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EU MDR Transition

Overview and management under the Australian regulatory framework

This guidance is to help Australian medical device suppliers and users transition to the new European Union Medical Devices Regulation (EU MDR) and to understand and meet their obligations under the Australian regulatory framework. Please see separate guidance about the transition of In Vitro Diagnostic (IVD) medical devices to the EU IVD Regulation.

EU MDR transition extension: read about the key dates and changes.

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