Decision of the Board of the Eurasian Economic Commission dated December 22, 2015 No. 174

"On the Approval of the Rules for Monitoring the Safety, Quality, and Effectiveness of Medical Devices"

BOARD OF THE EURASIAN ECONOMIC COMMISSION

DECISION

of December 22, 2015 N 174

ON THE APPROVAL OF THE RULES

MONITORING OF SAFETY, QUALITY

AND EFFECTIVENESS OF MEDICAL DEVICES

In accordance with paragraph 2 of Article 31 of the Treaty on the Eurasian Economic Union of May 29, 2014, paragraph 2 of Article 8 of the Agreement on common principles and rules of circulation of medical devices (medical devices and medical equipment) within the Eurasian Economic Union of December 23, 2014, paragraph 25 of Annex N 2 to the Regulations of the Eurasian Economic Commission, approved by the decision of the Supreme Eurasian Economic Council of December 23, 2014 N 98, and in order to implement the decision of the Supreme Eurasian Economic Council of December 23, 2014 N 98
1. To approve the attached Rules for monitoring the safety, quality and effectiveness of medical devices.
2. This Decision shall enter into force 30 calendar days after the date of entry into force of the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices (Medical Devices and Medical Equipment) within the Eurasian Economic Union of December 23, 2014 or after the date of entry into force of the Protocol signed on December 2, 2015, on the accession of the Republic of Armenia to the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices (Medical Devices and Medical Equipment) within the Eurasian Economic Union of December 23, 2014.

Chairman of the Board

Eurasian Economic Commission

V. CHRISTENKO

Approved

By the decision of the Board of the Eurasian

economic commission

of December 22, 2015 N 174

RULES.

