How we are managing medical device supply disruptions resulting from changes in Europe

Many health services, procurement areas and suppliers are concerned about possible disruptions to the supply of medical devices in Australia resulting from changes happening in Europe – the new EU MDR.

Most medical devices in Australia will be impacted by the changes. Manufacturers are facing extensive delays and costs in obtaining new European certificates for their devices. 

Some manufacturers may choose to stop supplying some devices and, for a variety of reasons, others may not get new European certificates for all their existing devices. 

We are actively managing the impact in Australia and have arrangements in place to minimise supply disruptions for Australian patients, including:

• where possible, we have aligned our regulatory requirements with the changes in Europe
• putting in place a streamlined process and reduced our fees for sponsors to seek regulatory approvals of their EU MDR certified devices in Australia 
• established a voluntary web publication service for suppliers to advise health care providers, procurement teams and consumers about low-risk changes to devices (such as changes in the intended patient group for the device) 
• continuing to accept non-European regulatory approvals from several other comparable regulators for medical devices (such as the US FDA, Health Canada, Singapore HSA, and Japan PMDA).

We encourage health services to work with sponsors and their state or territory health department if they face a disruption in supply, and to consider alternative suppliers if necessary.

In the event of a serious medical device disruption, we can help state and territory health departments find alternative suppliers to minimise disruptions to patient care. Private health facilities can provide information about emerging supply disruptions to us at md.supplydisruptions@health.gov.au.

More information

EU MDR Transition. 

Contact us

For questions on the EU MDR email devices@tga.gov.au.