Australia IVD Market Pathway: IVDD Transition Deadlines by Class

1. Key takeaways

The three transition dates Australia has set for IVDs are: Class 4 → 1 January 2028, Class 3 → 1 January 2029, and Class 2 → 1 January 2030. The three dates constrain the time at which the ARTG inclusion application is submitted, not the validity of EU IVDD certificates; once the date passes, an application can no longer rely on IVDD evidence. The dates were inserted by amendment in late 2024 and now sit in the compiled instrument, so they should be treated as settled planning parameters. Facts verified as of 29 October 2026.

• Schedule 2 of the Information Determination maps Class 2 to 1 January 2030, Class 3 to 1 January 2029 and Class 4 to 1 January 2028.
• The usable evidence is an IVDD (Directive 98/79/EC) certificate, or an EU declaration of conformity (DoC) under Annex III made before 26 May 2022.
• Applications relying on IVDD evidence must additionally evidence compliance with the transition conditions of Article 110(3c) of the EU IVDR.
• The additional IVDR evidence sits in regulations 6(1)(c) (Class 2), 6(3)(c) (Class 3) and 6(5)(c) (Class 4).
• The IVDR is version-locked: Regulation (EU) 2017/746 as in force on 1 December 2024.

2. Legal basis

The transition regime is set entirely within the Information Determination and the amendment that inserted the dates, with the supporting IVDR evidence requirement layered on top. Read them with the class of the IVD in hand, because the evidence menu differs by class.

• Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018 (F2018L01410, compilation version 13 F2025C01150, effective 1 December 2025): Schedule 2 provides — Class 2 corresponds to 1 January 2030; Class 3 corresponds to 1 January 2029; Class 4 corresponds to 1 January 2028; the formulation is that applications submitted before those dates may use IVDD (Directive 98/79/EC) certificates, or an Annex III EU declaration of conformity (DoC) made before 26 May 2022.
• Amendment instrument that inserted the dates: Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Amendment (No. 3) Determination 2024 (F2024L01674), registered 17 December 2024, in force from 17 December 2024 to 31 July 2025 (subsequently absorbed into the compilation).
• Additional evidence requirement: applications relying on an IVDD CE certificate or that DoC must also attach evidence of compliance with the transition conditions of Article 110(3c) of the EU IVDR (Regulation (EU) 2017/746) (a manufacturer self-declaration or a notified body confirmation letter); the corresponding provisions are regulation 6(1)(c) of the Information Determination (Class 2), regulation 6(3)(c) (Class 3) and regulation 6(5)(c) (Class 4).
• EU legal version lock: in the definitions of regulation 4 of the Information Determination, “EU IVD regulation” means Regulation (EU) 2017/746 as in force on 1 December 2024.
• Practical estimate: the exact provision location of the Article 110(3c) evidence requirement in the primary instrument is relayed here through secondary sources; verify against the current text of the Information Determination before formal submission.

3. Expert insights

Insight 1: the three dates are submission cut-offs, not certificate end-dates. This single sentence determines the scheduling strategy: as long as the application is submitted before the cut-off, it stands even if the EU certificate lapses afterwards. Conversely, a certificate still within its validity cannot be used if the submission is late. The variable a company controls is the filing date, and every plan should be anchored to it rather than to the certificate’s expiry column. Teams that build the countdown into the master project calendar, with the submission date as a hard milestone, avoid the end-of-year rush these dates tend to create.

Insight 2: Class 2 and Class 3 IVDs have an extra DoC option. Besides the IVDD CE certificate, a declaration of conformity made by the manufacturer before 26 May 2022 under Annex III of Directive 98/79/EC can also be used. This matters enormously for the large population of lower-risk IVDs that never went through a notified body audit at all, since many of them hold exactly that kind of legacy DoC in their files. Checking the archive for that declaration should be one of the first tasks on any Class 2 or Class 3 IVD project, before new testing is even considered.

Insight 3: the Article 110(3c) evidence is additional, not alternative. When applying with IVDD evidence, the applicant must still prove compliance with the IVDR transition conditions. Many companies assemble the IVDD certificate but omit this second document, and the application comes back with a request for further information. Treat the IVDR evidence as a separate attachment with its own owner on the project plan, never as an appendix to the CE certificate. A short manufacturer self-declaration or a notified body confirmation letter is usually sufficient, but it must exist as a separate document in the application.

4. Practical recommendations

• Build a countdown ledger by device class: Class 4 projects anchored to 1 January 2028, Class 3 to 1 January 2029, Class 2 to 1 January 2030, each working backwards to a preparation period of at least 6 months, with the countdown visible in the project dashboard.
• For Class 2 and 3 IVDs, confirm first whether an Annex III DoC made before 26 May 2022 exists, and preserve the original.
• For projects filing with IVDD evidence, prepare the IVDR Article 110(3c) transition condition evidence in parallel as an independent attachment.
• When citing IVDR provisions, state the version baseline (Regulation (EU) 2017/746 as in force on 1 December 2024).

5. Verification checklist

• □ The applicable cut-off has been confirmed by class (1 January 2028 / 2029 / 2030)
• □ It has been confirmed that the dates constrain the application submission point
• □ Class 2 and 3 IVDs have been checked for an Annex III DoC made before 26 May 2022
• □ IVDR Article 110(3c) transition condition evidence has been prepared
• □ The IVDR version baseline (as in force on 1 December 2024) has been stated

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Australian market. Our team manages TGA ARTG inclusion across all classes, prepares conformity assessment dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanlang.com