20 June 2026

Conformity Assessment of Medical Devices in Russia: Technical Testing, Toxicological Research, and Clinical Trials

June 20, 2026

BRACE Law Firm ©

The Russian Federation permits the circulation of medical devices that have passed state registration. Since a medical device directly impacts human life and health, conformity assessment is a mandatory procedure preceding registration to confirm quality, efficacy, and safety. The conformity assessment takes the form of technical testing, toxicological research, and clinical trials.

This article provides a detailed analysis of:

The procedure for conducting each assessment;
Requirements for organizations conducting research and testing, along with the authority and liability of the entities involved;
Specifics of contractual structures;
The procedure for documenting the results;
The allocation of liability among the participants of research and testing.

Legal and Regulatory Framework for Conformity Assessment of Medical Devices

Until December 31, 2027, applicants may file an application for the registration of a medical device under the national rules in accordance with the Resolution of the Government of the Russian Federation No. 1684 dated November 30, 2024, On the Approval of the Rules for State Registration of Medical Devices, or under the EAEU rules in accordance with the Decision of the EEC Council No. 46 dated February 12, 2016, On the Rules for Registration and Assessment of Safety, Quality, and Efficacy of Medical Devices. The regulatory framework and the conformity assessment procedures will vary depending on the chosen registration route.

Under Russian legislation, the following regulatory acts govern the conformity assessment procedure for a medical device:

Federal Law No. 323-FZ dated November 21, 2011, On the Fundamentals of Health Protection of Citizens in the Russian Federation (the "Law No. 323-FZ");
The Rules for State Registration of Medical Devices, approved by the Resolution of the Government of the Russian Federation No. 1684 dated November 30, 2024 (the "Resolution No. 1684");
The Procedure for Conducting Conformity Assessment of Medical Devices in the Form of Technical Testing, Toxicological Research, and Clinical Trials for the Purposes of State Registration of Medical Devices, approved by the Order of the Ministry of Health of Russia No. 885n dated August 30, 2021 (the "Order No. 885n"). Order No. 885n remains effective until September 1, 2026.
Documents of the national standardization system: GOST ISO 10993-1, Interstate Standard. Medical Devices. Biological Evaluation of Medical Devices, GOST R ISO 14155-2022, Medical Devices. Good Clinical Practice, and others. GOSTs are documents of voluntary application, but in practice, compliance with them is necessary for conducting testing and research and for subsequent registration.

When registering a medical device under EAEU law, such acts include:

The Rules for Registration and Assessment of Safety, Quality, and Efficacy of Medical Devices, approved by the Decision of the Council of the Eurasian Economic Commission No. 46 dated February 12, 2016 (the "EEC Decision No. 46");
The Rules for Conducting Technical Testing of Medical Devices, approved by the Decision of the Council of the Eurasian Economic Commission No. 28 dated February 12, 2016 (the "EEC Decision No. 28");
The Rules for Conducting Research (Testing) for the Registration of Medical Devices, approved by the Decision of the Council of the Eurasian Economic Commission No. 38 dated May 16, 2016 (the "EEC Decision No. 38");
The Rules for Conducting Clinical and Clinical-Laboratory Testing (Research) of Medical Devices, approved by the Decision of the Council of the Eurasian Economic Commission No. 29 dated February 12, 2016 (the "EEC Decision No. 29").

Looking ahead, we note that the differences in the requirements for the content of the testing are minimal, but the document forms, the list of mandatory parameters, and the procedure for interaction with the competent authorities differ. Below, we analyze the assessment procedures under Russian legislation and highlight the main differences from the corresponding procedure under EAEU law.

Forms and Procedure for Conformity Assessment of Medical Devices

The conformity assessment comprises three independent but interconnected procedures:

Technical testing: establishing the device's conformity with the requirements of the manufacturer's regulatory, technical, and operational documentation, as well as with national and international standards;
Toxicological research: evaluating the biological effect of the device's materials on the human body;
Clinical trials: confirming the clinical efficacy and safety of the device when used as intended.

