A clinical trial is a scheduled systematic study involving the presence of human beings as a subject of a study and is conducted for assessment of safety and/or clinical efficacy of a specific medical device (GOST R ISO 14155-1-2008).
The procedure of clinical trials of medical devices is regulated by the Order of the Ministry of Health of the Russian Federation dated January 9, 2014 № 2n “On Approval of the Procedure of Assessment of Compliance of Medical Devices in the form of Technical Tests, Toxicological Studies, Clinical Trials for the Purposes of the State Registration”.
Two forms of conduction of clinical trials are approved by the Order of the Ministry of Health of the Russian Federation № 2n:
- trials involving the presence of human beings are carried out in the following cases:
new types of a medical device;
application of new complicated and (or) unique and (or) specialized methods of prevention, diagnosis and treatment of illnesses and states as well as application of new complicated medical technologies;
previously obtained results have not proved the efficacy and safety of a medical device.
- trials conducted in the form of analysis and assessment of clinical data.
Clinical trials of medical devices for in vitro diagnosis are held in the form of clinical laboratory trials.
Clinical trials are carried out on the base of:
- permission for conduction of a clinical trial (issued by Roszdravnadzor);
- conclusion on ethical feasibility of clinical trials (issued by the Ethics Committee of the Ministry of Health of the Russian Federation);
- Import licence for a medical device into the territory of the Russian Federation for the purposes of state registration thereof (required for medical devices of foreign manufacture, issued by Roszdravnadzor).
Results of clinical trials are processed in accordance with Annex № 4 of the Order № 2n of the Ministry of Health of the Russian Federation, for in vitro – as per Annex №5 to the Order № 2n of the Ministry of Health of the Russian Federation
Clinical trials are held in medical institutions, which meet the requirements established by the Order of the Ministry of Health of the Russian Federation dated May 16, 2013 № 300n “On approval of requirements for medical institutions, carrying out clinical trials of medical devices and medical institutions compliance”.