State Control over the Circulation of Medical Devices and Safety Monitoring

 

February 17, 2022

BRACE Law Firm ©

 

State control in the healthcare sphere is essential for protecting the rights of citizens to receive high-quality and timely medical care. Article 85 of Federal Law No. 323-FZ dated November 21, 2011, On the Fundamentals of Health Protection of Citizens in the Russian Federation (the "Law on Health Protection" or "Law No. 323-FZ"), lists the types of control the state exercises in this field. One such type is control over the circulation of medical devices.

Before discussing this topic, we note that under Part 1 of Article 38 of the Law on Health Protection, medical devices (the "MDs" or "Medical Devices") include any instruments, apparatus, devices, equipment, materials, and other products used for medical purposes, alone or in combination with other accessories necessary for the intended use of such products, including special software. The manufacturer intends these devices for the prevention, diagnosis, treatment, and medical rehabilitation of diseases, monitoring of the human body, medical research, restoration, replacement, or modification of anatomical structures or physiological functions of the body, and the prevention or termination of pregnancy. In practice, disputes often arise regarding whether a specific product constitutes a medical device, which directly determines whether the product falls under state control and safety monitoring regulations.

In this article, we analyze the rules for exercising state control (the "State Control" or "Control") over the circulation of medical devices, examine its primary types, and discuss the safety monitoring of medical devices.

Procedure for Controlling the Circulation of Medical Devices

Government Decree No. 1066 dated June 30, 2021 (the "Decree No. 1066"), defines the procedure for exercising Control.[1] Additionally, the provisions of Federal Law No. 248-FZ dated July 31, 2020, On State Control (Oversight) and Municipal Control in the Russian Federation (the "Law on State Control"), apply to relations involving inspections of MD circulation.

Roszdravnadzor and its territorial bodies are the authorities authorized to conduct Control. Control applies to all medical device circulation entities. Under Part 3 of Article 38 of the Law on Health Protection, these entities include legal entities and individual entrepreneurs performing technical testing, toxicological research, clinical trials, and expertise of the quality, efficiency, and safety of medical devices, as well as their state registration, production, manufacturing, import into or export from the Russian Federation, conformity assessment, storage, transportation, sale, installation, adjustment, use, and operation. This also includes technical maintenance provided for by the manufacturer's regulatory, technical, and (or) operational documentation, as well as repair, disposal, or destruction.

According to Clause 2 of Decree No. 1066, the subject of Control includes:

• compliance with requirements for the circulation of medical devices;
• compliance with licensing requirements for the production and technical maintenance of medical equipment;
• compliance with requirements for providing information on identified adverse events during the circulation of medical devices;
• execution of decisions made based on the results of control measures.

State Control over the circulation of medical devices is based on a risk-oriented approach, which involves selecting the timing and types of control measures based on an assessment of the risks of harm (damage) to legally protected interests.

Roszdravnadzor Order No. 4043 dated April 27, 2017, defines the list of regulatory acts whose compliance is assessed during Control.[2] We must also address the use of checklists during inspections. The list of checklists for State Control over medical device circulation was approved in 2017.[3] A draft decree approving new checklist forms (Project ID 00115748) has been posted on the portal for draft regulatory acts. Notably, due to the reform of control and supervisory activities, the obligation to use checklists is now determined by the regulations governing the specific type of control. Regarding State Control over the circulation of medical devices, this obligation was excluded as of July 1, 2021.

Types and Grounds for Inspections

Inspections may be scheduled or unscheduled. Scheduled inspections are conducted based on an annual plan for scheduled control (oversight) measures coordinated with the prosecutor's office. Roszdravnadzor publishes the plan on its website by December 31 of the current year, and the General Prosecutor’s Office includes it in the annual consolidated plan on its official website.

The types and frequency of scheduled inspections depend on the assigned risk category. Roszdravnadzor calculates the risk category using criteria developed separately for each type of activity in the MD circulation sphere. Tables 1–9 of Decree No. 1066 provide the criteria and the assigned points. The risk category is determined by the total points accumulated across all types of activities performed.

