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Regulation impact statement: Amendments to the new regulatory framework for in vitro diagnostic medical devices (IVDs)

Version 1.0, October 2014 - OBPR Reference: 14631

17 October 2014

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Appendix 1 - classification of IVD medical devices

The medical devices regulatory framework has a separate classification system for IVD medical devices. Under this system, IVD medical devices are classified according to the risk posed to the health of the public or an individual, and relates to the risk of an incorrect result arising from the use of the IVD.

The detailed legislation describing the classification of IVDs can be found in:

  • Regulation 3.1 of the Regulations
  • Subregulations 3.2 (2) and 3.3 (2) of the Regulations
  • Schedule 2A of the Regulations.
IVDs are classified according to Subregulation 3.3 (2) as follows:
Classification Level of risk
Class 1 IVD no public health risk or low personal risk
Class 2 IVD low public health risk or moderate personal risk
Class 3 IVD moderate public health risk or high personal risk
Class 4 IVD high public health risk

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

The manufacturer is responsible for determining the class of an IVD using the classification rules in Schedule 2A and having regard to:

  • the manufacturer's intended use of the device
  • the level of risk to the patient and the public (taking into account the likelihood of harm and the severity of that harm).

Identical devices may be classified differently if they are to be used for different diagnostic purposes. This is why the manufacturer's intended use of the device is critical to determining the appropriate class. The intended use can be obtained from the:

  • Information provided with the IVD (including Instructions for Use and labelling)
  • Advertising materials
  • Design dossier (if applicable).

Please note: There are IVD medical devices where the classification in Australia may be different to the classification in other countries. Australia has aligned the principles for classification of IVDs with those of the Global Harmonisation Task Force (GHTF); however the manufacturer should take into account Australian legislation when determining the classification of a device that is to be supplied in Australia.

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