Medical Device Testing

Medical Device Testing is a mandatory stage in the medical device registration process, providing the comprehensive evidence required to demonstrate the quality, efficacy, and safety of your product. Successfully executed tests form the critical proof for market approval in both the Russian Federation and the Eurasian Economic Union (EAEU).

Key Terminology for Medical Device Testing:

• Safety of a medical device: The absence of unacceptable risk associated with causing harm to human life, health, and the environment;
• Quality of a medical device: A set of properties and characteristics that affect its ability to perform as intended, provided it complies with the requirements of normative documentation, and the manufacturer’s technical and operational documentation. The intended purpose of a medical device is the manufacturer’s decision regarding its target use, based on its specific properties that ensure the achievement of clinical objectives, as reflected in the manufacturer’s technical and operational documentation;
• Efficacy of a medical device: The ability of a medical device to meet the purpose established by the manufacturer. The efficacy of a medical device is confirmed by clinical practice, including clinical trials;
• Technical Testing: Evaluation of a medical device’s quality and safety to verify that its characteristics meet the requirements of normative documentation, the manufacturer’s technical and operational documentation, and to support the decision on proceeding to clinical trials. Technical testing must be conducted in a testing laboratory accredited within the national accreditation system, according to its scope of accreditation. A positive outcome is a mandatory prerequisite for initiating clinical trials;
• Toxicological Studies (Biological Safety Assessment): Investigation conducted to assess the biological safety of a medical device and support the decision on proceeding to clinical trials. These studies must be performed in a testing laboratory accredited within the national accreditation system, according to its scope of accreditation. A positive outcome is a mandatory prerequisite for initiating clinical trials;
• Clinical Trials: A systematic, designed, and planned study, often involving human subjects, undertaken to evaluate the safety and efficacy of the device in real-world use according to its intended purpose.

Timeline for Medical Device Testing*:

Organizing and overseeing a single type of test typically takes about 2.5 months, depending on the speed of sample and document provision by the manufacturer/AR.

* Certain tests (e.g., technical, EMC, toxicological) can be conducted in parallel.

Our Service Fees for Medical Device Testing (Managment):

Factors Influencing the Cost of Medical Device Testing: 

• Number of medical device models requiring evaluation;
• Volume of applicable standards and device characteristics to be checked;
• Number of different materials used in the device’s construction;
• Number of sterilization methods to be validated (if applicable);
• Completeness and quality of documentation provided by the client, which directly impacts preparation time;
• Current workload and scheduling at the accredited laboratory;
• Urgency or expedited service requirements for the testing project.

Mandatory Requirements for Testing Laboratories:

Technical testing must be performed by laboratories accredited within the national accreditation system. For a test report to be valid for submission to Roszdravnadzor, the laboratory must fulfill key conditions:

• Hold a valid accreditation certificate issued under Federal Law No. 412;
• Comply with the GOST ISO/IEC 17025-2019 standard;
• Be listed in the official public register maintained by the Federal Accreditation Service (Rosakkreditatsiya).

You can verify a laboratory’s status via the Rosakkreditatsiya official website.

For EAEU registration, laboratories and clinical sites must be listed in the specific registers maintained by Roszdravnadzor. Official Registers (Roszdravnadzor):

• Labs for Technical Testing (EAEU);
• Labs for Biological Safety Testing (EAEU);
• Medical Organizations for Clinical Trials (EAEU).

Ensure your device generates flawless test data. Partner with us for end-to-end management of all mandatory registration testing.