The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published a guidance document describing changes to the regulatory framework for software-based medical devices. The document describes the changes related to the software intended to specify or recommend a treatment or intervention.

According to the TGA guidance, the appropriate classification should be determined depending on the input required from healthcare professionals in terms of making decisions regarding the actions to be taken. According to the guidance, the regulatory requirements described therein are applicable for medical devices intended to:

  • Directly specify a treatment or intervention (the software makes the decision); or
  • Recommend a treatment or intervention (the user makes the decision). 

As mentioned before, the approach to be applied in each of the cases should be different. In the second case, the information provided by a medical device would be subject to assessment by a healthcare professional having the necessary skills and qualifications. The final decision regarding the particular actions to be taken would be made by such a healthcare professional. It is important to mention that in this regard, the authority refers to the concept of a “relevant healthcare professional” associated with the knowledge and specialization of a healthcare professional. 

Another important concept used in this regard is the concept of harm that could be caused to a patient. For instance, according to the guidance, software will be class I if the treatment or intervention (or its absence) cannot cause harm. 

Software Specifies or Recommends a Treatment or Intervention

The first case describes the situation when the software is initially intended to specify or recommend a treatment or intervention. As mentioned, the class of such software should be determined based on the significance of harm that could be caused to a patient by the treatment or intervention specified or recommended by the software or by the absence of such treatment or intervention. In particular, the following classifications should be applied:

  1. Could result in severe deterioration and pose a high risk to public health – Class III;
  2. May be otherwise harmful to a person, may pose a moderate risk to public health – Class IIb.

If any of the points above cannot be applied, the product in question should be assigned to Class IIa. 

The TGA guidance also provides an example describing the software intended to perform an analysis of a patient’s coronary angiogram and use this information to provide recommendations regarding the treatment. In accordance with the classification rules described above, such software should be assigned to Class III since it specifies the particular treatment while the treatment or its absence could result in significant negative consequences for the patient’s health. 

Software Recommends a Treatment or Intervention to a Relevant Health Professional 

The second case applies in the case of software-based medical devices intended to provide recommendations that should be considered by healthcare professionals, provided that the final decision regarding the particular treatment or intervention should be taken by such a healthcare professional. The general approach to classification is similar to the one applied for the software that recommends a treatment or intervention and should also be based on the risks associated with the treatment or intervention or the absence thereof, namely:

  • Severe deterioration in the state of a person’s health / high risk to public health – Class IIb;
  • Harmful to a person / may pose a moderate risk to public health – Class IIa. 

If any of the categories listed above cannot be applied, the product in question should be assigned to Class I. 

The guidance further provides an example describing software that performs an analysis of a patient’s coronary angiogram but provides its recommendations regarding the intervention to a cardiac surgeon. In accordance with the applicable classification rules, such a software should be assigned to Class IIb since it provides recommendations to a relevant healthcare professional. 

Information as Therapy 

The present TGA guidance additionally describes the approach to be applied with regard to software-based medical devices intended to provide therapy through the provision of information. According to the document, the particular class such a product should be assigned to should be determined depending on the potential to cause harm to the person using the information. The authority distinguishes four levels of harm, namely:

  • Harm that may result in a severe deterioration in the state of a person’s health;
  • Serious harm;
  • Harm that is not serious and will not harm that may result in a severe deterioration in the state of a person’s health;
  • No harm. 

Additional Recommendations 

Apart from clarifications regarding the new classification rules for software-based medical devices, the present TGA guidance also provides additional recommendations with regard to the particular steps to be taken by medical device manufacturers in order to achieve and sustain compliance with the applicable regulatory requirements. In this regard, the authority states that the changes to the classification rules for software-based medical devices commenced on 25 February 2021; all applications for the inclusion of software-based medical devices in the ARTG [as defined below] made after this date must meet these classification rules. Should the new rules provide an increase in the applicable class under the risk-based classification, the appropriate transitional regime should be applied in the context of inclusion in the Australian Register of Therapeutic Goods (ARTG), the country’s national register of healthcare products, including medical devices. Under the transitional regime rules, medical device manufacturers responsible for the products that are subject to such changes in classification should ensure compliance before November 1, 2024, when the transitional period ends. 

In particular, medical device manufacturers shall:

  • Inform the regulating authority about the devices requiring inclusion under the new framework;
  • Obtain the appropriate evidence of conformity assessment; 
  • Submit an application for [the] medical device to be included in the ARTG under the new classification rules before 1 November 2024. 

If the manufacturer fails to notify the regulating authority about medical devices already placed on the market that are subject to reclassification before August 25, 2021, such devices should not be marketed starting from the aforementioned date. The application for inclusion in the ARTG under the new classification rules should be submitted to the TGA before the end of the transitional period. Otherwise, the supply of the device in question should be ceased as well. 

The authority also outlines the scope of information to be included in a notification to be submitted by the medical device manufacturer, namely:

  • The ARTG inclusion number for the medical device; 
  • For Class III medical devices, the unique product identifier for each medical device. 

In summary, the present TGA guidance highlights the most important aspects related to the changes to classification rules for software-based medical devices. The document describes the approach based on hazards associated with therapy or intervention the device recommends, the absence thereof, as well as whether the decision is taken by a relevant healthcare professional. 

Sources:

https://www.tga.gov.au/sites/default/files/regulatory-changes-software-based-medical-devices.pdf 

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