Decision of the Board of the Eurasian Economic Commission dated February 12, 2016 No. 29
(as amended on January 26, 2024)
«On the Rules for the Conduct of Clinical and Clinical-Laboratory Trials (Research) of Medical Devices»

COUNCIL OF THE EURASIAN ECONOMIC COMMISSION

DECISION

dated February 12, 2016. N 29

ABOUT THE RULES

CONDUCTING CLINICAL AND CLINICAL-LABORATORY TRIALS

(RESEARCH) OF MEDICAL DEVICES

List of amending documents (ed. decisions of the Council of the Eurasian Economic Commission from 24.12.2021 N 146, from 26.01.2024 N 7)

In accordance with paragraph 2 of Article 31 of the Treaty on the Eurasian Economic Union of May 29, 2014, paragraphs 4 and 5 of Article 4 of the Agreement on Uniform Principles and Rules of Circulation of Medical Devices (Medical Devices and Medical Equipment) within the Eurasian Economic Union of December 23, 2014, paragraphs 105 and 106 of Annex N 1 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 Decision of the Supreme Eurasian Economic Council of December 23, 2014

1. To approve the attached Rules for conducting clinical and clinical-laboratory tests (trials) of medical devices.

2. To establish that for medical devices of potential risk classes 3, 2b and implantable medical devices (except for medical devices for in vitro diagnostics and software, which is a medical device) clinical trials (research) for registration purposes, if it is not proved that clinical efficacy and safety of the claimed medical device can be confirmed in another way, shall be conducted in the form of multicenter trials (research) and comply with one of the following conditions

(in edition of the decision of the Council of the Eurasian Economic Commission from 26.01.2024 N 7)

a) clinical trials (studies) were conducted in accordance with the legislation of the member states of the Eurasian Economic Union and on their territories before January 1, 2022 (by the date of the last visit of the last patient or subject of the trial (study)) or continued to be conducted as of January 1, 2022 (in case of completed patient enrollment);

(in edition of the decision of the Council of the Eurasian Economic Commission from 24.12.2021 N 146)

b) clinical trials (studies) were conducted in the territories of states that are not members of the Eurasian Economic Union before January 1, 2022 (according to the date of the last visit of the last patient or subject of the trial (study)) or continued as of January 1, 2022 (in case of completed patient enrollment) in accordance with recommendations of the International Medical Device Regulators Forum (IMDRF);

(in edition of the decision of the Council of the Eurasian Economic Commission from 24.12.2021 N 146)

c) clinical trials (studies) initiated after January 1, 2022 were conducted in accordance with the law of the Eurasian Economic Union, with one of the clinical trials (studies) conducted in one of the member states of the Eurasian Economic Union.

(in edition of the decision of the Council of the Eurasian Economic Commission from 24.12.2021 N 146)

(3) This Decision shall enter into force upon expiration of 10 calendar days from 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, but not earlier than upon expiration of 10 calendar days from the date of official publication of this Decision.

Members of the Council of the Eurasian Economic Commission:

From the Republic of ArmeniaV.GABRIELYAN

From the Republic of BelarusV.MATYUSHEVSKY

From the Republic of KazakhstanB. SAGINTAEV

From the Kyrgyz RepublicO. PANKRATOV

From the Russian FederationI. SHUVALOV

Approved

By decision of the Council

Eurasian Economic Commission

dated February 12, 2016. N 29

RULES.

CONDUCTING CLINICAL AND CLINICAL-LABORATORY TRIALS

(RESEARCH) OF MEDICAL DEVICES

List of amending documents (ed. Decision of the Council of the Eurasian Economic Commission dated 26.01.2024 N 7)

I. General provisions

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, paragraphs 4 and 5 of Article 4 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 within the Eurasian Economic Union (hereinafter — the Union) the rules for clinical and clinical-laboratory tests (studies) of medical devices.

2. For the purposes of these Regulations, the terms used shall mean the following:

«analyte» is a sample component with a measurable property;

«analytical performance of an in vitro diagnostic medical device» means the ability of an in vitro diagnostic medical device to detect the presence or determine the content of a particular analyte in a biological sample;

«biological reference population» — a homogeneous population of individuals in a well-defined state of health or disease;

«investigator’s brochure» — a summary of relevant clinical and non-clinical information about the medical device under test (investigational) related to the clinical trial (study) or clinical-laboratory trial (research) (when conducting an interventional clinical efficacy trial);

«principal investigator» — a qualified person responsible for conducting a clinical or clinical-laboratory trial (study). In case the trial (research) is conducted by a team of investigators, the head of this team is the principal investigator;

«double-blind method» — a procedure of clinical trials (research) in which subjects of trials (research) and researchers involved in obtaining and processing primary data are not aware of the actual application to the subjects of trials (research) of the effects of a medical device;

«clinical trial (study) design» — a methodology for conducting a clinical trial (research) involving a human subject in a trial (research) with the help of which it is planned to obtain statistically reliable evidence of clinical safety and efficacy of a test (investigational) medical product, including the use of control groups of test (research) subjects, and (or) distribution of test (research) subjects into groups randomly, and (or) use of single or double-blind method, as well as the choice of the main methodology of clinical trial (research) design.

«additional endpoint» — indicator(s) used to test an additional hypothesis of a clinical trial (study);

«legal representative» — a natural or legal person who, in accordance with the legislation of a Member State of the Union, has the right to give informed consent to participate in a clinical or clinical-laboratory (when conducting an interventional clinical efficacy trial) trial (research) on behalf of a potential subject of the trial (research);

«applicant» — the manufacturer of the medical device or its authorized representative;

«individual registration card» — a document designed to record all information provided by the trial (research) program about each trial (research) subject;

«interventional clinical efficacy study» means a study of the clinical effectiveness of an in vitro diagnostic medical device, the results of which influence patient management decisions and/or are used in the management of treatment to achieve the objectives of the clinical trial;

«informed consent» — a written document in which the subject of a trial (research) or his/her legal representative confirms voluntary consent to participate in clinical or clinical-laboratory (in case of interventional clinical efficacy trials) trials (research) based on the full information provided to him/her about the clinical or clinical-laboratory trial (research);

«test (investigational) medical device» — a medical device that is evaluated for safety and (or) efficacy in the course of a clinical trial (research) or clinical and laboratory tests (research) for in vitro diagnostic medical devices;

«investigator» means a member of the investigational team designated by the principal investigator to perform basic procedures related to the clinical or clinical-laboratory trial(s) or to make decisions related to the clinical or clinical-laboratory trial(s) and reporting to the principal investigator;

«clinical and laboratory tests (studies) of an in vitro diagnostic medical device» means systematic tests (studies) of analytical performance and, where applicable, clinical efficacy conducted to establish or confirm the conformity of an in vitro diagnostic medical device with the intended use as specified by the manufacturer;

«clinical efficacy of an in vitro diagnostic medical device» means the ability of an in vitro diagnostic medical device to show results that correlate with a specific clinical or physiologic condition in a target population when administered to the intended user;

«clinical data» — data on safety and (or) efficacy obtained during clinical use of a medical device. Clinical data may be obtained by searching the scientific literature for data on the medical device, from the experience of clinical use of the medical device, as a result of clinical or clinical-laboratory tests (studies), through the application of several of these methods or otherwise. Clinical data are also data on safety and (or) efficacy obtained during clinical use of medical devices, the equivalence of which to the medical device under consideration can be proved;

«clinical evidence of efficacy and safety of a medical device» means a set of clinical data confirming the clinical efficacy and safety of a medical device when used as intended by the manufacturer and their evaluation;

«clinical evidence of efficacy and safety of an in vitro diagnostic medical device» means a set of data confirming the scientific validity of the analyte, analytical efficiency and clinical effectiveness of an in vitro diagnostic medical device when used for its intended purpose as established by the manufacturer, and their evaluation;

«clinical trial (research) of a medical device» — any trial (research) involving a human being as a subject of the trial (research), conducted for the purpose of studying the safety and (or) efficacy of the tested (investigated) medical device;

«ethics committee» — an independent expert body that acts in accordance with these Rules and the legislation of the Union Member State and considers issues of ensuring the rights, safety and health protection of trial (research) subjects;

«control medical device» — a device used in a clinical trial (study) for comparison with the tested (investigational) medical device;

«research coordinator» — a researcher appointed by the applicant and responsible for coordinating work during a multicenter clinical (clinical-laboratory) trial (research);

«medical organization (clinical center)» — an organization acting as a research center in conducting clinical (clinical and laboratory) trials (research);

«multicenter trial (study)» — a clinical (clinical and laboratory) trial (research) that is conducted in two or more medical organizations (clinical centers) under a single trial (research) program;

«clinical (clinical-laboratory) trial (study) monitoring» — an activity related to the observation of the progress of a clinical (clinical-laboratory) trial (study) to verify that data from the ongoing trial (study) are recorded and a monitoring report is generated in accordance with the trial (study) program, documented procedures, and these Rules;

«scientific validity of the analyte» — the relationship of the analyte to the clinical or physiologic state of the human body;

«single-blind method» — a procedure of clinical trials (research) in which subjects of trials (research) are not aware of the actual application to them of the effects of a medical product;

«primary endpoint» — indicator(s) used to test the primary hypothesis of a clinical trial (study);

«report on clinical and laboratory test (study) of a medical device» means a written description of a clinical and laboratory test (study) of a medical device with using samples and specimens, including those obtained by genetic engineering, combining clinical and laboratory and statistical descriptions, data presentation and analysis, according to the established form;

«report on a clinical trial (study) of a medical device» means a written description of a clinical trial (study) of a medical device involving a human being as a subject of the trial (study), combining clinical and statistical descriptions, data presentation and analysis, according to the established form;

«primary data» — any information in the form of original records or certified copies of original records of clinical facts, observations and other events during clinical (clinical and laboratory) trials (research), necessary for monitoring and evaluation of the results of clinical (clinical and laboratory) trials (research);

«intended user» — a specific group(s) of individuals identified in the accompanying documentation for a medical device who may use the medical device in accordance with its intended use;

«trial (study) program» — a document that establishes the rationale, objectives, clinical (clinical-laboratory) trial (study) design and intended analysis, methodology, monitoring, requirements for keeping records of the clinical (clinical-laboratory) trial (study), and describes the conduct of the clinical (clinical-laboratory) trial (study);

«trial (research) subject» — an individual participating in a clinical or clinical-laboratory (in the case of an interventional clinical efficacy trial) trial (study) as a member of the group to which the medical device under test (investigational) is applied, or as a member of the control group;

«technical file» — documented data confirming compliance of a medical device with the General Requirements for Safety and Effectiveness of Medical Devices, requirements for their labeling and operational documentation for them, approved by the Decision of the Council of the Eurasian Economic Commission dated February 12, 2016. N 27;

«vulnerable subjects of a trial (study)» — individuals whose willingness to participate in a clinical or clinical-laboratory (in the case of interventional clinical efficacy trials) trial (research) may be influenced by the expectation (justified or unjustified) of certain benefits associated with participation in the trial (research), or by possible sanctions from superiors in case of refusal to participate in the trial (research). Vulnerable trial (research) subjects include students of higher and secondary medical, pharmaceutical, and dental schools, junior staff of medical institutions and laboratories, military personnel, and prisoners, as well as patients with terminal illnesses, persons in nursing homes, low-income and unemployed persons, stateless persons, emergency patients, members of ethnic minorities, homeless persons, vagrants, refugees, minors, and persons under guardianship and custody.

