-Device Identifier (UDI-DI) issued by one of our 3 TGA recognised Issuing Agencies, and a UDI-Production Identifier (UDI-PI) formatted according to the rules of the relevant Issuing Agency.

The EU IVDR transition extension introduces additional transition provisions for devices with an extension to their EU IVDD certificate. 

In vitro diagnostic (IVD) medical devices supplied in Australia under an EU IVDR certificate or any other overseas regulator conformity assessment certificate other than an EU IVDD certificate must meet UDI requirements at the standard compliance dates.

*An EU IVDD certificate refers to a conformity assessment document issued under Directive 98/79/EC of the European Parliament and the Council of the European Union.

Unique Device Identification (UDI) is mandatory for some Class 1* in vitro diagnostic (IVD) medical devices after 1 July 2029.

*Only Class I IVDs that are instruments and software are required to comply with the UDI requirements. Such devices are typically covered under the following Global Medical Device Nomenclature Collective Term:

• instrument/analyser IVDs (GMDN Code CT943)
• software IVDs (GMDN Code CT944).

Many in vitro diagnostic (IVD) medical devices are already UDI compliant because they are also supplied in countries that have implemented UDI requirements, such as the United States.

UDI compliant means that the device bears a UDI Carrier that includes a UDI-Device Identifier (UDI-DI) issued by one of our 3 TGA recognised Issuing Agencies, and a UDI-Production Identifier (UDI-PI) formatted according to the rules of the relevant Issuing Agency.

The EU IVDR transition extension introduces additional transition provisions for devices with an extension to their EU IVDD certificate. 

In vitro diagnostic (IVD) medical devices supplied in Australia under an EU IVDR certificate or any other overseas regulator conformity assessment certificate other than an EU IVDD certificate must meet UDI requirements at the standard compliance dates.

*An EU IVDD certificate refers to a conformity assessment document issued under Directive 98/79/EC of the European Parliament and the Council of the European Union.

Unique Device Identification (UDI) is mandatory for all Class 2 in vitro diagnostic (IVD) medical devices after 1 July 2029.

Many in vitro diagnostic (IVD) medical devices are already UDI compliant because they are also supplied in countries that have implemented UDI requirements, such as the United States.

UDI compliant means that the device bears a UDI Carrier that includes a UDI-Device Identifier (UDI-DI) issued by one of our 3 TGA recognised Issuing Agencies, and a UDI-Production Identifier (UDI-PI) formatted according to the rules of the relevant Issuing Agency.

The EU IVDR transition extension introduces additional transition provisions for devices with an extension to their EU IVDD certificate. 

In vitro diagnostic (IVD) medical devices supplied in Australia under an EU IVDR certificate or any other overseas regulator conformity assessment certificate other than an EU IVDD certificate must meet UDI requirements at the standard compliance dates.

*An EU IVDD certificate refers to a conformity assessment document issued under Directive 98/79/EC of the European Parliament and the Council of the European Union.

Unique Device Identification (UDI) is mandatory for all Class 3 in vitro diagnostic (IVD) medical devices after 1 July 2028.

Unique Device Identification (UDI) is mandatory for all Class 4 in vitro diagnostic (IVD) medical devices after 1 July 2028.

Many medical devices are already UDI compliant because they are also supplied in countries that have implemented UDI requirements, such as the United States.

UDI compliant means that the device bears a UDI Carrier that includes a UDI-Device Identifier (UDI-DI) issued by one of our 3 TGA recognised Issuing Agencies, and a UDI-Production Identifier (UDI-PI) formatted according to the rules of the relevant Issuing Agency.

The EU MDR transition extension introduces additional transition provisions for devices with an extension to their EU MDD certificate. 

Medical devices supplied in Australia under an EU MDR certificate or any other overseas regulator conformity assessment certificate other than an EU MDD certificate must meet UDI requirements at the standard compliance dates.

*An EU MDD certificate refers to a conformity assessment document issued under Council Directive 93/42/EEC of the Council of the European Communities.

Unique Device Identification (UDI) is mandatory for all Class Is medical devices after 1 July 2028.

Many medical devices are already UDI compliant because they are also supplied in countries that have implemented UDI requirements, such as the United States.

UDI compliant means that the device bears a UDI Carrier that includes a UDI-Device Identifier (UDI-DI) issued by one of our 3 TGA recognised Issuing Agencies, and a UDI-Production Identifier (UDI-PI) formatted according to the rules of the relevant Issuing Agency.

The EU MDR transition extension introduces additional transition provisions for devices with an extension to their EU MDD certificate. 

Medical devices supplied in Australia under an EU MDR certificate or any other overseas regulator conformity assessment certificate other than an EU MDD certificate must meet UDI requirements at the standard compliance dates.

*An EU MDD certificate refers to a conformity assessment document issued under Council Directive 93/42/EEC of the Council of the European Communities.

Unique Device Identification (UDI) is mandatory for all Class IIa medical devices after 1 July 2027.

Transition dates for Class IIb devices differ depending on whether the device is implantable or non-implantable, reflecting the separate compliance timelines established in the EU.

Many medical devices are already UDI compliant because they are also supplied in countries that have implemented UDI requirements, such as the United States.

UDI compliant means that the device bears a UDI Carrier that includes a UDI-Device Identifier (UDI-DI) issued by one of our 3 TGA recognised Issuing Agencies, and a UDI-Production Identifier (UDI-PI) formatted according to the rules of the relevant Issuing Agency.

The EU MDR transition extension introduces additional transition provisions for devices with an extension to their EU MDD certificate. 

Medical devices supplied in Australia under an EU MDR certificate or any other overseas regulator conformity assessment certificate other than an EU MDD certificate must meet UDI requirements at the standard compliance dates.

*An EU MDD certificate refers to a conformity assessment document issued under Council Directive 93/42/EEC of the Council of the European Communities.

Unique Device Identification (UDI) is mandatory for all Class IIb medical devices after 1 July 2026.

UDI requirements depend on whether the device was manufactured and labelled before or after 1 July 2026.

Many medical devices are already UDI compliant because they are also supplied in countries that have implemented UDI requirements, such as the United States.

UDI compliant means that the device bears a UDI Carrier that includes a UDI-Device Identifier (UDI-DI) issued by one of our 3 TGA recognised Issuing Agencies, and a UDI-Production Identifier (UDI-PI) formatted according to the rules of the relevant Issuing Agency.

The EU MDR transition extension introduces additional transition provisions for devices with an extension to their EU MDD certificate. 

Medical devices supplied in Australia under an EU MDR certificate or any other overseas regulator conformity assessment certificate other than an EU MDD certificate must meet UDI requirements at the standard compliance dates.

*An EU MDD certificate refers to a conformity assessment document issued under Council Directive 93/42/EEC of the Council of the European Communities.

Unique Device Identification (UDI) is mandatory for all Class III medical devices after 1 July 2026.

UDI requirements depend on whether the device was manufactured and labelled before or after 1 July 2026.

Unique Device Identification (UDI) requirements are being introduced in Australia over 5 years, starting with high risk devices followed by lower risk devices over later years.

Please note:
Class I and Class Im (measuring) are not included, as these device risk classifications are not in scope of UDI requirements.

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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.