
Clinical trials for IVD
In accordance with Order N 885n, clinical trials of medical devices for in vitro diagnostics are conducted in laboratory conditions using patient biomaterial samples taken in the process of treatment and diagnostics to test the functional characteristics and (or) effectiveness of a medical device when used in accordance with its intended use as stipulated in the manufacturer's documentation. In the process of clinical trials of medical devices for in vitro diagnostics in the Russian Federation, biological materials such as human blood, liquid blood fractions, tissues or cells are used (biomaterial must be obtained from a reference population, including residual samples, archival samples or purposefully selected samples). In order to assess the safety, effectiveness and quality of in vitro medical devices before their market introduction, trials should be conducted by method comparison using a reference methodology. For medical devices for in vitro diagnostics it is not allowed to conduct clinical trials in the form of clinical evaluation, however, the form of the act of evaluation of the results of clinical trials of a medical device for in vitro diagnostics in accordance with the Order N 885n requires comparison of functional characteristics of registered MD with the characteristics of medical devices used in the reference methodology. In this regard, the problem of the lack of operational documentation for MDs used in the reference methodology on the website of Roszdravnadzor remains relevant. Furthermore, in order to conduct in vitro clinical trials in the Russian Federation, it is not required to obtain a permit for clinical trials of medical devices from Roszdravnadzor. Thus, in vitro clinical trials of medical devices are obliged to include comparison of methods using the reference methodology for all types of biological material, methods of analysis, modes, etc. declared in the intended use of MD, evaluation of functional characteristics of MD in accordance with the declared methods and comparison of functional characteristics of registered MDs with the characteristics of medical devices used in the reference methodology, in this regard we offer the following range of services: 1. Search for a clinical organization according to the profile of clinical trials. 2. Search and selection of devices for the reference methodology. 3. Design of clinical trials according to the declared intended use and functional characteristics. 4. Supporting the clinical trials. 5. Drafting/verification of the clinical trial report, programme and protocol. 6. Drafting a request to Roszdravnadzor to add unpublished instructions for use for potential interchangeable products to the state register of medical devices and organizations (individual entrepreneurs) engaged in the manufacture of medical devices.