Other concepts used in these Rules shall be applied in the meanings defined by the acts in the field of medical devices circulation included in the Union law.

II. Justification of clinical effectiveness and safety of medical devices, except for medical in vitro diagnostic products

3. To prove the clinical efficacy and safety of a medical device, the manufacturer must:

a) identify requirements from the General Requirements for Safety and Effectiveness of Medical Devices, requirements for their labeling and operational documentation for them (hereinafter — the General Requirements), evidence of compliance with which shall be based on clinical data;

b) identify clinical data related to the medical device and its intended use, which are obtained by searching the scientific literature, from experience in clinical use or from clinical trials (studies) of the medical device;

c) evaluate clinical data to determine whether they can be used to prove the clinical efficacy and safety of the medical device;

d) conduct clinical trials (studies) on those aspects of safety and efficacy of medical devices for which the available clinical data are insufficient;

e) analyze both favorable and unfavorable clinical data obtained by searching the scientific literature, from the experience of clinical use or as a result of clinical trials (studies), and make a reasonable conclusion on clinical evidence of efficacy and safety of the medical device in the form of a report. The analysis shall be carried out taking into account the class of potential risk of use, purpose and specific features of the use of the medical device. The report on clinical evidence of efficacy and safety of the medical device shall be coordinated with a specialist in the field of medical application of the medical device. Qualification of such specialist is confirmed by a document on education in the field of medicine and specialty in accordance with the field of medical application of the medical device (specialist certificate and (or) diploma, etc.), publications of the medical specialist (scientific articles, and (or) monographs, and (or) dissertations in the field of medical application of the medical device). The said report shall be a part of the documentation of the manufacturer of the medical device.

4 The substantiation of clinical efficacy and safety of a medical device is based on clinical data obtained during clinical trials (studies), for:

medical devices (except for software that is a medical device), unless it is proved that the clinical efficacy and safety of the claimed medical device can be confirmed in another way;

medical devices (except for software that is medical device), functional characteristics, principle of operation, purpose, indications for medical use or features of medical use of which have not been previously studied;

medical devices containing new materials in contact with the human body that have not been previously studied in terms of biological effect or known materials in contact with human organs or tissues for which there is no experience of their medical use, or if such contact is longer than previously studied.

Clinical trials (studies) of medical devices of potential risk classes 3, 2b and implantable medical devices (except for software which is a medical device) initiated after January 1, 2022 shall be conducted in the form of multicenter trials (studies), including in one of the Member States of the Union (hereinafter referred to as Member States).

5. Obtaining clinical data for software that is a medical device, including software with application of artificial intelligence technologies, shall be performed using medical data of patients verified by a medical organization (clinical center), obtained in the course of diagnosis, treatment, rehabilitation.

6. Clinical data obtained during clinical trials (research) or during the use of a medical device in non-member states of the Union shall be recognized as a source of clinical data on a medical device if one of the following conditions is met:

a) clinical data are confirmed by publications in specialized journals or reports of the World Health Organization’s program for monitoring the safety and efficacy of medical devices («The WHO prequalification project») available on the World Health Organization’s website on the information and telecommunication network «Internet» (hereinafter — the Internet);

b) the results of clinical trials (research) in accordance with the recommendations of the International Medical Device Regulators Forum (IMDRF) are presented. Evidence of compliance of the conducted clinical trials (studies) with international requirements must be verifiable.

7. Clinical data obtained for another medical device may be accepted for consideration only if evidence of its equivalence to the medical device being claimed is provided, provided that the following conditions are simultaneously met:

(a) The medical devices in question have the same intended use, including (by applicability) with respect to:

indications for use;

of the intended user;

the severity and stage of the patients’ disease or condition;

patient groups for whom the medical device is intended;

parts of the human body exposed to or in contact with a medical device;

like a contact;

duration of use or body contact;

conditions of use (e.g. medical facility, for home use);

the frequency of administration, including any restrictions on the number or duration of repeated applications;

b) technical characteristics (including the principle of operation, basic parameters, materials and design features of the product) and biological characteristics (including biocompatibility of materials and biological effect of the medical device) of the medical devices under consideration are the same to the extent that guarantees the absence of differences in their clinical efficacy and safety;

c) the medical device declared as equivalent is registered under Union law or the law of a Member State.

8. The report on clinical evidence of efficacy and safety of a medical device shall be kept up to date with the data obtained during post-marketing monitoring and (or) when new confirmed information related to its safety and efficacy appears in the scientific literature.

For medical devices of potential application risk class 3, as well as for 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 in accordance with the plan included in the report on clinical evidence of efficacy and safety of a medical device submitted in accordance with the Rules for monitoring b

III. Requirements for conducting clinical trials (research) of medical devices, except for medical in vitro diagnostic products

9. Clinical trials (research) of medical devices are conducted in accordance with the principles of the 1964 Declaration of Helsinki of the World Medical Association «Ethical Principles of Medical Research Involving Human Subjects».

Clinical trials (tests) of medical devices on the territories of Member States shall be conducted in medical organizations (clinical centers) selected by the applicant, information about which is included in the unified register of authorized organizations having the right to conduct trials (tests) of medical devices for the purposes of their registration (hereinafter — the register of authorized organizations).

10. Medical organizations (clinical centers), which conduct clinical trials (research), as well as specialists of these organizations conducting clinical trials (research), may not be with the manufacturer of a medical device, authorized representative of the manufacturer or other persons interested in the results of trials (research) in relations affecting their impartiality.

Commercial, financial or other pressures that jeopardize the impartiality of the medical organization (clinical center) conducting the clinical trial(s) are not allowed.

11. Clinical trials (studies) of medical devices shall be conducted on the basis of test (research) programs in such a way that the results of tests (studies) can confirm or refute the clinical efficacy and safety of medical devices declared by the manufacturer. The number of conducted observations shall be sufficient to ensure statistical reliability, reproducibility of results and scientific validity of conclusions.

Tests (studies) of medical devices intended for use by persons without medical education shall be conducted under conditions that simulate the conditions of use of these medical devices for their intended purpose.

12. Clinical trials (studies) of medical devices shall be conducted under conditions established by the manufacturer for the use of these medical devices and stipulated by the programs of trials (studies).

13. The researcher is responsible for conducting the clinical trial (study) of the medical device. The researcher must have access to all available technical and clinical data on the medical device being tested (investigational).

14. In order to provide researchers with the necessary amount of information about the medical device, the applicant shall submit a researcher’s brochure, the content of which complies with the requirements according to Annex No. 1.

15. The content of the clinical trial (research) program for a medical device shall comply with the requirements according to Appendix N 2.

16. The description of the design of a clinical trial (study) must include:

(a) A strategy for ensuring the clinical relevance and scientific validity of the results, with a rationale for its choice;

b) primary and secondary endpoints with justification for their selection and measurement.

17. The program of a clinical trial (research) is coordinated with medical organizations (clinical centers) and the coordinator-researcher when conducting a multicenter trial (research) and is approved by the applicant.

18. To conduct a clinical trial (research) of a medical device, the applicant shall submit to the medical organization (clinical center) the following information and documents drawn up in accordance with the legislation of the Member State on whose territory the clinical trial (research) is conducted:

a) permission of the authorized body (expert organization) to conduct a clinical trial (research) of a medical device (except for software which is a medical device) or details of the register entry in the register in which information on issued permissions and submitted notifications on conducting clinical or clinical-laboratory trials (research) of medical devices is entered (hereinafter — the register of permissions);

b) an application for conducting a clinical trial (research) of a medical device;

c) written confirmation that the medical device meets all applicable safety and efficacy requirements, except for those properties and characteristics that must be investigated during the ongoing clinical trial (study) of the medical device;

d) the researcher’s brochure;

e) test (research) program drawn up in accordance with the requirements stipulated in Annex No. 2 to these Rules;

f) samples (specimen) of the medical device together with accessories required for the intended use of the medical device (if accessories are available);

g) information on compliance of the medical device with the General Requirements;

h) instructions for use of the medical device (operational documentation);

i) technical file for the medical device, the content of which complies with the requirements according to Annex N 3 (for medical devices, except for software and medical devices for in vitro diagnostics) or Annex N 4 (for software, which is a medical device), except for the properties and characteristics of safety and efficacy of the medical device, which shall be determined as a result of the ongoing clinical trial (research);

j) opinion of the Ethics Committee on the conduct of a clinical trial (research) of a medical device;

k) copy of the document on conditions of insurance or indemnification (compensation) of possible harm in case of occurrence of adverse events (incidents), carried out in accordance with the legislation of the Member State, on the territory of which the clinical trial (research) of the medical device is conducted;

m) The informed consent form, including any necessary explanatory materials, and other information provided to the trial (research) subject;

(m) Forms for individual registration cards, diaries and questionnaires to be completed by the researchers;

(o) Adverse event (incident) report form;

p) a form for reporting deficiencies in a medical device;

p) forms of reports on clinical trial (study) of a medical device, including interim report;

(c) Materials (including promotional materials) used to attract potential trial (research) subjects.

19. When conducting clinical trials (research) of medical devices, the following shall be carried out:

(a) Procedures in accordance with test (research) programs;

b) maintenance of unambiguously identifiable records on the results of conducted clinical trials (research);

c) evaluation and analysis of data obtained during clinical trials (research) of medical devices;

d) finalization of the manufacturer’s operational documentation for the medical device based on the results of testing (research) (if necessary);

e) preparation and issuance to the applicant of a report on clinical trial (research) of a medical device.

