This guidance on the classification of in-vitro diagnostic medical devices (IVDs) is to assist manufacturers to classify their IVDs according to the Australian classification rules for supply in Australia.

Follow this guidance in conjunction with the legislative basis for classifying IVDs to gain the best possible understanding of the IVD classification framework.

These classification rules apply to both commercial and in-house IVDs.

Basis for classifying

The classification rules are based on a risk based approach to regulation, and IVDs are classified according to the health risk (either to the public or an individual) that may arise from an incorrect result.

• The higher the potential risk an incorrect result would pose, the higher the classification.
• The higher the risk class of a device, the higher the level of assessment and monitoring is required to demonstrate initial and ongoing compliance with the conformity assessment procedures.

Responsibility for classifying IVDs

The manufacturer is responsible for determining the class of the IVD by:

• using the classification rules in Schedule 2A of the Therapeutic Goods (Medical Devices) Regulations 2002, and
• taking into consideration both the:
  • intended purpose of the device,
  • level of risk to the patient and public of an incorrect result.