In 2015, the Report of the Expert Panel Review of Medicines and Medical Devices Regulation (MMDR) made 58 recommendations for reform of the regulatory framework for medicines and medical devices in Australia. The Australian Government Response to the Review of Medicines and Medical Devices Regulation was released in September 2016. The Government accepted 56 MMDR recommendations including Recommendation Twenty which provided that the regulation of medical devices, wherever possible and appropriate, align with the European Union (EU) framework including the classification of medical devices.

The focus of this consultation was to seek feedback on whether the Australian medical device regulatory framework should be aligned to the new EU framework for medical devices containing nanomaterials introduced in 2017, and how this could occur.