20. A report on a clinical trial (study) of a medical device (with appendix of summarizing tables (graphs) of trial (study) results with appropriate statistical processing and comments to them) shall contain a critical evaluation of all data obtained during the trial (study), including negative data. Such report shall be prepared in the form according to Appendix N 5, signed by the researchers and approved by the head of the medical organization (clinical center).

When conducting multicenter clinical trials (studies), a general report is prepared, which is signed by researchers and heads of medical organizations (clinical centers) and approved by the coordinator-researcher.

21. The applicant shall have the right to control the conduct of the clinical trial (research) of the medical device at all stages by appointing appropriately qualified persons and conducting monitoring procedures or independent assessment of compliance in order to obtain reliable data.

IV. Justification of clinical efficacy and safety medical devices for in vitro diagnostics

22. Proof of compliance of medical devices for in vitro diagnostics with the General Requirements includes substantiation of clinical efficacy and safety of medical devices for in vitro diagnostics.

Justification of clinical efficacy and safety shall be in the form of a report on clinical evidence of efficacy and safety of the medical device and, where applicable, shall be based on the determination or confirmation of the scientific validity of the analyte, analytical performance and clinical performance of the medical device for in vitro diagnostics when used for its intended purpose as specified by the manufacturer. The inapplicability of the specified characteristics shall be justified in the report on clinical evidence of efficacy and safety of the medical device.

23. Determination or confirmation of the scientific validity of an analyte is not necessary when the relationship of the analyte to a clinical or physiologic condition of the human body is well known and based on available information.

24. For a new analyte or a new intended use of an in vitro diagnostic medical device, the scientific validity of the analyte shall be established in the course of clinical and laboratory tests (investigations) of the in vitro diagnostic medical device, unless it is demonstrated that the scientific validity of the analyte can be established in another way, e.g. on the basis of:

(a) data derived from clinical experience with in vitro diagnostic medical devices in Member States that detect the same analyte by the same method and have the same intended use;

b) data obtained from the scientific literature on in vitro diagnostic medical devices that detect the same analyte by the same method and have the same intended use.

25. Analytical efficiency of an in vitro diagnostic medical device shall be confirmed by the results of clinical and laboratory tests (studies) for the claimed in vitro diagnostic medical device.

26. Determination or confirmation of clinical efficacy during clinical and laboratory tests (studies) of an in vitro diagnostic medical device is not necessary for in vitro diagnostic medical devices if clinical efficacy of this device is fully determined by analytical efficacy and this fact is well known and substantiated in the report on clinical evidence of efficacy and safety of the medical device.

27. The clinical effectiveness of an in vitro diagnostic medical device shall be established in the course of clinical and laboratory tests (studies) of an in vitro diagnostic medical device, unless it is proved that the clinical effectiveness of the medical device can be established in another way, for example, on the basis of:

(a) Data obtained from peer-reviewed scientific literature on the use of the medical device on samples obtained from a biological reference population;

b) data derived from clinical experience with an in vitro diagnostic medical device in Member States or published data on clinical experience with a medical device on samples obtained from a biological reference population.

V. Requirements for conducting clinical and laboratory trials (research) of medical in vitro diagnostic products

28. Clinical trials (research) in respect of in vitro diagnostic medical devices shall be conducted in the form of clinical and laboratory trials (research).

Clinical and laboratory tests (trials) of medical devices are conducted in medical organizations (clinical centers) selected by the applicant, information about which is included in the register of authorized organizations.

29. Medical organizations (clinical centers) that conduct clinical and laboratory tests (investigations), as well as specialists of these organizations conducting clinical and laboratory tests (investigations), may not be in relations affecting their impartiality with the manufacturer of a medical device, authorized representative of the manufacturer or other persons interested in the results of tests (investigations).

Commercial, financial or other pressures that jeopardize the impartiality of the medical organization (clinical center) conducting clinical and laboratory trials (research) are not allowed.

30. Clinical and laboratory tests (studies) of medical devices for in vitro diagnostics are conducted on the basis of test (study) programs in such a way that the results of tests (studies) can confirm or refute the analytical efficiency and clinical efficacy of medical devices for in vitro diagnostics declared by the manufacturer. The number of laboratory tests performed shall be sufficient to ensure statistical reliability of the results of tests (studies).

31. The content of the program of clinical and laboratory testing (research) of a medical device for in vitro diagnostics shall comply with the requirements according to Appendix N 6.

32. Tests (studies) of medical devices for in vitro diagnostics, intended for use by persons who do not have medical education in the field of clinical laboratory diagnostics, shall be conducted under conditions that simulate the conditions of use of these medical devices for their intended purpose.

33. Clinical and laboratory tests (trials) of in vitro diagnostic medical devices intended for use in combination with each other in the form of analytical systems may be conducted as part of a single test (trial) (together with accessories necessary for the intended use of the medical device).

34. Samples used in clinical and laboratory tests (studies) of in vitro diagnostic medical devices may be collected from several sources, including residual samples, archival samples, or purposively selected samples.

Residual specimens are considered to be the remains of specimens collected during the treatment and diagnostic process.

Archival specimens or samples include characterized specimens or samples that have been previously collected and obtained from repositories (including tissue banks, standard panels, museum test strains, and other collections).

Purposively collected specimens are defined as specimens that have been collected from patients specifically for use in a particular test (study).

When conducting tests (research) of medical devices for in vitro diagnostics using purposively selected samples, informed consent must be obtained.

35. The results of sample testing during clinical and laboratory trials (studies) of an in vitro diagnostic medical device (except for cases of interventional clinical efficacy studies) shall not be used for purposes other than the evaluation of its analytical and (or) clinical efficacy, unless ethical considerations fully shared by all investigators participating in the trial (study) suggest otherwise (including the need to inform the subjects of the trial (study) of the results of the clinical trial (study)). In such a case, the investigator assumes full responsibility for the consequences of any other use of the data obtained.

36. Clinical and laboratory tests (trials) of medical devices for in vitro diagnostics of new or especially dangerous infectious diseases, including natural focal infectious diseases, may be conducted in laboratory conditions using archival samples and (or) samples obtained by genetically engineered method.

For medical devices for in vitro diagnostics of potential risk classes 1, 2a and 2b, clinical and laboratory tests (studies) of which have been conducted under the specified conditions, as well as for medical devices for in vitro diagnostics of rare diseases, the manufacturer, in coordination with the authorized body (expert organization), conducts post-registration clinical monitoring of safety and efficacy of medical devices in accordance with the Rules for Monitoring of Safety, Quality and Efficacy of Medical Devices.

37. The program of clinical and laboratory testing (research) of a medical device for in vitro diagnostics shall be coordinated with medical organizations (clinical centers) and approved by the applicant.

38. To conduct a clinical and laboratory test (research) of a medical device for in vitro diagnostics, the applicant shall submit to a medical organization (clinical center) the following information and documents drawn up in accordance with the legislation of the Member State on whose territory the clinical and laboratory test (research) is conducted:

a) an application for conducting a clinical and laboratory trial (research) of a medical device for in vitro diagnostics;

b) written confirmation that the in vitro diagnostic medical device meets all applicable safety and efficacy requirements, except for those properties and characteristics that must be investigated during clinical and laboratory testing (research) of the in vitro diagnostic medical device;

c) test (research) program drawn up in accordance with the requirements stipulated in Annex No. 6 to these Rules;

d) samples (specimen) of the medical device for in vitro diagnostics together with accessories required for the medical device to be used as intended (if accessories are available);

e) information on compliance of the in vitro diagnostic medical device with the General Requirements;

(e) Instructions for use of the medical device for in vitro diagnostics (operational documentation);

g) technical file for the medical device for in vitro diagnostics that meets the requirements stipulated in Annex N 5 to the Requirements for the implementation, maintenance and evaluation of the quality management system of medical devices depending on the potential risk of their use, approved by the Decision of the Council of the Eurasian Economic Commission of November 10, 2017. N 106, except for the properties and characteristics of safety and effectiveness of the medical device, which must be determined as a result of an ongoing clinical and laboratory test (study);

h) permission of the authorized body (expert organization) to conduct a clinical and laboratory trial (research) (when conducting an interventional clinical efficacy trial) or details of the registry entry in the register of approvals;

i) opinion of the Ethics Committee on the conduct of a clinical and laboratory trial (study) (when conducting an interventional clinical efficacy trial);

j) Investigator’s brochure (for interventional clinical efficacy studies);

k) informed consent form, including all necessary explanatory materials, as well as other information provided to the trial (research) subject (when conducting an interventional clinical efficacy trial);

m) copy of the document on the terms of insurance or reimbursement (compensation) of possible harm in case of adverse events (incidents), carried out in accordance with the legislation of the Member State, on the territory of which the clinical and laboratory trial (research) of an in vitro diagnostic medical device is conducted (when conducting an interventional clinical efficacy trial);

m) forms of individual registration cards, diaries and questionnaires to be completed by researchers (when conducting an interventional clinical effectiveness trial);

o) adverse event (incident) report form (when conducting an interventional clinical efficacy trial);

p) the form of a deficiency report form for an in vitro diagnostic medical device (when conducting an interventional clinical efficacy study);

p) materials (including advertising) used to attract potential trial (research) subjects (when conducting an interventional clinical efficacy trial).

39. When conducting clinical and laboratory tests (research) of medical devices for in vitro diagnostics, the following shall be carried out:

(a) Procedures in accordance with test (research) programs;

b) maintaining uniquely identifiable functional performance evaluation records containing all measurement results;

c) evaluation and analysis of the obtained data in order to confirm their compliance with the declared characteristics;

d) finalization of the manufacturer’s operational documentation for the medical device for in vitro diagnostics based on the results of tests (studies) (if necessary).

40. The results of a clinical and laboratory test (research) of an in vitro diagnostic medical device shall be considered negative if they indicate that the analytical and (or) clinical efficacy of the said medical device does not correspond to those declared by the manufacturer.

41. A report on a clinical and laboratory trial (study) of an in vitro diagnostic medical device shall contain a critical evaluation of all data obtained during the trial (study), including negative data. Such report shall be prepared in the form according to Annex N 7, signed by the researchers and approved by the head of the medical organization (clinical center).

In case of multicenter clinical and laboratory trials (studies) of a medical device for in vitro diagnostics, a general report shall be prepared, which shall be signed by the researchers and heads of medical organizations (clinical centers) and approved by the coordinator-researcher.

VI. Ethics Committee

42. In order to protect the life, health and rights of trial (research) subjects when conducting clinical or clinical-laboratory (when conducting an interventional clinical efficacy trial) trials (research) of medical devices, ethics committees are in place in Member States, including at the level of a medical organization (clinical center).

