The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, has published guidance dedicated to software as in vitro diagnostic medical devices. The initial version of the document was published in September 2013.
The authority states that the general definition of an in vitro diagnostic (IVD) medical device provided in the Therapeutic Goods (Medical Devices) Regulations 2002 includes software products. This type of software is widely used both as a component to a medical device and also together with another medical device (standalone software). At the same time, the regulatory status of IVD software does not depend on its type – the authority applies the same regulatory requirements irrespectively of the particular way the software in question operates. Under the general rule, any and all software products intended to be used for medical purposes should comply with the Essential Principles prescribing safety and performance requirements software as a medical device shall meet in order to be allowed for marketing and use in Australia.
The regulatory requirements applicable to the IVD software will depend on its intended purpose. In the course of the assessment, the authority will analyze information about the software subject to review provided by its manufacturer and contained in:
- The instructions for use supplied with the software;
- Additional technical documentation which covers aspects related to interactions between the software and medical device the IVD software is intended to be used with;
- Marketing and advertising materials used by the manufacturer and other parties involved to promote the software – the authority will analyze the claims made by the manufacturer with regard to the functions and features of the software.
The TGA also describes the standards to be applied in the case of in vitro diagnostic software. According to the information published by the authority, the following International standards could be applied:
- IEC 62304 Medical device software – Software life cycle processes which describe the aspects related to the software products, including the ones related to design; and
- IEC 62366 Medical devices – Application of usability engineering to medical devices standard, which describes general requirements applicable to medical devices.
The international standards listed above are recognized by the Australian regulating authority as the ones the medical device manufacturers are allowed to make references to. As in the case of any other medical devices, the life cycle approach should be applied to IVD software. Such an approach prescribes that medical device manufacturers (software developers) shall duly implement special measures sufficient to ensure the safety and effectiveness of a medical device within the whole period it is being used. The scope of a life cycle approach covers all the steps, including the initial design and development, as well as post-marketing surveillance and ongoing monitoring of safety-related issues. The authority additionally emphasizes the importance of the design stage.
IVD Software Requirements in Detail
The guidance further provides examples of various software products and describes the way they should be regulated under the applicable legislation.
1. Software as a component of a medical device. If the software constitutes an integral part of an in vitro diagnostic medical device, such software should not be treated as a separate product. Hence, it is not subject to mandatory inclusion in the Australian Register of Therapeutic Goods – the country’s national register of healthcare products. This category includes all software products that operate hardware IVD medical devices. The aforementioned approach applies to any and all cases when the software is embedded.
2. Software is supplied separately but is intended to be used together with the in vitro diagnostic medical device. Such software can operate a hardware medical device or otherwise impact its operations. For instance, this category includes computer programs intended to control IVD instruments. Under the applicable medical device classification rules, such software should be assigned to the same class as the medical device it is intended to be used with due to the similarity of risks associated thereto. The TGA states that such software should be treated as Class 1 IVD since all instruments that are IVDs are Class 1 IVDs. Consequently, such software should be included in the Australian Register of Therapeutic Goods as a separate product with a separate code. Should the software be intended to operate the product other than IVD, its classification should be determined separately under the applicable medical device classification rules.
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. Such software could be run on a general (non-medical) device (e.g., smartphone or computer). Irrespectively of the particular platform used, such software should be treated as a standalone medical device with its own functions. Software of this type is usually used to analyze data deriving from IVD medical devices and provide information intended to be used for diagnostic or treatment as an output. This category covers software intended to provide interpretation of test results. Classification of such software will depend on its intended purpose and risks associated thereto. Depending on the aforementioned factors, the software could be assigned to IVD Class 2, Class 3, or Class 4, respectively.
4. Software that is intended for handling (e.g., receiving, storing, transferring) patient-related information, including results from IVD devices, which may be used in combination with an IVD instrument or other electronic devices. The authority mentions that such software actually falls outside the scope of the definition of a medical device. However, certain exclusions could be applied: for instance, such software could also have diagnostic functions. The TGA emphasizes that if the operations performed by the software impact the interpretation of data it processes, such software would probably be treated as medical software and subject to regulation under the IVD software framework accordingly (if the data used by the software derives from an in vitro diagnostic medical device).
5. Corrections to software errors. Under the general rule, they are not treated as separate products. At the same time, corrections that affect the functionality of the software could be regulated as software products.
According to the TGA guidance, any and all software products, irrespectively of their type, should also comply with the applicable labeling requirements. In particular, the authority distinguishes the following ways the software could be provided:
- Direct download from the Internet;
- Installation from a media carrier (e.g., CD);
- Pre-installation on a device itself.
As stated by the TGA, the information accompanying the software should comply with the requirements set forth by the Essential Principles. This applies to all types of information, including such software-specific ones as the graphic user interface, screenshots, CD labels, and product demos.
In summary, the information published by the TGA describes the approach to be applied in the case of IVD software. The guidance outlines the most important aspects and describes classification rules and principles to be applied when determining the regulatory status of the product.
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