Technical tests are a mandatory stage of the state registration of medical devices in the Russian Federation and the Eurasian Economic Union (EAEU). They are a complex of laboratory tests aimed at objectively verifying the quality, safety and compliance of the product with the established requirements. According to the legislation of the Russian Federation (for example, Article 38 of Federal Law No. 323), technical, toxicological and clinical trials are considered mandatory stages of treatment of a medical device. In other words, no new device can be allowed on the market without confirmation in the testing laboratory that its characteristics and operation comply with regulatory requirements and the manufacturer's stated documentation. The results of such tests are drawn up in the form of a protocol and an act, which are included in the registration dossier and are subject to examination by Roszdravnadzor.
The role of technical tests in registration
In the process of registering a medical device, technical tests perform the critical function of confirming the product's compliance with all necessary standards and regulations. They are carried out at the stage of preparation of the registration dossier, before submitting documents to Roszdravnadzor. According to the rules, for state registration it is required to provide evidence of passing three types of tests, technical, toxicological and clinical. Technical tests, unlike clinical trials, are carried out on product samples in the laboratory and precede the verification stage in medical practice. Their successful completion is certified by a special act, which confirms the possibility of moving to the next stages of registration, including, if necessary, clinical trials. The technical test data is included in the set of documents sent for the examination of quality, efficiency and safety, and the final decision of the regulator largely depends on the content of these data. If the tests reveal that the product does not meet the established requirements, the registration authority refuses to issue a registration certificate.
Organization and conduct of tests
Only testing laboratories with proper accreditation and independence are allowed to carry out technical tests. The manufacturer (applicant) chooses the laboratory independently, but it must be accredited in the national system for the profile of this product and the type of testing. Such laboratories are included in the official list of organizations authorized to conduct tests for registration, which is maintained by Roszdravnadzor in accordance with the requirements of the EAEU. Accredited centers are required to meet strict criteria for technical equipment and staff qualifications, act in accordance with the methods approved by the Ministry of Health of the Russian Federation, and comply with GOST ISO/IEC 17025 standards. The most important principle is impartiality: the testing organization cannot depend on the manufacturer or other interested parties, it must ensure the objectivity of the results obtained. Before starting work, the laboratory, together with the applicant, develops a technical testing program that defines a list of tests, methods and evaluation criteria. This program is approved by the head of the testing organization, after which the tests are carried out strictly according to the approved plan. All stages of testing are performed according to validated methods that meet the requirements of the legislation of the Russian Federation and the EAEU. On average, a full cycle of technical tests takes several weeks, including document analysis, program approval, direct laboratory tests of samples, and preparation of final protocols and certificates.
What is checked during technical tests
The purpose of technical tests is to make sure that the product, when used for its intended purpose, meets the stated characteristics, regulatory documentation and mandatory safety requirements. According to the EAEU rules, tests are conducted to establish compliance with general safety and efficiency requirements, as well as labeling and operational documentation requirements. In practice, this means that the laboratory checks the quality of the design and assembly of the product, its functional parameters and reliability, comparing the actual indicators with the technical and operational documentation of the manufacturer. Depending on the type of medical device, various physico-chemical, mechanical, electrical and other tests are performed. For example, experts evaluate the strength and stability of the structure, tightness (absence of leaks or integrity violations), electrical safety and electromagnetic compatibility, stability of basic performance characteristics in specified ranges, reliability during the declared service life, etc. The materials and components of the product can also be examined for their compliance with standards and biological safety. All the results revealed during the tests are recorded in protocols with accurate measurements and laboratory conclusions. The final act of technical tests summarizes these data and contains a conclusion on the compliance (or non-compliance) of the medical device with the established criteria of quality, safety and effectiveness.
The value of the results
The results of the technical tests are crucial for the fate of the registration application. The positive conclusion of the testing laboratory confirms that the device meets the requirements of the legislation of the Russian Federation and the rules of the EAEU, fully complies with its technical documentation, and also meets the criteria of quality, safety and effectiveness required for this type of product. Such a protocol becomes part of the registration dossier and is reviewed by Roszdravnadzor experts when evaluating the product. Based on the totality of the data (including the test results), a decision is made on registration. If technical tests reveal problems, registration is usually postponed or terminated.