MONITORING OF SAFETY, QUALITY

AND EFFECTIVENESS OF MEDICAL DEVICES

1. These Rules are developed in accordance with paragraph 2 of Article 31 of the Treaty on the Eurasian Economic Union of May 29, 2014 and paragraph 2 of Article 8 of the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices (Medical Devices and Medical Equipment) within the Eurasian Economic Union of December 23, 2014 and establish the procedure for monitoring the safety, quality and effectiveness of medical devices (hereinafter - monitoring).
2. The objectives of monitoring are to ensure the safety of users, to preserve and promote public health, to improve the quality of medical care, to identify and prevent adverse actions and adverse reactions not specified in the instructions for use or instruction manual of a medical device (hereinafter - instructions for use), adverse events (incidents), circulation of medical devices that do not meet the general safety and effectiveness requirements approved by the Eurasian Economic Commission.
3. Monitoring includes collecting, recording, analyzing information on adverse events (incidents) and taking appropriate decisions.
4. Monitoring is based on:
a) analysis of reports on adverse events (incidents) at all stages of medical devices circulation within the Eurasian Economic Union (hereinafter - the Union) received:
from medical device users;
from medical device manufacturers;
when the authorized bodies of the Union Member States exercise state control (supervision) over the circulation of medical devices;
b) analysis of periodic reports on safety and clinical efficacy of medical devices of potential risk class 3, as well as medical devices of potential risk classes 2b and 3 implanted in the human body at the post-registration stage, received from manufacturers of medical devices or their authorized representatives;
c) a system for collecting and analyzing data from the manufacturer of medical devices on the safety and efficacy of medical devices at the post-sale stage and conducting corrective actions in accordance with the requirements for the implementation, maintenance and evaluation of the quality management system of medical devices depending on the potential risk of use, approved by the Eurasian Economic Commission.
5. For the purposes of these Regulations, the terms used shall mean the following:
"corrective action" - An action taken by a manufacturer of medical devices to eliminate the cause of a detected nonconformity or adverse event;
"medical device safety corrective action" means an action taken by a medical device manufacturer to reduce the risk of death or serious impairment of the health of users or third parties associated with the use of a medical device. Such actions may include:
return of the medical device to the manufacturer of medical devices or its authorized representative;
modification of a medical device (modernization in accordance with changes in the design of the medical device made by the manufacturer of medical devices, changes in instructions for use, updating of the medical device software);
replacement of a medical device;
withdrawal of a medical device from circulation;
destruction of a medical device;
informing about actions of medical device users in case a medical device is withdrawn from circulation, but there is a probability of its use;
"adverse event (incident)" - any malfunction and (or) deterioration of the characteristics or malfunction of the medical device, or insufficiency or incorrectness of the accompanying information (documentation) for the medical device, or an adverse effect not specified in the instructions for use, which directly or indirectly resulted or could have resulted in death or serious deterioration of the health condition of users or third parties (whereby serious deterioration of the health condition is understood to mean a life-threatening illness, permanent impairment of an organism function, or
"adverse event" means any undesirable medical event, unpredictable illness or injury, or undesirable clinical signs (including abnormal laboratory values) in users or third parties related to the use of a medical device;
"user" means a patient, medical professional, or any other individual who uses a medical device for the intended purpose specified by the medical device manufacturer;
"reference state" - a member state of the Union chosen by the applicant, whose authorized body carries out registration of a medical device;
"serious health risk" means any malfunction and/or impairment or malfunction of a medical device, or insufficient or incorrect accompanying information (documentation) for a medical device, or adverse effect not specified in the instructions for use, which has resulted or may result in an imminent risk of death, life-threatening illness, irreversible impairment of bodily function, permanent damage to bodily structure or condition requiring medical or surgical intervention.
"accompanying information (documentation)" - labeling, instructions for use and other information related to the identification, description, purpose, rules of operation of the medical device, except for shipping documents;
"subjects of circulation of medical devices" - organizations established in accordance with the established procedure in the member states of the Union, or representative offices of foreign organizations accredited in accordance with the established procedure in the member states of the Union, or individual entrepreneurs registered in the member states of the Union, or individuals carrying out technical tests, research (tests) to assess the biological effect, clinical trials, expert examination of safety, quality and effectiveness of medical devices, their reg
"medical device safety notification" means a communication sent by a medical device manufacturer or its authorized representative to the subjects of medical device circulation in connection with a corrective action on the safety of a medical device;
"authorized representative of the manufacturer" - a legal entity or an individual registered as an individual entrepreneur, who are residents of a Member State of the Union, authorized on the basis of a power of attorney of a manufacturer of medical devices to represent its interests and bear responsibility on the issues of circulation of medical devices within the Union and fulfillment of mandatory requirements for medical devices.
6. The manufacturer of medical devices or its authorized representative shall be obliged to submit to the authorized body of the Member State of the Union, in whose territory the adverse event (incident) occurred, a report on the adverse event (incident) (hereinafter - incident report) and a report on corrective actions on the safety of the medical device (hereinafter - corrective action report) in the forms according to Annexes N 1 and 2 by filling them out on the information resource of the authorized body of the Member State of the Union in the information and telecommunication system.
The initial incident report shall be sent within the following timeframes:
in the case of a serious health threat immediately (without undue delay), but no later than 2 calendar days after the manufacturer of the medical device becomes aware of the threat;
in case of death or unexpected serious deterioration of the user's health - immediately (without undue delay) after the medical device manufacturer has established a link between the use of the medical device and the event, but no later than 10 calendar days after the medical device manufacturer becomes aware of the event;