In addition to these procedures, other measures may be conducted to confirm quality and safety for medical devices: electromagnetic compatibility testing, testing for the approval of measuring instrument types, analysis of evidence materials, and manufacturing inspection.

The sequence of the assessment procedures follows from the provisions of Order No. 885n:

Technical testing.
Toxicological research.
Clinical trials.

We note that EAEU law provides for the same set of conformity assessment procedures for a medical device. However, toxicological research is referred to in EAEU law as testing (research) to evaluate the biological effect of a medical device.

Generally, the conformity assessment takes place before submitting the documents for registration. An exception applies to clinical trials (except for research in the form of analyzing and evaluating clinical data). They are conducted only after submitting the documents for the registration of the medical device, based on an authorization from Roszdravnadzor. During the period of clinical trials, the state registration procedure is suspended. The timeframe for their completion is not included in the overall timeframe for the registration of the medical device.

Conducting testing and research is performed on a fee-paying basis. The manufacturer of the medical device or its authorized representative makes the payment. The methodology for determining the fee amount and its maximum limits within the Russian Federation are approved by the Order of the Ministry of Health and Social Development of Russia No. 1386n dated November 22, 2011.[1] The cost of testing and research is agreed upon in the contract within the established limits.

When registering medical devices under EAEU law, the cost of such testing and research is determined by the competent authority of the state where they are conducted.

Below we review the specifics of each of the mentioned procedures.

Technical Testing of Medical Devices

Technical testing of medical devices involves testing to determine the quality and safety of a medical device, the conformity of its characteristics (properties) with the requirements of the regulatory documentation, the technical and operational documentation of the manufacturer, and to make a subsequent decision on the feasibility of conducting clinical trials (paragraph 23 of Item 4 of Resolution No. 1684).

During technical testing, the following shall be determined:

Conformity of the device with the requirements of the regulatory documentation, as well as the manufacturer's technical and operational documentation;
Completeness and objectivity of the characteristics subject to control as established in the technical documentation;
Quality and safety of the medical device.

Additionally, during the technical testing, the potential risk class of the medical device is established upon agreement with the applicant. We recall that the potential risk class of a medical device is determined in accordance with the Order of the Ministry of Health of Russia No. 4n dated June 6, 2012, according to which each medical device may only be assigned to one class:

Class 1: medical devices with a low degree of risk;
Class 2a: medical devices with a medium degree of risk;
Class 2b: medical devices with an elevated degree of risk;
Class 3: medical devices with a high degree of risk.

The procedure for conducting technical testing is governed by Chapter II of Order No. 885n. For in vitro diagnostic medical devices, the specific aspects of conducting such testing are established in Chapter III of Order No. 885n.

Stages of conducting technical testing:

Submission of the application and the set of documents to the testing laboratory. The list of necessary documents is specified in Item 5 of Order No. 885n.
Execution of an agreement with the selected testing laboratory.
Development of the testing program.
Transfer of testing samples and special equipment (if necessary).
Conducting the testing.
Execution of testing protocols and the assessment report based on the testing results.

The timeframe for conducting technical testing is no more than 30 business days from the date the applicant provides the samples of the medical device. The head of the testing organization may extend it by 20 business days upon agreement with the applicant.

The results of the technical testing are formalized by a technical testing results assessment report (the recommended form is in Appendix No. 1 to Order No. 885n).

According to the EEC Council Decision No. 28, technical testing within the framework of the Union is conducted under a harmonized program based on the principles set forth in international standards. This allows the testing results to be recognized in all EAEU member states.

Toxicological Research of a Medical Device

Toxicological research of a medical device constitutes research aimed at evaluating the biological safety of the medical device and making a subsequent decision on the feasibility of conducting clinical trials (paragraph 24 of Item 4 of Resolution No. 1684).

It is conducted for medical devices whose use involves contact with the human body (body surface, mucous membranes, internal body environments).

