Safety Monitoring of Medical Devices in Russia and the EAEU: Legal Regulation and Liability

June 18, 2026

BRACE Law Firm ©

The state guarantees Russian citizens free and high-quality medical care. Achieving this is impossible if healthcare providers use medical devices that fail to meet safety and efficacy requirements.

Under Part 1 of Article 96 of 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" or the "Law on Health Protection"), all medical devices circulating within the Russian Federation are subject to safety monitoring. Medical device safety monitoring constitutes an integral element of the state regulation of medical device circulation aimed at ensuring their safety. Its primary objective is to identify and prevent various adverse events during the circulation of medical devices.

This article examines the rules for monitoring the safety of medical devices, the obligations that legislation imposes on all medical product circulation entities, and the liability for violating these statutory requirements.

Scope of Medical Device Safety Monitoring

Safety monitoring encompasses the collection, processing, registration, and analysis of information regarding adverse events associated with the circulation of medical devices, as well as the adoption of appropriate regulatory decisions.

Regulators monitor the safety of all medical devices across all stages of their circulation, from manufacturing to destruction. This directly follows from Part 2 of Article 96 of the Law on Health Protection. The only exception applies to medical devices circulating within the international medical cluster and territories of innovative scientific and technological centers.

The safety monitoring procedure varies depending on the legal framework under which the medical device was registered:

Under Russian legislation;
Under EAEU law.

If the applicant registered the medical device under the Russian national procedure,[1] the following regulatory acts govern the monitoring process:

The Procedure for Monitoring the Safety of Medical Devices, approved by Order of the Ministry of Health of Russia No. 980n dated September 15, 2020 (the "Order No. 980n");
The Procedure for Reporting by Medical Product Circulation Entities on All Cases of Detecting Side Effects Not Specified in the Instructions for Use or Operating Manual of the Medical Device, Adverse Reactions During Its Use, Features of Interaction Between Medical Devices, and Facts and Circumstances Creating a Threat to the Life and Health of Citizens and Medical Workers During the Use and Operation of Medical Devices, approved by Order of the Ministry of Health of Russia No. 1113n dated October 19, 2020 (the "Order No. 1113n").

The monitoring of medical devices registered under the legislation of the EAEU member states, [2] is conducted in accordance with the Rules for Monitoring the Safety, Quality, and Efficacy of Medical Devices, approved by Decision of the Board of the Eurasian Economic Commission No. 174 dated December 22, 2015 (the "EEC Decision No. 174").

The authority empowered to conduct monitoring within the Russian Federation is Roszdravnadzor and its territorial bodies.

In addition to the authorized body, the participants in the safety monitoring process include medical product circulation entities at all stages of circulation:

Manufacturers of medical devices, and authorized representatives of foreign manufacturers in the Russian Federation;
Importers and distributors of medical devices;
Medical organizations;
Organizations that store, transport, install, set up, operate, maintain, repair, dispose of, or destroy medical devices (the "Medical Product Circulation Entities").

Defining "Adverse Events" in Medical Device Safety Monitoring

Before examining the monitoring procedure, we must clarify what constitutes an adverse event associated with the circulation of medical devices, as this issue often causes confusion.

Russian legislation does not contain a formal definition of an adverse event. Based on the provisions of Part 1 of Article 96 of the Law on Health Protection and paragraph 3 of Order No. 980n, an adverse event includes:

Any side effects not specified in the instructions for use or operating manual of the medical device;
Adverse reactions during the application of the medical device;
Specific features of interaction between medical devices;
Facts and circumstances creating a threat to the life and health of citizens and medical workers during the application and operation of medical devices.

Order of Roszdravnadzor No. 4513 dated May 20, 2021, [3] approved the Classifier of Adverse Events Associated with the Circulation of Medical Devices (the "Classifier"). It encompasses events such as:

