Skip to main content

IVD Class 1, 2, 3 & 4

Overview​

In vitro diagnostic (IVD) medical devices are classified separately from general medical devices under Schedule 2A of the Therapeutic Goods (Medical Devices) Regulations 2002. The IVD classification system uses four classes (1–4), based on the risk the device poses to an individual patient and to public health. IVD classification considers the intended use of the device, the condition being diagnosed or monitored, and whether the test is used by trained laboratory personnel or by consumers as a self-test.

IVD Class 1 — Low Individual Risk, Low Public Health Risk​

Risk level: Low
Examples: General purpose laboratory instruments, reagents for general chemistry analytes (protein, electrolytes), culture media, accessories such as specimen collection tubes for non-listed analytes, histological stains.

Class 1 IVDs are those where an incorrect result poses low risk to the individual patient and minimal risk to public health. Most general laboratory instruments fall here when the intended analyte is not specifically listed in higher-risk schedules.

Key regulatory requirements:

  • Declaration of Conformity only
  • No third-party QMS certification required
  • Sponsor submits ARTG inclusion application
  • Lower TGA review scrutiny

IVD Class 2 — Moderate Individual Risk, Low Public Health Risk​

Risk level: Medium
Examples: Blood glucose monitors, home pregnancy tests, cholesterol tests, urinalysis test strips, haemoglobin measurement, fertility monitors, drug-of-abuse tests (for non-forensic monitoring).

Class 2 IVDs are those where an incorrect result could cause significant harm to an individual patient but pose low risk to the broader population. Many common point-of-care and consumer tests fall in this class.

Key regulatory requirements:

  • QMS certification (ISO 13485 or equivalent) required
  • Declaration of Conformity
  • Conformity assessment evidence from comparable overseas regulator accepted
  • Sponsor submits ARTG inclusion application

IVD Class 3 — High Individual Risk, Moderate Public Health Risk​

Risk level: Medium–High
Examples: HIV self-tests, PSA (prostate-specific antigen) tests, companion diagnostics (tests that determine eligibility for a specific therapy), HER2 testing, certain prenatal screening tests, mycobacterium tuberculosis detection.

Class 3 IVDs are those where an incorrect result could have serious consequences for an individual patient or could pose moderate risk to public health. Companion diagnostics — tests used to determine whether a patient should receive a specific medicine — are a key Class 3 category.

Key regulatory requirements:

  • Full QMS certification required
  • Product-specific conformity assessment certificate required
  • Comparable overseas regulator evidence accepted (requirements updated 1 July 2024)
  • Applications are subject to mandatory audit in many cases
  • Closer TGA scrutiny

IVD Class 4 — High Individual Risk, High Public Health Risk​

Risk level: High
Examples: Blood group typing and compatibility testing (ABO, Rh), HIV and hepatitis B/C screening of blood supply, tissue typing for transplantation, screening donations for infectious agents.

Class 4 IVDs carry the highest level of risk — an incorrect result could directly endanger a patient's life or cause widespread harm to the blood or organ supply. These devices are subject to the most rigorous regulatory requirements.

Key regulatory requirements:

  • Full QMS certification (ISO 13485) required
  • Product design assessment required
  • Historically required TGA conformity assessment certificate; EU notified body certificates now accepted from 28 July 2021
  • Applications are subject to mandatory audit
  • Closest pre-market TGA scrutiny

Self-Tests and Point-of-Care IVDs​

Self-tests (designed for use by consumers without clinical training) and point-of-care tests (designed for use in near-patient settings such as GP clinics, pharmacies, or emergency departments) are treated as higher risk regardless of analyte, because:

  • Consumers may lack training to interpret results correctly
  • Testing may occur without clinical oversight
  • Incorrect results may lead to delayed treatment or inappropriate self-treatment

Self-tests and point-of-care tests for certain analytes that would otherwise be Class 2 may be reclassified to Class 3 or higher. The TGA's IVD classification guidance provides specific worked examples.

👉 IVD classification guidance — TGA

In-House IVDs​

In-house IVDs are IVDs manufactured and used within a single laboratory, not supplied commercially. They are subject to specific regulatory requirements introduced in recent years. In-house Class 4 IVDs are subject to mandatory audit requirements.

👉 In-house IVDs — TGA guidance

Summary Comparison​

Class 1Class 2Class 3Class 4
RiskLowMediumMed-HighHigh
QMS requiredNoYesYesYes
Product certificateNoYesYesYes
Mandatory auditNoNoManyYes
Self-test upliftN/AOften Class 3——

Official Sources​

The section ends with 'Self-tests (designed for use by consumers without clinical training) and point-of-care tests (designed for use in near-patient settings such as GP clinics, pharmacies, or emergency departments) are treated as higher risk regardle' — this appears to be truncated. The complete thought should be: 'Self-tests (designed for use by consumers without clinical training) and point-of-care tests (designed for use in near-patient settings such as GP clinics, pharmacies, or emergency departments) are treated as higher risk regardless of the underlying test methodology, as errors in execution or interpretation are more likely when clinical training is absent or limited.'