43. In its work, the Ethics Committee is guided by the principles of the 1964 Declaration of Helsinki of the World Medical Association «Ethical Principles for Medical Research Involving Human Subjects» and the legislation of Member States.

44. The basic principles of activity of the ethics committee shall be:

a) ensuring the rights, safety and health protection of individuals participating in clinical or clinical-laboratory (when conducting an interventional clinical efficacy trial) trials (research) of medical devices;

b) compliance with moral and ethical norms and norms of public morality;

c) adherence to the principles of humanity;

d) independence of judgment;

e) observance of confidentiality of the information received;

(e) Compliance with professional ethics;

g) avoidance of conflicts of interest.

45. The main functions of the ethics committee shall be:

a) review of programs of clinical or clinical-laboratory (when conducting an interventional clinical efficacy trial) trials (studies);

b) drawing a conclusion on the ethical validity or ethical unreasonableness of conducting clinical or clinical-laboratory (in case of interventional clinical efficacy study) trials (research) of medical devices within the framework of submitted draft programs of clinical or clinical-laboratory (in case of interventional clinical efficacy study) trials (research);

c) assessment of whether the researcher is qualified to participate in the proposed trial (study).

46. All documents and information necessary for a full and thorough review of the planned research shall be submitted to the ethics committee. These documents and information shall include:

(a) Application for review;

b) draft program of the planned trial (research);

c) forms of individual registration cards, diaries and questionnaires to be completed by the researchers;

d) description of safety data of the medical device, the trial (research) of which is planned, as well as its technical characteristics, data of technical tests and research (tests) conducted to assess the biological effect, description of clinical experience in the use of the medical device;

e) the researcher’s brochure;

(e) Resume of the researcher and/or other materials confirming his/her qualifications;

g) Materials (including promotional materials) used to attract potential trial (research) subjects;

h) The informed consent form, including any necessary explanatory materials and other information provided to the trial (research) subject;

i) A description of all compensation for trial (research) participation for trial (research) participants, including coverage of expenses and medical care;

j) information on the terms of payments and compensation to trial (research) subjects;

k) a description of the terms and conditions of insurance for trial (research) participants;

(m) A provision for agreeing to follow the ethical principles set out in the relevant guidelines;

m) previous decisions taken by ethics committees (if any).

47. The Ethics Committee shall consider the proposed clinical or clinical-laboratory (in case of interventional clinical efficacy trial) trial (study) within 30 business days from the date of receipt of documents and information stipulated by paragraph 46 of these Rules and shall give a conclusion in writing, which shall identify the trial (study) with the indication of the reviewed documents and the date of the decision:

a) on approval (issuance of a conclusion) to conduct a trial (research);

b) the need to make changes to the submitted documentation in order to obtain approval (issue an opinion) to conduct the trial (research);

c) on refusal to approve (issue a conclusion) to conduct a trial (research);

d) on revocation (suspension) of the earlier approval (issued conclusion) of conducting a trial (research).

48. The Ethics Committee shall be comprised of individuals who possess, in combination, the necessary qualifications and experience to review and provide expert review of the scientific, medical, and ethical aspects of the planned trial (research).

49. The Ethics Committee shall operate in accordance with documented procedures.

50. The Ethics Committee is responsible for acting fully in the best interests of potential trial (research) subjects, taking into account the interests and needs of vulnerable trial (research) subjects and the availability of legal representatives when necessary.

VII. Authorization to conduct clinical or clinical and laboratory tests (studies)

51. In order to conduct clinical or clinical-laboratory (when conducting an interventional clinical efficacy trial) trial (research) of a medical device, permission must be obtained from the authorized body (expert organization) of the Member State on whose territory it is planned to conduct these trials (research) (hereinafter in this section — authorized body (expert organization)).

The permit shall be issued on paper or by making an entry in the permit register.

In order to conduct a clinical and laboratory trial (research) of a medical device for in vitro diagnostics (except for interventional clinical efficacy studies) and clinical trials (research) of software that is a medical device, a free-form notification shall be sent to the authorized body (expert organization) within 10 working days from the date of the beginning of the procedures in accordance with the trial (research) program, the information about which shall be entered into the register of approvals.

52. Expenses related to obtaining an authorization to conduct clinical or clinical-laboratory (when conducting an interventional clinical efficacy trial) trials (research) or to making an entry in the register of authorizations in respect of the said trials (research) shall be borne by the applicant in accordance with the legislation of the Member State. Fees for carrying out the relevant actions shall be determined in accordance with the procedure established by the legislation of the Member State.

Inclusion in the Register of Permits of information on notifications of clinical and laboratory tests (studies) of a medical device for in vitro diagnostics (except for interventional clinical efficacy studies) or clinical tests (studies) of software that is a medical device shall be carried out by an authorized body (expert organization) on a free-of-charge basis.

53. To obtain permission to conduct clinical or clinical-laboratory (in case of interventional clinical efficacy study) trial (research) of a medical device, the applicant shall send to the authorized body (expert organization) an application for such permission (hereinafter — application for permission) in the form according to Appendix N 8 or 9, respectively, with the following documents and information attached:

a) a statement by the manufacturer of the medical device that the medical device meets the applicable safety and efficacy requirements, except for the properties and characteristics of safety and efficacy of the medical device to be investigated during clinical or clinical-laboratory (in the case of interventional clinical efficacy studies) trials (research), and that precautions have been taken to protect the health and safety of the subjects of the trials (research);

b) the manufacturer’s contract with the manufacturer’s authorized representative or a copy thereof (if the application is submitted by the manufacturer’s authorized representative);

c) the opinion of the Ethics Committee issued in accordance with these Rules or a copy thereof certified by the applicant;

d) the researcher’s brochure, the content of which complies with the requirements stipulated in Annex No. 1 to these Rules;

e) a sample of an individual registration card of a test (research) subject;

f) technical file for a medical device, the content of which complies with the requirements stipulated in Annex N 3 to these Rules (for medical devices other than software and medical devices for in vitro diagnostics), or Annex N 4 to these Rules (for software that is a medical device), or Annex N 5 Annex N 5 to the Requirements for implementation, maintenance and evaluation of the quality management system for medical devices depending on the potential risk of their use (for medical devices for diagnostics), or to the Requirements for implementation, maintenance and evaluation of the quality management system for medical devices depending on the potential risk of their use (for medical devices for in vitro diagnostics)

g) trial (research) program, the content of which complies with the requirements stipulated in Appendix N 2 or 6 to these Rules, respectively, with justification of the number of medical devices submitted for clinical or clinical-laboratory (in case of interventional clinical efficacy study) trial (research), the terms of its conduct;

h) list of adverse events (incidents), in case of occurrence of which it is necessary to report to the authorized body (with indication of terms for sending the report);

i) copy of the document on the terms of insurance or indemnification (compensation) of possible harm in case of occurrence of adverse events (incidents) in accordance with legislation of the Member State, on the territory of which the clinical or clinical-laboratory (in case of interventional clinical efficacy trial) trial (research) is conducted;

j) copies of documents confirming payment for actions related to the issuance of an authorization to conduct clinical (clinical-laboratory) trials (research) or making an entry in the register of approvals.

54. The applicant shall submit information and documents drawn up in accordance with the legislation of the Member State on whose territory the clinical or clinical-laboratory trial (research) is conducted.

55. The authorized body (expert organization) within 7 working days from the date of receipt of the application for a permit, documents and information specified in paragraph 53 of these Rules shall verify the completeness and accuracy of the information contained therein.

56. If an application for a permit is submitted in violation of the requirements of these Rules, or it contains unreliable information, or the documents specified in paragraph 53 of these Rules are not submitted in full, the authorized body (expert organization) shall, within 7 working days from the date of receipt of such application and documents, send to the applicant in the manner specified in the application, a notification on the need to eliminate the identified violations and (or) submission of missing documents within 30 working days from the date of sending of the application and documents.

If after 30 working days the applicant has not eliminated the identified violations and (or) has not submitted missing documents and information, the authorized body (expert organization) within 3 working days shall make a decision to return the application for a permit and attached documents to the applicant (with justification of the reasons for return).

57. Within 3 working days from the date of completion of the inspection provided for in paragraph 55 of these Rules (in case of submission of an application for a permit and documents complying with the requirements of these Rules), as well as in case of elimination of the identified violations and (or) submission of documents complying with the requirements of these Rules within the established time limit, the authorized body (expert organization) shall take a decision on consideration of the said application and documents.

58. If during the expert review of the application for authorization and the documents specified in paragraph 53 of these Rules, after a decision has been made to review these documents, it is found that the materials and information are insufficient to make a decision on the possibility (impossibility) to conduct a clinical or clinical-laboratory (in the case of an interventional clinical efficacy trial) trial (research), the authorized body (expert organization) shall send the applicant a corresponding request (specifying the nature of the remarks). The request is sent once in the manner specified in the application for authorization.

The applicant is obliged to submit a response to the request within 60 working days from the date of its receipt. In case of failure to submit a response within the specified period, the authorized body (expert organization) shall make a decision regarding the possibility of conducting clinical or clinical-laboratory (in case of interventional clinical efficacy trial) trials (research) of the medical device on the basis of the documents at its disposal.

If the authorized body (expert organization) reveals inaccurate data in the documents submitted by the applicant in response to the request, the authorized body (expert organization) shall, within 2 working days from the date of receipt of such documents, deliver to the applicant in the manner specified in the application for a permit, a decision to return the said documents (with justification of the reasons for return and notification of the possibility for the applicant to resubmit the documents before the expiration of the period specified in the second paragraph of this item).

The time from the day of sending a request by the authorized body (expert organization) to the day of receipt of a response to the request or notification of failure to provide a response to the request shall not be taken into account when calculating the time period for the authorized body (expert organization) to make a decision on the possibility of conducting clinical or clinical-laboratory (in the case of an interventional clinical efficacy trial) trials (research).

59. The authorized body (expert organization) shall conduct an expert examination of the submitted documents and draw up an expert opinion in the form according to Annex No. 10 within 30 working days from the date of its decision to consider the application for a permit and the documents specified in paragraph 53 of these Rules. The conclusions contained in the expert report shall be unambiguous and understandable.