Discrepancy between the intended use and performance characteristics recommended by the manufacturer and the age, gender, weight, height, or other patient metrics;
Deviations from the design parameters of the medical device occurring during manufacturing, packaging, or delivery;
Deviations from the design parameters of the medical device (chemical characteristics) occurring during manufacturing, packaging, or delivery;
Deviations from the design parameters of the medical device regarding the reliability of materials used during its manufacturing;
Unforeseen mechanical impact of the medical device on the patient;
Unsatisfactory quality of the transmitted image affecting the operation of the medical device;
Malfunction of the electrical circuit of the medical device;
Calibration failure affecting the accuracy of the medical device;
Deviations from the technical documentation affecting the data transmitted by the medical device;
Deviations from the operating temperature range causing overheating or overcooling of the medical device;
Negative impact of software code or software on the operation of the medical device;
Incorrect connection of the medical device or its functional units to fluid, gas, electricity, or data transmission systems;
Failures in sending or receiving signals or data between internal components of the medical device;
Effects of fluid or gas circulation within the medical device (including the vacuuming process);
Deviations from the design parameters resulting in a disruption of the sequence of events required to activate, position, or disconnect the medical device;
Deviations from the design parameters intended to mitigate risks or maintain an acceptable level of risk for the patient or operator;
Individual intolerance to the medical device by the patient;
Presence of any foreign substance, not provided for by the technical documentation, within the medical device, on its surface, or in its packaging, which may affect the efficacy of the device or its intended use, or which compromises the efficacy of device disinfection;
Inconsistency of the environment with the conditions specified in the technical documentation for operating or storing the medical device;
Incorrect installation, setup, or configuration of the medical device;
Labeling, instructions for use, and training or maintenance documentation that do not correspond to the medical device;
Result of the medical device's impact on the patient not anticipated by the manufacturer or operator;
Maintenance or operational errors violating the manufacturer's recommendations;
An event unrelated to the medical device.

Unlike Russian national law, the supranational EAEU legislation provides a specific definition for an adverse event. It defines it as any malfunction and (or) deterioration of characteristics, or failure in the functioning of a medical device, or insufficiency or inaccuracy of the accompanying information (documentation) for the medical device, or a side effect not specified in the instructions for use, which directly or indirectly led or could lead to death or serious deterioration of the health of users or third parties (paragraph 5 of EEC Decision No. 174).

When assessing adverse events occurring with medical devices registered under EAEU law, entities use the Classifier approved by Decision of the EEC Board No. 47 dated April 3, 2018. This classifier is highly detailed, contains hundreds of code items, and classifies events across multiple levels.

Consequently, EEC Decision No. 174 interprets an adverse event more broadly (encompassing insufficient documentation, malfunctions, etc.). When submitting notifications regarding the detection of adverse events, medical product circulation entities must indicate the event code according to the applicable classifier. The choice of the applicable classifier depends on the specific medical device involved in the adverse event.

Below, we examine the specifics of medical device monitoring under national legislation and EAEU law.

Medical Device Safety Monitoring Procedure Under Russian Legislation

Order No. 980n governs the monitoring procedure for medical devices registered under Russian legislation.

The safety monitoring of medical devices relies on the following sources of information:

Reports from medical product circulation entities (medical and other organizations, medical device users, etc.);
Information received from medical device manufacturers;
Data obtained during state control over the circulation of medical devices;
Information published on the official websites of foreign regulatory authorities (agencies) in the field of medical device circulation regarding adverse events that occurred in other states with medical devices registered in the Russian Federation;
Data retrieved from specialized medical information systems regarding implantable medical devices;
Analysis of information provided by the medical device manufacturer (its authorized representative) or the entity importing the medical devices into the Russian Federation.

Protocol for Medical Product Circulation Entities Upon Detecting an Adverse Event

Part 3 of Article 96 of Law No. 323-FZ imposes an obligation on medical product circulation entities to report all instances of adverse events detected across all stages of circulation of the respective medical device within the Russian Federation and in other states.

Pursuant to paragraph 2 of Order No. 1113n, a medical product circulation entity, excluding the manufacturer, must submit a report to Roszdravnadzor within 20 working days of detecting an adverse event. This report must contain information about the reporting entity, the medical device, a description of the adverse event, and data regarding the affected individual. The reporting entity determines the type and category of the adverse event using the Classifier. Appendix No. 1 to Order No. 1113n provides a recommended report template. The entity must attach supporting documents to the report.

Entities can submit reports through several channels:

Online via the Roszdravnadzor website using the automated "Medical Device Safety Monitoring" system;
Through the Roszdravnadzor mobile application;
Via the "Gosuslugi" (State Services) portal;
In hard copy to the address of Roszdravnadzor (if internet access is unavailable).

Medical organizations that detect an adverse event must additionally inform the manufacturer and provide it with access to the subject medical device.