In accordance with GOST ISO 10993-1, Interstate Standard. Medical Devices. Biological Evaluation of Medical Devices, medical devices must be classified into categories depending on the nature and duration of contact with the human body.

According to Section 5.2 of GOST ISO 10993-1, medical devices are divided by the type of contact with the human body into:

Non-contacting devices (e.g., blood collection tubes);
Surface-contacting devices (skin and mucous membranes) (e.g., electrodes);
Externally communicating devices: contacting the blood path, tissue/bone/dentin (e.g., laparoscopes, infusion lines, etc.);
Implantable devices (e.g., pacemakers).

According to Section 5.3 of GOST ISO 10993-1, depending on the duration of contact, devices are distinguished as:

Limited exposure devices (up to 24 hours);
Prolonged exposure devices (from 24 hours to 30 days);
Long-term exposure devices (over 30 days).

Toxicological research of a medical device includes:

Determination of sanitary-chemical parameters;
Evaluation of biological parameters under in vitro and in vivo conditions;
Microbiological testing (research).

The toxicological research program is developed considering the type and duration of contact and may include: research to determine the migration of chemical substances from the device's materials, cytotoxicity, irritation, sensitization, genotoxicity, reproductive toxicity, pyrogenicity, carcinogenicity, hemocompatibility, and other parameters of biological effect.

The procedure for conducting toxicological research is governed by Chapter IV of Order No. 885n.

Stages of conducting toxicological research:

Submission of the application and the set of documents to the testing laboratory. The list of necessary documents is specified in Item 27 of Order No. 885n.
Execution of an agreement with the selected testing laboratory.
Development of the research program.
Provision of device samples or extracts from materials.
Conducting research according to approved methodologies.
Execution of research protocols and the conclusion based on the research results.

The timeframe for conducting toxicological research is 30 business days from the date of providing the medical device samples and the document package. It may also be extended by 20 business days.

Based on the results of the toxicological research, a conclusion is formalized (the recommended form is in Appendix No. 3 to Order No. 885n).

Under the EEC Council Decision No. 38, research to evaluate the biological effect is conducted in a much broader scope: evaluation of biocompatibility, with mandatory classification of the medical device by the nature and duration of contact. The research program must include the rationale for selecting or waiving each of the biological effects.

Requirements for Laboratories Conducting Technical Testing and Toxicological Research

Only accredited testing laboratories with the appropriate scope of accreditation may conduct technical testing and toxicological research (Item 3 of Order No. 885n). The applicant has the right to independently select testing organizations that meet the specified requirements. The register of accredited organizations is available on the federal state information system of the Federal Accreditation Service (Rosakkreditatsiya) on the Internet. We note that it is extremely important to carefully select the contractor for the necessary testing and research to avoid a refusal of registration.

For example, in Case No. A40-126860/2022,[2] the Company petitioned the court to invalidate the refusal to issue a Marketing Authorization for a medical device. During the proceedings, the court found that the technical testing of the medical device was conducted by a testing laboratory whose accreditation certificate lacked the necessary scope of accreditation for such testing. Roszdravnadzor concluded that the documents based on the technical testing results did not confirm the medical device's conformity with the requirements of the regulatory documentation and the manufacturer's technical and operational documentation, and therefore refused registration. The court agreed with the registering authority's opinion and dismissed the claim.

Laboratories conducting testing for the purposes of Union registration must be included in the Unified Register of Authorized Organizations of the EAEU. The Eurasian Economic Commission maintains this register. It is available on the EAEU Information Resources Portal.

According to Item 3 of Order No. 885n, testing laboratories must ensure the principle of impartiality and cannot be in any form of dependence on the developer, the manufacturer of the medical device, its authorized representative, or other persons interested in the testing (research) results.

Clinical Trials of Medical Devices

Clinical trials represent the most complex procedure in conformity assessment. Unlike the preceding procedures, they are conducted during the state registration of medical devices, frequently involving human subjects.

