Clinical trials of medical devices
Clinical trials of medical devices is a designed and planned systematic study, undertaken, including with the participation of a person as a subject to assess the safety and efficacy of a medical device.
Clinical trials of medical devices are a mandatory type of testing, necessary for their registration and subsequent circulation both on the territory of the Russian Federation, and on the territory of the Eurasian Economic Union.
Purpose of clinical trials: security check, effectiveness and compliance with the declared characteristics of a medical device for the purpose of its registration.
FRC FTM is included in the list of medical organizations, conducting clinical trials of medical devices. Equipment of the clinic and laboratories FITs FTM, as well as the level of qualification of employees allow us to test any type of medical devices. During the FIC FTM tests, the principle of impartiality and independence from any interested parties is ensured.
Clinical trials of medical devices in accordance with the national registration procedure.
The rules for conducting tests are established by the Order of the Ministry of Health of the Russian Federation dated 30 August 2021 G. N 885н “On approval of the Procedure for assessing the conformity of medical devices in the form of technical tests, toxicological studies, clinical trials for the purpose of state registration of medical devices” (further - Order No. 885n).
Based on the results of clinical trials, an Act for evaluating the results of clinical trials is drawn up..
Human participation in clinical trials, according to Order No. 885n, required in the following cases:
1) new type of medical device;
2) application of new complex and (or) unique and (or) special methods of prevention, diagnosis and treatment of diseases and conditions, as well as the use of new complex medical technologies;
3) the effectiveness and safety of the medical device have not been confirmed during the analysis and evaluation of clinical data;
4) medical device contains new, in contact with the human body, previously unexplored biologically active materials or known materials, in contact with those human organs or tissues, for which there is no experience of their medical use, or in case, if such contact is longer, than previously studied.
Conducting clinical trials of a medical device with human participation is carried out on the basis of a positive opinion of the Ethics Council.
In other cases, clinical trials of medical devices are carried out in the form of analysis and evaluation of clinical data..
Clinical trials of medical devices for in vitro diagnostics are carried out in the laboratory using patient biomaterial samples, taken during the diagnostic and treatment process to check the functional characteristics and (or) effectiveness of a medical device when used in accordance with its intended use, provided by the manufacturer's documentation.
Clinical trials of medical devices in accordance with the registration procedure of the Eurasian Economic Union.
The rules for conducting tests are established by the Decision of the Council of the Eurasian Economic Commission dated 12 February 2016 G. N 29 “About the Rules for Conducting Clinical and Clinical Laboratory Tests (research) medical devices” (hereinafter - Decision No. 29).
Permission must be obtained to conduct a clinical trial. The exception is medical products for in vitro diagnostics, about the testing of which a notification is sent to the authorized body.
For medical devices, not related to medical devices for in vitro diagnostics, clinical trials are conducted on those aspects of the safety and efficacy of medical devices, for which insufficient clinical data are available.
Mandatory human clinical trials, in accordance with Decision No. 29, for the following medical devices:
1) implantable medical devices and medical devices of the potential risk class 3, unless specifically proven, that the clinical efficacy and safety of the claimed medical device can be proven in another way;
2) medical devices, functional characteristics, action principle, appointment, indications for medical use or features of medical use of which have not been previously studied;
3) modifications of medical devices, previously approved for medical use, when, if the changes made are associated with the emergence of new functional characteristics, software change, the action principle, purpose or features of medical use, that have not been previously explored;
4) medical devices, containing new, in contact with the human body, previously unexplored biologically active materials or known materials, in contact with those human organs or tissues, for which there is no experience of their medical use, or in case, if such contact is longer, than previously studied.
Clinical trials of medical devices for in vitro diagnostics are carried out in the form of clinical laboratory trials (research). The number of laboratory tests performed should be sufficient to, to ensure the statistical validity of test results (research).