60. The authorized body (expert organization) within 5 working days from the date of execution of the expert report:

a) takes a decision on the possibility (impossibility) to conduct clinical or clinical-laboratory (when conducting an interventional clinical efficacy study) trials (studies) of a medical device, which is formalized by an order of the authorized body (expert organization), and notifies the applicant of the decision;

b) issue (send by registered mail with return receipt requested or in the form of an electronic document signed with an electronic signature) to the applicant an authorization to conduct clinical or clinical-laboratory tests (trials) of a medical device and (or) enter the relevant data into the register of authorizations or issue to the applicant a notice of impossibility to conduct them with an attached expert opinion (with justification of the reasons for refusal of authorization to conduct clinical or clinical-laboratory tests (trials) of a medical device); c) issue an authorization to conduct clinical or clinical-laboratory tests (trials) of a medical device and (or) enter the relevant data into the register of authorizations

61. An authorization (registry entry) to conduct a clinical or clinical-laboratory trial (research) of a medical device shall contain the following information:

a) number and date of such authorization (registry entry);

b) name of the applicant, its location (address of a legal entity) — for a legal entity or surname, name, patronymic (if any), place of residence — for an individual person registered as an individual entrepreneur, information on state registration of a legal entity or an individual as an individual entrepreneur, as well as contact details of the applicant (phone number, e-mail address);

c) name of the medical device (specifying the model (brand) of the medical device, its composition, accessories required for the intended use of the medical device);

d) name of the manufacturer, its location (address of a legal entity) — for a legal entity or surname, name, patronymic (if any), place of residence — for a natural person registered as an individual entrepreneur;

e) name of the manufacturer’s authorized representative (if any), its location (address of a legal entity) — for a legal entity or surname, name, patronymic (if any), place of residence — for a natural person registered as an individual entrepreneur;

e) the name and address of the place of business of the production site(s) carrying out the entire process of production of the medical device or certain stages thereof;

g) names and addresses of medical organizations (clinical centers) where clinical or clinical-laboratory (in case of interventional clinical efficacy study) trial (research) of a medical device is conducted, information about which is included in the register of authorized organizations.

62. The grounds for the authorized body (expert organization) to issue a conclusion on impossibility to conduct clinical or clinical-laboratory (in case of interventional clinical efficacy study) trials (research) of a medical device are:

a) failure to confirm with relevant documents and information submitted by the applicant the admissibility of risks associated with clinical or clinical-laboratory (when conducting an interventional clinical efficacy trial) trials (studies);

b) failure to eliminate the identified violations and (or) failure to provide documents and information upon request.

VIII. Requirements for medical organizations (clinical centers), which conduct clinical and clinical and laboratory tests (studies) medical devices

63. Formation and maintenance of the register of authorized organizations is carried out by the Eurasian Economic Commission (hereinafter — the Commission) in accordance with the Procedure for the Formation and Maintenance of the Information System in the Field of Circulation of Medical Devices, approved by the Decision of the Council of the Eurasian Economic Commission of 12 February 2016. N 30, on the basis of information submitted by authorized bodies using the means of the integrated information system of the Union.

64. The register of authorized organizations shall include information on medical organizations (clinical centers) that conduct clinical trials (research) of medical devices and meet the following requirements:

a) registration of the medical organization (clinical center) as a legal entity on the territory of the Member State in accordance with its legislation;

b) availability of a permit (license) to carry out medical activities (indicating the list of works (services) constituting medical activities), corresponding to the purpose and field of application of medical devices in respect of which tests (trials) are conducted, if there is such a requirement in the legislation of the Member State;

c) availability of documents (standard operating procedures) regulating the conduct of clinical trials (research) of medical devices, including those defining:

qualification requirements and personnel training procedures;

interaction with the ethics committee;

obtaining informed consent;

procedure for conducting clinical trials (research);

registering and sending reports of adverse events (incidents) to the authorized body;

maintaining and recording documentation on clinical trials (studies);

Ensuring the protection of confidential information;

d) availability of conditions for conducting the claimed profile of clinical trials (research) of medical devices;

e) availability of conditions for intensive care and resuscitation;

f) availability of personnel with medical education and a document confirming the completion of training in the rules of conducting clinical trials (research) (good clinical practice).

65. The register of authorized organizations shall include information on medical organizations (clinical centers) which carry out clinical and laboratory trials (research) of medical devices for in vitro diagnostics and which meet the following requirements:

a) registration of the medical organization (clinical center) as a legal entity on the territory of the Member State in accordance with its legislation;

b) the presence of a permit (license) to carry out medical activities in the field of laboratory diagnostics (clinical laboratory diagnostics) if there is such a requirement in the legislation of the Member State;

c) availability of documents (standard operating procedures) regulating the conduct of clinical and laboratory tests (studies) of medical devices for in vitro diagnostics, including those defining:

qualification requirements and personnel training procedures;

procedure for verification and calibration of equipment;

procedure for conducting clinical and laboratory tests (studies);

Maintaining and recording documentation on clinical and laboratory trials (studies);

Ensuring the protection of confidential information;

interaction with the Ethics Committee (in case a medical organization (clinical center) has declared the possibility to conduct interventional clinical efficacy trials).

66. Within 20 working days from the date of receipt of an application from a medical organization (clinical center) for inclusion in the register of authorized organizations, the authorized body shall consider the said application and notify the medical organization (clinical center) of the decision made in writing by handing the notification personally to its representative for signature, or sending it by registered mail with return receipt requested, or transmitting it electronically via telecommunication channels or in the form of an electronic document signed by the representative of the medical organization (clinical center).

In case the authorized body makes a decision to include a medical organization (clinical center) in the register of authorized organizations, information about the medical organization (clinical center) shall be sent to the Commission using the means of the integrated information system of the Union for inclusion in the register of authorized organizations, and may also be placed on the official website of the authorized body in the Internet.

In case of non-compliance of a medical organization (clinical center) with one of the criteria specified in paragraph 64 or 65 of these Rules, respectively, and taking a decision on refusal to include a medical organization (clinical center) in the register of authorized organizations, the authorized body shall notify the medical organization (clinical center) of the reasons for refusal in writing by handing the notification in person against signature to its representative, or sending it by registered mail with return receipt requested, or transmitting it in electronic form.

67. The appeal against the decision of the authorized body shall be made in accordance with the legislation of its Member State.

68. In case of changes in the data contained in the register of authorized organizations, a medical organization (clinical center) included in the register of authorized organizations (hereinafter referred to as the authorized organization) shall, within 30 calendar days, submit to the authorized body an application for making changes in the specified data, as well as documents confirming these changes.

The authorized body within 10 working days from the date of submission by the authorized organization of an application for amendments to the information contained in the register of authorized organizations:

considers the submitted application and documents;

sends the relevant information to the Commission using the means of the integrated information system of the Union (in case the authorized body adopts a decision to make changes), and may also post it on its official website on the Internet;

informs the authorized organization about the adopted decision in writing by handing the notification personally to its representative for signature, or sends it by registered mail with return receipt requested, or transmits it electronically via telecommunication channels or in the form of an electronic document signed with an electronic digital signature.

69. Exclusion of a medical organization (clinical center) from the register of authorized organizations shall be carried out by the authorized body in the following cases:

a) receipt of an application for exclusion of a medical organization (clinical center) from the register of authorized organizations signed by the head of the medical organization (clinical center);

b) detection of non-compliance of a medical organization (clinical center) with the requirements of these Rules based on the results of control carried out by the authorized body;

c) liquidation of the medical organization (clinical center) or termination of the permit (license) to carry out medical activities (if there is such a requirement in the legislation of the Member State);

d) untimely submission or non-submission of information and documents stipulated by paragraph 68 of these Rules.

70. The Authorized Body shall, within 3 working days from the date of taking a decision to exclude information from the register of Authorized Organizations, submit the relevant information to the Commission using the means of the integrated information system of the Union, and may also place it on its official website on the Internet.

71. Storage, systematization and modification of information on authorized organizations, as well as protection from unauthorized access to it shall be ensured by authorized bodies.

72. The Register of Authorized Organizations shall be published on the information portal of the Union.

73. Control of compliance by medical organizations (clinical centers), having the right to conduct clinical or clinical-laboratory tests (trials) of medical devices, with the requirements of these Rules shall be carried out by the authorized body in accordance with the legislation of its state.

74. Provision of information on organizations included in the register of authorized organizations to interested persons shall be carried out by authorized bodies in accordance with the legislation of the Member States.

Annex N 1

to the Rules for the Conduct of Clinical

and clinical and laboratory tests

(research) of medical devices

REQUIREMENTS

TO THE CONTENT OF THE INVESTIGATOR’S BROCHURE ON THE MEDICAL DEVICE

I. General description of the medical device

1 The investigator’s medical device brochure must contain the following information:

(a) The name of the medical device;

b) description and purpose of the medical device;

c) information enabling to identify the medical device, including the model (brand) number of the medical device (if any) or indication of the identifying number of the model (brand) of the medical device;

d) type of medical device in accordance with the nomenclature of medical devices applicable within the Eurasian Economic Union;

e) information on intended users;

(e) The principles of operation of the medical device;

g) class of potential risk of use and applicable classification rules in in accordance with the Rules of classification of medical devices depending on the potential risk of use, approved by the Decision of the Board of the Eurasian Economic Commission of December 22, 2015 N 173;

h) description of new properties and characteristics of the medical device;

(i) A description of accessories and medical devices intended for use in combination with the investigational medical device;

j) description and (or) list of models (brands) of the medical device (if any);

k) description of the main functional elements of the medical device (diagrams, photographs and drawings demonstrating the main parts (components) of the medical device and including explanatory notes to the diagrams, photographs and drawings);

(m) A description of materials that come into direct or indirect contact with the human body.

II. Use of the medical device

2 The investigator’s brochure must contain the following information about the use of the medical device:

(a) The purpose of the medical device;

b) installation (commissioning) instructions;

c) instructions for use, including transportation and storage conditions.

III. Information on tests (research) medical device

(3) The investigator’s brochure must contain the following information on previously conducted trials (studies) of the medical device:

a) results of preclinical tests (studies);

b) available clinical data, including:

scientific literature data (indicating the sources of data, as well as information ensuring their traceability) containing information on the design, safety, efficacy and purpose of similar or equivalent medical devices;

scientific literature data (with indication of data sources as well as information ensuring their traceability) containing information on the design, safety, efficacy and purpose of similar or equivalent medical devices of the same manufacturer, including data on the time of their market circulation, as well as information on identified problems related to the safety of use of the medical device and its efficacy and corrective actions taken;

c) results of risk analysis, information on side effects and contraindications;

d) a list of possible adverse events (incidents) and adverse effects resulting from the use of the medical device;

e) a list of standards applied in full or in part.