Risk Category	Total Points	Frequency of Scheduled Inspections
Significant Risk	Over 70 points	Once every 4 years
Medium Risk	From 53 to 70 points	Once every 6 years
Moderate Risk	From 36 to 52 points	Once every 6 years
Low Risk	Less than 36 points	Not conducted

Entities performing only the import/export, storage, or transportation of medical devices are classified as a low-risk category without a point calculation. The risk category may be increased if the entity is held administratively liable for violations in the circulation of medical devices (under Article 6.28, Parts 1 and 2 of Article 6.33, Part 21 of Article 19.5, or Article 19.7.8 of the CAO RF) within two years prior to the risk category assignment. Conversely, the absence of such violations allows the risk category to be lowered by one level.

An entity may determine its risk category and the grounds for its assignment by submitting a request to the supervisory authority. One can also check the risk category using the calculator on the Roszdravnadzor website in the "Services" section.

The grounds for an unscheduled inspection may include:

• the control body possessing information regarding harm (damage) or a threat of harm to legally protected values;
• the identification of the control object's compliance with parameters established by risk indicators for the violation of mandatory requirements. Under Clause 9 of Article 27 of the Law on State Control, a risk indicator refers to compliance with or deviation from control object parameters that are not themselves violations but indicate a high probability of such violations and the risk of harm (damage) to legally protected values.

Currently, one risk indicator is approved for assessing the need for an unscheduled inspection:

• a two-fold or greater increase in the number of documents (acts, protocols, conclusions, or other documents) regarding the results of clinical trials of medical devices issued by a medical organization entitled to conduct such trials during a calendar year compared to the preceding calendar year;
• a prosecutor's demand based on materials and appeals received by the prosecutor's office;
• expiration of the deadline for executing a control body’s decision to eliminate an identified violation.[4]

As a general rule, an unscheduled test purchase is conducted after coordination with the prosecutor's office. However, in cases involving a threat of harm (damage) requiring urgent measures, it is conducted immediately with simultaneous notification to the prosecutor's office. Decree No. 1066 defines the types and content of unscheduled measures.

Types of Control Measures

Pursuant to Part 3 of Article 95 of the Law on Health Protection, the following types of control (oversight) measures are conducted during State Control over the circulation of medical devices:

• documentary inspection;
• onsite inspection;
• selective control;
• test purchase;
• inspection visit;
• safety monitoring.

Let us examine each type of control measure in more detail.

1. Documentary Inspection.

A documentary inspection is conducted at the location of the control body. The duration is 10 working days. The subject of such an inspection is documents available to the control body or received from the controlled entity. During the inspection, the control body may perform the following actions: obtaining written explanations, requesting documents, and conducting an expert examination. The deadline for complying with a Roszdravnadzor request for documents or written explanations is 10 working days from the date of receipt.

2. Onsite Inspection.

An onsite inspection is conducted at the location of the controlled person. The duration is 10 working days. Decree No. 1066 establishes limits on the total duration of interaction with the supervisory body:

• for small enterprises: no more than 50 hours;
• for micro-enterprises: no more than 15 hours.

The control body sends a copy of the decision to conduct the inspection to the controlled person 24 hours before it begins. Onsite inspections are generally conducted if the control body has information about potential harm (damage), upon a prosecutor's demand, or after the expiration of the deadline for eliminating previously identified violations. During the inspection, the control body may perform the following actions: inspection, questioning, obtaining written explanations, requesting documents, sampling, testing, and expert examination. Sampling of medical devices is performed in the presence of the controlled person's authorized representative, with a mandatory protocol prepared according to the approved form.[5]

3. Selective Control.

Selective control involves sampling and instrumental examination to assess the safety and quality of medical devices. It is conducted at the locations of their use, storage, and operation. During the control, the authorities may conduct an inspection, obtain written explanations, request documents, take samples, perform instrumental examinations, tests, and expert examinations. Decree No. 1066 does not establish regulated timeframes for this. Results are sent to the controlled person within 24 hours of their receipt.

4. Test Purchase.

The subject of a test purchase is verifying compliance with the prohibition on the sale of falsified, substandard, and counterfeit medical devices. A test purchase is conducted only if it is the only way to verify compliance with mandatory requirements.

A test purchase is performed without prior notice in the presence of two witnesses or with video recording. Remote purchases (using the Internet, postal services, etc.) are permitted. After completion (except for remote purchases), the official announces the test purchase, presents their service ID, and provides a copy of the decision to the controlled person. The funds spent must be returned to the official, and the purchased medical devices returned to the employee of the controlled person. If no violations are discovered, an unscheduled inspection on the same grounds cannot be conducted.

