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IVD Medical Devices

Overview​

In vitro diagnostic (IVD) medical devices are a regulated subset of medical devices used to examine specimens — such as blood, urine, or tissue — outside the body. They are defined in the Therapeutic Goods (Medical Devices) Regulations 2002 and classified separately from other medical devices under Schedule 2A (Class 1–4). This page covers regulatory requirements specific to IVDs beyond what applies to all medical devices.

IVD-Specific Essential Principle — EP 15​

EP 15 applies only to IVD medical devices and requires that:

  • Analytical and clinical characteristics support the intended use
  • The IVD demonstrates adequate accuracy, precision, sensitivity, specificity, stability, and control of interferences
  • For IVDs using calibrators or control materials, traceability of assigned values must be assured through the QMS

Performance evaluation studies demonstrating compliance with EP 15 must be documented in the technical file.

Performance Evaluation vs Clinical Evaluation​

For IVDs, clinical evidence requirements under EP 14 are addressed through performance evaluation rather than clinical investigation in the traditional sense. Performance evaluation includes:

  • Analytical performance — accuracy, precision, measurement range, interference, cross-reactivity
  • Clinical performance — sensitivity and specificity relative to a reference standard or clinical diagnosis
  • Scientific validity — the association between the analyte and the clinical condition being diagnosed

The IVD performance evaluation report is equivalent to the clinical evaluation report for other medical devices.

Self-Tests and Point-of-Care Tests​

Self-tests (for consumer use) and point-of-care tests (for use in near-patient settings) have additional regulatory considerations:

  • May be classified at a higher risk class than equivalent laboratory tests (see IVD classification)
  • Must include information appropriate for the target user (lay language for self-tests)
  • Labelling and instructions must be suitable for use without clinical training (self-tests)
  • Additional clinical performance data may be required to demonstrate performance in the intended setting

In-House IVDs​

In-house IVDs are manufactured and used within a single laboratory (not supplied commercially). They have specific regulatory requirements introduced progressively since 2020. In-house IVDs above Class 1 are subject to regulatory requirements including Essential Principles compliance and notification or inclusion requirements depending on their class.

👉 In-house IVD guidance — TGA

Official Sources​