Annex N 2

to the Rules for the Conduct of Clinical

and clinical and laboratory trials(research) of medical devices

REQUIREMENTS

TO THE CONTENT OF THE CLINICAL TRIAL (RESEARCH) PROGRAM

MEDICAL DEVICE

I. General description of the medical device

1. The program of a clinical trial (study) of a medical device shall contain the following information:

(a) The name of the medical device;

b) name of the manufacturer, its location (address of a legal entity) — for a legal entity or surname, name, patronymic (if any), place of residence — for a natural person registered as an individual entrepreneur;

c) name of the applicant, its location (address of a legal entity) — for a legal entity or surname, name, patronymic (if any), place of residence — for an individual registered as an individual entrepreneur, information on state registration of a legal entity or an individual registered as an individual entrepreneur, as well as contact details of the applicant (phone number, e-mail address);

d) name of the manufacturer’s authorized representative (if any), its location (address of a legal entity) — for a legal entity or surname, name, patronymic (if any), place of residence — for a natural person registered as an individual entrepreneur;

e) information enabling to identify the medical device, including the model (brand) number of the medical device (if any) or indication of the identifying number of the model (brand) of the medical device;

(e) Type of medical device in accordance with the nomenclature of medical devices applicable within the Eurasian Economic Union;

g) class of potential risk of use and applicable classification rules in accordance with the Rules of classification of medical devices depending on the potential risk of use, approved by the Decision of the Board of the Eurasian Economic Commission of December 22, 2015 N 173;

h) the purpose of the medical device;

(i) A description of the medical device;

j) Explanation of new properties and characteristics of a medical device;

k) description of materials that come into direct or indirect contact with the human body;

m) information on control medical devices, including information on authorization documents for their circulation in the country where the trials (research) are conducted;

m) a description of how traceability is achieved during and after the conduct of the clinical trial (study) of the medical device (through the assignment of series numbers, lot numbers, factory serial numbers, or otherwise);

o) subjects of clinical trials (research) (patient group) and medical indications for which the medical device is intended.

II. Data on the clinical trial (study)

medical device

2. The program of a clinical trial (study) of a medical device shall contain the following information on the clinical trial (study) procedure:

a) name and identification data of the clinical trial (study);

b) name and location address of the medical organization (clinical center) (medical organizations (clinical centers)) conducting (conducting) clinical trial(s);

c) data on researchers, research coordinator (if any);

d) requirements for professional training and education of medical specialists;

e) the process of obtaining informed consent from clinical trial (research) subjects;

e) description of ethical aspects of the clinical trial (research), including the interests of vulnerable subjects of the clinical trial (research);

g) total expected duration of the clinical trial (study);

h) a description of special surgical and other medical procedures related to the use of the medical device;

and) a description of the conditions for conducting a clinical trial (study) as determined by the manufacturer;

j) a description of the risks and benefits of using the medical device in a clinical trial (study);

k) a description of accessories, other medical devices and non-medical devices intended for use in combination with the medical device;

m) a description of the design of the clinical trial (study);

m) objectives and hypotheses of the clinical trial (study);

o) primary and secondary endpoints of the clinical trial (study);

p) the sample size of subjects of the clinical trial (study);

p) calculation of the sample size, including the expected attrition rate of clinical trial (research) subjects;

c) Inclusion criteria, exclusion criteria for selecting subjects, criteria and procedures for terminating or suspending the participation of clinical trial (research) subjects;

t) the number of investigational medical devices used (with justification);

y) description of clinical trial (research) procedures;

f) a description of the procedures for reporting any deviations from the original clinical trial (research) program;

x) plan for monitoring during clinical trials (studies) with indication of frequency of visits (visits), number of monitors and their contacts;

ts) statistical methods of data analysis.

Annex N 3

to the Rules for the Conduct of Clinical

and clinical and laboratory trials

(research) of medical devices

REQUIREMENTS

TO THE CONTENT OF THE TECHNICAL FILE FOR A MEDICAL DEVICE

(EXCEPT FOR SOFTWARE AND MEDICAL DEVICES

FOR IN VITRO DIAGNOSTICS)

I. General description of the medical device

(1) The technical file for a medical device (other than software and in vitro diagnostic medical devices) shall contain the following information:

(a) The name of the medical device;

b) general description and purpose of the medical device;

c) information enabling to identify the medical device, including the model (brand) number of the medical device (if any) or indication of the identifying number of the model (brand) of the medical device;

d) type of medical device in accordance with the nomenclature of medical devices applicable within the Eurasian Economic Union;

e) intended users;

(e) The principles of operation of the medical device;

g) class of potential risk of use and applicable classification rules in accordance with the Rules of classification of medical devices depending on the potential risk of use, approved by the Decision of the Board of the Eurasian Economic Commission of December 22, 2015 N 173;

h) an explanation of the properties and characteristics of the medical device;

(i) A description of accessories, other medical devices and non-medical devices intended for use in combination with the medical device under consideration;

j) description and (or) list of models (brands) of the medical device (if any);

k) description of the main functional elements of the medical device (diagrams, photographs and drawings demonstrating the main parts (components) of the medical device, including explanatory notes to the diagrams, photographs and drawings);

(m) A description of materials that come into direct or indirect contact with the human body.

II. Description of the medical device

2 The technical file shall contain a list of the main characteristics, dimensions and instructions for use of the medical device, its models (brands) and accessories, which are available in the technical documentation of the medical device and other materials available to the end user, as well as a list of standards applied by the manufacturer.

III. History of medical device circulation, information

about similar and previous modifications to the medical device

3 The technical file should contain information on the presence or absence of a history of the medical device in international markets, including information on marketing, cases of adverse events (incidents) related to the use of the medical device and recalls of the medical device from the market, as well as a description of corrective actions taken in response to these cases and (or) their analysis.

4. In the case of using information on similar or previous modifications of a medical device to prove compliance with the General requirements for safety and effectiveness of medical devices, requirements for their labeling and operational documentation for them, approved by the Decision of the Council of the Eurasian Economic Commission of February 12, 2016. N 27 (hereinafter — the General Requirements), the technical file must contain a brief description:

a) previous modifications of the medical device (if any);

b) similar modifications of medical devices in circulation within the Eurasian Economic Union and on international markets.

IV. Accompanying information

5. The technical file must contain:

a) data on labeling of the medical device and its packaging (labeling projects);

b) instructions for use of the medical device (operational documentation).

V. Design and development of a medical device

6. The technical file must contain information that provides an overview of the main stages of design and development of a medical device. This information may be presented in the form of a flowchart of processes.

VI. Production processes

7. The technical file must contain information that provides an overview of the manufacturing processes. This information may be presented in the form of a flowchart of processes, giving a general idea of production, assembly, final testing (research) of the medical device and final packaging of the finished medical device.

VII. Production sites

8. The technical file shall identify the manufacturing sites where the medical device is manufactured. If quality management system certificates or equivalent documents are available for these sites, copies must be attached to the technical file.

VIII. Information on compliance with the General Requirements

9. The technical file shall include information on compliance of the medical device with the General Requirements.

IX. Results of risk analysis and management

10. The technical file shall contain a brief list of risks identified in the risk analysis process and a description of the ways to manage these risks in order to reduce them to an acceptable level.

X. Verification and validation activities

11. The technical file shall contain the following information and verification and validation documents used to demonstrate that the medical device complies with the General Requirements (including the applicability of the General Requirements):

a) results of tests (studies) in testing laboratories (centers) and medical organizations (clinical centers);

b) the results of the medical device manufacturer’s own laboratory and (or) factory tests (investigations), including the results of tests (investigations) under conditions simulating operational conditions;

c) results of laboratory tests (investigations) on animals to confirm the correctness of the concept of the finished medical product;

d) declaration (declarations) of conformity to standards from the list of standards, as a result of the application of which, on a voluntary basis, fully or partially ensures compliance of medical devices with the General requirements for the safety and effectiveness of medical devices, requirements for their labeling and operational documentation for them (Annex to the Recommendation of the Board of the Eurasian Economic Commission dated September 4, 2017. N 17), or other standards with justification for their application;

e) a review of published literature containing information on the medical device or similar medical device.

12. the technical file shall contain:

(a) Biocompatibility information;

b) information on medicinal products included in the medical device;

c) information on biological safety of medical devices that include cells, tissues or their derivatives taken from humans or animals;

d) information on sterilization methods;

e) information on verification and validation of software in the design of a medical device;

e) a report on substantiation of clinical efficacy and safety of the medical device.

13. The statement of the results of clinical trials (studies) conducted, in addition to the conclusions, must include reports (protocols) on trials (studies) in full.

14. The technical file must contain a list of materials in direct or indirect contact with the human body. In order to determine the physical, chemical, toxicological and biological characteristics of the material, it is necessary to conduct tests (studies) of biological compatibility in accordance with the results of risk analysis.

The technical file should include detailed information on the tests (studies) performed, standards applied, test (study) protocols, analysis of the data obtained and a summary of the test (study) results.

15. If the medical device includes medicinal products, the technical file shall contain detailed information on the medicinal products used, their manufacturer(s), the reason for inclusion in the medical device, safety of use and mechanism of action as part of the device for the intended use, as well as a document confirming the registration of the medicinal product in the country of the manufacturer of the medicinal product.

16. The technical file should contain a list of materials of animal or human origin used in the medical device, as well as detailed information on these materials, specifying the selection of sources (donors), sampling, processing, storage, examination and handling of tissues, cells and substances of animal or human origin.

The technical file should also include the results of process validation confirming that production procedures are in place to minimize biological risks, in particular with regard to viruses and other pathogens.

A description of the record retention system that allows traceability from material sources to the finished medical device should also be included.

17. If the medical device is supplied in sterile form, the technical file should contain information on validation of the sterilization process (including tests (studies) on biological load, presence of pyrogenic substances, presence of residual amount of sterilizing agent) and on validation of the packaging process. Information on validation should include the method applied, the level of sterility achieved, the standards applied, the sterilization protocol developed in accordance with these standards and a summary of the results obtained.

18. The technical file shall contain information on the process of design and development of software and validation of software used in the finished medical device. The specified information includes a summary of the results of verification, validation activities and the results of tests (studies) performed in the manufacturing organization, as well as information on available hardware configurations and operating systems contained in the supporting documentation.

19. The technical file shall contain information on animal tests (studies) conducted to confirm compliance with the General Requirements (if any). The technical file shall describe the objectives of these studies, methodology, results, analysis and conclusions.

