. 2023 Feb 20;5:1101476. doi: 10.3389/fmedt.2023.1101476

Table 5.

IVD software regulations in Australia.

Type of software/intended purposed	Regulation
1. Software that is built into an IVD medical device	The instrument with the installed/embedded software is a single IVD. The IVD classification rule 1.6 in Schedule 2A specifies that all instruments that are IVDs are Class I IVDs
2. Software that is supplied separately to and IVD medical device but is intended to operate or influence the IVD	A distinct IVD that is separate to the IVD instrument or analyzer. According to Regulation 3.3 (5) under Principles for applying the classification rules in the Regulations, software that drives or influences a medical device has the same classification as the medical device
3. Software that is intended to be used to provide diagnostic or therapeutic information and is not intended to drive or influence an IVD medical device	An IVD. IVD software that is not intended to drive or influence an IVD instrument (or medical device that is not an IVD) is classified according to its intended purpose. This applies to Class II, III, and IV IVDs
4. Software that is intended for handling patient-related information. Including results from IVD devices, which may be used in combination with an IVD instrument	Does not meet the definition of a therapeutic good. Software that handles clinical information and has a diagnostic and therapeutic function is considered an IVD. Software that performs a manipulation on the data that affects the interpretation of results, or generates new diagnostic data, makes the software a medical device
5. Corrections to software errors	A correction to the IVD (not a distinct IVD). Correction to software may be a product correction under the Uniform Recall Procedure for Therapeutic Goods. If the functionality that changes the intended purpose of the software is added, the software may be considered a distinct IVD to the original