in other cases, immediately (without undue delay) after the medical device manufacturer has established a link between the use of the medical device and the event, but no later than 30 calendar days after the medical device manufacturer becomes aware of the event.
Medical organizations operating in the sphere of medical devices circulation shall inform the manufacturer of medical devices or its authorized representative about undesirable events that have signs of an adverse event (incident), as well as provide access to medical devices with which the said events may be associated.
Reports on an adverse event (incident) shall be sent to the authorized body of the Member State of the Union, in the territory of which the specified event occurred, by any subjects of circulation of medical devices, including those involved in their use (users, health care organizations), in the form of a notification of an adverse event (incident) according to Annex N 3. The notification shall be filled in by typewriting or handwriting in the Russian language and (or) the state language of the Member State of the Union.
The notice shall contain accurate information supported by relevant documents, copies of which shall be attached to the notice.
7. The authorized body of the Member State of the Union on whose territory the adverse event (incident) occurred shall register the initial incident report received, inform the manufacturer of medical devices or its authorized representative of the receipt of the said report and agree with it the deadlines for submission of the subsequent or final incident report, as well as the deadlines for submission of the initial, subsequent (if necessary) and final corrective action reports.
The manufacturer of medical devices or its authorized representative has the right to perform corrective actions before sending the initial report on corrective actions to the authorized body of the Member State of the Union, in the territory of which the adverse event (incident) occurred, in urgent cases of protection of users or third parties from the threat of death or serious deterioration of health condition. In this case, the initial report on corrective actions shall be sent to the authorized body of the Member State of the Union not later than 2 calendar days after the manufacturer of medical devices or its authorized representative has performed the corrective actions.
8. In case the manufacturer of medical devices or its authorized representative has no possibility to investigate an adverse event (incident), it shall without delay notify the authorized body of the Member State of the Union, in the territory of which the said event (incident) occurred.
9. The manufacturer of medical devices or its authorized representative shall have the right to apply to the authorized body of the Member State of the Union, in the territory of which the adverse event (incident) occurred, for assistance in access to the medical device to determine the relationship of the medical device to the undesirable event and compliance of the undesirable event with the criteria of the adverse event (incident) as soon as possible.
10. If several manufacturers of medical devices are involved in the process of investigation of an adverse event (incident), the authorized body of the Member State of the Union shall coordinate their actions.
11. The authorized body of the Member State of the Union, on whose territory the adverse event (incident) occurred, shall inform the manufacturer of medical devices or its authorized representative and the authorized bodies of other Member States of the Union about the results of consideration of the said reports not later than 30 working days from the date of receipt from the manufacturer of medical devices or its authorized representative of the final report on the incident, the final report on corrective actions.
The authorized bodies of the Union Member States shall be informed through the use of the information system of the Union in the sphere of circulation of medical devices.
12. According to the results of corrective actions on medical device safety, the manufacturer of medical devices or its authorized representative shall be obliged to issue a notification on medical device safety in the form according to Annex N 4 and communicate it to users.
13. Incident reports, reports on corrective actions and notification on safety of a medical device shall be placed by the authorized body of the Member State of the Union, in the territory of which the adverse event (incident) occurred, in the unified information database for monitoring safety, quality and effectiveness of medical devices.
14. With regard to adverse events (incidents) related to medical devices registered in the territory of the Union and occurred in non-member states, the manufacturer of medical devices or its authorized representative shall send notifications on the safety of medical devices to the authorized body of the reference state.
The authorized body of the reference state shall place the received notification on the safety of a medical device in the unified information database for monitoring the safety, quality and effectiveness of medical devices.
15. Incident reports may not be submitted to the authorized body of a Member State of the Union:
a) for each individual adverse event (incident) from those described in the medical device safety notifications and occurred after investigation of adverse events (incidents) and dispatch of such notifications by the manufacturer of medical devices or his authorized representative and corrective actions. Instead, the manufacturer of medical devices or its authorized representative may agree with the authorized body of the Member State of the Union on the possibility of periodic submission of consolidated reports on the specified adverse events (incidents), as well as their content and terms of submission;
b) for each individual adverse event (incident) from among frequently occurring and documented adverse events (incidents) (identified as such in the medical device risk analysis, on which reports have already been submitted, analyzed by the manufacturer of medical devices or its authorized representative and the authorized body). Periodic summary reports may be submitted instead. The content and timing of submission of periodic consolidated reports shall be agreed with the authorized body of the Member State of the Union;
c) adverse events (incidents) related to obvious defects of medical devices, which the user can always detect immediately before using the medical device;
d) adverse events (incidents) that did not result in serious impairment of health or death due to the design features that protect against endangerment due to a medical device malfunction;
e) expected and foreseeable adverse events (incidents) that meet all of the following criteria simultaneously:
adverse events (incidents) are clearly identified in the accompanying information (documentation) for the medical device;
Adverse events (incidents) are well known in clinical practice and can be qualitatively and quantitatively predicted if the medical device is used and functions as intended;
adverse events (incidents) are documented in the technical documentation for the medical device with an appropriate risk assessment performed before the adverse event (incident) occurred;
Adverse events (incidents) are clinically acceptable in terms of the benefit of the medical device for each individual patient;
