The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the recent changes in the regulatory framework for software-based medical devices.
The new classification rules were introduced by virtue of changes to the applicable regulations implemented on 25 February 2021. The present article describes in detail the new classification rules to be applied for different types of medical devices intended to be marketed and used in Australia. In particular, they are divided into groups based on the intended purpose of the device subject to classification.
According to the TGA guidance, in the case of software-based medical devices intended to be used for diagnosing or screening purposes, the applicable classification should depend on whether the device provides the diagnosis/screening directly, or whether a relevant health professional makes the diagnosis using information provided by the device. Hence, the class of such devices actually depends on the input needed from a healthcare professional and the extent to which he/she is involved in the decision-making process.
The aforementioned rule applies for software-based medical devices intended to be used in the course of general screening carried out in order to identify potential issues and also those intended for diagnosing patients that already have symptoms triggering a further investigation.
Software for Diagnosing Purposes
The classification approach to be applied in such a case is based on the concept of “relevance” of a healthcare professional who receives information from the software-based medical device in question. According to the guidance, for the purpose of this rule, “relevance” refers to the necessity of qualification and expertise to use the information provided by the device in the course of the decision-making process. In such a case, the diagnostic decision made should not be based only on the information provided by the device. The “relevance” of a healthcare professional depends on the disease in question. Should the diagnosing of a particular disease require special qualifications and expertise, only someone having them would be considered “relevant” for the purpose of this rule.
Another important concept used in this regard is the seriousness of the disease or condition. As defined in the Therapeutic Goods (medical devices) Regulations, a serious disease is one that could result in long-term health deterioration and require significant intervention in the course of its treatment. It also requires accurate diagnosing due to the relatively high risks associated thereto.
According to the flowchart provided by the TGA, should the diagnosis be made by the software, such software would be assigned to a higher class in comparison to devices wherein a healthcare professional makes the diagnosis while the software only provides additional information used to support the diagnosis.
If simplified, the classification rule for software that performs screening and diagnosing provides the following:
- The software intended to be used in the context of serious diseases associated with high risk to public health should be assigned to Class III.
- The software intended to be used for diagnosing serious diseases exposing patients to moderate risks should be assigned to Class IIb, and
- All other software products falling outside the two categories above should be assigned to Class IIa.
If the software only assists healthcare professionals in diagnosing and screening, the approach to classification should be slightly different:
- The software intended to assist in diagnosing serious diseases associated with high risk should be assigned to Class IIb.
- The software intended to be used in the context of a serious disease or condition associated with a moderate risk should be assigned to Class IIa, and
- The software that meets none of the criteria above should be assigned to Class I.
Software for Monitoring Purposes
The document further describes the approach to be applied in the case of the software intended to be used for monitoring purposes. According to the guidance, for software-based medical devices intended to provide information to monitor the state or progression of a disease or condition, the classification depends on both the potential risk to public health and whether the information could indicate if a person is in “danger.” For the purpose of this rule, both immediate and not immediate danger should be considered.
Consequently, the rules to be applied for classifying software-based medical devices used in the course of monitoring the progression of a disease are the following:
- Software intended to be used in the context of conditions related to immediate danger and high risk to public health should be assigned to Class IIb.
- The software providing information about a disease or condition related to non-immediate danger and moderate risk respectively should be assigned to Class IIa.
- The software products intended to be used in any other cases should be assigned to Class I.
In order to assist medical device manufacturers (software developers) in interpreting and applying the classification rules for software-based medical devices intended for diagnosing and monitoring, the TGA also provides some examples of such products together with the indication of proper classification and additional clarifications justifying the decision made. These examples include the following:
- A cloud-based software utilizing the deep learning neural network intended to be used to monitor the process of recovery from shingles, where the patient (customer) should upload images to the system. The constant input from a healthcare professional is not required – in such a case, the patient could use the software without the need for additional oversight (however, healthcare professionals could have access to such software and the results it provides as well). Due to the fact that the particular software-based medical device is intended to monitor conditions associated with relatively low risk for public health, and information it provides will not warn its user about the danger, the product should be assigned to Class I under the applicable classification.
- Software used to analyze X-ray images in order to provide a relevant healthcare professional with information to be used for diagnosing purposes. In particular, the guidance provides an example of software intended to analyze angiograms in the context of acute arterial occlusion. Due to the nature of the disease (once the diagnosis is confirmed, urgent treatment is required) and the use of the software by relevant healthcare professionals, such software should be classified as a Class IIb medical device.
- The same classification should be applied in the case of a software-based medical device intended to be used for diagnosing measles by virtue of analyzing the images of a rash – such a product should be classified as a Class IIb medical device as well.
In summary, the present TGA guidance describes in detail the new classification rules to be applied in the case of software-based medical devices intended for diagnosing and monitoring purposes. The document highlights the most important aspects to be taken into consideration when determining the particular class to which such a product should be assigned.
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