Sponsor and manufacturer obligations in meeting UDI requirements

Sponsors and manufacturers both have roles in meeting Unique Device Identification (UDI) requirements. These obligations for meeting UDI requirements are in addition to, and do not override, any existing obligations. 

Manufacturer role and obligations

As a medical device manufacturer, your role and obligations include:

• choosing a TGA recognised Issuing Agency
• allocating a UDI Device Identifier (UDI-DI) and UDI Production Identifier (UDI-PI) to your device using the relevant coding standard set by your chosen Issuing Agency
• ensuring the UDI is applied per Issuing Agency requirements
• containing both the UDI-DI and the UDI-PI in the UDI Carrier, unless exempt
• ensuring the chosen UDI Carrier is appropriate for expected use
• applying the UDI Carrier in Human Readable Interpretation (HRI) and Automatic Identification Data Capture (AIDC) forms on:
  • the label
  • on the device itself, if applicable
  • all higher levels of packaging, if applicable
• ensuring that the UDI Carrier is in addition to, and does not replace any existing labelling requirements for Australia
• ensuring all packaging levels of the device bear a Package DI, where required
• direct marking the UDI Carrier on reusable medical devices, where applicable
• allocating a Unit of Use DI, where applicable
• assigning a new UDI-DI when there is a change to your device that could lead to misidentification or ambiguity in its traceability (UDI Trigger)
• providing the UDI-DI and related data to the AusUDID, either yourself or through your Australian sponsor
• designing, producing, packaging and labelling of the medical device
• demonstrating compliance with the relevant Essential Principles for your medical device, including those that relate to labelling
• ensuring that you meet all requirements in the Essential Principles.

Your obligations for UDI requirements are in addition to, and do not override, any existing obligations you have as a manufacturer. 

Sponsor role and obligations

As a sponsor, your role and obligations include:

• ensuring that your manufacturer has complied with their obligations relating to UDI requirements
• ensuring that, where applicable, your manufacturer has assigned a UDI to devices you supply, before making the device available
• ensuring that the chosen UDI Carrier format is appropriate for the expected use
• ensuring the UDI-DI and related data for the devices you supply to the AusUDID is submitted to the TGA according to UDI requirements
• meeting record keeping requirements
• ensuring your device meets all Essential Principles. 

Your obligations for UDI requirements are in addition to, and do not override, any existing obligations you have as a sponsor.

Sponsor of medical devices supplied by multiple sponsors

In Australia, it is possible that a medical device has more than one sponsor. 

Your obligations as a sponsor do not change even if the device(s) you supply are also supplied by other sponsors. You are still responsible for submitting and maintaining the UDI-DI and related data to the AusUDID according to the UDI requirements. 

Third party role and obligations

As a manufacturer, you may choose to allow a third party to apply the UDI Carrier on your behalf. In this circumstance, you remain responsible for the conformity of the UDI Carrier. 

As a sponsor, you may choose to allow a third party to submit the UDI-DI and related data to the AusUDID on your behalf. In this circumstance, you remain responsible for the data submitted. 

As a third party, you are responsible for ensuring that you meet UDI requirements.