5. Inspection Visit.

An inspection visit is carried out without prior notice at the location (place of activity) of the controlled person. The duration is 1 working day. During the inspection, the control body may perform the following actions: inspection, questioning, obtaining written explanations, and requesting documents. Sampling, expert examinations, and tests are not performed.

Preventive Measures

In addition to control measures, Roszdravnadzor may conduct preventive measures to prevent legislative violations:

• informing;
• generalization of law enforcement practice;
• issuing a warning;
• counseling;
• preventive visit.

Counseling is provided during personal visits, upon receipt of a written request, or during a preventive visit. Written requests are considered in the manner provided by the Federal Law On the Procedure for Considering Appeals from Citizens of the Russian Federation.

A preventive visit is conducted as a preventive conversation at the controlled person's location or via video conferencing. Preventive visits are mandatory for persons classified as significant risk or those who began MD circulation activities during the year. The person must be notified 5 working days in advance and has the right to refuse no later than 3 working days prior. Prescriptions are not issued based on the results of a preventive visit.

A warning is issued if the State Control body receives information about imminent violations or signs thereof. A person who receives a warning may submit an objection with a justification of their position within 15 working days. The State Control body must send a reasoned response within 20 working days of considering the objection.

Reporting Inspection Results

An inspection act is drawn up based on the results of the inspection. On the day the inspection ends, it is handed to the head of the inspected organization or another authorized person against a signature or sent by registered mail with acknowledgment of receipt.

If violations of mandatory requirements are identified during the control measures, a prescription is also issued specifying the necessary measures for their elimination and the deadlines for completion. Furthermore, Roszdravnadzor may decide to suspend the use of a medical device or, if circumstances pose a threat to the life and health of citizens and medical workers, withdraw it from circulation.

Pre-trial Appeal of Inspection Results

A pre-trial appeal procedure was introduced on July 1, 2021. The appeal is submitted electronically via the Unified Portal of State Services or regional portals and must be signed with an enhanced qualified electronic signature, except for appeals containing state secrets.

Decisions to conduct inspections, acts and prescriptions of the control body, and the actions of officials during control measures are subject to appeal. Attempts to challenge Roszdravnadzor information letters regarding the suspension or withdrawal of medical devices from circulation, or the conclusions of expert organizations, are common. In most cases, courts refuse these claims, stating that these documents are not non-normative acts and are not subject to challenge.[6] The Supreme Court of the Russian Federation adopted a similar position, stating that the issuance of information letters does not constitute an action to withdraw products from circulation and is not subject to challenge in this manner.[7]

The deadline for filing an appeal against a decision to conduct an inspection is 30 days, and against a prescription – 10 working days. A higher-ranking official (higher body) must consider the appeal within 20 working days of its registration. Monitoring the review and results is also possible through the State Services Portal.

Safety Monitoring of Medical Devices

Safety monitoring of medical devices is a type of State Control. Under Part 1 of Article 96 of Law No. 323-FZ, all medical devices subject to circulation in the Russian Federation must undergo safety monitoring. Monitoring includes the collection, processing, registration, and analysis of information on adverse events related to the circulation of medical devices, and the adoption of relevant decisions. The classifier of potential adverse events was approved by Ministry of Health of Russia Order No. 4513 dated May 20, 2021.[8]

The purpose of monitoring is to identify and prevent:

• adverse actions not specified in the instructions for use or the operating manual of the medical device;
• undesirable reactions during its use;
• specifics of interactions between medical devices;
• facts and circumstances creating a threat to the life and health of citizens and medical workers during the use and operation of medical devices.

Ministry of Health of Russia Order No. 980n dated September 15, 2020, establishes the procedure for monitoring medical devices circulating in the Russian Federation.[9] An exception is the monitoring of medical devices registered under EAEU legislation, which is conducted according to the Decision of the Eurasian Economic Commission Board No. 174 dated December 22, 2015.[10]

Safety monitoring of medical devices is carried out based on:

• reports from medical device circulation entities (medical and other organizations, MD users, etc.);
• information received from medical device manufacturers;
• information obtained during State Control over the circulation of medical devices;
• information posted on the official websites of MD regulatory bodies;
• information obtained from specialized medical information systems regarding implantable medical devices.

