Clinical Evaluation Report and IVD Additional Evidence Requirements

1. Key takeaways

The additional information for Class III devices and for IVDs consists of two distinct sets of requirements that cannot be applied interchangeably: on the Class III side, a clinical evaluation report (CER) and instructions for use must be submitted where the application is not supported by a TGA conformity assessment certificate; on the IVD side, evidence of conformity with Article 110(3c) of the European IVDR must be submitted, together with technical documentation assessment under the corresponding Annex IX clauses. Because the two regimes run in parallel, the evidence plan for every project should be built by first identifying which side of the split the product sits on, and only then selecting the documents.

• The Class III CER obligation in section 5(7)(c) is conditional: the trigger is the absence of a TGA conformity assessment certificate.
• The CER is defined in section 4 of the Determination.
• The IVD items appear at section 6(1)(c) (Class 2, item 2 or 2B), section 6(3)(c) (Class 3, item 3, 3B or 4) and section 6(5)(c) (Class 4, item 3 or 4).
• Annex IX allocation (Schedule 2 Part 2 item 5, column 4): self-testing and point-of-care testing (POCT) IVDs go to Annex IX clause 5.1; IVD companion diagnostics go to Annex IX clause 5.2; other devices go to Annex IX clause 4, with at least one representative device within the same generic device group.
• The version is locked: in the section 4 definitions, the term EU IVD regulation refers to Regulation (EU) 2017/746 as in force on 1 December 2024, and the term generic device group follows the same definition.

2. Legal basis

Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018 (F2018L01410, compilation version 13, effective 1 December 2025).

Class III side: section 5(7)(c) — where the application is not supported by a conformity assessment certificate issued by the TGA, a clinical evaluation report (CER) and instructions for use must be submitted in addition; the CER is defined in section 4. The condition turns on the supporting certificate named in the application, so the same product can carry this obligation on one application and not on another.

IVD side: section 6(1)(c) (Class 2, item 2 or 2B), section 6(3)(c) (Class 3, item 3, 3B or 4) and section 6(5)(c) (Class 4, item 3 or 4) — where the specific item pathway is used, evidence of conformity with Article 110(3c) of the European IVDR must be submitted. The obligation therefore attaches to the choice of item within the schedule, not to the class alone, and the same class can carry different documentary consequences depending on which item is selected.

The allocation of IVDR Annex IX technical documentation assessment (Schedule 2 Part 2 item 5, column 4): self-testing IVDs and point-of-care testing (POCT) IVDs fall to Annex IX clause 5.1; IVD companion diagnostics fall to Annex IX clause 5.2; other devices fall to Annex IX clause 4 (at least one representative device within the same generic device group).

Version lock: in the section 4 definitions, the term “EU IVD regulation” refers to Regulation (EU) 2017/746 as in force on 1 December 2024, and the term “generic device group” follows that same definition. Fixing the reference version inside the definitions removes any ambiguity about which text of the European regulation the Australian requirements point to.

3. Expert insights

Insight 1: the Class III CER obligation is conditional, and the trigger is the absence of a TGA certificate. A Class III device supported by a TGA conformity assessment certificate does not need to submit a CER, whereas devices relying on overseas evidence pathways such as the European MDR, FDA or Health Canada do. This runs counter to the common intuition that every Class III device must submit a CER, and it explains why the pathway decision should be made before the evidence plan is drafted rather than after.

Insight 2: IVD technical documentation assessment is divided into three tiers by intended use. Self-testing and point-of-care products go through clause 5.1, companion diagnostics go through clause 5.2, and everything else goes through clause 4. The “other” tier requires assessment of only at least one representative device in the same generic device group — a cost optimisation point for combined IVD submissions, since the assessment scope is anchored to the representative device rather than duplicated for every item in the group.

Insight 3: the IVDR version is locked at 1 December 2024. The Determination expressly cites the version “as in force on 1 December 2024”. Later European amendments do not flow through automatically to Australia, and citations of the provisions should note this baseline date so the reviewer can confirm that the referenced text matches the version the Determination actually points to.

4. Practical recommendations

• For Class III projects, first decide between the TGA certificate pathway and the overseas evidence pathway, then determine whether a CER must be prepared, avoiding duplicated investment.
• For IVD projects, locate the Annex IX clause by intended use (self-testing, POCT, companion diagnostics or other), and verify the corresponding clause number on the technical documentation assessment certificate.
• In combined submissions, use the representative-device rule within the generic device group to reduce the scope of assessment.
• Note the version baseline (as in force on 1 December 2024) for every IVDR citation.

5. Verification checklist

• □ Whether the Class III application is accompanied by a TGA certificate has been confirmed, and the CER obligation determined accordingly
• □ The CER and instructions for use have been prepared per section 5(7)(c) where applicable
• □ Annex IX clauses 4, 5.1 or 5.2 have been located by intended use for IVD projects
• □ Evidence of conformity with IVDR Article 110(3c) has been prepared
• □ Citations note the as in force on 1 December 2024 version baseline

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 prepares TGA-compliant CTOs and evidence dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com