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.
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:
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