The Therapeutic Goods Administration (TGA), a division of Australia’s Department of Health responsible for medical devices circulation, issues new guidance dedicated to the evidence requirements. The new guidance published by the TGA is intended to provide entities that research entirely new medical devices with supplementary information needed to comply with the requirements and provide required evidence when applying for market authorization. The scope of the document also covers In Vitro Diagnostic devices (IVD) and software as a medical device (SaMD). In particular, the document provides a brief description of the medical device life-cycle, highlights the most important points on the design and development phase, describes the requirements applicable to clinical evidence and explains the specifics of pre-market application preparation.
According to the guidance, the life-cycle of any medical device consists of the following phases and stages:
- Pre-market application preparation phase (including clinical and manufacturing stages),
- Processing of the application (supply stage),
- Post-market phase (including marketing and post-market surveillance and reporting),
- Removal of the product from the market.
Medical Device Design and Development
The authority provides that the development of any medical device should be based on the essential principles. Utilizing these principles would allow the manufacturer to avoid additional expenses related to making changes to the design of the device in order to comply with requirements and perform the additional study. At the same time, it would also reduce the number of health risks participants are exposed to during clinical trials.
The particular scope of clinical evidence the manufacturer must provide depends on the classification of the medical device in accordance with risk-based classification.
The essential principles the authority refers to are initially outlined in the Therapeutic Goods (Medical Devices) Regulations 2002. There are 15 core principles: 6 of them are applicable to any medical device, and the remaining 9 are dedicated to certain aspects related to the design and construction of medical devices and thus should be applied when appropriate. To confirm compliance with some of these principles, the manufacturer may use the appropriate standards and regulations, such as:
- National standards (e.g. Medical Device Standards Orders, Conformity Assessment Standards Orders),
- General standards (e.g. American Society for Testing and Materials),
- Special (device-specific) standards,
- Regulations on procedures (e.g. Clinical Laboratory and Standards Institute Measurement procedure),
- Guidelines issued by Australia`s medical devices regulating authority, and also by foreign national authorities, as well as the appropriate scientific literature.
All these elements could be used by the manufacturer of the device for the purpose of demonstrating compliance with applicable requirements. In certain cases, it would substantially reduce the burden of evidence.
As it was mentioned before, the particular scope of evidence to be provided should be defined by the manufacturer due to the risk classification of the medical device subject to assessment. In other words, it would be required to provide more information for the device with the higher associated risk than for the device with relatively low risk. The authority also emphasizes that it is important to provide sufficient information regarding high-risk devices during the initial pre-market application assessment while for low-risk devices it is better to focus on post-market surveillance and reporting.
The manufacturer shall collect all the data in the appropriate way for the data to be deemed reliable. Actually, the data provided by the manufacturer shall confirm that the device meets all applicable safety and performance requirements, and the manufacturing process complies with applicable requirements too.
Clinical Evidence Collection and Clinical Trials
According to the guidance, there are two types of evidence possible:
- Direct clinical evidence – one obtained directly from the device subject to assessment. This is the most trustworthy and relevant evidence confirming the safety and performance of the device for the intended purpose.
- Indirect clinical evidence – provided by the manufacturer by making references to a similar device already present on the market – a predicate. To be allowed to make such references, the manufacturer shall compare both similar and different features of the devices and explain in detail the reasons why such reference is acceptable.
According to the guidance, every time they provide evidence the manufacturer shall explicitly indicate the particular type of evidence provided, specify the device version and provide information about all additional changes.
Clinical trials could be performed in Australia or abroad. As usual, clinical investigation data consists of:
- Documents describing the way the trials were performed,
- Quantitative or qualitative information collected during trials and properly recorded,
- A report by a qualified professional in the appropriate sphere providing the assessment of the data collected through the clinical trials.
The authority also mentions that the report should meet the appropriate requirements to be deemed reliable.
The guidance also describes feasibility (pilot) studies as those performed to collect preliminary information. The studies of this type are usually to collect the information to be used to make modifications to the device. At the same time, such information should be also submitted to the regulating authority together with the premarket approval application.
All the information collected in the course of clinical trials should be composed into Clinical Evaluation Report (CER).
Clinical Evidence Compilation
The document also describes in detail the way clinical trial information should be processed before using it to demonstrate compliance with safety and performance requirements.
In particular, the whole process includes the following steps:
- Compilation of all the data available
- Data evaluation and assessment
- Performing additional clinical trials in case if any additional evidence required
- Providing the evidence to the authority in the form of a clinical evaluation report
During the data compilation step, the manufacturer shall compose the data of all types (including analytical and clinical investigation data, scientific literature review and also the data collected through post-market surveillance).
All data should be properly evaluated in order to exclude any bias impacting the results, and also for the purpose of weighting determination for the relevance and quality of the data. To determine the relevance of data, it is necessary to take into account the connection between the data and particular device subject to evaluation and coverage of the core factors (e.g. safety, hazards, risk, performance). It is also important to check whether the data covers all possible variations of the device (e.g. variations in models or sizes), types of potential users, age groups and genders and the appropriate duration of use. The data provided for the in vitro diagnostic devices (IVD) should be based on different sample types to ensure its accuracy and relevance.
The agency also noticed that the data collected through the pivotal trials has greater weight for the purpose of its assessment.
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