A clinical trial is a designed and planned systematic investigation, undertaken involving a human subject, to assess the safety and efficacy of a medical device (paragraph 8 of Item 4 of Resolution No. 1684).

Clinical trials of medical devices are conducted in the form of:

Research (analysis and evaluation of clinical data);
Testing, including involving human subjects.

Testing involving human subjects is conducted in the following cases:

a) a new type of medical device;

b) the application of new complex and (or) unique and (or) special methods of prevention, diagnosis, and treatment of diseases and conditions, as well as the application of new complex medical technologies;

c) if the analysis and evaluation of clinical data fail to confirm the efficacy and safety of the medical device;

d) for medical devices containing new materials contacting the human body that have not been previously studied regarding biological effect, or known materials contacting those human organs or tissues for which there is no medical application experience, or if such contact is more prolonged than previously studied (Item 37 of Order No. 885n).

Medical devices for in vitro diagnostics undergo clinical trials in a laboratory using samples of patient biomaterial collected during the medical diagnostic process. In other instances, clinical trials take the form of research (analysis and evaluation of clinical data) without involving patients.

Clinical trials are conducted based on an authorization for clinical trials issued by Roszdravnadzor. Such authorization is not required for medical devices with a low degree of potential risk, medical software, or medical devices included in the list of medical devices with a low degree of potential risk of use that are subject to specific state registration rules (Item 38 of Order No. 885n). You can read more about the specifics of the registration and conformity assessment of such medical devices in our separate article.[3] A notification regarding the issuance of the authorization is sent to the applicant's personal account on the Gosuslugi portal (State Services portal) following the results of Stage 1 of the quality and safety expert review. The register of issued authorizations is published on Roszdravnadzor's official website on the Internet.

In the event of conducting trials involving human subjects, it is also necessary to obtain a conclusion on the ethical justification of the clinical trials, issued by the Ethics Council in the Sphere of Medical Device Circulation of the Ministry of Health of Russia. The procedure for the Ethics Council's operation is governed by Items 32-49 of Resolution No. 1684. The timeframe for issuing the conclusion is 30 business days from the date of receiving the documents for review.

Stages of conducting clinical trials (the "CT"):

Obtaining Roszdravnadzor's authorization to conduct the CT.
Submitting the application and the set of documents to a medical organization authorized to conduct the CT. The list of necessary documents is specified in Item 38 of Order No. 885n.
Executing an agreement with the medical organization.
Drafting and approving the clinical trial program.
Obtaining a positive conclusion from the Ethics Council (for CTs involving human subjects).
Conducting the clinical trials.
Drafting the assessment report on the results of the clinical trials.

Based on the results, an assessment report on the clinical trial results of the medical device is formalized (the recommended form is in Appendices No. 4 and 5 to Order No. 885n).

Requirements for Medical Organizations Conducting Clinical Trials of Medical Devices

Clinical trials of medical devices (excluding in vitro diagnostic medical devices) are conducted in medical organizations. Such medical organizations must meet the following requirements:

Possess a license to conduct medical activities covering works (services) based on the intended purpose and area of application of the medical devices undergoing the trials;
The charter of the medical organization must include the following types of activities: scientific (research) activities and the execution of clinical trials of medical devices;
Have an intensive care and resuscitation unit (ward) (when conducting clinical trials of medical devices involving human subjects, classified as Class 2b and 3 based on potential application risk);
Maintain standard operating procedures governing the conduct of clinical trials;
Ensure the protection of confidential information;
Ensure the entry of information on the conducted trials into the Unified Information System (UIS) of the registering authority (Item 6 of Resolution No. 1684).

For medical organizations conducting clinical trials of in vitro diagnostic medical devices, the requirements differ in several details (Item 7 of Resolution No. 1684).

The verification of the medical organization's compliance with these requirements is carried out by Roszdravnadzor. The list of medical organizations authorized to conduct clinical trials is available on Roszdravnadzor's official website on the Internet.

