On 25 August 2026, Australia’s Therapeutic Goods Administration (TGA) issued an updated notice confirming its recognition of the extended transition periods under the EU Medical Devices Regulation (EU MDR). For MDD certificates that satisfy the EU extension criteria, the TGA will continue to accept them as valid throughout the applicable transition period—even if the expiry date shown on the certificate has already passed. Manufacturers and sponsors are reminded to retain all supporting documentation for verification purposes.
Original source: https://www.tga.gov.au/products/regulations-all-products/tga-reforms/eu-mdr-transition/eu-mdr-transition-extension
I. EU MDR Transition Period Extension Rules
On 15 March 2023, the European Union formally extended the transition timeline for moving from the Medical Devices Directive (MDD) to the EU MDR. The extended transition periods vary by device class, as set out below:
| Device Category | Transition Deadline |
|---|---|
| Class III implantable custom-made devices | 26 May 2026 |
| Class III devices and Class IIb implantable devices | 31 December 2027 |
| Non‑implantable Class IIb devices and lower‑risk devices | 31 December 2028 |
| Devices that were Class I under the MDD but are reclassified as higher‑risk devices under the EU MDR | 31 December 2028 |
It is important to note that MDD Notified Bodies will not reissue certificates reflecting the extended validity dates. Eligible certificates will be granted an automatic extension of validity, and the original expiry date printed on the certificate remains unchanged.
MDD Notified Bodies will continue to oversee manufacturers they have already certified, until those manufacturers transition to the oversight of an EU MDR Notified Body.
II. Conditions for MDD Certificate Extension
Under the TGA announcement, to qualify for the EU MDR extended transition period, manufacturers must meet both of the following conditions:
- Submit an application for EU MDR certification no later than 26 May 2024, and before the expiry of the MDD certificate;
- Enter into a formal agreement with an EU MDR Notified Body no later than 26 September 2024.
Manufacturers that fail to satisfy either of these conditions cannot rely on the EU transition extension to keep their MDD certificates valid.
Accordingly, companies should not assess certificate validity solely by looking at the expiry date on the MDD certificate. Instead, they must also verify the timing of the EU MDR application, the date of the Notified Body agreement, and the current status of the certificate.
III. TGA Regulatory Arrangements for Extended MDD Certificates
The TGA has confirmed that the core elements of its existing EU MDR transition policy remain unchanged.
1. MDD certificates continue to serve as evidence of manufacturer certification
For Australian sponsors, the TGA will continue to accept eligible MDD certificates as evidence of manufacturer certification for new or updated applications—provided that sponsors can also demonstrate that the manufacturer has entered into a formal agreement with an EU MDR Notified Body:
2. Requirements for new registration applications
If a new Australian registration application relies on an MDD certificate, and the certificate’s stated expiry date has already passed at the time of submission, the sponsor must provide evidence that the manufacturer meets the EU MDR certificate extension eligibility criteria.
3. Requirements for existing ARTG entries
For products already included in the Australian Register of Therapeutic Goods (ARTG) and supported by an EU MDD certificate, the TGA will continue to recognise that certificate as valid in Australia—provided it qualifies for the EU extension. The TGA will not deem such certificates invalid solely on the basis of the expiry date printed on them.
However, MDD certificates may not be relied upon beyond the following deadlines:
- Class III and Class IIb implantable devices: 31 December 2027
- Other eligible devices: 31 December 2028
4. Notification obligations for sponsors
Australian sponsors do not need to separately notify the TGA when an MDD certificate qualifies for the EU extension, nor are they required to submit a conformity assessment expiry notification form. However, sponsors must retain evidence of the extension for potential TGA verification.
If an MDD certificate supporting an ARTG entry is suspended, cancelled, withdrawn, or no longer meets the extension criteria, sponsors must notify the TGA within 60 days of becoming aware of the change.
For products that lack a valid conformity assessment certificate, the TGA may conduct compliance reviews and, where appropriate, suspend or cancel the relevant ARTG entries.
5. TGA support measures and streamlined pathways
- Reduced application fees for supply applications involving devices whose labelling does not yet meet regulatory requirements, and for updates to EU certificates already submitted to the TGA;
- Streamlined market notification procedures for low-risk device changes arising from the EU MDR transition;
- Sponsors may use the TGA website notification service to issue notices to healthcare providers and consumers as needed.
IV. Transitional Arrangements for Specific Device Categories
1. Reclassified devices
As of 25 November 2021, Australia implemented reclassification changes for certain medical devices to align with the EU MDR.
Eligible existing ARTG entries may continue to be supplied throughout the transition period, with some device categories receiving an extended transition deadline of 1 July 2029. New applications that do not satisfy the transition conditions must be submitted under the updated, higher classification and may only be supplied once approved.
2. Devices extended to 1 July 2029
| Device Category | ARTG Transition Deadline |
|---|---|
| Active therapeutic devices with diagnostic functions, including associated software | 1 July 2029 |
| Spinal implantable devices that preserve motor function | 1 July 2029 |
| Devices that come into direct contact with the heart, central circulatory system, or central nervous system, including associated software | 1 July 2029 |
| Devices that administer medicinal products or deliver biologicals via inhalation, including associated software | 1 July 2029 |
| Substance-based devices that enter the body through natural orifices or are applied to the skin, including associated software | 1 July 2029 |
| Patient-matched devices | 1 July 2029 |
3. Patient-matched devices
Patient-matched devices continue to be exempt from ARTG inclusion until 1 July 2029, and may be manufactured and supplied up to that date. Beyond that point, unless the device is exempt, excluded, or otherwise approved by the TGA, it must be included in the ARTG before importation, supply, or export.
4. Software as a medical device
The original transitional arrangement for the reclassification of software as a medical device ended on 1 November 2024. However, certain software products that are also subject to other reclassification reforms may be eligible for the transitional arrangements extending to 1 July 2029.
5. Australian UDI requirements
Australia is implementing Unique Device Identification (UDI) requirements on a phased basis. Manufacturers and sponsors using EU MDR documentation to access the Australian market should monitor Australia’s domestic UDI requirements and associated compliance timelines.
V. Recommendations for Medical Device Companies
- Verify whether your MDD certificate meets the EU extension eligibility criteria.
- Retain all supporting documentation, including EU MDR applications and Notified Body agreements.
- Confirm the applicable transition deadline based on your product’s classification.
- Continuously monitor the status of your certificate and notify the TGA promptly if it ceases to be valid.
- Advance your EU MDR certification and Australian registration updates as early as possible.
Should you have any questions, please do not hesitate to contact us.
Figure 1: EU MDR extended transition periods
Figure 2: TGA regulatory arrangements for extended MDD certificates
Figure 3: Devices with transition extended to 1 July 2029