UDI and existing TGA processes for sponsors and manufacturers
After the UDI regulations are in effect, if a UDI is available, you must include it on:
- Patient Implant Cards (PICs)
- any notifications submitted to the TGA including adverse events, incident reports and recalls.
UDIs on Patient Implant Cards (PICs)
Healthcare facilities provide Patient Implant Cards (PICs) to patients who receive a medical device implantation.
Currently, the following information is required on a PIC:
- name of the device
- model of the device
- batch code, lot number or serial number of the device
- manufacturer’s name, address, and website.
If available, you must also supply the UDI on the PIC for all implantable devices, including:
- the full UDI (UDI-DI and UDI-PI) in machine-readable form
- UDI-DI in human readable form.
The UDI-PI should either be shown as a single field or split into the above data elements, per the current PIC requirements.
An example of a PIC with a UDI:
You do not need to supply the UDI on Instructions for Use (IFU), although some manufacturers may choose to do so.
Adverse events
Where a UDI is available, you must include it in adverse event reports.
Device incident reports
Where a UDI is available, you must include it in device incident reports.
Recall notices
Where a UDI is available, you must include it recall notices, including mandatory recall procedures and voluntary recalls.