The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to software-based medical devices. In particular, the document provides examples of software products that are either subject to regulation under the applicable framework or explicitly excluded (unregulated). The guidance is intended to assist medical device manufacturers (software developers) in determining the regulatory status of their products and ensuring compliance with the applicable regulatory requirements. It is important to mention that provisions of the TGA guidance are non-binding, and in case of any discrepancies with provisos of existing legislation, the latter should prevail.

Regulated Software: Basics

According to the TGA’s current risk-based classification, all medical devices subject to regulation in Australia are divided into four classes (I, IIa, IIb, and III). Class I stands for the lowest classification and Class III for the highest, respectively. The applicable regulatory requirements and the level of regulatory oversight would depend on the class of the device to be determined on the basis of the risk associated thereto. The aforementioned classification rules are prescribed by the Therapeutic Goods (Medical Devices) Regulations 2002. The authority also mentions that additional clarifications and recommendations provided in the present guidance are relevant only in the case of general medical device software and should not be applied with regard to in vitro diagnostic medical device software. It is also important to mention that the applicable TGA classification rules are subject to certain changes addressed in a separate document.

Class I Software Medical Devices 

Class I is the lowest class under the applicable classification system and applies to the devices with the lowest risk associated thereto. Hence, the applicable regulatory controls are quite low as well. In the case of software-based medical devices, this class applies for the devices that are:

  • Intended to monitor the state or progression of a disease;
  • Providing information that does not indicate if an individual may be in danger;
  • Associated with a low public health risk. 

Class IIa Software Medical Devices 

This category applies to medical devices associated with medium risk. An example provided by the TGA describes diabetes diagnosis software that is intended to be used by a healthcare professional. Thus, such a product is a Class IIa medical device as the device provides information to a relevant health professional to inform the diagnosis of a serious disease. This category also covers risk prediction software, as well as the tools that record data from a patient monitor or images directly from an MRI scanner (provided that such software does not impact the operations of a scanner itself). 

Class IIb Software Medical Devices 

This category applies to medical devices associated with medium-high risk. For instance, such classification should be applied to a product that is intended to analyze a cardiac MRI in order to provide information used in making diagnoses of related diseases. As in the previous example, the software is intended to provide information to healthcare professionals only. As described in the guidance, Class IIb applies to medical software that is intended by the manufacturer (the software developer) to provide information to a relevant health professional to inform the diagnosis of a serious disease. Other examples of Class IIb products include tools intended to be used to diagnose an acute arterial occlusion due to the severity of potential consequences of this disease if the necessary treatment is not applied. This category also covers software products that are intended to provide recommendations for treatment or intervention on the basis of input data (e.g., a coronary angiogram). As in the previous cases, such software should be used only by healthcare professionals. Consequently, a Class IIb software-based medical device is the one that is intended to:

  • Recommend a treatment or intervention to a relevant health professional for the purposes of making a decision about the treatment or intervention; and 
  • Be used in cases when the absence of a treatment or a treatment itself could result in severe health deterioration or other adverse consequences. 

The same classification applies to wearable devices intended to collect and analyze data for screening for serious heart diseases, as well as questionnaire apps intended to analyze the information provided by a patient and provide a diagnostic output. 

Class IIa Software Medical Devices 

This category applies to medical devices associated with medium risk. An example provided by the TGA describes diabetes diagnosis software that is intended to be used by a healthcare professional. Thus, such a product is a Class IIa medical device as the device provides information to a relevant health professional to inform the diagnosis of a serious disease. This category also covers risk prediction software, as well as the tools that record data from a patient monitor or images directly from an MRI scanner (provided that such software does not impact the operations of a scanner itself). 

Class IIb Software Medical Devices 

This category applies to medical devices associated with medium-high risk. For instance, such classification should be applied to a product that is intended to analyze a cardiac MRI in order to provide information used in making diagnoses of related diseases. As in the previous example, the software is intended to provide information to healthcare professionals only. As described in the guidance, Class IIb applies to medical software that is intended by the manufacturer (the software developer) to provide information to a relevant health professional to inform the diagnosis of a serious disease. Other examples of Class IIb products include tools intended to be used to diagnose an acute arterial occlusion due to the severity of potential consequences of this disease if the necessary treatment is not applied. This category also covers software products that are intended to provide recommendations for treatment or intervention on the basis of input data (e.g., a coronary angiogram). As in the previous cases, such software should be used only by healthcare professionals. Consequently, a Class IIb software-based medical device is the one that is intended to:

  • Recommend a treatment or intervention to a relevant health professional for the purposes of making a decision about the treatment or intervention; and 
  • Be used in cases when the absence of a treatment or a treatment itself could result in severe health deterioration or other adverse consequences. 

The same classification applies to wearable devices intended to collect and analyze data for screening for serious heart diseases, as well as questionnaire apps intended to analyze the information provided by a patient and provide a diagnostic output. 

Class III Software Medical Devices

As mentioned before, Class III applies to medical devices associated with the highest risk. Consequently, such products are subject to the highest regulatory control and oversight. This category covers, inter alia, the products intended to specify the particular treatment or intervention that is necessary for a situation in question. Such products are intended to be used with regard to diseases and health conditions that, in the absence of treatment, could result in severe health deteriorations and other adverse consequences. This applies to mobile apps intended to diagnose severe diseases or impact the operations of an implanted medical device. 

Similar Products With Different Classification 

The TGA guidance also provides examples of software products that are similar in their nature but different in their regulatory status. The authority additionally emphasizes that these examples are provided to illustrate the way the applicable regulatory requirements could be interpreted, but should not be construed as legal advice of any kind, so the determination of the regulatory status of a particular product subject to review should be performed on a case-by-case basis. The borderline products that could be either subject to regulation as medical devices or excluded from the regulation, depending on their functions and features include, inter alia, the following:

  • Software intended for self-management of an existing disease or condition that is not serious (without providing specific treatment or treatment suggestions);
  • Consumer health and wellness products (maybe software or a combination of non-invasive hardware and software), which do not make claims about serious diseases or conditions;
  • Behavioral change or coaching software intended to be used to improve general health or wellness factors (such as weight, exercise, sun exposure or dietary intake) that does not provide information to the consumer that would generally be accepted to require the interpretation of a health professional. 

In summary, the present TGA guidance provides examples of software-based medical devices subject to regulation under the existing framework, as well as a brief overview of existing risk-based classification for medical devices. The document also highlights the most important aspects to be considered when determining the regulatory status of a product and deciding on the regulatory controls to be applied.  

Sources:

https://www.tga.gov.au/sites/default/files/examples-regulated-and-unregulated-software-excluded-software-based-medical-devices.pdf 

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