The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, has published a consultation paper dedicated to the suggested regulatory approach with regard to the nanomaterials used in medical devices. The document was issued as part of the ongoing improvement of medical devices legislation.
In particular, the Australian lawmakers are intended to align the country’s national regulatory requirements for medical devices with the ones introduced in the European Union, while the TGA is the regulating authority responsible for the actual implementation of the new approach. In this regard, Australian legislation is in the process of harmonization with the new regulatory requirements for medical devices containing nanomaterials set forth under the Medical Devices Regulation 2017/745 (MDR) which introduced a new approach to be applied for such products. The present document describes the current stage of the regulatory development and further steps to be performed in order to implement the best practices introduced by the MDR.
Regulatory Background
Under the general rule, the approach for regulatory requirements for medical devices is based on the evaluation of risks and benefits associated with the medical device used for its intended purpose. The regulating authority acknowledges that any and all medical devices have certain risks associated thereto, and states that it is important to compare these risks with the clinical benefits the device provides.
The classification of medical devices in Australia also employs the risk-based approach. The aspects to be considered when determining the class of the device under the risk-based classification include, inter alia, the following ones:
- Potential harm that could be caused by the device to the user`s health, and/or environment;
- Invasiveness and its level;
- Use of power (e.g. electricity);
- Application site (the particular place of the human body the device should be used on);
- Intended use of a medical device initially prescribed by the manufacturer;
- Intended user of a medical device and required level of qualification and knowledge (e.g. healthcare professional or layperson).
The document mentions that the regulatory requirements are subject to changes implemented from time to time to introduce new improvements and ensure the highest level of safety and effectiveness of medical devices allowed to be marketed and used in Australia.
Medical Devices Containing Nanomaterials: European Approach
The TGA outlines the most important aspects associated with the regulatory requirements for medical devices containing nanomaterials adopted in the European Union under the new framework introduced by the MDR. Key points of the aforementioned approach are the following ones:
- Nanomaterials are defined as “particles with one or more external dimensions in the size range 1-100 nm”;
- MDR makes special emphasis on the risks associated with the nanomaterials due to the size of particles;
- The new classification rules are being introduced for “all devices incorporating or consisting of nanomaterials”. Under these rules, such devices are to be assigned to higher-risk classes.
Thus, the new regulatory requirements for medical devices containing nanomaterials are more strict and detailed. The Australian lawmakers used them as an example when developing a new national regulatory framework to be applied for this type of medical device.
Main Regulatory Concerns
The document also describes in detail the most important aspects considered when developing the new regulatory requirements for medical devices containing or composed of nanomaterials. The TGA states that nowadays the risks associated with nanomaterials are still subject to scientific investigation. According to the document, additional time is needed to identify potential risks associated with the use of nanomaterials in medical devices. That is why the regulating authority reserves the right to modify the applicable framework and implement amendments necessary to ensure the safety of patients and effectiveness of medical devices in case if such amendments are needed and justified under the new information obtained by the TGA about risks and benefits of medical devices containing nanomaterials. For this purpose, the TGA also performs continuous monitoring of adverse events and incidents associated with medical devices incorporating nanomaterials in order to collect additional data about the potential and identified risks associated thereto.
Consultation on Medical Devices Containing Nanomaterials
The present document is intended to describe the regulatory approach suggested by the TGA and encourage medical device manufacturers and other parties involved in operations with medical devices containing nanomaterials in further discussion on the matter highlighted herein. In particular, the regulating authority is expecting to receive feedback and suggestions to be considered when developing the final version of the regulatory requirements for this type of medical device.
According to the consultation paper, there are three approaches (options) suggested by the TGA with regard to the applicable regulatory framework, namely:
- To leave the regulatory framework as it is now and to abstain from implementing any changes. Current regulatory requirements already incorporate the definition of nanomaterials and provide general rules with regard to their use in medical devices.
- To clarify the regulatory requirements by adding the appropriate definitions and amending the Essential Principles accordingly. At the same time, this approach does not provide any changes to the classification rules for medical devices. Under this approach, existing legislation would be supplemented with the definition of nanomaterials aligned with the one set forth under the MDR. Moreover, several related definitions would be also added to define other important terms used in the context of nanomaterials, while these terms are currently not covered by existing legislation. This approach also provides certain amendments to the Essential Principles outlining the main safety and effectiveness requirements medical devices should meet in order to be allowed to be marketed and used in Australia. In particular, they would be aligned to the corresponding provisions of the EU MD Regulation general safety and performance requirement (GSPR).
- To add new classification rules. As described above, the MDR provides special classification rules to be applied for medical devices containing or comprised of nanomaterials. The TGA additionally emphasizes that this would result in a certain increase in the regulatory burden since medical devices containing nanomaterials would have to be assigned to higher risks classes, hence they will be subject to more strict and detailed regulatory requirements. The TGA suggests using as an example the risk-based classification of medical devices incorporating or consisting of nanomaterials introduced by the MDR, under which such devices could be assigned to classes IIa – IIb – III depending on the potential level of internal exposure in or on the human body.
The TGA also describes in detail the potential consequences of the application of each approach and the way it would impact the regulatory requirements and also encourages the industry representatives and other parties involved in further discussions on the matter. The document also contains additional clarifications on the most important aspects associated with nanomaterials and their use in medical devices.
Summarizing the information provided here above, the new consultation paper published by the TGA is dedicated to the medical devices incorporating or comprised of nanomaterials. The document describes suggested approaches to the modification of regulatory requirements and outlines the impact such changes would potentially make in terms of the regulatory status of medical devices in question and the corresponding responsibilities of the parties involved.
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