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EU MDR Transition web publication service
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.
Health care providers and consumers can use the service to find out about changes to devices.
The web publication service can also be used to provide market notifications to health care providers and consumers of devices that are not transitioning from the EU MDD to the EU MDR and where supply of the non-transitioning device will cease in Australia.
Market notifications published on this web publication service relate to low-risk changes only.
If there are any safety issues with the devices, the sponsor will contact health care providers and consumers directly.
This is 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.
It's updated weekly on Tuesdays only when new submissions come in. Submissions are due by 11:59pm on Sundays.
Market notifications as of 26 February 2024.
Read more about the overview and management under the Australian regulatory framework - guidance for manufacturers and sponsors on EU MDR Transition.
In Australia, many medical devices have certification from the European Union Medical Devices Directives (EU MDD).
To keep providing these devices, they must switch to the new EU MDR certification by 26 May 2024.
In recognition of the scale of the EU MDR transition, and in the interest of minimising regulatory burden on the industry, we are undertaking a risk-based approach by streamlining the type of actions sponsors need to undertake in meeting their obligations.
You can get streamlined market notifications if you meet the criteria. Sponsors who qualify can either:
- Use this web publication service to provide market notifications to health care providers and/or end users
- 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 us on request.
For transitioning devices, 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 met all Australian requirements when supplied, and
- There are no deficiencies in safety, quality, performance, or presentation of the devices as currently supplied to the market, and
- The changes are not because of any reported safety related incidents that have resulted in patient or user harm, and
- The changes don't come from adverse event reporting or investigation, and,
- The manufacturers produced the devices while the 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.