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Australia’s TGA Recognises Extended EU MDR Transition Periods, Deadlines up to End‑2028

Time：2026-08-25 11:19:03

Australia’s Therapeutic Goods Administration (TGA) has formally released an official notice confirming full recognition of the extended transition timelines under the EU Medical Device Regulation (EU MDR). For medical device manufacturers relying on EU MDD certificates to access the Australian market, this means extended regulatory transition buffers and more predictable alignment for market‑access workflows.

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https://www.tga.gov.au/products/regulations-all-products/tga-reforms/eu-mdr-transition/eu-mdr-transition-extension

一、Extended EU MDR Transition Timelines

On 15 March 2023, the European Union introduced extended transition deadlines under EU MDR for devices migrating from the old Medical Device Directive (MDD). The TGA has adopted exactly these timelines:

Class III implantable custom‑made devices：26 May 2026

Class III devices & implantable Class IIb devices：31 December 2027

Non‑implantable Class IIb devices and lower‑risk devices：31 December 2028

Class I devices re‑classified to a higher risk class under MDR：31 December 2028

Important note: Existing MDD Notified Bodies will not re‑issue MDD certificates with updated expiry dates. Eligible MDD certificates gain extended validity automatically under regulatory provisions.

二、Two Mandatory Eligibility Criteria for MDD Certificate Validity Extension

Not all MDD certificates qualify for the transition extension. Manufacturers must satisfy both conditions below:

Submit an MDR certification application by 26 May 2024, prior to the expiry date of the relevant MDD certificate;
Have a formal contract signed with an MDR‑designated Notified Body by 26 September 2024.

During transition, legacy MDD Notified Bodies shall continue surveillance oversight over certified manufacturers until those manufacturers complete transfer to an MDR Notified Body.

三、Supporting Regulatory Rules for the Australian Market

The TGA states its core EU‑MDR‑transition strategy remains unchanged. Alongside recognition of EU extended timelines, the regulator has rolled out facilitative measures plus clear compliance obligations.

（一）TGA Administrative Support Measures

Reduced application fees for devices bearing labels not yet fully MDR‑compliant, and for updates of EU certificates lodged with TGA.

Streamlined market‑notification procedures for low‑risk changes triggered by EU MDR requirements. A web‑publication service is available for sponsors to notify healthcare providers and consumers via the TGA official website.

（二）Certificate Recognition for Two Scenarios

New registration applications：Where an applicant submits a new TGA application supported by an MDD certificate whose printed expiry date has lapsed, evidence proving the manufacturer meets EU MDR extension eligibility must be provided for TGA acceptance of that certificate.

Existing ARTG‑listed products：For devices already included in the Australian Register of Therapeutic Goods (ARTG) and backed by EU MDD certificates: if the certificate qualifies for extended validity under EU rules, it remains legally effective in Australia despite its printed expiry date.

Final validity cut‑offs for MDD certificates in Australia:

For Class III and implantable Class IIb devices: expire 31 December 2027

For all other device categories: expire 31 December 2028

（三）Sponsor Compliance Obligations

No proactive notification required for extension status：Sponsors do not need to inform TGA about MDD‑certificate extension, nor submit a conformity‑assessment lapse notification form.

Retain supporting documentation：TGA may request proof of extended certificate validity during routine compliance audits; sponsors must keep such evidence readily available.

Mandatory 60‑day reporting for certificate invalidation：If an MDD certificate supporting ARTG listings becomes invalid in the EU (suspended, cancelled, withdrawn, or fails extension criteria), sponsors shall notify TGA within 60 calendar days upon becoming aware of the event.

TGA will conduct ongoing compliance surveillance. ARTG entries without valid conformity‑assessment certification risk suspension or cancellation.

四、Special Transition Arrangements for Multiple Device Categories

Beyond core EU‑MDR transition timelines, TGA has defined special reclassification‑reform transition deadlines for multiple product groups, with a unified cutoff date of 1 July 2029.

（一）Devices Subject to Australian Re‑classification Reforms

On 25 November 2021 Australia implemented medical‑device re‑classification reforms to align local rules with EU MDR. Qualified already‑listed devices benefit from transition until 1 July 2029. Sponsors may obtain MDR certificates by the end of EU MDR transition (31 Dec 2028), then use those MDR certificates to apply for TGA ARTG updates.

This transition provision does not apply to new ineligible applications: new devices must be submitted under their higher re‑classified risk class and gain approval prior to supply in Australia.

（二）Patient‑Matched Medical Devices (PMMDs)

The PMMD transition notification window closed on 1 November 2024. Nevertheless, the ARTG‑exemption for manufacture and supply of PMMDs remains valid until 1 July 2029.

After 1 July 2029, all PMMDs (including previously notified ones) require ARTG inclusion before import, domestic supply or export from Australia (unless exempt, excluded or otherwise approved by TGA).

A low‑volume exemption persists: the first five units of the same device type supplied by one entity in a financial year are exempt from ARTG listing. Exempt devices are still subject to regulatory controls; manufacturers and sponsors must comply with Essential Principles and advertising requirements.

（三）Selected High‑Risk Devices & Associated Software

The transition period for software‑based‑medical‑device re‑classification ended on 1 November 2024. However the below device groups retain special‑reform transition until 1 July 2029:

Active therapeutic medical devices with diagnostic function (including associated software)

Motion‑preserving spinal implantable devices

Devices in direct contact with the heart, central circulatory system or central nervous system (including associated software)

Devices delivering medicines or biologicals via inhalation (including associated software)

Substance‑based devices introduced via body orifices or applied to skin (including associated software)

Patient‑matched medical devices (PMMDs)

（四）Unique Device Identifier (UDI)

TGA is currently assessing how the EU MDR transition extension impacts Australia’s UDI implementation. Further guidance will be released in due course.

五、Practical Recommendations for Export‑Oriented Manufacturers

Relevant enterprises are advised to take these actions promptly:

Conduct full inventory of all held MDD certificates. Verify compliance against the two EU extension prerequisites and securely preserve MDR‑application records and Notified‑Body contracts.
Progress MDR certification according to planned timelines, to avoid compliance delays impacting both EU and Australian market access.
For product categories with the 1 July 2029 transition deadline, start early work on re‑classification assessment and ARTG update planning, reserving sufficient regulatory‑review lead‑time.

五、Closing Remarks

The TGA’s recognition of extended EU MDR transition timelines reflects realistic adaptation to industry‑wide compliance challenges. It grants medical‑device exporters to Australia additional preparation time, but does not relax regulatory compliance standards.

For further enquiries, please consult Wiselink.

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