Laboratory tests of medical devices

Laboratory tests are a mandatory part of the state registration of a medical device and serve as the main proof of its safety, quality and compliance with established requirements. It is impossible to obtain a registration certificate without the results of such tests. The regulator evaluates not only the product itself, but also the completeness of the evidence base, so the laboratory stage is considered as a key element of the registration dossier. As of 2026, the requirements for testing are fixed in the Russian legislation and regulations of the EAEU. Regardless of whether registration is carried out according to the national procedure or according to the rules of the Union, the applicant is obliged to confirm the characteristics of the product with the results of technical and, if necessary, biological studies performed in accredited laboratories.
The mandatory tests include technical studies aimed at confirming the functional characteristics and compliance of the product with the declared parameters. Depending on the purpose and method of use of the product, toxicological studies and assessment of the biocompatibility of materials, microbiological tests for sterile products, as well as validation of sterilization, packaging and shelf life processes may be required. The list of studies is determined by the type of product and its risk class. All tests must be carried out according to approved methods and standards, and laboratories must have valid accreditation in the established field. When registering under the rules of the EAEU, the status of the laboratory as an authorized organization of the Union is additionally taken into account.
Most often, it is the laboratory stage that often becomes a source of delays and refunds. Common problems are related to an incorrectly designed test program, the choice of an unsuitable laboratory, non-compliance of methods with the requirements of standards, or errors in the design of protocols. Even if the tests are successful, formal flaws in the documents may lead to requests for revision or the need for repeated studies. Therefore, it is important to determine the full scope of the tests in advance, coordinate the work program and ensure the correct design of all materials that will be included in the registration dossier.
Laboratory research support requires not only technical, but also regulatory expertise. At the preparation stage, it is important to correctly identify a set of tests, select accredited centers, and establish interaction with laboratories so that the results are accepted by the regulator without comment. Elibrium specialists are involved in the project at the planning stage and accompany the laboratory stage until the final protocols are received.