A specific protocol applies to medical device manufacturers (and their authorized representatives). They must collect information from medical organizations regarding detected adverse events and verify its accuracy and completeness. The manufacturer has the right to request assistance from Roszdravnadzor in gaining access to the medical device to establish the causal link between its use and the identified adverse event.

Based on the review of the received information, the manufacturer submits the following reports to Roszdravnadzor:

An initial report on the adverse event (using the form specified in Appendix No. 2 to Order No. 1113n);
A report on corrective actions (using the form specified in Appendix No. 3 to Order No. 1113n).

The manufacturer must submit the initial report on the adverse event within the following timeframes:

Within 2 calendar days in the event of a serious health threat;
Within 10 calendar days in the event of death or an unanticipated serious deterioration in the user's health;
Within 30 calendar days for all other cases.

Prior to submitting the initial report, the manufacturer may implement corrective actions in emergency situations to protect users or third parties from the threat of death or serious health deterioration. A corrective action is defined as an action undertaken by the manufacturer to eliminate the cause of the detected event. These actions may involve recalling a batch of medical devices, revising operating instructions, or adjusting equipment. In such instances, the initial report on corrective actions must be submitted to Roszdravnadzor no later than 2 calendar days after the manufacturer implements these measures.

Following the execution of corrective actions, the medical device manufacturer must also issue a safety notification (the recommended template is provided in Appendix No. 4 to Order No. 1113n) by publishing it on its official website and submitting it to Roszdravnadzor.

In certain situations, reports may be waived. For example, if the user can detect obvious defects immediately prior to using the medical device, or if the risk of death or serious health deterioration is deemed negligible and documented as acceptable in the product's registration dossier. Paragraph 7 of Order No. 1113n provides an exhaustive list of such exemptions.

Class 3 high-risk medical devices and Class 2b high-risk implantable medical devices require additional clinical monitoring. This entails the manufacturer collecting information on the device's safety and clinical efficacy for three years following its registration. The clinical monitoring proceeds according to a plan, which must include the following details:

The goals and objectives of the monitoring, taking into account available clinical data, specific features, and risk factors associated with the medical device;
The monitoring scheme, including the rationale for the methods used to obtain and statistically analyze clinical data, the selection of the study population, inclusion/exclusion criteria, and the minimum number of subjects in the study group.

Based on the results of such monitoring, the manufacturer must annually submit a clinical monitoring report to Roszdravnadzor (the recommended template is in Appendix No. 5 to Order No. 1113n). The manufacturer must submit this report no later than February 1, commencing the year following the year of registration.

Consequently, Russian legislation imposes strict obligations on medical product circulation entities to identify instances of adverse events during the circulation of medical devices and to promptly notify the authorized regulatory body.

Enforcement Actions by Roszdravnadzor in Medical Device Safety Monitoring

Upon receiving information regarding an adverse event, Roszdravnadzor registers it on the day of receipt.

Subsequently, within 5 working days from the date of registration, the regulatory authority takes the following steps:

Notifies the manufacturer (or its authorized representative) of the requirement to provide a reasoned position on the identified facts. The deadline is 10 working days. If necessary, the manufacturer must attach reports on corrective actions;
Forwards the information to an expert institution subordinate to Roszdravnadzor.

Within 3 working days, the expert institution submits an expert opinion to the regulatory body regarding the causal link between the use of the medical device and the development of adverse consequences. Furthermore, within 10 working days, it provides an expert conclusion containing recommendations on whether it is necessary to conduct compliance inspections and adopt regulatory decisions regarding the medical device.

Based on the review of the manufacturer's reasoned position and the expert opinion/conclusion, Roszdravnadzor adopts a decision within 10 working days of receiving the final document:

To conduct compliance inspections or determine that no grounds exist for such measures;
To suspend the use of the medical device.

Regulators apply suspension measures proportionately to the volume of received information:

For the medical device as a whole – if adverse event reports involve 2 or more models (variants) of execution;
For a specific model (variant) of execution – if the reports involve 2 or more batches (series) of a single model (variant);
For a specific batch (series) – if the reports solely concern that specific batch (series) (paragraph 7 of Order No. 980n).

If compliance inspections confirm actual harm to life and health, the manufacturer must draft and coordinate a mitigation program. The expert institution evaluates this program to determine the adequacy of the proposed measures.

