Clinical trials of medical devices

Clinical trials of medical devices are one of the key stages of state registration and confirm that the product is safe and effective when used as intended. Russian legislation assumes that technical and laboratory data are insufficient to bring a product to market: it is necessary to prove its clinical effectiveness and the absence of unacceptable risks for the patient. Therefore, a clinical assessment is a mandatory part of the registration dossier. 
In Russia, clinical trials are regulated by Federal Law No. 323-FZ and by-laws in the field of medical device circulation. The authorized body is Roszdravnadzor. He decides on the need for clinical trials, approves the research program and monitors compliance with the requirements for their conduct.           Depending on the risk class of the product, its novelty and the availability of analogues, a clinical assessment may include either an analysis of available clinical data and literature, or full-fledged trials involving patients.
The main objective of clinical trials is to confirm that the product works as stated in the technical documentation and does not pose risks to the patient and medical staff. 
The research evaluates:
- application safety;
- stability of characteristics;
 - achieving the stated medical effect;
 - possible adverse reactions. 
Tests are conducted in medical organizations that have the right to conduct them, according to an approved program and in compliance with ethical requirements.
It is worth noting that not every medical device requires full-scale clinical trials. For low-risk products with proven analogues, a clinical assessment based on scientific publications and data on the handling of similar products may be sufficient. However, for high-risk and high-risk products, as well as for fundamentally new solutions, clinical trials are most often mandatory. The decision is made at the stage of examination of the registration dossier.                                                                  Proper planning of the clinical part of the project is critically important. Errors at this stage lead to registration delays, returns of materials, and the need for repeated research. In practice, risks arise if the test program is not coordinated with the regulator, the study design is incorrectly selected, there is no connection between the technical characteristics of the product and clinical performance indicators, or data traceability is impaired.
Clinical trials are completed with the preparation of a report, which is included in the registration dossier. Experts evaluate the results obtained in conjunction with technical, toxicological and other laboratory data. And only after confirming the safety and effectiveness, the product can receive a registration certificate and be allowed to be used on the territory of the Russian Federation.