The new article describes in detail the regulatory requirements to be applied for clinical evidence for adaptable medical devices.
The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to clinical evidence for medical devices. In particular, the document provides device-specific recommendations regarding the scope of clinical evidence the authority expects to receive for various types of medical devices intended for marketing and use in Australia. The scope of the updated guidelines covers, inter alia, the aspects related to patient-matched and adaptable medical devices. At the same time, it is important to mention that provisions of the guidance are non-binding in their legal nature and are not intended to introduce new rules or impose new obligations, but rather to provide additional clarifications regarding the existing regulatory framework. Recommendations provided in the guidance could be also subject to changes, should such changes be necessary to reflect the respective amendments to the underlying legislation.
Considerations for Adaptable Medical Devices
According to the guidance, adaptable medical devices are the ones that are mass-produced and intended to be assembled or adapted after supply, according to the manufacturer’s instructions, to address anatomical and/or physiological features of a particular individual, or a pathological condition (for example, devices such as craniofacial implants, dental implants, and orthotics that are mass-produced, but adapted by a health professional at the point-of-care). Under the general rules, such products should be accompanied by detailed enough instructions for use ensuring their safety and effectiveness during use. Furthermore, the authority additionally emphasizes the importance of a clear indication of all the risks associated with the device that arise when the product is being used for its intended purpose. The information provided therein should be in line with the appropriate risk management report. It is also stated that in some cases it would be necessary to carry out an additional usability study to validate the accuracy and relevance of the instructions communicated to potential users, especially the ones related to the way the device should be assembled or adapted to meet the needs of a specific patient.
As explained by the TGA, the main regulatory concerns associated with adaptable medical devices are quite similar to the ones related to patient-matched products – the devices of both these types are not subject to assessment in a way they will be used for a specific patient. This aspect should be taken into consideration when determining the scope of data necessary to substantiate the claims made by the manufacturer about the safety and effectiveness of the product intended to be marketed and used in Australia. The above risks and challenges are specific to patient-matched and adaptable medical devices, while the regulatory approach to be applied to general medical devices is quite more straightforward. Hence, the principles regarding worst-case and common-use scenarios will generally apply to adaptable medical devices and should be considered and discussed; while clinical trials should be designed to consider these variables and allow for subgroup analysis. The authority additionally emphasizes the importance of conducting a comprehensive risk analysis addressing all the aspects related to the device concerning its parameters and characteristics. In particular, such an assessment should cover, inter alia, the risks relating to parameters for device adaptation, potential device failure modes, and device usability. All the aforementioned factors should be taken into consideration when determining the scope of clinical evidence required to substantiate the application for marking approval.
According to the guidance, medical device manufacturers are allowed to submit data related to comparable medical devices, however, in case it is provided concerning the product’s usability, the data should derive from the assessment of a medical device assigned to a higher risk class under the existing risk-based classification, or from the product which is more novel. The study itself should be designed in a way ensuring that all the important points are duly addressed, while the results are accurate and reliable.
The authority also mentions that in the PMS plan, the manufacturer should include adequate details on PMCF activities to collect, categorize, and analyze the data on the performance and safety of such devices throughout the device lifecycle and update the clinical evidence periodically; while data from PMCF activities should be collected in a way that allows for subgroup analyses of parameters relating to device adaptation, for objective assessment of claims made by the manufacturer on the safety and clinical performance of the devices.
To assist medical device manufacturers in interpreting the applicable regulatory requirements and following the recommendations provided in the guidance, the document also contains an example illustrating the most common situations. The example describes a situation when the product is a mass-produced stainless steel molar crown which is available in a range of sizes. Hence, it should be slightly aligned in terms of dimensions to be used for a specific patient. The instructions for use accompanying such devices should describe in detail the aspects related to sizing, and also to trimming and crimping necessary to ensure the device fits the needs of a specific patient. The said product should be subject to rigorous usability testing to be conducted to assess its safety and performance when used for the intended purpose. The scope of such an assessment should also cover any adverse event taking place during the study. As a result, a comprehensive risk management report should be created, describing the way the residual risks could be mitigated. Based on this, the manufacturer should develop the measures to be implemented to ensure the safety and proper performance of the device throughout the whole period of its being used.
In summary, the present TGA guidance provides a brief overview of the existing regulatory requirements for adaptable medical devices and also outlines the criteria the clinical evidence associated with such products should meet to be admissible in the context of applications for marketing approval. The document also highlights the key points to be considered by medical device manufacturers when planning a clinical study.
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