When the European Union replaced the outdated Medical Devices Directive (MDD) with the Medical Devices Regulation (MDR) in 2017, it was hoped a staggered transition period to 2021 would allow ample time for medical devices to be re-assessed and recertified under updated regulatory standards.
Instead, what we’ve seen is a lengthy backlog, with devices approved under the previous MDD still waiting for re-assessment under the new MDR, some four years on. This raises questions about ongoing mutual recognition regulatory arrangements and medical device compliance in Australia.
Australia has a harmonised regulatory arrangement with the European Union, as well as other countries. This is an efficient way to bring approved medical devices to other markets and gives Australian consumers access to a broader range of devices, and faster.
However, because the Australian Government is continuing to recognise the extended MDR transition period, there are now medical devices available in the Australian market which have not yet been assessed by the MDR system and are not required to be assess by the TGA. These are the products that were approved under now-expired MDD certificates.
Some of these products will upgrade to the new system without issue, but we expect that many will not because they will not be able to meet the more stringent requirements of the MDR or Australia’s medical device regulation.
This was the point of Europe’s change to the MDR, to remove unsafe and poorly performing products that snuck in under the more lenient MDD.
With no clear timeframe for the transition period to end, the Australian Government needs to address the current arrangement for three key reasons;
- Fairness in the System: New products must meet current regulatory requirements before being allowed on the market, and rightly so. However legacy medical devices first assessed under the outdated guidelines are allowed to remain on the market while they wait for re-assessment under the MDR.
- Consumer Transparency: Do consumers know that some medical devices are being supplied with expired evidence? It’s a complex issue, as the removal of medical devices from the market is also a risk to people who are dependent upon them. It highlights again, the need for the current arrangement to be addressed, to allow consumers to plan accordingly.
- Increased Pressure on TGA: Because of the ongoing backlog in Europe, approval times for medical devices has increased significantly. The harmonised regulatory system means overseas medical device developers and manufacturers may find it faster to seek approval through Australia’s Therapeutic Goods Administration (TGA), which then places increased pressure on the agency as it must adhere to legislated maximum wait times.
It's important to note that the current arrangement isn’t necessarily the fault of any particular Government or organisation. However there is a need for the Australian Government to outline its intentions, particularly as other medical reforms continue to progress.
Will the Australian Government continue to follow Europe, and the extended medical device transition period be allowed to continue until the back log is eventually cleared? Will there be a cut-off date for medical devices with expired certification? Currently, we don't know.
What happens to devices with expired evidence that never pass the new MDR requirements? Is the Australian Government actively monitoring this situation? Will it oversee removal from the market, or will these devices remain under the radar?
Neither outcome is necessarily right or wrong, but the sector, patients and consumers more broadly need to know what the Government's intention is so they can plan accordingly.