Due to the transition from the European Union Medical Devices Directives (EU MDD) to the European Union Medical Devices Regulation (EU MDR), medical device manufacturers are required to go through the new certification under the EU MDR by 26 May 2024.
As for Australia, sponsors would need to take actions to maintain the compliance of their ARTG entries for continuous supply in the market, depending on the nature of the changes and its relevance to the Australian regulatory compliance regulation.
Changes may include device classification, the scope of indications or intended purpose, functional description, labelling, and instructions for use etc. However, only low-risk changes impacted by the MDR transformation, the approach for market notifications to health care providers and end users is required.
To minimize the regulatory workload among TGA, manufacturers and sponsors, TGA has created a web publication service as a platform for the sponsor to provide market notifications to health care providers and end users. However, manufacturers and sponsors need to fully comply with 6 criteria (refer to Background section) set by TGA for the qualification for market notifications. After passing the qualification for market notification, the web publication service can be utilised for either way below for the market notification:
- (1) Use the web publication service to achieve market notifications.
- (2) Health care providers and end users could be informed with changes. The related documents including proofs for market notifications are required to be maintained upon TGA’s requests.
Most importantly, it is limited to low-risk changes where no deficiency related to the safety, quality, or effectiveness occurs in comparison to the existing devices under supply in Australia for the web publication service. If medical devices come with safety issues, it is necessary to contact health care providers and end users directly by conducting the regular recalls or post-market action.