Knowledge

Clinical Evaluation of Medical Devices



In accordance with the provisions of the regulations on Supervision and Administration of Medical Devices, applications for the registration of medical devices of the second and third categories shall submit clinical evaluation materials, Although the amendment to the regulations on Supervision and Administration of Medical Devices (draft) (hereinafter referred to as "the Amendment") mentions that the second type of medical device may in principle no longer carry out clinical evaluation, however, since the amendment is still in the stage of being submitted for trial, Therefore, the clinical evaluation of medical devices is still one of the necessary data in the process of medical device registration.

Definition and working objective of Clinical Evaluation of Medical Devices

Among the many medical device registration data, the clinical evaluation data has higher uncertainty and investment risk than other registration data. Therefore, most registration applicants pay particular attention to the implementation of clinical evaluation. In this paper, the author will discuss the clinical evaluation of medical devices for peer reference. Before carrying out the clinical evaluation of medical devices, the first question that needs to be clear is what is the clinical evaluation of medical devices and the working objectives of clinical evaluation of medical devices. According to the definition of "Technical guidelines for Clinical Evaluation of Medical Devices" (hereinafter referred to as "guiding principles"), clinical evaluation of medical devices refers to the applicant for registration through clinical literature, clinical experience data, The process by which information such as clinical trials confirms whether the product meets the requirements or scope of application. Therefore, the objective of clinical evaluation of medical devices is to confirm and verify the intended use or scope of application of the declared product, and to answer the question whether the product can be used for a certain purpose or for a certain population. Instead of answering the question "what kind of disease the product might apply to or to what population." This requires applicants for registration to have a clear understanding of the intended use and scope of application of the declared product before conducting a clinical evaluation. If the intended use or scope of application of the declared product is not clear, It is suggested to carry out exploratory research on the declared products to clarify the intended use of the products. Exploratory research can be used as a part of clinical evaluation of medical devices, but it is not the main content of clinical evaluation of medical devices.

Approach to Clinical Evaluation of Medical Devices

In accordance with the definition and relevant requirements of clinical evaluation of medical devices in the guiding principles, the medical devices registered and declared within the territory of China, There are three main ways of clinical evaluation: the inclusion of the list of Medical Devices exempted from Clinical trial (hereinafter referred to as the exemption catalogue) for clinical evaluation (that is, the exemption pathway). The data obtained from clinical trials or clinical use of medical devices of the same variety were analyzed and evaluated (i.e. the same variety approach) and the clinical trials of medical devices. Although the choice of clinical evaluation approach is one of the most important issues for registration applicants, regardless of which way they choose, the goal of clinical evaluation is the same. This is to confirm and verify the expected use or scope of application of the declared products, and to discuss the ways of exemption and the same variety of ways to evaluate the clinical application of medical devices.

Clinical evaluation in exemption catalogue

 The first step is to characterize the declared product before clinical evaluation. The so-called characteristic representation is to clarify the basic principle, action mechanism, structure composition, manufacturing material, application scope, usage method and so on of the declared product, in order to confirm the essential attribute of the product. It also provides the basis for clinical evaluation and comparison of product selection. After clarifying the nature of the product, the next step is to confirm that the product complies with the exemption catalogue. For products that conform to the description of the exemption catalogue, in accordance with the requirements of the guiding principles, they need to be compared with the description in the exemption catalogue and the medical devices (hereinafter referred to as the same products) that have been approved for registration in the territory of the exemption catalogue, To confirm whether the declared product is exempt from clinical trials. It should be noted that since the description of some products in the exemption catalogue is relatively simple and broad, the description in the exemption catalogue does not limit the full characteristics of the declared product, so the risk control considerations. The compliance of the declared product with the exemption list is only one of the basic conditions under which it can be exempted from clinical trials. Whether the final declared product needs further comparison or even clinical trial depends on the difference between the product and the similar product. If the declared product meets the requirements of exemption catalogue, but there is a great difference with other similar products, it will often have a higher risk of clinical evaluation. On the other hand, if the declared product consists of a collection of different products from the exemption list (or has a variety of applications in the exemption catalogue), it is often possible to conduct a clinical evaluation through the exemption approach. Because in most cases, this set of products or functions does not increase the security risk during clinical application, but in the process of discussion, Attention should be paid to whether the collection will have an impact on the overall safety and effectiveness of the product. Similarly, if the product adds functional modules that do not affect clinical use (such as Bluetooth, SD card storage, printing, etc.) relative to the description of the exemption Catalog, it is often possible to try an exemption approach because in practical applications, Adding functional modules that do not affect clinical use generally does not increase security risks during clinical use. Therefore, in order to determine whether the product can exempt from clinical trials, it is necessary to consider the characteristics of the product in addition to the basic legal requirements. In practice, it is very flexible to judge whether declared products can be exempted from clinical trials.

Conclusion

The clinical evaluation of medical devices is a systematic work. Because its clinical application is often finalized in the design and development stage, the clinical evaluation of medical devices should be considered from the perspective of the design and development of medical devices. According to the inherent characteristics of the product, it is the key to write the clinical evaluation report of the medical device to formulate the corresponding evaluation strategy and demonstration direction.