Clinical trials are a key stage in the evaluation of a medical device, conducted to confirm its safety and effectiveness when used in humans. Unlike technical and toxicological studies, clinical trials assess how the device performs in real-world medical practice.
When are they mandatory?
The decision on the need for clinical trials is made individually for each device. As a rule, they are required for:
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Devices of elevated and high potential risk classes (classes 2a, 2b, and 3);
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New medical devices that do not have registered analogues;
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Devices for which data from technical and toxicological studies are insufficient to confirm their effectiveness.
What is assessed during the trials?
Clinical trials involve a comprehensive evaluation of:
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Safety of the device when used as intended;
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Achievement of the claimed medical effect;
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Stability of characteristics during use;
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Possible adverse reactions and risks to the patient and medical personnel.
Important! Clinical trials are conducted only in medical organisations authorised to carry out such studies, according to an approved programme and in compliance with ethical requirements. A detailed report is produced based on the results, which becomes an integral part of the registration dossier.
When can clinical trials be avoided?
In some cases, clinical evaluation without a full-scale study is permitted. This is possible if the device has confirmed analogues and sufficient clinical data available on the market. However, for high-risk devices and new solutions, clinical trials are generally mandatory.
New rules from September 1, 2026
On September 1, 2026, an updated procedure for conducting clinical trials comes into force (Ministry of Health Order No. 421n of May 13, 2026). Key changes:
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The timeframe for conducting clinical trials is up to 30 working days from the date of sample receipt by the medical organisation.
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Requirements for the independence of medical organisations have been tightened: they must be impartial in relation to the applicant.
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Results can be documented in both paper and electronic form.
Elibrium will organise and conduct clinical trials for your medical device
We offer a full range of services for organising clinical trials:
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determining the need and developing a trial programme;
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selecting an accredited medical organisation from the official register;
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preparing and processing all necessary documentation;
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coordinating interaction between the applicant and the medical organisation;
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monitoring the quality of protocols and reports;
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aligning results with Roszdravnadzor requirements.
Why choose us?
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Many years of experience in medical device registration;
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Direct contracts with leading medical centres;
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Individual approach to each project;
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Full turnkey support of the process;
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Fixed pricing and transparent reporting.
Contact us through our website, and our specialists will promptly calculate the cost and timeline of clinical trials for your device. We will ensure full process support and provide a high-quality report necessary for successful registration.