Procedure for Reporting Identified Adverse Events

Part 3 of Article 96 of Law No. 323-FZ obliges medical device circulation entities to report all identified adverse events at all stages of the circulation of the corresponding medical device in the Russian Federation and other states. Ministry of Health of Russia Order No. 1113n dated October 19, 2020 (the "Procedure" or "Order No. 1113n"), regulates the reporting procedure.[11]

According to Clause 11 of the Procedure, organizations involved in MD circulation must appoint a person responsible for the safety monitoring of medical devices. This person's duties include collecting and sending information on adverse events to Roszdravnadzor, monitoring Roszdravnadzor information letters, and implementing the measures specified therein (withdrawal from use, placement in a quarantine zone). An order or another local act defines the detailed workflow and duties of the responsible official.

The person who identifies an adverse event must send a report to Roszdravnadzor within 20 working days of the identification. The report must contain information about the reporting person, details of the medical device, a description of the adverse event, and data on the affected person. Appendix No. 1 to Order No. 1113n establishes the full list of requirements for the report content. This form is mandatory for all circulation entities.

Reports can be submitted in several ways:

• online on the Roszdravnadzor website via the "Safety Monitoring of Medical Devices" automated system;
• via the Roszdravnadzor mobile application;
• via the "Gosuslugi" portal;
• in hard copy to the Roszdravnadzor address (if Internet access is unavailable).

According to Roszdravnadzor, the preferred method for submitting adverse event reports is uploading data via the agency's website. The procedure for registration in the AIS is explained in Roszdravnadzor Information Letter No. 04I-749/12 dated August 15, 2012.

Medical organizations that identify an adverse event must also inform the manufacturer and provide them with access to the medical device.

Medical device manufacturers must additionally submit the following reports:

• an initial report on the adverse event;
• a report on corrective actions.

Appendices No. 2 and 3 to Order No. 1113n provide the requirements for these reports. To protect human life and health, initial reports must be submitted within shortened timeframes:

Grounds	Timeframes
In case of a serious threat to health	Immediately, but no later than 2 calendar days after the threat became known
In case of death or an unforeseen serious deterioration of a user's health	Immediately after the manufacturer established a link to the event, but no later than 10 calendar days after the event became known
In other cases	Immediately after the manufacturer established a link to the event, but no later than 30 calendar days after the event became known

Based on the results of corrective actions, the medical device manufacturer issues a safety notice, which is posted on the manufacturer's website and submitted to Roszdravnadzor.

Clinical monitoring has been introduced for high-risk medical devices (Class 3) and high-risk implantable devices (Class 2b). Specifically, the manufacturer must collect safety and clinical efficacy information for these MDs for three years after receiving the Marketing Authorization and submit a clinical monitoring report to Roszdravnadzor by February 1 each year (requirements in Appendix 3 to Order No. 1113n).

As of May 11, 2021, Article 38 of Law No. 323-FZ was supplemented with Part 3.1, establishing an obligation for MD manufacturers (their authorized representatives) and persons importing medical devices into the Russian Federation to notify Roszdravnadzor of the introduction of a medical device into circulation. Roszdravnadzor Order No. 11020 dated November 25, 2021, regulates the notification procedure.[12] Thus, from March 1, 2022, these persons must submit information regarding each series (batch) number and serial (identification) number produced or imported into the Russian Federation within 15 working days of the date of introduction into circulation. This information is provided through the AIS Roszdravnadzor personal account.

All persons involved in the circulation of medical devices must strictly comply with these requirements. Failure to submit information, late submission, or submission of deliberately unreliable information entails administrative liability under Article 19.7.8 of the CAO RF, with fines on officials from 10,000 to 15,000 rubles and on legal entities from 30,000 to 70,000 rubles. Furthermore, concealing information about circumstances that create a danger to human life or health carries the risk of criminal liability under Article 237 of the Criminal Code of the Russian Federation.

