The implementation of the IVD regulatory framework in 2010 means that laboratories that use in-house tests are required to include them on the Australian Register of Therapeutic Goods (ARTG).  The regulations define an in-house IVD as

a.    within the confines or scope of an Australian medical laboratory or Australian medical laboratory network:

                              i.        developed from first principles; or

                             ii.        developed or modified from a published source; or

                            iii.        used for a purpose, other than the intended purpose assigned by the manufacturer; and

b.   not supplied outside that medical laboratory or medical laboratory network.

The regulations stipulate IVD classification that is based on the risk to public health and the personal risk-burden associated with their use.  An IVD must be shown to be compliant with the Essential Principles relating to safety, quality and performance. Laboratories that wish to include in-house IVDs on the ARTG must meet the requirements specified for the risk class into which the IVD falls. Class 3 in-house IVDs are assessed by NATA for compliance with the National Pathology Accreditation Advisory Council (NPAAC) performance standard. Laboratories wishing to register a Class 3 in-house IVD must provide validation data that establishes the safety, quality and performance of their device. Several standards exist for the validation of medical devices; however these generally provide a broad overview and do not focus on IVDs used for infectious disease, resulting in considerable variability and lack of consistency between validations.

NRL has been contracted by TGA for over 20 years to conduct performance evaluation of IVDs. These evaluations include examination of manufacturers’ dossiers of evidence that support application for inclusion of IVDs on the ARTG.  In examining these dossiers we have identified key areas where information is often lacking or unclear with regard toscientificprotocols, performance testing of the device and communication of the findings. This presentation will focus on NRL’s development of a guidance document aimed at standardising approaches to validation of Class 3 in-house IVDs and suggest appropriate experimental designs and protocols for various testing scenarios.