The Therapeutic Goods Administration (TGA), the division of the Australian Department of Health responsible for medical device regulation, issues guidance on IVD companion diagnostic devices.

Definition of IVD Companion Diagnostics


According to the guidance, the definition of an IVD that would be implemented in the Australian legislation regarding medical devices in 2020 is a companion diagnostic medical device that is intended to provide information related to use of a particular medicine or other medicinal product. The appropriate definition meets criteria set forth in the respective regulation of both the US and EU.

Apart from the general criteria applicable to IVD medical devices, there are special criteria that can be applied to identify medical devices as an IVD companion diagnostics. Such devices are intended to be used to:

      Identify the potential health benefit resulting from the use of a medicinal product, or

      Identify the potential health risk associated with the use of a medicinal product by the patient, or

      Track the results of using a medicinal product by the patient.

The information supplied with the medicinal product should also contain a detailed description of the correspondence between the medicinal product and the medical device intended to accompany its use. According to the guidance, the instruction should describe the intended purpose of the device. This includes whether the intended purpose is the selection of patients or monitoring of the treatment or both. The instruction should also contain the name of medicine to be used with. It is important to mention that such medicine should be approved in Australia, or else the medical device manufacturer will not be allowed to make references to it. The name of the corresponding device should also be indicated in the documentation provided with the medicinal product. In accordance with the new changes, the phrase “validated test” that refers to the particular device should be replaced with “TGA approved IVD companion diagnostic”. The new wording includes both IVDs registered under the standard procedure and also in-house IVDs about which the authority has been duly informed. At the same time, the IVD companion diagnostic device should not be intended to identify the compatibility of the medicinal product with the particular patient in general. To assist medical device manufacturers, the TGA provides examples of descriptions that could accompany devices. The guidance covers all of these topics.

In-house IVD companion diagnostics are regulated in the same way as other IVD devices. At the same time, there are no rules on obligatory inclusion of these devices to the register of medical devices. However, they should be mentioned in the results of examinations for which they had been used. The laboratory developing and using its own IVD companion diagnostics should duly notify the authority and provide a list of these devices. To be allowed to manufacture its own IVD devices, the laboratory should be properly accredited as a testing library.

Exclusions from the IVD Companion Diagnostics


The authority also provides explanations regarding the rules on exclusions applicable to identify the device that falls outside the scope of the IVD companion diagnostics regulation. There are several types of medical devices that have certain features similar to features that IVD companion diagnostic devices have, however, such devices should be attributed to another category. To clarify these issues and assist medical device manufacturers, the authority has published guidelines on the approaches that allow manufacturers to define whether the particular device is an IVD comparison diagnostic or not.

The list of exclusions provided by the authority includes the following devices:

  1. Complementary diagnostic devices could be used to evaluate both potential benefits and risks associated with the use of a particular medicinal product. The main difference between complementary diagnostics and companion diagnostics is that complementary diagnostics are not needed to use the medicinal product in a safe and effective manner since it only provides additional information. In this case, the manufacturer should state that the device “may be associated with” the particular medicinal product.
  2. Compatibility tests including tests for blood products or human organs are excluded due to the highest risk associated with this type of devices. According to the current framework, compatibility tests used in the course of transplantation procedures should be classified as Class 4 IVD devices.
  3. Drug monitoring tests – in general, devices intended to monitor the effect caused by the treatment, are not included in the scope of companion diagnostics unless the application of such tests is necessary to ensure safety and effectiveness. This should be directly indicated in documents supplied with such products. The authority also emphasizes that in such cases, the wording should include “may” and “should” instead of “must” which indicates the obligatory application of a device.
  4. Diagnostic tests are also excluded due to the principle of being “essential”, i.e. necessary to be used with the particular medicinal product.

Summarizing the information provided in the guidance, it is possible to state that the main approach used to distinguish IVD companion diagnostic devices is to check whether its application is essential for the safe and effective use of the particular medicinal product or not.


IVD Companion Diagnostics Regulation: Aspects And Details


The guidance also provides detailed information regarding the most important aspects of the IVD companion diagnostics regulation under the existing regulatory framework. According to the risk-based classification, depending on the particular intended use type, IVD companion diagnostics could belong either to Class 3 IVDs or to Class 3 in-house IVDs.

The manufacturers of IVD companion diagnostics would also have to place Unique Product Identifiers (UPI) on the device in order to comply with regulations on medical device registration, taking effect at the beginning of 2020. Under these requirements, an application for inclusion in the Australian Register of Therapeutic Goods (ARTG) should also include the UPI determining the particular type of device. Each device should have its own UPI composed of words, letters or other symbols. It is also important to mention that all such applications would be subject to mandatory audits. Apart from the initial application, the manufacturer should submit information regarding the following changes:

      Any changes in the name of the device,

      Changes to the intended purpose including new claims.

The authority announced that the detailed guidelines on clinical evidence for IVD devices would be published shortly to provide medical device manufacturers with necessary information regarding the new requirements that would enter into force in 2020. Under the current legal framework, the authority accepts the certificates issued by foreign regulating authorities and assessment bodies, so the TGA intends to harmonize the requirements with ones implemented in the EU and US. The authority is going to publish the list of approved IVD companion diagnostics (including in-house IVDs) on its website.

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