Following the review, Roszdravnadzor notifies the manufacturer within 10 working days regarding the approval of the Program or issues a notice requiring specific amendments. If the manufacturer fails to adopt the necessary measures, Roszdravnadzor has the authority to order the withdrawal of the medical device from circulation.

During the compliance inspections and Program coordination, the manufacturer (or its authorized representative) must implement measures to prevent any escalation of harm associated with the device's circulation and ensure that purchasers, including consumers, have access to real-time information regarding the mitigation efforts (paragraph 12 of Order No. 980n). The regulatory authority revokes its suspension decision based on, among other things, the approval of the manufacturer's report on the Program's execution, accompanied by supporting documentation such as test results from a laboratory accredited by the national accreditation system (paragraph 13 of Order No. 980n). Roszdravnadzor publishes information on its safety monitoring decisions on its official website, subject to restrictions established by legislation on personal data, commercial, state, and other legally protected secrets (paragraph 16 of Order No. 980n).

Safety Monitoring for Medical Devices Registered Under EAEU Law

The safety monitoring of medical devices registered under EAEU law is governed by EEC Decision No. 174. Despite sharing the overarching objective of identifying and preventing threats to life and health during the use of medical devices, the EAEU procedure exhibits several distinctions compared to national legislation. We provide a brief overview of these differences below.

As previously noted, EEC Decision No. 174 thoroughly defines the applicable terminology.

Order No. 980n explicitly identifies the channels through which information regarding adverse events is received. Conversely, EEC Decision No. 174 does not detail the use of data from foreign sources or specialized patient registries as distinct information channels, relying instead on broad phrasing regarding the submission of data through the national information systems of member states.

EEC Decision No. 174 outlines similar rules for submitting reports, timeframes, and notification procedures, yet the framework is less detailed than national regulations. Entities transmit information regarding detected adverse events to the authorized regulatory body of the EAEU member state where the event occurred via national information systems.

Furthermore, EEC Decision No. 174 establishes a post-market safety monitoring system for medical devices. Specifically, the framework incorporates the following mechanisms:

Individual reporting for each adverse event (incident). The manufacturer must notify the authorized body of every identified case involving a device malfunction, deterioration of characteristics, or labelling defects that caused or could cause harm to the patient's or user's health;
The option to coordinate the periodic submission of consolidated reports with the authorized body. Instead of submitting isolated notifications, the manufacturer may provide aggregated reports for a specified period, thereby reducing the administrative burden while maintaining data completeness;
A streamlined reporting procedure is permitted for routine, previously studied, and documented incidents with known causes and predictable outcomes.

Liability for Non-Compliance with Medical Device Safety Monitoring Requirements

Under Part 4 of Article 96 of the Law on Health Protection, individuals who fail to report or who conceal detected adverse events known to them through their professional duties may face disciplinary, administrative, civil, or criminal liability.

Disciplinary liability arises from a disciplinary offense – specifically, the employee's culpable failure to perform or improper performance of their assigned employment duties. Under Article 192 of the Labor Code of the Russian Federation, an employer holds the right to impose disciplinary sanctions on an employee, taking the form of a reprimand, a formal warning, or termination on applicable grounds.

For instance, an employer may discipline an individual responsible for safety monitoring if they fail to execute their duty to report an adverse event to Roszdravnadzor within the statutory timeframe. Prior to imposing sanctions, the employer must request an explanatory statement from the employee, verify that the employee had acknowledged their assigned duties, and confirm that the statute of limitations for disciplinary action has not expired.

Article 19.7.8 of the Code of Administrative Offenses of the Russian Federation (CAO RF) establishes administrative liability for the failure to submit, or the delayed submission of, mandatory information to Roszdravnadzor or its territorial bodies, as well as for the submission of knowingly false information. Such violations trigger an administrative fine of 10,000 to 15,000 rubles for corporate officers, and 30,000 to 70,000 rubles for legal entities.

By way of illustration, in Case No. 12-720/2021,[4] a Roszdravnadzor resolution found a company guilty of an administrative offense under Article 19.7.8 of the CAO RF and imposed an administrative fine of 30,000 rubles. The company petitioned the court to invalidate the regulatory body's resolution.

