Medical device testing support in Russia and EAEU

At NVR Consult Group, we recognize that methodical compliance testing is the foundation for obtaining regulatory approvals. That’s why we offer comprehensive support in performance testing and safety evaluation.

Working with Industry’s Best Specialists

We exclusively collaborate with accredited testing laboratories that meet the highest standards of quality, reliability, and efficiency. Our partners have extensive experience across all test types and device categories, along with proven expertise in conducting efficient and ethical research.

Protocol Verification and Documentation Amendments for Final Results

Our experts work closely with laboratories to verify testing protocols that rigorously assess your device and adhere to international standards. We ensure all plans align with established requirements, leaving no room for regulatory bodies to contest the results. Throughout the testing process, we continuously liaise with laboratories to guarantee the acquisition of reliable data that meets requirements.

Seamless Process Control

Following the development of plans, our team oversees the testing process from start to finish. We ensure proper execution, address any discrepancies, and confirm the authenticity of the documentation required for submission. With the constant support of our specialists, knowledgeable in regulatory acts, laboratories achieve the final results necessary for preliminary approvals.

Partner with Seasoned Experts

Our team is seasoned with extensive experience in the testing and approval processes of medical devices across the globe. We possess a deep understanding of both regional and international regulatory standards. Through our profound expertise, NVR Consult Group delivers bespoke advice at each testing phase. We ensure meticulous oversight over the execution and technical documentation process, enabling the development of medical devices that are controlled, verifiable, and fully meet regulatory requirements with ease.

Specializing exclusively in the registration services of medical equipment in Russia and the EAEU, our expertise offers invaluable insights and analytics that enhance operational efficiency. Choosing to work with us means adding a team of skilled experts to your roster. Our commitment to a personalized approach ensures the quickest and most reliable route to obtaining approvals. Reach out to NVR Consult Group today to embark on your journey.

Navigating Clinical Trials

Clinical trials are a critical requirement for the successful registration of medical devices, ensuring their suitability for medical use. These trials, conducted after preliminary technical and toxicological evaluations, are pivotal for regulatory bodies to decide on a device’s registration. 

Unsatisfactory outcomes in clinical trials often necessitate restarting the registration process from scratch, incurring significant time and financial costs.

Approaches to Clinical Trials

Clinical trials can vary in form, tailored to the type of medical device and the clinical data available:

• Research-Based Evaluation: This is the most straightforward and rapid approach, currently the norm for most clinical trials within the Russian Federation. It involves collating clinical data for the device in question, either from international markets (for foreign devices) or from an equivalent device previously registered in Russia (for domestic productions). An assessment is then made based on this data to evaluate the device’s quality, safety, and efficacy, culminating in a verdict on its medical applicability.

• Human Participation Trials: These are the most comprehensive and time-intensive trials, necessitating substantial investment and time. Approval from Roszdravnadzor, the Russian health authority, is mandatory for this trial form. Human participation trials are required when:

• The device introduces a new type of technology or falls under a new classification;
• It incorporates novel, complex methods or technologies for the prevention, diagnosis, or treatment of diseases;
• It is made from new materials or utilizes known materials in novel ways that have not been previously studied for their biological impact on human health.

• Clinical-Laboratory Trials: Specifically for in vitro diagnostic devices, this method involves conducting trials exclusively in laboratory settings, as mandated by current legislation.

The outcomes of clinical trials are meticulously documented, including a detailed assessment report, program, and protocol of the medical device trials. Only medical institutions that comply with the stringent requirements of Russian legislation and standards for conducting clinical trials are eligible to undertake these evaluations.

 Leverage NVR Consult Group’s extensive expertise in conducting clinical trials across various methodologies. Our team is ready to guide you in selecting the appropriate medical institution for your clinical trials, offering optimal cost solutions and ensuring a successful outcome.