Similar requirements apply to medical organizations conducting clinical trials in accordance with EEC Decision No. 29. A medical organization authorized for clinical trials must be included in the relevant Register of Authorized Organizations of the EAEU.

Below we will review the procedure for conducting clinical trials involving human subjects in greater detail.

Clinical Research Involving Human Subjects

The procedure for clinical trials involving human subjects under the national rules is governed by GOST R ISO 14155-2022, Clinical Investigation of Medical Devices for Human Subjects. Good Clinical Practice.

The GOST establishes the following fundamental principles for conducting clinical trials:

Ethical considerations: priority of the rights, safety, and well-being of the human subjects;
Scientific validity: the presence of a clear trial plan (protocol), a statistically justified sample, and valid evaluation methods;
Independent expert review: mandatory ethical review of the protocol prior to commencing the trial;
Informed consent: voluntary written consent from the subject after receiving comprehensive information about the trial;
Confidentiality: protection of the subjects' personal data;
Traceability: documenting all events and decisions throughout the trial;
Risk management: assessing the benefit-risk balance at all stages.

These principles are further elaborated through specific procedural requirements.

The participants of a clinical trial include:

Sponsor (applicant): initiates, organizes, funds, and oversees the trial;
Medical organization: conducts the research;
Principal investigator: a physician responsible for conducting the trial at the medical organization;
Investigators: members of the research team;
Research subject: the individual on whom the trial is conducted;
Legally authorized representative: a person authorized by law to consent to participation in a clinical trial on behalf of a potential research subject.

The rights, safety, and well-being of the research subject must be of paramount importance and must prevail over the interests of science and society. To protect the subject's rights, the standard provides several measures:

1. Obtaining voluntary informed consent from each subject prior to their inclusion in the research.

The consent must comply with the requirements of Article 20 of the Law No. 323-FZ and GOST R ISO 14155-2022:

Be executed in writing;
Contain comprehensive and clear information about the goals, methods, anticipated benefits, potential risks, and alternative treatment methods;
Allow for the possibility of withdrawing consent at any time without negative consequences for the patient;
Stipulate special procedures for vulnerable populations: minors, individuals with impaired legal capacity, and patients in emergency conditions.

The minimum scope of information provided to the clinical trial subject is specified, and detailed requirements are established for the accessibility of its presentation and the procedure for obtaining it.

2. Ensuring the confidentiality of the subject's participation in the clinical research and the protection of the subjects' personal data.

In practice, this means complying with the requirements of Federal Law No. 152-FZ dated July 27, 2006, On Personal Data: restricting access, ensuring secure storage and transmission of data, including when using automated data processing systems.

3. The availability of compensation and additional medical care for subjects harmed by adverse events associated with participation in the clinical research.

It should be noted that life and health insurance for patients participating in clinical trials of medical devices (unlike clinical trials of medicinal products, where insurance is mandatory under Article 44 of Federal Law No. 61-FZ dated April 12, 2010, On Circulation of Medicinal Products), as well as compensation for potential harm, are not expressly stipulated by Russian legislation. However, it stems from the provisions of the Civil Code on the compensation of harm (Articles 1064, 1095–1097 of the Civil Code) and the clinical trial principles enshrined in GOST R ISO 14155-2022.

4. Adverse event management.

The standard introduces the classification of adverse events during a clinical trial, the risk assessment procedure, necessary measures, and notifications of their occurrence.

Additionally, GOST R ISO 14155-2022 establishes requirements for the traceability of documents and data. Specifically, all documents and data must be created and maintained in a manner that ensures completeness, integrity, control, and traceability. All documents and their subsequent versions relating to the clinical research must be identifiable, traceable, and appropriately stored to provide a complete history of the clinical research.

Although GOST R ISO 14155-2022 is formally a document of voluntary application, in practice, compliance with it is a prerequisite for obtaining Roszdravnadzor's authorization to conduct clinical research and for the subsequent state registration of the medical device.

In contrast to Order No. 885n, EEC Decision No. 29 itself regulates the procedure for conducting clinical research and the requirements for the documentation forms drafted during the clinical trial in much greater detail.

