Medical device testing

Any product related to medical devices is subject to research, which is obvious, because these products will interact with the human body, either directly or indirectly. And the full cycle of research includes tests before launching into production, directly in the production process and on the finished product. And it is not one test, it is a set of tests, they are needed to make sure that the product is safe in all aspects. Of course, these tests are divided into types.

Types of medical device testing

Globally, the types of medical device testing include technical testing, biosafety studies, stability studies, and clinical trials. The results of these tests are not considered in isolation, but as complementary to each other. In general, it is also possible to view them as stages of product testing. For example, without confirmation of successful completion of technical tests, the product is not examined for biosafety. These requirements are prescribed in ISO 10993-1, since the study of biological (toxicological) characteristics is mostly based on animal tests. Also, without full verification of technical and biological data, a medical device is not put on stability. And of course, without all of the above checks, the product will not be tested on humans in clinical trials.

Testing of medical devices is a mandatory requirement and applies to all products without exception, including medical devices, of course, with its own subtleties. Testing of medical equipment, for example, does not always include toxicological indicators, but only in cases where parts of the equipment have contact with human skin or mucous membranes, including indirect contact. The type of tests to which the product is subjected is determined during the design and development of the MI/MT.

Rules for testing medical devices

We understand that in order to test our product, we don't just grab whatever requirements we can find. Every medical product, whether it is a medical device or an appliance, has its own regulatory document that we test it against. Any laboratory, which is entrusted to study the properties of the product, before testing, studies the relevant standard or document, conducts its full analysis and draws up a test program. When studying the normative document for the product in the conditions of registration, it is also analyzed whether all international or other requirements have been included in it. For example, earlier we mentioned the standard ISO 10993-1. Its full name is "Medical devices. Evaluation of the biological effect of medical devices". As we can see, the name speaks for itself. And this standard is not just one, there is a whole series of them and they are adopted at the international level. That is, in terms of biological research, the manufacturer has little choice. How and on what he will test the medical product will be taken from this normative document. The same applies to clinical protocols.

There is an international guideline for stability studies, the ASTM series. Stability is conducted to study the shelf life of a medical device and this type of testing does not apply to medical equipment and software (Software as medical device). Stability has its own rules and regulations, and they also depend on whether the type of stability is real-time or accelerated or both.
As far as technical testing is concerned, there are many nuances. Firstly, not all MIs have approved international requirements. This is especially true for new products with no analogs on the market. Secondly, most often it is not one standard, but a combination of several. For example, for medical equipment, in addition to the requirements for direct functionality, there are mandatory conditions for testing electrical safety, EMC, IP protection, etc. and sometimes it is all together. And thirdly, those standards that are already in place are not always fully applicable to your product or their requirements are not sufficient. For example, when a product is a hybrid product or has a medicinal coating or drug in its composition. For this reason, the product has its own regulatory document, which specifies specific quality requirements and methodologies for both semi-finished and finished products.

Testing of medical devices is carried out in some cases and as part of the registration process under national rules. When we say in some cases, we mean the legislation of the Republic of Kazakhstan. Because according to the EAEU rules, testing of the finished product is a mandatory condition and the first step. After testing, the registration of medical devices will follow directly.

Where medical devices are tested

Since, the importance of these tests is not exaggerated, the following question arises. Where to conduct all these tests? There are accredited laboratories, which have the right to conduct these or those tests within their competence or, scientifically speaking, accreditation area. That is, a certain body authorizes the laboratory to do some type of analysis and gives it a certificate. In the future, the laboratory on a permanent basis confirms this certificate and expands its area. We are interested in such laboratories. Within the EAEU there is a register of such laboratories, and there is also information about what kind of tests they do. Naturally, we are unlikely to find those that do the whole range of tests we need. But it is not prohibited to collect test reports on the basis of different protocols, the main thing is that all the tests should be carried out in the end. There are such laboratories in every country, we need to be able to find them and match them to the needs of our product. Sometimes, it is necessary to clarify or explain your normative document, perhaps some tests will have to be carried out on similar equipment. Lcs-kz is in the process of selecting such testing centers.
Ultimately, at the threshold of registration, we must be confident that the product has been comprehensively tested and must be prepared to respond to additional inquiries from experts during the examination process regarding medical device testing.