The amendment strengthens the safety and quality requirements of companion diagnostics (CDx) in the development and use of in-house IVDs by introducing:
- a new CDx framework
- actions for validation when CDx is used for treatment selection
- actions for equivalence with clinical trial assays.
The amendment is enforceable from 20 April 2026.
The updated version of the Requirements for the Development and Use of In-House In Vitro Diagnostic Medical Devices (Fifth Edition, 2025) is available on the Commission’s website.
Important note: In Vitro Diagnostic Device Software Requirements are currently being developed and will be shared when they become available.
More information
Visit safetyandquality.gov.au/pathology or email pathology@safetyandquality.gov.au
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