Engagement of Third Parties for Testing and Research and Formalizing Relations

The manufacturer does not always possess adequate resources to fully control the testing and research procedure and fulfil its obligations, compelling it to engage third parties. The engagement of third parties is typically executed under a contract for the provision of services for a fee, the legal regulation of which is governed by Chapter 37 of the Civil Code, as well as by the specific provisions of Order No. 885n and EEC Decision No. 29.

For example, in accordance with Section 9.3 of GOST R ISO 14155-2022, the sponsor may delegate some or all its trial-related duties and functions to a Contract Research Organization (CRO) provided that:

The transfer of duties and functions is formalized in writing;
The sponsor retains ultimate responsibility for the quality and integrity of the clinical trial;
The specific functions delegated to the CRO (monitoring, data management, statistical analysis, pharmacovigilance, etc.) are defined.

We note that according to Section 9.3 of GOST R ISO 14155-2022, delegating functions to a CRO does not release the sponsor from liability before the registering authority.

Clinical Trial Agreement for Medical Devices

The clinical trial agreement for medical devices is a contract for the provision of services for a fee. It may also contain elements of a contract for the performance of scientific research work—specifically, regarding the execution of scientific research with an outcome that is not predetermined.

The parties to the clinical trial agreement for medical devices are: the medical device manufacturer or its authorized representative acting as the Customer, and the medical organization authorized to conduct such clinical trials acting as the contractor. Furthermore, GOST R ISO 14155-2022 permits the inclusion of the principal investigator and other participating entities (contract research organizations, etc.) as a third party to the agreement.

Due to the comprehensive nature, specificity, and critical importance of the research to human life and health, the agreement must incorporate the following sections:

1. Subject Matter of the Agreement. It is necessary to detail what specific clinical trials of which device are being conducted, the purpose of the trials, the grounds for execution, and the applicable standards.

2. Trial Timeframes. Typically, the start and end dates of the trials and the timelines for individual stages are specified.

3. Requirements for the Contractor. The contractor must meet the established requirements (possess the requisite equipment, qualified personnel, etc.).

4. Amount and Payment Procedure for the Research.

5. Acceptance Procedure for Trial Results. The list of documents provided based on the research results and the requirements for their preparation, along with the procedure for transferring and storing medical data and documents.

6. Confidentiality and Intellectual Property Rights. We recommend stipulating a non-disclosure clause for information obtained during the research for a specified term, the allocation of rights to the research results, and the possibility of publishing the research results subject to certain conditions.

7. Insurance / Financial Provision for Potential Harm to Clinical Trial Subjects. Despite the absence of an imperative rule, it is advisable to define such a contractual condition to mitigate risks.

8. Allocation of Participant Liability. The liability of each clinical research participant must be defined, indicating the instances where the parties share liability with the sponsor while participating in the clinical research (Section 6.9 of GOST R ISO 14155-2022).

9. Procedure for Early Termination of the Trial. The agreement must outline the grounds and procedure for early termination of the clinical trials, including:

At the sponsor's initiative (upon discovering the device's inefficacy or lack of safety, or upon identifying serious or repeated deviations by the investigator).
At the medical organization's initiative (in case of systematic violations by the sponsor).

It is also necessary to stipulate the procedure and timeframes for notifying the other party regarding the termination of the clinical trial.

Entering Documents Confirming Clinical Trial Results into the Registering Authority's Automated Information System

Effective October 1, 2025, Resolution No. 1684 establishes the obligation of medical organizations to ensure the entry of documents confirming the results of clinical trials into the automated information system of Roszdravnadzor. In accordance with the clarifications of the registering authority,[4] information must be entered regarding clinical trials completed after September 1, 2025. The timeframe for entering the data is three business days after the completion of the clinical trial. The documents are entered into the Unified Information System through the personal account on the official Roszdravnadzor website.

