Consultation: Proposed changes to the IVD medical device classifications and definitions

We invited feedback on proposed changes to the classification rules and definitions for in vitro diagnostic (IVD) medical devices in Australia. The key elements of the proposal included:

• Aligning Australian IVD classification rules, principles and definitions with the European Union’s IVD Regulation (EU IVDR 2017/746) where appropriate.
• Reclassifying certain IVDs (e.g. cancer tests, newborn screening, control materials and subsets of software and instruments) to ensure scrutiny is proportionate to the risk posed by their intended purpose and use.
• Adopting clearer terminology and definitions to improve consistency and interpretation.

Participation: We received 25 submissions from a broad range of stakeholders including industry, laboratories, public pathology and community health organisations.

Overall support: There was overall support for international alignment and clearer, risk‑based classification, particularly for cancer‑related tests, preliminary testing and monitoring devices, and newborn screening tests. Stakeholders said this would reduce ambiguity and improve consistency across Australian Register of Therapeutic Goods (ARTG) entries.

Key considerations

• Respondents said that international alignment offers clear benefits, including reduced duplication and lower regulatory burden to access the Australian market.
• Some respondents said the TGA should treat already established instruments pragmatically with minimum regulatory burden, and any re-validation costs for small volume tests should also be minimised to reduce supply disruptions of those tests. 
• There was overall broad support for aligning the classification of assigned‑value controls with that of the associated assay. However, concerns were raised that any change should not include all qualitative controls and only include those controls that are used to validate the test result. Stakeholders asked the TGA to tighten the terminology and clarify its applicability in the guidance to avoid unintended consequences.  
• Respondents acknowledged that software should be classified based on its intended purpose but asked the TGA to develop clearer guidance, similar to internationally available guidance, to explain how intended purpose determines risk classification, supported by practical examples.
• Respondents asked us to align with the EU interpretation and published definition of ‘life-threatening condition’.
• There was strong feedback to retain Point‑of‑Care Testing (PoCT) terminology while incorporating the “near‑patient testing” concept, to avoid label divergence. Respondents also said that the change must not exclude trained healthcare workers given the demonstrated public‑health benefits in remote and priority settings.
• Some stakeholders supported a staggered transition period that ended 6 months after each of the respective staggered EU IVD Regulation transition timelines. However, others suggested a 12–24-month transition, to allow them time to update product portfolios and Quality Management System documentation.

Suggestions to support implementation

• Publish practical guidance and worked examples (especially for software, artificial intelligence, instruments and control materials); and
• Continue to align with international guidance, e.g. guidance under the European IVD Regulatory framework to minimise regulatory discrepancies.

We consolidated the consultation feedback on the proposed changes to the IVD classification and definitions and did further targeted consultation to understand concerns raised about the potential impact of the proposed changes. We published individual submissions in line with respondent consent for publication.

Next steps

• We will hold workshops with industry representatives to discuss transition arrangements (including the transition timelines) to minimise any potential impact on market availability.
• We will seek Government approval for the final proposal, informed by consultation feedback.
• Subject to approval by the Government, we will collaborate with industry representatives to develop clearer guidance, including practical examples, to support a smooth and effective transition.