The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices and other healthcare products, has published revised guidelines on clinical evidence for medical devices. The document is intended to provide medical device manufacturers and other parties involved with additional clarifications and recommendations regarding the applicable regulatory requirements.
The authority emphasizes the non-binding status of the recommendations provided therein. Moreover, in case of any discrepancies with the provisions of current legislation, the latter should prevail. The authority also reserves the right to amend the guidelines from time to time, should it be necessary to reflect the changes to the regulatory framework.
The scope of the present TGA guidelines covers all medical devices, including in vitro diagnostic ones. However, the authority states that the information provided with regard to the latter could be incomplete. The document also describes device-specific regulatory requirements to be applied to:
- Total and partial joint prostheses,
- Cardiovascular devices to promote patency or functional flow,
- Implantable pulse generators,
- Heart valve prostheses,
- Support devices – meshes, patches, and tissue adhesives,
- Implantable medical devices in the magnetic resonance environment.
The document provides additional clarification on clinical evidence in general and also on the processes and procedures associated with its generation.
The provisions of the present guidelines have also been aligned with the appropriate documents developed by the Global Harmonization Task Force (GHTF), later superseded by the International Medical Device Regulators Forum (IMDRF), a voluntary association of the national regulating authorities in the sphere of medical devices collaborating for further improvement of the regulatory framework.
Under the general rule, in order to be allowed for marketing and use in Australia, any and all medical devices should have the appropriate clinical evidence confirming their safety and performance. The devices should also be included in the Australian Register of Therapeutic Goods (ARTG), the country’s register of healthcare products. Some medical devices are exempted or excluded from mandatory inclusion in the aforementioned register – in such a case, the appropriate requirement could be waived.
The applicable regulatory requirements are prescribed by:
- The Therapeutic Goods Act 1989, and
- The Therapeutic Goods (Medical Devices) Regulations 2002.
The document also refers to the applicable risk-based classification rules for general medical devices and in vitro diagnostic medical devices, which are divided into Classes I, Im, Is, IIa, IIb, III, and Classes 1 – 4, respectively. The regulatory requirements the medical device should comply with in order to be allowed for marketing and use in Australia actually depend on its class under the aforementioned risk-based classification in terms of the scope of information to be provided by the interested party, and also the extent to which the regulating authority or a conformity assessment body should be involved in the review. In any case, the medical device should also comply with the Essential Principles outlining the requirements related to safety and effectiveness. The appropriate clinical evidence should also be provided by the interested party applying for the inclusion of a medical device in the ARTG.
The TGA additionally emphasizes that clinical evidence is required for the whole period of time the medical device is available on the market, and the regulating authority is entitled to require the manufacturer to provide clinical data for the medical device it is responsible for at any time. For instance, it could be requested in case of any safety-related issues identified. The approach for clinical evidence provided in the present guidelines could be applied in all cases.
Clinical evidence provides information about existing treatment options and the way the particular medical device operates. This includes the information to be considered when assessing risks and safety-related aspects associated with the medical device – the latter should meet the applicable regulatory requirements in terms of safety and effectiveness when being used for the intended purpose. The medical device manufacturer should duly implement the measures necessary to mitigate to the lowest extent possible all identified and potential hazards and risks associated with the medical device, while the clinical benefits provided by the device should outweigh the risk that could not be mitigated – the residual risk. It is also important to mention that the clinical evidence should be subject to updates in order to reflect new data deriving from post-market surveillance activities.
Clinical Evidence: General Requirements
As mentioned before, any and all medical devices intended to be marketed and used in Australia should comply with the Essential Principles, including six general, eight specific principles, and one for in vitro diagnostic medical devices.
1. According to the general principles, the medical device should not create additional risks for the patient`s health, should operate as intended by the manufacturer, should be designed and manufactured in a way ensuring its compliance with the regulatory requirements, and also the long-term safety, which should not be affected by the transportation or storing. The risks associated with the medical device should be outweighed by the clinical benefits it provides.
2. Specific principles are dedicated to the aspects related to chemical, physical and biological properties of the medical device, as well as the ones related to the use of radiation or energy sources.
The TGA also mentions that whilst the Essential Principles provide the main principles the medical device should comply with, they do not prescribe how exactly such compliance should be achieved. Hence, there is certain flexibility the medical device manufacturer could benefit from when determining the particular approach to be applied.
In accordance with the Essential Principle number fourteen, every medical device requires clinical evidence, appropriate for the use and classification of the device, demonstrating that the device complies with the applicable provisions of the Essential Principles. Consequently, the medical device manufacturer should also implement the appropriate clinical evaluation procedure, unless the medical device in question falls within the scope of some of the exemptions or exclusions and is not required to be included in the ARTG. The regulatory requirements for the clinical evaluation procedures are prescribed by the current Australian legislation, under which the manufacturer shall:
- Obtain clinical data, in the form of “clinical investigation data”, and/or “literature review”,
- Ensure that the clinical data held in relation to the device is critically evaluated by competent clinical experts in the relevant field, and that the clinical evidence demonstrating that the device complies with the applicable provisions of the Essential Principles is documented in writing.
Apart from the Essential Principles, the approach to clinical evidence employed by the medical device manufacturer should also comply with the applicable Australian or international standards. In particular, the medical device manufacturer may refer to the appropriate standards in order to demonstrate compliance with the applicable regulatory requirements. The international standards related to the clinical evidence include:
- ISO 13485:2016 – Quality Management Systems (QMS),
- ISO 14155:2011 – Good Clinical Practice,
- ISO 14971:2007 – Application of risk management to medical devices.
In summary, the revised clinical evidence guidelines issued by the TGA describe the most important regulatory requirements the medical device manufacturers comply with. The document also provides additional clarifications and recommendations on the particular approach to be applied in order to achieve and sustain compliance with such requirements.
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