According to EEC Decision No. 29, when a medical device is registered under Union rules, analogous information is entered into the EAEU integrated information system through the competent authority of the reference member state.

Although the medical organization enters the data, to avoid facing a refusal of registration, the applicant must ensure that the data is entered accurately and on time.

Who Bears Liability for Conducting Testing and Research on Medical Devices?

The key entity bearing the primary burden of liability is the applicant: the person applying to Roszdravnadzor for the state registration of the medical device. This role may be fulfilled by:

The manufacturer of the medical device;
The authorized representative of a foreign manufacturer within the Russian Federation (or within the EAEU when registering under Union rules).

The applicant:

Organizes the execution of all types of testing and research;
Provides testing organizations with accurate information regarding the device;
Ensures the transfer of the required quantity of samples;
Bears the costs of conducting the testing;
Is responsible for the accuracy of the information submitted to the registering authority.

The applicant's civil, administrative, and in certain instances, criminal liability is stipulated for:

Providing deliberately false information (Article 19.7 of the CAO RF);
Circulating falsified, substandard, or unregistered medical devices (Article 6.33 of the CAO RF, Article 238.1 of the Criminal Code of the Russian Federation);
Causing harm to the life and health of citizens due to the application of a substandard device (general civil tort liability).

The testing laboratory bears liability for:

The accuracy of the results of the conducted testing and research;
Adherence to the methodologies and the use of validated equipment;
The qualification of the personnel conducting the testing;
The secure retention of samples and documentation.

According to Article 25 of Federal Law No. 412-FZ dated December 28, 2013, On Accreditation in the National Accreditation System, an accredited entity is obligated to comply with the accreditation criteria throughout its operations. Violating these requirements leads to the suspension or termination of the accreditation.

Furthermore, in the event of violations in conducting testing, the risk of incurring civil liability in the form of damages and penalties cannot be ruled out.

Thus, in Case No. A57-14559/2022,[5] the medical device manufacturer and the testing laboratory executed an agreement for the provision of services to conduct technical testing of samples of the medical device "Multi-wave Irradiator". Following the conducted testing, the laboratory delivered the Program and the Protocol of the technical testing. The documents were submitted to Roszdravnadzor as part of the registration dossier to obtain a Marketing Authorization for the medical device.

However, Roszdravnadzor issued a notification refusing registration based on the conclusion of the expert organization. According to the conclusion, the following deficiencies were identified:

The submitted documents regarding the technical testing results did not fully confirm the medical device's conformity with the requirements of the regulatory documentation, as well as the manufacturer's technical and operational documentation;
The testing was conducted outside the laboratory's scope of accreditation.

The manufacturer filed a lawsuit against the laboratory seeking the recovery of 10,000 rubles received under the agreement and damages amounting to 1,052,000 rubles. The claim was justified by stating that the improper provision of services for the technical testing of the medical devices resulted in damages equal to the costs of conducting the medical device registration.

The court established that the refusal of registration was caused by the laboratory's improper conduct of the technical testing. Due to the refusal received by the plaintiff, the registration dossier with all its constituent documents completely lost its utility value for the plaintiff. The claim was satisfied in full.

It is noteworthy that the cited cases No. A40-126860/2022 and No. A57-14559/2022 are interconnected: both concern the same device ("Multi-wave Irradiator MVBO-01"), the same applicant (REMO-Technologies LLC), and the same testing laboratory. Having failed to challenge Roszdravnadzor's refusal of registration (Case No. A40-126860/2022), the applicant, in a separate proceeding, recovered from the laboratory both the remuneration paid under the agreement and the damages in the form of registration expenses (Case No. A57-14559/2022). Consequently, improperly conducting technical testing triggers not only a refusal of registration but also the civil liability of the testing laboratory to the applicant.

When conducting clinical trials, additional liability is imposed on the medical organization and the principal investigator:

The principal investigator bears personal liability for complying with the protocol, ensuring the rights and safety of the research subjects, and ensuring the accuracy of the collected data. The personal liability of the physician-investigator is established by Section 10 of GOST R ISO 14155-2022 and the general provisions of the Labor Code of the Russian Federation (disciplinary liability of the medical organization's employee). Additionally, the onset of criminal liability cannot be excluded if harm is caused to the research subject.

