The article provides an overview of the recent changes to the Australian guidelines on clinical evidence. In particular, the document highlights the key points related to the inclusion of recommendations related to software products and personalized devices.
The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published an updated version of the guidelines dedicated to clinical evidence for medical devices. The document is intended to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be followed by medical device manufacturers and other parties involved to ensure compliance thereto when applying for marketing approval for the devices they are responsible for. The version of the guidance described herein (3.1) has been published in June 2022. At this time, the document has been updated to provide device-specific recommendations for two new types of products – Software as Medical Device (SaMD) and personalized medical device (PMD). The guidelines outline the scope of information the authority would expect to receive about the said products in the context of applications for marketing approval. The authority also mentions that these products should anyway comply with any requirements set forth by the applicable Essential Principles (EPs).
As it is further explained by the HSA, PMDs will generally follow the same regulatory requirements and submission expectations as non-PMDs of the same classification; however, some additional considerations apply to PMDs.
According to the applicable regulations, personalized medical devices include:
- Patient-matched medical devices;
- Adaptable medical devices; and
- Custom-made medical devices.
The authority also mentions medical device production systems (MDPS) – a relatively new regulatory concept that has been recently introduced to the national legislation and describes the in-house production of medical devices by healthcare facilities for their own internal needs.
The authority acknowledges that “personalized medical devices” as a category covers quite a wide range of products that differ in terms of risk associated thereto. These products also employ a wide range of technologies, which should be also taken into consideration when determining the clinical evidence needed. The HSA additionally emphasizes a specific nature of PMDs – since the products are initially manufactured and/or later adapted to meet the requirements of a specific patient, there are no two PMDs that are identical. Thus, as it is mentioned by the authority, the uniqueness in design, manufacture, and/or point-of-care modification of PMDs poses additional challenges in designing and conducting clinical investigations, and for manufacturers conducting a clinical evaluation to demonstrate performance and safety and hence compliance with the EPs throughout the device lifecycle. To assist medical device manufacturers in determining the proper way clinical evidence should be collected and submitted for review, the authority provides additional recommendations to be followed.
PMDs: Key Points
As was mentioned before, for personalized medical devices the general principles for clinical evidence should still apply in both pre-and post-market stages. Under the general rule, the more significant is risk associated with the device, the more attention the manufacturer should pay to clinical investigation studies to be conducted to collect clinical data necessary to substantiate the claims and demonstrate compliance with the applicable safety and performance requirements set forth by the applicable national legislation.
The document further highlights the key aspects to be considered concerning each type of personalized medical device, namely:
- For patient-matched medical devices, manufacturers should consider generalisability – the extent to which available clinical data can be extrapolated to all potential device specifications within the device envelope; this should include discussions about worst-case and common-use scenarios.
- In the case of adaptable medical devices, the nature and extent of personalization need to be considered and the clinical evidence must substantiate the safety and performance of the device as modified, by the manufacturer’s instructions, after the device has been supplied.
- In the case of custom-made medical devices, consideration should be given to whether unique design parameters are expected to affect the device performance and safety; custom-made medical devices must still comply with all relevant provisions of the EPs and records must be maintained about performance and safety.
It is important to mention that there is a special rule on a “low-volume” exemption from the mandatory inclusion in the Australian Register of Therapeutic Goods (ARTG) which applies in case there are five or fewer patient-matched products manufactured within a year. However, these products should still meet any applicable regulatory requirements they are subject to.
Clinical Evidence Considerations for PMDs
When it takes to personalized medical devices, special attention should be paid to the Total Product Life Cycle (TPLC) approach ensuring that the device remains safe and operates as initially intended within the whole period of its lifetime. All the claims and statements manufacturers make concerning the safety and performance of the products they are going to place on the market should be duly substantiated with the respective clinical data. As it is further stated by the HSA, the general rules related to clinical evidence, sources of clinical data, and clinical evaluation are fully applicable concerning personalized medical devices; while the depth and extent of the clinical evidence should be appropriate to the risk-based classification, novelty, and parameters involved with personalization of the device.
In summary, the present HSA guidance provides an overview of the regulatory requirements for clinical data that are applicable in the case of personalized medical devices. The authority explained the way the general rules should be applied and also highlighted the aspects to be considered due to the specific nature of personalized medical devices, their design, manufacturing, and use.
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