Using EU CE Certificates for TGA Applications: Items and Time Anchors

1. Key takeaways

The legal vehicle under which Australia accepts EU certificates is the Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018 (registration number F2018L01410, compilation version 13, effective 1 December 2025). The decisive test is not the date the certificate expires, but the day on which the application is submitted — several table items set their time anchors using the formulation “application submitted before…”. Reading the anchors therefore turns on the filing calendar, and on nothing else. Facts verified as of 29 October 2026.

• Schedule 1 (non-IVD) and Schedule 2 (IVD) list, item by item, the documents that can serve as manufacturer evidence.
• MDD (Council Directive 93/42/EEC), AIMDD (90/385/EEC) and EU MDR certificates are available in parallel in the current instrument.
• Time anchors are tied to the application submission date, for example the IVD table item 2 formulation “for an application submitted before 1 January 2030”.
• Multiple ISO 13485 document items are limited to applications submitted before 26 May 2027.
• The 1 December 2025 version introduces the “applied Directive 93/42” and “applied Directive 98/79” concepts, recognising certificates issued by UK approved bodies under SI 2002/618.

2. Legal basis

The Determination is made under the Act, and its Schedules, definitions and amendment history together determine which certificates work for which devices and until when. Its operative logic reduces to three questions: which Schedule, which item, and which anchor date.

• Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018, registration number F2018L01410; made under sections 41FDB(7) and (8) of the Therapeutic Goods Act 1989; as made in 2018; current compilation version 13 (F2025C01150), effective 1 December 2025.
• Schedule 1 (non-IVD) and Schedule 2 (IVD) list item by item the documents usable as manufacturer evidence. In the current instrument, MDD (Council Directive 93/42/EEC), AIMDD (90/385/EEC) and EU MDR certificates are available in parallel; for example, for Class I sterile or measuring devices, certificates under 93/42/EEC Annex II (excluding Section 4), Annex IV (EC verification), Annex V (production quality assurance) and Annex VI (product quality assurance) can be submitted (Schedule 1 items 2, 3 and 4).
• Form of the time anchors: expressed by reference to the date the application is submitted; for example, IVD table item 2 uses “for an application submitted before 1 January 2030”, and multiple ISO 13485 document items are limited to “for an application submitted before 26 May 2027”.
• The 1 December 2025 version introduced the concepts of “applied Directive 93/42” and “applied Directive 98/79” (the UK-transposed versions), recognising certificates issued by UK approved bodies under the UK Medical Devices Regulations 2002 (SI 2002/618) (defined in regulation 4).
• Amendment history: F2024L00760 (registered 24 June 2024, effective 1 July 2024); F2024L01328 (registered 18 October 2024); F2024L01674 (registered 17 December 2024); F2025L01322 (registered 30 October 2025, effective 1 December 2025), which added UK approved body certificates under three directives and changed “recognised auditing organisation” to “recognised or authorised auditing organisation” to capture MDSAP authorised bodies.
• Practical estimate: whether a single unified application submission cut-off exists for non-IVD MDD certificates — no uniform formulation has been located in the current Schedule 1, and no corresponding provision has been identified in the official text.

3. Expert insights

Insight 1: the application submission date is a controllable variable; certificate validity is not. The time anchors constrain the moment of submission, which companies can manage through scheduling; certificate validity is decided by the issuing body. Conflating the two leads to the mistaken conclusion that “a certificate still within its validity can be used”. The anchors are about the filing calendar, not about the paper in hand, and planning should be built around the calendar. Companies that map the submission calendar against the anchors early preserve options that would otherwise expire quietly.

Insight 2: the 26 May 2027 anchor on ISO 13485 items is independent of the IVD transition dates. Besides the three IVD dates of 2028, 2029 and 2030, multiple ISO 13485 document items carry their own anchor requiring submission before 26 May 2027. These two date systems are unrelated to each other and must be checked separately; a project that tracks only the IVD transition calendar can silently fall outside the ISO 13485 anchor. A quick sweep of the Schedules for every occurrence of the two date families is worthwhile before any submission plan is locked.

Insight 3: UK certificates can no longer ride on the EU lane. After the 1 December 2025 version introduced the applied Directive concepts, UK approved body certificates are recognised on a separate footing. Companies holding UK certificates that report them under the “EU certificate” entries will be asked to correct their applications because the directive version does not match the item claimed. The correction is simple when caught early: restate the certificate under the correct applied Directive entry, naming the issuing body.

4. Practical recommendations

• Maintain a three-column ledger of “certificate — table item — anchor date”, recording for every certificate its specific item number in Schedule 1 or Schedule 2 and the applicable anchor, so the ledger can be re-checked in minutes when a compilation update lands.
• Plan the schedule backwards from the submission date, setting the key anchors (such as 26 May 2027 and 1 January 2030) as project milestones.
• Report UK certificates under the applied Directive entries, not under the EU entries.
• After every update of the Information Determination compilation (currently version 13), re-verify the item numbers and anchors in the ledger.

5. Verification checklist

• □ The specific item number of each certificate in Schedule 1 or Schedule 2 has been confirmed
• □ Time anchors have been checked against the application submission date, not certificate validity
• □ The 26 May 2027 anchor on ISO 13485 document items has been checked separately
• □ UK certificates have been reported under the applied Directive entries
• □ The ledger has been re-verified against the version 13 compilation

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