e) if the risk of death or serious impairment has been analyzed and found to be negligible, if neither death nor serious impairment has occurred and the risk has been characterized and documented as acceptable in the risk analysis report submitted as part of the registration dossier when the medical device is registered.
16. The manufacturer of medical devices or its authorized representative shall report to the authorized body of a Member State of the Union on errors made in the use of medical devices which have resulted in death or serious deterioration of the user's health condition.
17. Upon receipt of reports on undesirable events from the authorized body of the Member State of the Union, the manufacturer of medical devices or its authorized representative shall check the information received for compliance with the criteria of an adverse event (incident) and send reports on the incident and corrective actions to the authorized body of the Member State of the Union, in the territory of which the undesirable event occurred.
In the event that, according to the assessment of the manufacturer of medical devices or its authorized representative, an undesirable event does not meet the criteria of an adverse event (incident), the manufacturer of medical devices or its authorized representative shall submit to the authorized body of the Member State of the Union, in the territory of which the undesirable event occurred, a justification that the said event is not an adverse event (incident).
18. Notification on safety of a medical device shall be sent by the manufacturer of medical devices or its authorized representative using information and telecommunication means of communication ensuring its receipt by the organizations concerned with confirmation of receipt.
19. For medical devices of potential application risk class 3, as well as medical devices implanted in the human body of potential application risk class 2b, the manufacturer of medical devices or its authorized representative is obliged to conduct post-registration clinical monitoring of safety and efficacy of medical devices (hereinafter - post-registration clinical monitoring) and annually, within 3 years, submit reports on post-registration clinical monitoring to the authorized body of the reference state.
Initial, subsequent and final reports on post-registration clinical monitoring shall be submitted by the manufacturer of medical devices or its authorized representative to the authorized body of the reference state not later than February 1, starting from the year following the year of obtaining the registration certificate.
20. Post-registration clinical monitoring shall be conducted in accordance with the plan included in the report on clinical evidence of efficacy and safety of the medical device submitted by the manufacturer of the medical device or its authorized representative as part of the registration dossier upon registration of the medical device.
21. The post-registration clinical monitoring plan must contain:
(a) Goals and objectives of post-registration clinical monitoring, taking into account available clinical data, specific features and risk factors associated with the medical device;
b) the scheme of post-registration clinical monitoring, including justification of methods (methods) of obtaining and statistical analysis of clinical data, selection of the study population, inclusion (exclusion) criteria and minimum number of subjects in the study group and, where applicable, the need to include comparison groups in the study.
22. Reports on post-registration clinical monitoring of safety and efficacy of medical devices in the form according to Annex N 5 shall be submitted by the manufacturer of medical devices or its authorized representative to the authorized body of the reference state using the information resource of the authorized body of the reference state in the Internet.
23. The authorized body of the reference state has the right to engage an expert organization to analyze reports on post-registration clinical monitoring. Based on the expert opinion, the authorized body of the reference state has the right to make a decision on the need for corrective actions by the manufacturer of medical devices.
24. Reports on post-registration clinical monitoring shall be sent by the authorized body of the reference state for expertise to the expert organization.
25. The expert organization no later than 20 working days from the date of receipt of the report on post-registration clinical monitoring shall send to the authorized body of the reference state a conclusion on the possibility (impossibility) to complete the post-registration clinical monitoring.
26. Based on the expert opinion, the authorized body of the reference state shall take one of the following decisions:
(a) On completion of post-registration clinical monitoring;
b) on prolongation of post-registration clinical monitoring with indication of additional term, if the obtained data are insufficient to confirm safety and efficacy of the medical device or the manufacturer of medical devices has not taken necessary corrective actions based on the obtained data;
c) on suspension of the validity of the registration certificate of the medical device and extension of post-registration clinical monitoring with indication of additional term;
d) cancellation (withdrawal, annulment) of the registration certificate and, if necessary, withdrawal of the medical device from circulation.
27. The authorized body of the reference state shall not later than 10 working days from the date of its decision in accordance with paragraph 26 of these Rules inform the manufacturer of medical devices about it.
28. In case the manufacturer of medical devices or its authorized representative became aware of an adverse event (incident) but failed to report it to the authorized body of the Member State of the Union, in the territory of which the adverse event (incident) occurred, or violated the deadlines established for reporting, the said authorized body shall have the right to suspend the validity of the registration certificate of the medical device issued by it and conduct its own investigation of the adverse event (incident) or suspend the validity of the registration certificate of the medical device.
29. In case the manufacturer of medical devices or its authorized representative has not submitted to the authorized body of the Member State of the Union, in the territory of which the adverse event (incident) occurred, a subsequent or final incident report, the said authorized body, after notifying the manufacturer of medical devices or its authorized representative of this violation, shall have the right to suspend the validity of the registration certificate of the medical device issued by it or to take a decision to initiate the procedure of
30. If the manufacturer of a medical device or its authorized representative fails to submit the initial, subsequent or final report on post-registration clinical monitoring to the authorized body of the reference state, the said authorized body, after notifying the manufacturer of the medical device or its authorized representative of this violation, shall have the right to suspend the validity of the registration certificate of the medical device or decide to initiate the procedure for its cancellation (revocation, withdrawal, revocation of the registration certificate).

Annex N 1

to the Rules for monitoring

Safety, quality and efficiency

medical devices