Classification of IVD medical devices

Book pagination

Version 2.0 December 2015

7 December 2015

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:

Version history

Version Description of change Author Effective date
V1.0 Initial publication IVD Section 16/08/2010
V1.1 Minor updates Devices Conformity Assessment Section November 2011
V2.0 Updated to reflect regulatory reforms IVD Section December 2015

Book pagination