Understanding regulation of software as in-vitro diagnostic medical devices (IVDs)

Any software that is supplied pre-installed on an IVD instrument, e.g. operating software in a clinical analyser, point of care analyser or personal use IVD such as a glucose meter.

In these cases, the software is a part of the device and is not considered to be a separate or distinct device.

The IVD classification rule 1.6 in Schedule 2A specifies that all instruments that are IVDs are Class 1 IVDs

The legislation applies to all forms of medical device software including software that is embedded (for example, firmware in hardware) including:

• field-programmable gate arrays (FPGAs)
• electronic programmable read only memory (EPROM)
• flash memory
• static or dynamic random access memory (RAM)

Software for operating an IVD instrument that is installed on a computer interface used for the control of the IVD instrument.

Software for upgrading functionality that is to be installed on an IVD instrument or connected computer interface

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

As the IVD classification rules in Schedule 2A specify that all instruments that are IVDs are Class 1 IVDs, the software is therefore also a Class 1 IVD but requires a separate inclusion in the ARTG as it has a different GMDN code.

Note: Software that is intended to drive or influence a non-IVD medical device must be classified in accordance with Regulation 3.3(5) and the medical device classification rules in Schedule 2.

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 (e.g. instrument or analyser) *

* the software may be intended to be installed on a device such as a computer, mobile phone, tablet or other electronic device and not intended to drive or influence an IVD instrument/analyser (or a non-IVD medical device)

Standalone software able to combine a number of IVD results to calculate and report an additional result to be used for clinical purposes. For example, software intended for the interpretation of a series of results obtained as part of a first trimester screening assessment in order to determine foetal risk of trisomy 21.

Standalone software intended for use in staging or predicting severity of disease by means of an algorithm based on a combination of anthropometric measures and non-invasive biomarkers.

Patient record management system that handles admission dates, case notes, contact details.

Conversion, compression, and encryption functionality/tool.

Laboratory Information System (LIS) that is intended for the:

• input, storage and retrieval of clinical information or data,
• reporting of clinical information or data that has not been manipulated by the LIS to change or generate new therapeutic or diagnostic data or information.

Software functionality intended to:

• enable the effective communication of information or data, for example, between an IVD instrument and a LIS
• block test results that are invalid due to a QC failure
• flag test results that are performed in duplicate but are discrepant
• queue or order retesting or additional tests to be performed based on results of previous testing
• generate worklists of patient samples for batch testing.

^ Software that handles clinical information and also has a diagnostic or therapeutic function(s), according to the manufacturer's intended purpose, is an IVD.

The manufacturer/sponsor will need to consider the definition of a therapeutic good, medical device and IVD if the functionality of the software is not included in the examples provided in this table.

Software that performs a manipulation on the data that affects the interpretation of results, or generates new diagnostic data/information, would make the software a medical device. If the source of the original data was an IVD then the software would be considered an IVD medical device. See guideline 3 above for clarification.

Bug fix to resolve rounding errors in the algorithm used to calculate result thresholds

Stability fix to laboratory analysis tool to reduce incidence of crashing or freezing

Corrections to software may be considered to be a product correction under the Uniform Recall Procedure for Therapeutic Goods which is available from TGA website.

Note: If functionality that changes the original intended purpose of the software is added, then the software may be considered a distinct and separate IVD to that of the original.