The medical organization is responsible for possessing the necessary physical infrastructure, staff qualifications, and maintaining confidentiality protocols. In the event of violations during the clinical trial, the risk of license suspension or revocation, along with the imposition of civil liability, remains a distinct possibility.

Therefore, all participants in the testing and research bear liability for its quality and accuracy.

Evolving Regulatory Landscape for Medical Device Conformity Assessment

Effective September 1, 2026, the Order of the Ministry of Health of Russia No. 421n dated May 13, 2026, which approves the new procedure for conformity assessment of medical devices in the form of technical testing, toxicological research, and clinical trials, will enter into force. It will replace the current Order No. 885n and will apply until September 1, 2032. Overall, the conformity assessment mechanism will remain unchanged. We highlight the main innovations:

A specific timeframe is established within which the testing and medical organizations must inform the medical device manufacturer of the possibility (or impossibility) of conducting the testing and research. This period will be three business days from the date of making such a decision.

The instances requiring clinical trials involving human subjects are expanded to include:

Modifications to the design of the medical device that affect its intended purpose or principle of operation;
Expansion of the list of indications for using the medical device or adjustment to its intended use.

The content of the testing programs is further specified. A list of details required in the clinical trial program is defined, as well as the data set to be included in the clinical-laboratory testing program for in vitro diagnostic medical devices.

The conformity assessment results may be formalized not only on paper but also electronically.

It is codified that information on the conducted clinical and clinical-laboratory trials (including the assessment report) will be entered into Roszdravnadzor's information system.

In conclusion, we note that the conformity assessment of a medical device is a pivotal stage in the state registration process for medical devices and ensures the market authorization of high-quality, effective, and safe devices. The success of the registration and the subsequent legal protection of the manufacturer during the market circulation of the medical device rely heavily on the quality of these procedures.

Currently, two parallel legal regimes for conformity assessment operate in the Russian Federation: national and supranational. Concurrently, there is a steady trend towards harmonizing Russian regulations with EAEU law: alignment of terminology and procedures, transition to unified standards, and the anticipated phasing out of national registration. Therefore, even when registering under national rules, it is strategically advantageous for the applicant to adhere to the more detailed requirements of EAEU law to minimize future costs of aligning the registration dossier with Union standards.

Furthermore, we advise the applicant to exercise due diligence in selecting the testing laboratory and medical organization, to rigorously and comprehensively draft the contractual arrangements, and to oversee the assessment procedure at every stage of its execution.

A comprehensive approach to each stage of conformity assessment is a prerequisite for successfully registering a medical device, mitigating regulatory risks, and facilitating the seamless introduction of products into the Russian and Eurasian markets.

_________________

References

The Order of the Ministry of Health and Social Development of Russia No. 1386n dated November 22, 2011, On the Approval of the Methodology for Determining the Fee Amount for the Expertise and Testing of Medical Devices for the Purposes of State Registration of Medical Devices and the Maximum Fee Amounts for the Expertise and Testing of Medical Devices for the Purposes of State Registration of Medical Devices.
The Resolution of the Arbitration Court of the Moscow District No. F05-7663/2023 dated April 21, 2023, regarding Case No. A40-126860/2022.
The website of BRACE Law Firm: https://brace-lf.com/informaciya/farmatsevticheskoe-i-meditsinskoe-pravo/registraciya-mi-pravila-rf
Information of Roszdravnadzor "For Medical Organizations Conducting Clinical Research (Clinical-Laboratory Trials) of Medical Devices", published on the website https://roszdravnadzor.gov.ru as of October 20, 2025.
The Resolution of the Arbitration Court of the Povolzhsky District No. F06-9062/2023 dated October 24, 2023, regarding Case No. A57-14559/2022.