Annex N 4

to the Rules for the Conduct of Clinical

and clinical and laboratory trials

(research) of medical devices

REQUIREMENTS TO THE CONTENTS OF THE SOFTWARE TECHNICAL FILE,

MEDICAL DEVICE

I. General description of the software, which is

medical device

(1) The technical file for software that is a medical device (hereinafter referred to as «software») shall contain the following information:

(a) The name of the software;

b) general description and purpose of the software;

c) information on intended users of the software;

d) information allowing to identify the software, including information on software models (brands), its (their) version(s);

(e) Explanation of the numbering order of software versions;

f) information on possible changes in the software that affect (not affect) the invariability of its functional purpose and (or) principle of operation (if available);

g) type of medical device in accordance with the nomenclature of medical devices applicable within the Eurasian Economic Union;

h) class of potential risk of use and applicable classification rules in accordance with the Rules of classification of medical devices depending on the potential risk of use, approved by the Decision of the Board of the Eurasian Economic Commission dated December 22, 2015 N 173 (with justification of the selected class of potential risk of use);

(i) Principles of software operation;

j) information on the interpretation function, the source of the dataset, the hardware platform, the way in which the software is hosted and access to it is provided;

k) description of constituent parts, modules, blocks of the software, which may be accompanied by structural diagrams of the software architecture;

m) information on the presence (absence) of artificial intelligence technologies in the software and their description;

m) description of characteristics of software accessories, medical devices or non-medical devices, but provided for use in combination with the software, as well as description of special equipment and (or) software, test databases developed by the manufacturer for the use of the software (if any).

II. Software description

(2) The technical file shall contain a list of key features, including the following information:

(a) A description of the technical characteristics of the software;

b) description of hardware system requirements necessary for software operation (specifying supported operating systems, hardware platforms, required RAM, required disk space, additional requirements for hardware and software);

c) data exchange protocols for use of the software in conjunction with other medical devices and/or accessories;

d) efficiency parameters set by the manufacturer depending on the purpose of the software and taking into account the current level of development in the relevant field;

e) description of the procedure for installing (installing) and uninstalling (uninstalling) the software;

f) a list of requirements for professional training or qualifications of persons installing (installing) and uninstalling (uninstalling) software (if any);

g) a list of measures and means of protection against unauthorized access to the software, as well as measures to ensure its cybersecurity, including:

information on potential risks of cybersecurity threats (identification of assets, threats and vulnerabilities, etc.);

information on the procedure of access restriction for all levels with indication of methods by which such restriction is achieved (access only for trusted users, access by means of user authentication);

the extent and possibility of threats and vulnerabilities impacting software functionality and intended users;

information on the use of automatic synchronization methods to terminate sessions on the system, if necessary for the software usage environment;

information about the use of a tiered authorization model and differentiation of rights based on user role or device role;

information on technical and program protection means used in the software;

the procedure for user authentication before authorizing software updates, including those affecting the operating system and applications;

information on the need to use systematic procedures for authorized users when installing (installing) and updating software;

information on the need to use anti-malware protection means (anti-virus software), if such means are not provided by the manufacturer of the software to be used together with other software;

information on the use of means of cryptographic protection of information (if any);

information about the need to use the function of archiving, backup (duplication) of data on the organization’s servers with the help of an authenticated privileged user;

information on means used to protect against illegal distribution (if any);

h) clinical guidelines used by the software algorithm (if any);

(i) specifying how the user can obtain information on the current version of the software and how to update it;

j) a list of standards applied by the software manufacturer.

III. History of software circulation, information

about similar and previous versions of the software

(3) The technical file shall contain information on the presence or absence of a history of software circulation on international markets, including information on marketing, cases of adverse events (incidents) related to the use of software and software withdrawals from the market, as well as a description of the corrective actions taken in response to these cases and (or) their analysis.

4. In the case of using information about similar or previous versions of software to prove compliance with the General requirements for safety and effectiveness of medical devices, requirements for their labeling and operational documentation for them, approved by the Decision of the Council of the Eurasian Economic Commission of February 12, 2016. N 27 (hereinafter — the General Requirements), the technical file must contain a brief description:

(a) Previous versions of the software (if any);

b) similar versions of software in circulation within the Eurasian Economic Union and on international markets.

IV. Accompanying information

5. The technical file must contain:

(a) Data on the marking of the software, its electronic medium and packaging (marking projects);

b) instructions for use (operational documentation) of the software.

V. Software design and development

6. The technical file shall contain information on the software life cycle processes, including information on the main stages of software design and development, which may be accompanied by schemes, drawings, diagrams and other explanations.

VI. Production processes

7. The technical file should contain information that provides an overview of the manufacturing processes. This information may be presented in the form of a flowchart of the processes giving an overview of the production, final tests (studies) of the software and final packaging of the electronic medium of the software (if applicable).

VII. Production sites

8. The technical file shall identify the production sites where the software production activities are carried out. If quality management system certificates, inspection reports on the compliance of the systems with the requirements of standards or equivalent documents are available for these sites, copies of these documents shall be attached to the technical file.

VIII. Information on compliance with the General Requirements

9. The technical file shall include information on compliance of the software with the General Requirements.

IX. Results of risk analysis and management

10. The technical file shall contain a brief list of risks identified in the risk analysis process and a description of the ways to manage these risks in order to reduce them to an acceptable level.

X. Verification and validation activities

11. The technical file shall contain the following information and verification and validation documents used to demonstrate that the software complies with the General Requirements (including the applicability of the General Requirements):

a) results of tests (studies) in testing laboratories (centers) and medical organizations (clinical centers);

b) protocols of preliminary tests (studies) of software (including reports on testing, validation and verification of software), tests (studies) of software on test databases;

c) declaration (declarations) of software compliance with standards from the list of standards, as a result of the application of which, on a voluntary basis, fully or partially ensures compliance of medical devices General requirements for the safety and effectiveness of medical devices, requirements for their labeling and operational documentation for them (Annex to the Recommendation of the Board of the Eurasian Economic Commission dated September 4, 2017. N 17), or other standards with justification for their application;

d) a review of published literature sources containing information on the software or similar software under consideration.

12. the technical file must contain a report on the substantiation of the clinical efficacy and safety of the software.

13. The technical file must contain information on the clinical trials (studies) conducted, except for conclusions, which must include reports, protocols of trials (studies) in full.

Annex N 5

to the Rules for the Conduct of Clinical

and clinical and laboratory trials

(research) of medical devices

REPORT FORM

ON CLINICAL TRIAL (RESEARCH) OF A MEDICAL DEVICE

APPROVED

_____________________________________

(head of medical organization (clinical center), surname, first name, patronymic, signature (research coordinator, surname, first name, patronymic (if available), signature — in case of multicenter trials)))

REPORT

on clinical trial (research) of a medical device

____________________________________________________________

(name of medical device)

N ____ dated «__» ____________ 20__.

1. Compiled by

______________________________________________________________________

(name and address of the location of the medical organization (clinical center))

2. Authorization to conduct a clinical trial (research)

______________________________________________________________________

3. Authorization to conduct a clinical trial (research) of a medical device (except for software that is a medical device), or information on a notification to conduct a clinical trial (research) of a medical device (for software that is a medical device), or details of a register entry in a register in which information on issued authorizations and submitted notifications to conduct clinical or clinical-laboratory trials (research) of medical devices is entered

______________________________________________________________________

4. Period of the clinical trial (research)

______________________________________________________________________

5. Name and address of the manufacturer’s location

____________________________

6. Name and address of the place of operation of the production site(s) 

______________________________________________________________________

7. Name and address of the applicant’s location

____________________________

8. Name and location address of the manufacturer’s authorized representative (if any) 

______________________________________________________________________

9. Data on researchers, research coordinator (if any)

_______________________________________________________________________________________

(surname, name, patronymic (if any), place of work, position, academic degree (title) (if any))

10. Identification and description of the investigational medical device, including a list of models (brands) of the medical device (including their composition and accessories) to which the results of the clinical trial (research) apply (if any) 

______________________________________________________________________

11. purpose of the medical device

____________________________

12. Potential risk class of the medical device 

______________________________________________________________________

13. Code of type of medical device in accordance with the nomenclature of medical devices applied within the Eurasian Economic Union

______________________________________________________________________

14. Objectives and hypotheses of a clinical trial (study)

______________________________________________________________________

15. Clinical trial (study) design, including description of endpoints

______________________________________________________________________

16. Number of subjects of clinical trial (research) (in case of multicenter trials (research) the number of subjects of clinical trial (research) in each medical organization (clinical center)) or information on medical data of patients obtained in the course of diagnosis, treatment, rehabilitation, verified by a medical organization (clinical center) (for software that is a medical device)____________________

17. Number of samples of the medical device under study and their identification features (make, model, software version, weight, volume, date of production (manufacturing), expiration date (service life), catalog number, factory (serial) number (series number, batch (lot) number), etc.) (if applicable).

______________________________________________________________________

18. Medical organizations (clinical centers) where the clinical trial (research) was conducted (for multicenter trials (research))

______________________________________________________________________

19. Statistically processed data on clinical trial (study) endpoints 

______________________________________________________________________

20. Confirmed (rejected) hypotheses based on the results of a clinical trial (study)

______________________________________________________________________

21. Conclusions on the results of the clinical trial (study) 

______________________________________________________________________

Signatures of heads of medical organizations (clinical centers) (in case of multicenter trials (studies)):

______________________________________________________________________________________

(surname, name, patronymic (if any), place of work, position, academic degree (title) (if any))

______________________________________________________________________________________

(surname, name, patronymic (if any), place of work, position, academic degree (title) (if any))

Researchers’ signatures:

______________________________________________________________________________________

(surname, first name, patronymic (if available))

______________________________________________________________________________________

(surname, first name, patronymic (if available))

List of attached documents:

1) clinical trial (research) program;

2) primary data from a clinical trial (study);

3) a copy of the authorization to conduct clinical trials (research);

4) a copy of the opinion of the ethics committee;

5) Informed consent;

6) researcher’s brochure;

7) samples and completed forms of individual registration card, diaries and questionnaires;

8) technical file for the medical device, the content of which meets the requirements according to Annex N 3 (for medical devices, except for software and medical devices for in vitro diagnostics) or Annex N 4 (for software, which is a medical device) to the Rules for clinical and clinical-laboratory tests (studies) of medical devices, approved by the Decision of the Council of the Eurasian Economic Commission of February 12, 2016. N 29, except for the properties and characteristics of safety and effectiveness of a medical device, which must be determined as a result of an ongoing clinical trial (research);

9) the form of the list of adverse events (incidents), in case of occurrence of which it is necessary to report to the authorized body (with indication of the deadlines for reporting), as well as the report on adverse events (incidents) that occurred during the clinical trial (research), including information on adverse events (incidents) that were reported to the authorized body (with indication of the deadlines for reporting);

10) application for authorization to conduct clinical trials (research) of a medical device;

11) a report on deficiencies of the medical device identified during the clinical trial (research); 12) interim report on clinical trial (research) of the medical device (if any).

