Official Q & A| What Aspects Concerned in the Evaluation of In Vtro Diagnostic Instruments?
I.Product performance
One of the requirements of in vitro diagnostic instruments different from other medical devices is that clinical project analysis performance research should be carried out. Considering the situation of the detected substances and the main functions of the product (for example, quantitative / qualitative analysis, different detection methods / modes, etc.), representative items are selected for research according to different types of analytes and different functions of the instrument. it should be repeated many times and include the process of confirmation and verification. Research items generally include accuracy, repeatability, linearity, stability, carrying pollution and so on.
Safety indicators mainly include electrical safety indicators and electromagnetic compatibility indicators. The applicant can study the above items by himself or verify them through entrusted inspection. If the difference in product design structure does not have a significant impact on safety and effectiveness, typical models of products in the same registration unit can be selected for electrical safety performance testing, but the electromagnetic compatibility performance between different models of products is often not covered.
In addition, the performance of each component module should be evaluated.
II.Product validity
The use conditions and duration of the product should be determined and specified in the instructions. There are many ways to determine the validity period of such products. The product of the single-cycle life of key components and the maximum number of replacements can be used as the validity period of the instrument, and the validity period can also be determined by fatigue test or accelerated test.
III. Clean and disinfect
Due to the use of human samples, corresponding measures should be taken in the product design and instructions to reduce the risk of pathogen transmission. The cleaning / disinfection method should achieve the expected effect (e.g. resistance to pathogenic microorganisms) and will not affect the main performance of the device.
IV.Clinical study
In vitro diagnostic instruments generally need to carry out clinical trial research with supporting kits. Attention should be paid to whether the claims of supporting kits are consistent with the instructions. Clinical research is basically the same as other medical devices, and the requirements of relevant guiding principles can be referred to.
V.Requiement of product technology
It shall be compiled in accordance with The Cuidelines for the Compilation of Technical Requirements for Medical Device Products, including product names, product models / specifications and their division instructions, performance indicators, inspection methods and appendices to basic safety features, etc. Sometimes it also includes specific analytical performance, such as accuracy, precision, sensitivity, coincidence rate and so on. The appendix should be clear in the following four aspects, namely, environmental conditions, types of equipment, power supply and insulation.
VI.Software and network
For details, please refer to the relevant requirements of the guiding principles for software registration and review of medical devices and the guiding principles for network security registration and review of medical devices.
VII.Other
In the research data part, it should be noted that if the product has been issued with corresponding industrial standards, it should meet the requirements of industrial standards. The above items may not be applicable to all products, and the applicant shall conduct corresponding research according to the specific conditions of the products.
The setting of various indicators of the product shall have sufficient basis, and relevant research and verification data shall be submitted in the application process. If there are technical innovation points, it should be clarified in the data and corresponding supporting documents and data should be provided.
There are many types of in vitro diagnostic instruments, with large spans and different expected uses. In the process of product review, the characteristics of the product should be considered and the relevant domestic and foreign standards, documents and guidelines should be referred to, and key technical issues should be considered and reviewed. It is possible to conduct a more comprehensive and scientific evaluation of the product to ensure better safety and efficacy.
[Source:CMDE]
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