In the medical device industry, almost every extension of the EU MDR (Medical Device Regulation) transition period affects product lines that rely on EU certification to enter other markets. A recent notice from Australia’s TGA (Therapeutic Goods Administration) is a typical example of this knock-on effect – rather than designing its own transition timetable, it chose to follow the EU’s schedule directly.
It started on the EU side. In 2023 the European Commission extended the EU MDR transition period, giving manufacturers that had not yet moved from the old MDD (Medical Device Directive) to MDR certification more time. The problem is that many medical devices on sale in Australia were included in the ARTG (Australian Register of Therapeutic Goods) on the strength of EU MDD/MDR certificates. If Australia didn’t adjust when the EU did, there would be a mismatch where “the certificate is still valid in the EU but Australia already requires a new one”.
The TGA therefore announced that it will apply exactly the same deadlines as the EU MDR to devices already on the Australian market that still rely on MDD certificates. This also means that sell-off restrictions the TGA might have considered have been dropped: distributors can continue to sell the products until stock runs out, without being caught by a separate Australian deadline.
2. The Timetable After the Extension
By device risk class, the new transition deadlines are:
3. Which Products Benefit from the Extension
The extension does not apply unconditionally to every product not yet recertified; manufacturers must meet both of the following conditions:
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Before the MDD certificate expired, an application for MDR certification was submitted to a Notified Body before 26 May 2024;
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A written certification agreement was signed with an MDR Notified Body before 26 September 2024.
Implementation is in three stages: before 26 May 2024, the TGA continued to accept unexpired MDD certificates; between 26 May and 26 September 2024, it accepted MDD certificates accompanied by evidence of an MDR application; after 26 September 2024, evidence of a signed MDR certification agreement with a Notified Body is required to continue using the extended deadlines.
4. Related Adjustment 1: UDI Compliance Dates Deferred Accordingly
UDI (Unique Device Identification) is another regulatory requirement Australia is introducing to enable traceability of medical devices. Because the UDI compliance schedule for many devices is tied to their EU certification status, the TGA has adjusted UDI compliance dates accordingly: if a device is supplied under an MDD certificate with extended validity, its UDI compliance date is deferred; but if the device has already moved to an EU MDR certificate, the standard Australian start date applies with no deferral.
In other words, the deferred UDI timetable applies specifically to products “still relying on old MDD certificates”. Once recertification succeeds, the UDI requirements apply immediately on the standard dates – there is no room to “enjoy the MDD extension while also delaying UDI obligations”.
5. Related Adjustment 2: IVDR Transition Periods for IVD Products
Besides general medical devices (MDR), the TGA also recognizes the extended transition periods of the EU In Vitro Diagnostic Medical Devices Regulation (EU IVDR). Manufacturers must apply for certification with an IVDR Notified Body and sign an agreement within the deadlines for each IVD risk class:
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Class 4 IVDs: apply by 26 May 2025 and sign by 26 September 2025;
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Class 3 IVDs: 26 May 2026 and 26 September 2026;
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Class 2 IVDs: 26 May 2027 and 26 September 2027.
This follows essentially the same logic as the MDR – a two-step “apply first, then sign” confirmation.
At the same time, other measures in the TGA’s existing MDR transition strategy remain unchanged, including application fee waivers for products whose labeling is not yet fully compliant and for updating conformity evidence to EU IVDR certification.
6. Summary
The TGA’s extension notice is essentially “unilateral alignment” in regulatory coordination – not agreed through a multilateral mechanism such as the IMDRF, but Australia deciding on its own to align its timetable with the EU’s.
The practical reason is simple: the Australian medical device market is highly dependent on imports, a large share of which come via EU certification. If the TGA insisted on its own transition schedule, it would only add to the compliance burden on manufacturers and distributors without necessarily bringing extra safety benefits.
For companies serving both the EU and Australia, the message is clear: as long as you complete EU MDR applications and agreements on time, Australian compliance can largely follow the EU schedule, without maintaining a separate Australia-specific timetable. But if MDR recertification of a product line falls behind, the risks are amplified in both markets at once – something companies need to factor into their compliance planning in advance.
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