During the court hearing, the facts established that an endodontic instrument broke and became lodged in a patient's root canal during dental treatment. The court concluded that complications involving the unintended displacement of a device, resulting from malfunction or improper handling, fall under the Classifier of Adverse Events approved by EEC Board Decision No. 47. Nevertheless, the company had failed to submit an adverse event report to Roszdravnadzor. Consequently, the court dismissed the company's claims.

Practical experience also demonstrates that non-compliance with monitoring obligations can trigger civil liability in the form of actual damages and statutory compensation for emotional distress.

For example, in Case No. 2-124/2025, [5] the plaintiff, B., filed a lawsuit against a Hospital, the Ministry of Health, and the organization servicing the Hospital's equipment, seeking joint and several liability for 10,000,000 rubles in emotional distress damages. The cause of action arose when the plaintiff sustained a chemical burn to her anterior abdominal wall during a Cesarean section, classified as moderate harm to health.

An inspection by the Ministry of Health established that the injury resulted from an electrosurgical unit exhibiting current leakage, which caused the nominal output power to exceed permissible limits. Concurrently, an audit by the territorial body of Roszdravnadzor revealed that the Hospital lacked both an internal order appointing an officer responsible for medical device safety monitoring and a formalized procedure for executing such monitoring. The Hospital submitted the adverse event notification over a month late. Consequently, Roszdravnadzor issued a formal warning to the Hospital against violating mandatory regulatory requirements.

Taking the regulatory findings into account, the court determined that the Hospital's internal quality and safety control systems were inadequate, and that its medical staff lacked proper vigilance regarding the safe operation of electrical equipment. The court ruled in favor of the plaintiff, awarding 100,000 rubles in emotional distress damages against the Hospital, while dismissing the claims against the remaining defendants.

Furthermore, individuals concealing information regarding circumstances that endanger human life or health may face criminal liability under Article 237 of the Criminal Code of the Russian Federation.

The objective element (actus reus) of this crime consists of concealing or distorting information regarding events, facts, or phenomena that pose a danger to human life, health, or the environment. The subject of the crime is any individual obligated to provide this information to the public and the authorities empowered to mitigate such hazards.

The penalties include a fine of up to 300,000 Rubles or the equivalent of the convicted person's salary for up to 2 years, forced labour for up to 2 years, or imprisonment for up to 2 years. The court may also impose an auxiliary penalty prohibiting the individual from holding specific offices or engaging in certain activities for up to 3 years. These penalties escalate if the violation results in harm to human health or other severe consequences, or if the offense is committed by a state official or the head of a local government body.

While we have not identified judicial precedent applying this specific criminal provision to the failure to report medical device adverse events, companies cannot definitively rule out the risk of criminal liability under Article 237 of the Criminal Code.

Structuring Internal Medical Device Safety Monitoring Systems

To safeguard against regulatory enforcement actions, organizations must prioritize the implementation of robust internal medical device safety monitoring systems.

Pursuant to paragraph 11 of Order No. 1113n, entities participating in the circulation of medical devices must designate an officer responsible for medical device safety monitoring. The duties of this compliance officer must encompass:

Collecting and forwarding information to Roszdravnadzor upon the detection of an adverse event;
Tracking Roszdravnadzor's information letters published on the regulatory body's official website and executing the prescribed directives (e.g., withdrawing devices from use, placing them in quarantine zones, etc.).

The designated officer must register in Roszdravnadzor's Automated Information System (AIS) to access the medical device safety monitoring portal. To secure personalized access credentials (login and password), legal entities must submit a request to Roszdravnadzor using the template outlined in Roszdravnadzor's Information Letter No. 04I-749/12 dated August 15, 2012.

Companies must define the detailed operational procedures and duties of the responsible officer through internal corporate policies. We strongly advise drafting and implementing a dedicated Standard Operating Procedure (SOP) titled "Medical Device Safety Monitoring Procedure." This policy should delineate the operational algorithm for staff facing an adverse event, the deadlines for notifying the compliance officer, and the specific channels for transmitting the incident data.

Furthermore, management must conduct routine staff training on this SOP. Practical experience indicates that general personnel often lack awareness of these protocols or underestimate the associated compliance risks.

Safeguarding the Rights of Medical Product Circulation Entities During Safety Monitoring

The primary adverse enforcement actions facing a medical product circulation entity and its corporate officers during Roszdravnadzor's safety monitoring include the imposition of various forms of liability, the issuance of formal warnings or compliance orders mandating the remediation of violations, the suspension or withdrawal of the medical device from circulation, and the suspension or revocation of the medical device's state registration.

