This web publication service is a platform for sponsors to provide market notifications to health care providers and consumers for devices going through low-risk changes as part of the EU MDR Transition. The web publication service publishes changes to devices that health care providers and consumers may need to be aware of.
Important information
Market notifications published on this web publication service relate to low-risk changes only, where the changes are not due to deficiencies in the safety, quality, performance, or presentation of the devices as currently supplied to the market. Should there be any safety issues associated with the devices, the sponsor would contact health care providers and consumers directly via the usual recalls or post-market action pathways.
This web publication service is updated weekly on Tuesdays only when there are new submissions received. The cut-off for market notification submissions is 11:59pm the preceding Sunday.
Market notifications as of 25 September 2023.
You can read more about the overview and management under the Australian regulatory framework - guidance for manufacturers and sponsors on EU MDR Transition.
Most medical devices supplied in Australia are supported by certification under the now repealed European Union Medical Devices Directives (EU MDD). To continue supply, these devices will need to transition by 26 May 2024 to the new certification under the European Union Medical Devices Regulation (EU MDR).
In recognition of the scale of the EU MDR transition, and in the interest of minimising regulatory burden on the industry, the TGA is undertaking a risk-based approach by streamlining the type of actions sponsors need to undertake in meeting their obligations.
If certain criteria are met, sponsors of medical devices transitioning to the EU MDR can qualify for streamlined market notifications. Sponsors who qualify can either:
- Use this web publication service to provide market notifications to health care providers and/or end users
or
- Notify health care providers and end users about changes to their devices and maintain documentation to confirm that the notifications have occurred and be able to produce them to the TGA upon request.
All of the following 6 criteria will need to be met to qualify for this streamlined market notification process:
- The changes being notified only relate to devices transitioning from the EU MDD to EU MDR certification. The changes are due to a change in regulatory requirements and not because devices currently supplied to the market are unsafe or defective, and
- The devices complied with all Australian regulatory requirements when supplied to the market, and
- There are no deficiencies in safety, quality, performance, or presentation of the devices as currently supplied to the market, and
- The changes being notified are not because of any reported safety related incidents that have resulted in patient or user harm, and
- The changes being notified are not because of any signals arising from adverse event reporting and investigation, and
- The devices were manufactured whilst a conformity assessment certificate was valid.
You can read more about the overview and management under the Australian regulatory framework - guidance for manufacturers and sponsors on EU MDR Transition.