Procedure for Monitoring by Roszdravnadzor

Roszdravnadzor registers received appeals on the day of their receipt. Then, within 5 working days of registration, it:

• notifies the manufacturer (authorized person) of the need to provide a reasoned position on the identified facts. The submission deadline is 10 working days. If necessary, reports on adverse events and corrective actions are attached;
• sends the information to an expert organization (FSBI "VNIIMT" of Roszdravnadzor, FSBI "TsMIKEE" of Roszdravnadzor).

The expert organization must provide the state body with an expert opinion on whether a causal link exists between the use of the MD and the development of adverse consequences and, if necessary, an expert report.

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

• on conducting control measures or on the absence of grounds for such measures;
• on the need to suspend the use or circulation of the medical device.

If the control measures confirm that harm was caused to life and health, the manufacturer must develop and coordinate a program of measures to prevent such harm, including measures to notify of the threat. If no measures are taken, Roszdravnadzor may decide to withdraw the medical device from circulation.

The control exercised by Roszdravnadzor is undoubtedly important for ensuring safety in use and preventing the circulation of substandard, counterfeit, and falsified medical devices. The transition to a risk-oriented approach will certainly have a positive impact on control activities by moving away from formalized inspection measures. At the same time, we should note that a significant number of regulatory acts currently establish mandatory requirements for the circulation of medical devices. This complicates law enforcement practice and control and oversight activities. Adopting a law on the circulation of medical devices to systematize circulation rules would help solve this problem.

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References

[1] Government Decree No. 1066 dated June 30, 2021, On Federal State Control (Oversight) over the Circulation of Medical Devices.

[2] Federal Service for Surveillance in Healthcare Order No. 4043 dated April 27, 2017, On Approval of the List of Legal Acts and Their Individual Parts (Provisions) Containing Mandatory Requirements, Compliance with Which is Assessed During Control Measures within a Separate Type of State Control (Oversight) (as amended on March 4, 2019).

[3] Federal Service for Surveillance in Healthcare Order No. 10449 dated December 20, 2017, On Approval of Checklist Forms (Lists of Control Questions) Used by the Federal Service for Surveillance in Healthcare and its Territorial Bodies During Scheduled Inspections when Exercising State Control over the Circulation of Medical Devices.

[4] Ministry of Health of Russia Order No. 503n dated May 24, 2021, On Approval of the Risk Indicator for the Violation of Mandatory Requirements Used by the Federal Service for Surveillance in Healthcare in the Exercise of Federal State Control (Oversight) over the Circulation of Medical Devices.

[5] Federal Service for Surveillance in Healthcare Order No. 7880 dated August 20, 2021, On Approval of the Form for the Protocol of Medical Device Sampling During Federal State Control (Oversight) over the Circulation of Medical Devices.

[6] Resolution of the Ninth Arbitration Appeal Court dated December 14, 2021, No. 09AP-73839/21 in Case No. A40-24897/2021.

[7] Ruling of the Supreme Court of the Russian Federation dated November 19, 2021, No. 305-ES21-21361 in Case No. A40-182593/2020.

[8] Ministry of Health of Russia Order No. 4513 dated May 20, 2021, On Approval of the Classification of Adverse Events Related to the Circulation of Medical Devices.

[9] Ministry of Health of Russia Order No. 980n dated September 15, 2020, On Approval of the Procedure for Carrying Out Safety Monitoring of Medical Devices.

[10] Decision of the Eurasian Economic Commission Board No. 174 dated December 22, 2015, On Approval of the Rules for Carrying Out Monitoring of the Safety, Quality, and Efficiency of Medical Devices.

[11] Ministry of Health of Russia Order No. 1113n dated October 19, 2020, On Approval of the Procedure for Reporting by Medical Device Circulation Entities of All Cases of Identifying Adverse Actions Not Specified in the Instructions for Use or Operating Manual of a Medical Device, of Undesirable Reactions During Its Use, of Specifics of Interactions Between Medical Devices, of Facts and Circumstances Creating a Threat to the Life and Health of Citizens and Medical Workers During the Use and Operation of Medical Devices.

[12] Federal Service for Surveillance in Healthcare Order No. 11020 dated November 25, 2021, On Approval of the Procedure for the Submission of Information by a Medical Device Manufacturer (Manufacturer) (Its Authorized Representative) or a Person Importing Medical Devices into the Russian Federation to the Authorized Federal Executive Body Exercising Functions for Control and Oversight in the Sphere of Health Protection.