Because of the implications of the European Union Medical Device Regulations (EU MDR) transition, the government recently agreed to extend the deadlines for numerous medical device reforms now ongoing in Australia.
Regulatory amendments are being made and are expected to be implemented this year. Some of the amendments are the extension of the timelines, which would grant manufacturers enough time to get an EU MDR certificate.
The transition period for reclassification of medical devices to align with EU MDR, initially set until 1 November 2024, is proposed to be extended to 1 July 2029 by regulatory amendments.
Visit the EU MDR transition extension page to read more about the key dates and changes.