Classification in Australia

Australia classifies under Schedule 2 of the Therapeutic Goods (Medical Devices) Regulations 2002, drawn from the European directives rather than from the MDR. That inheritance shows: the questions are largely the ones Annex VIII asks, and the class labels are the European ones. Two things set it apart. Active implantable devices form a distinct category rather than being folded into the general rules as MDR Rule 8 does. And the TGA has revised its software classification rules in recent years, on its own terms rather than by adopting Rule 11 — so a piece of software can land differently here than in either the EU or Great Britain.

Australia uses I, IIa, IIb and III, the same four labels as the EU, plus AIMD. That shared vocabulary is the trap: the labels came from the directives, the rules behind them have moved separately since, and reading an Australian class as a European one is an assumption rather than a translation.

Not the same rules. The Australian rules in Schedule 2 derive from the European directives rather than from the MDR, and have been amended separately since — notably for software. The class labels are shared, which makes the differences easy to overlook.

A distinct category for active implantable medical devices. The MDR brings active implantables inside Rule 8 and classifies them as Class III; Australia keeps them as a category of their own.

The conformity assessment procedure the manufacturer must follow, and the evidence required before the device can be included in the Australian Register of Therapeutic Goods.