If a medical product circulation entity concludes that the regulatory body has adopted an unlawful enforcement measure, it must initiate a timely appeal.

Effective July 1, 2021, the law mandates a pre-trial dispute resolution procedure. Decisions to conduct audits, acts and orders of the regulatory body, and the actions of officials during compliance inspections are subject to this appeal mechanism. The relevant procedure is codified in Federal Law No. 248-FZ dated July 31, 2020, On State Control (Supervision) and Municipal Control in the Russian Federation, and the Regulation on Federal State Control (Supervision) Over the Circulation of Medical Devices, approved by Decree of the Government of the Russian Federation No. 1066 dated June 30, 2021.

Entities submit complaints electronically via the Unified State Services Portal, authenticated with an Enhanced Qualified Electronic Signature (UK(E)P). The statutory deadline to appeal a decision initiating an audit is 30 days, whereas the deadline to appeal a compliance order is 10 working days. A higher-ranking official (or higher-level authority) must review the complaint within 20 working days of its registration. Appellants can track the status and outcome of the review directly through the State Services Portal.

If the pre-trial settlement proves unsuccessful, the aggrieved party proceeds to litigation. Legal entities and individual entrepreneurs litigate such disputes under Chapter 24 of the Arbitration Procedure Code of the Russian Federation (APC RF), titled "Challenging Non-Normative Legal Acts, Decisions, and Actions (Inactions) of State Authorities."

To secure a favorable court ruling, the petitioner must prove the cumulative presence of the following circumstances:

That the contested decision, action, or inaction violates the law or another regulatory act;
That the enforcement measure infringes upon the applicant's rights and legitimate interests in their entrepreneurial or other economic activities, unlawfully imposes obligations, or otherwise creates obstacles to conducting business.

Individual citizens challenge unlawful actions and decisions under Chapter 22 of the Code of Administrative Judicial Procedure of the Russian Federation.

Consider the following example from judicial practice.

In Case No. A40-182593/2020,[6] Roszdravnadzor published an official letter on its website identifying a medical device in circulation that failed to conform to its operational documentation, alongside a directive requiring medical product circulation entities to execute appropriate measures to halt its distribution. The company – arguing that Roszdravnadzor's actions violated its rights and legitimate interests by rendering the further commercialization of the goods impossible through a de facto withdrawal – petitioned the commercial court to declare the regulatory body's actions unlawful.

Upon reviewing the merits, the court concluded that Roszdravnadzor had lawfully identified, during its safety monitoring protocols, medical devices in circulation that failed to meet the operational documentation standards established by the manufacturers. The court further noted that the informational letters did not constitute formal regulatory decisions withdrawing the devices from circulation; therefore, issuing such letters did not equate to an enforcement action mandating product withdrawal. Consequently, the court dismissed the petition.

In summary, safeguarding the rights of medical product circulation entities during safety monitoring relies on a comprehensive understanding and execution of statutory obligations, meticulous documentation of all compliance measures and activities, and the timely pursuit of legal remedies against unlawful regulatory actions.

In conclusion, medical device safety monitoring extends far beyond bureaucratic red tape; it serves as a critical risk management mechanism. Strict compliance empowers organizations to mitigate life-threatening risks to patients and medical personnel, avoid severe legal and financial liabilities, elevate the quality and safety profiles of their medical products, and ultimately strengthen their market reputation.

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References

[1] In accordance with Decree of the Government of the Russian Federation No. 1684 dated November 30, 2024, On the Approval of the Rules for the State Registration of Medical Devices, and prior to March 1, 2025, in accordance with Decree of the Government of the Russian Federation No. 1416 dated December 27, 2012, On the Approval of the Rules for the State Registration of Medical Devices.

[2] In accordance with Decision of the Council of the Eurasian Economic Commission No. 46 dated February 12, 2016, On the Rules for the Registration and Expertise of the Safety, Quality, and Efficacy of Medical Devices.

[3] Order of Roszdravnadzor No. 4513 dated May 20, 2021, On the Approval of the Classification of Adverse Events Associated with the Circulation of Medical Devices.

[4] Decision of the Novocherkassk City Court of the Rostov Region dated September 2, 2021, in Case No. 12-720/2021.