Annex N 6

to the Rules for the Conduct of Clinical

and clinical and laboratory trials

(research) of medical devices

REQUIREMENTS

TO THE CONTENT OF THE CLINICAL LABORATORY TRIAL PROGRAM

(RESEARCH) OF A MEDICAL DEVICE FOR DIAGNOSTICS

IN VITRO

I. General description of the diagnostic medical device in vitro

1. The program of a clinical and laboratory trial (research) of an in vitro diagnostic medical device shall contain the following information:

(a) The name of the in vitro diagnostic medical device;

b) name of the manufacturer, its location (address of a legal entity) — for a legal entity or surname, name, patronymic (if any), place of residence — for a natural person registered as an individual entrepreneur;

c) name of the applicant, its location (address of a legal entity) — for a legal entity or surname, name, patronymic (if any), place of residence — for an individual registered as an individual entrepreneur, information on state registration of a legal entity or an individual registered as an individual entrepreneur, as well as contact details of the applicant (phone number, e-mail address);

d) name of the manufacturer’s authorized representative (if any), its location (address of a legal entity) — for a legal entity or surname, name, patronymic (if any), place of residence — for a natural person registered as an individual entrepreneur;

e) description and purpose of the in vitro diagnostic medical device;

e) information enabling to identify the medical device for in vitro diagnostics, including the model (brand) number of the medical device (if any) or indication of the identifying number of the model (brand) of the medical device for in vitro diagnostics;

g) type of medical device for in vitro diagnostics in accordance with the nomenclature of medical devices applicable within the Eurasian Economic Union;

h) characterization of specimens or samples used in the clinical-laboratory test (study);

and) class of potential risk of use and applicable classification rules in accordance with the Rules of classification of medical devices depending on the potential risk of use, approved by the Decision of the Board of the Eurasian Economic Commission of December 22, 2015 N 173;

j) Explanation of new properties and characteristics of a medical device for in vitro diagnostics.

II. Data on the clinical and laboratory trial (study) in vitro diagnostic medical device

2. The program of a clinical and laboratory trial (research) of an in vitro diagnostic medical device shall contain the following information:

(a) The purpose and objectives of the clinical and laboratory trial (study);

b) name and address of the location of the medical organization (clinical center) (medical organizations (clinical centers)) taking part in the clinical and laboratory trial (research);

c) place(s) of measurements (analysis) (if it does not coincide with the address of the location of the medical organization (clinical center));

d) methods of data analysis;

e) statistical significance levels;

(e) Sample size for the assessment of clinical effectiveness indicators;

g) biological reference population of the population;

h) Sample eligibility criteria, sample volume and sample exclusion criteria;

(i) Details of the pre-analytical phase;

(j) Blind sample procedures;

k) Consideration of the effects of interference factors caused by sample collection conditions or by the pathologic (physiologic) condition of the Sample Donor or treatment;

(m) Selection and justification of the method of comparison;

(m) Calibration procedures, including traceability data for calibrators;

(o) Criteria for retesting and data exclusion;

n) appropriate measures to prevent the risk of infection of the user.

Annex N 7

to the Rules for the Conduct of Clinical

and clinical and laboratory trials

(research) of medical devices

REPORT FORM

ON A CLINICAL AND LABORATORY TRIAL (STUDY) OF A MEDICAL

IN VITRO DIAGNOSTIC PRODUCTS

APPROVED

_______________________________

(head of medical organization (clinical center), surname, first name, patronymic, signature (research coordinator, surname, first name, patronymic (if available), signature — in case of multicenter trials)))

REPORT

on clinical and laboratory testing (research) of a medical device for in vitro diagnostics

___________________________________________________________________________

(name of in vitro diagnostic medical device)

N ____ dated «__» ____________ 20__.

1. Compiled by

______________________________________________________________________

(name and address of the location of the medical organization (clinical center))

2. Authorization to conduct a clinical and laboratory trial (study) 

______________________________________________________________________

3. Authorization to conduct a clinical and laboratory trial (study) of a medical device for in vitro diagnostics (when conducting an interventional clinical efficacy trial), or details of a notification to conduct a clinical and laboratory trial (study) of a medical device for in vitro diagnostics, or details of a registry entry in a register in which information is entered on issued authorizations and submitted notifications to conduct clinical or clinical and laboratory trials (studies) of medical devices ________________

4. Time period of the clinical and laboratory trial (research)

______________________________________________________________________

5. Name and address of the manufacturer’s location
______________________________________________________________________

6. Name and address of the place of operation of the production site(s)

______________________________________________________________________

7. Name and address of the applicant’s location

______________________________________________________________________

8. Name and location address of the manufacturer’s authorized representative (if any) _________________________________________________________________________

9. Data on researchers, research coordinator (if available)

_____________________________________________________________________________

(surname, name, patronymic (if any), place of work, position, academic degree (title) (if any))

10. Identification and description of the investigational medical device for in vitro diagnostics, including the list of models (brands) of the medical device (including their composition and accessories) to which the results of the test (investigation) apply (if any)

______________________________________________________________________

11. Purpose of an in vitro diagnostic medical device

______________________________________________________________________

12. Potential risk class of in vitro diagnostic medical device

______________________________________________________________________
13. Code of type of medical device in accordance with the nomenclature of medical devices applied within the Eurasian Economic Union

______________________________________________________________________

14. Objectives of the clinical and laboratory trial (study)

______________________________________________________________________

15. Selection and justification of the comparison method

______________________________________________________________________

16. Sample size for assessing analytical and clinical performance measures (by applicability) _____________________________________________________________________

17. Number of samples of the investigated medical device for in vitro diagnostics and their identification features (make, model, weight, volume, date of production (manufacturing), expiration date (service life), catalog number, factory (serial) number (series number, batch (lot) number), etc.) (if applicable) ____________

18. Medical organizations (clinical centers), where the clinical and laboratory test (study) was conducted, and (or) measurement locations (if different from the address of the location of the medical organization (clinical center))

______________________________________________________________________

19. Statistically processed data from a clinical and laboratory trial (study) _____________________________________________________________________
20. Evaluation of the claimed characteristics and obtained results of clinical and laboratory test (study) _____________________________________________________________________

21. Conclusions on the claimed characteristics of an in vitro diagnostic medical device based on the results of a clinical and laboratory test (study) __________________________________________________________________________

Signatures of heads of medical organizations (clinical centers) (in case of multicenter trials (studies)):
_________________________________________________________________________________
(surname, name, patronymic (if any), place of work, position, academic degree (title) (if any))

_________________________________________________________________________________
(surname, name, patronymic (if any), place of work, position, academic degree (title) (if any))

Researchers’ signatures:

_________________________________________________________________________________

(surname, first name, patronymic (if available))

_________________________________________________________________________________

(surname, first name, patronymic (if available))

List of attached documents:

1) program of clinical and laboratory trial (research);

2) primary data from a clinical and laboratory test (study);

3) a copy of the authorization to conduct a clinical and laboratory trial (research) (when conducting an interventional clinical efficacy trial);

4) a copy of the ethics committee’s opinion (when conducting an interventional clinical efficacy trial);

5) informed consent (when conducting an interventional clinical efficacy trial and when conducting trials (studies) using purposively selected samples);

6) Investigator’s brochure (when conducting an interventional clinical efficacy study);

7) samples and completed forms of individual registration card, diaries and questionnaires (when conducting an interventional clinical efficacy trial);

8) technical file for the medical device for in vitro diagnostics, the content of which meets the requirements according to Annex N 5 to the Requirements for the implementation, maintenance and evaluation of the quality management system of medical devices depending on the potential risk of their use, approved by the Decision of the Council of the Eurasian Economic Commission on November 10, 2017. N 106, except for the properties and characteristics of safety and efficacy of the medical device, which must be determined as a result of an ongoing clinical and laboratory test (study);

9) the form of the list of adverse events (incidents), in case of occurrence of which it is necessary to report to the authorized body (with indication of deadlines for reporting), as well as the report on adverse events (incidents) that occurred during the clinical and laboratory trial (research), including information on adverse events (incidents) that were reported to the authorized body (with indication of deadlines for reporting);

10) application for authorization to conduct clinical and laboratory tests (trials) of a medical device (when conducting an interventional clinical efficacy trial);

11) a report on deficiencies of the medical device identified during the clinical and laboratory test (study);

12) interim report on clinical and laboratory test (study) of the medical device for in vitro diagnostics (if any).

Annex N 8

to the Rules for the Conduct of Clinical

and clinical and laboratory tests

(research) of medical devices

(form)

To the authorized body (expert organization) of a member state of the Eurasian Economic Union
__________________________________________

__________________________________________

(name of the authorized body (expert organization) of the Eurasian Economic Union member state)

APPLICATION

on obtaining authorization to conduct clinical trials (research) of a medical device

I. Information about the medical device

1.	Name of medical device
2.	Purpose of medical device
3.	Potential risk class of the medical device
4.	Does the medical device contain a drug product?	Yes No

5.	Model (brand) of the medical device, its composition and accessories

N	Name	Manufacturer	Country
1.	Model (brand) of medical device (if available)
2.	Composition (if any)
3.	Accessories(if any)

6.	Manufacturer information

legal form of organization, full name and abbreviated name (if any), country (full name of individual entrepreneur)

number, date registration

address of the legal person or address of residence of a natural person registered as an individual entrepreneur

address of place of business

telephone and fax numbers, e-mail address (if available)

Full name and position of the manager

7.	Information about the production site(s)

N	legal form, full name and abbreviated name (if any) (full name of an individual entrepreneur)	number, date and validity of the authorization document (if any)	business address	Telephone and fax numbers, e-mail address (if available)	Full name and position of the manager
1.
…

8.	Information on the manufacturer’s authorized representative (if any)

legal form, full name and abbreviated name (if any), country (full name of individual entrepreneur)

registration number, date of registration

address of a legal entity or address of residence of an individual registered as an individual entrepreneur

business address

Telephone and fax numbers, e-mail address (if available)

Full name and position of the manager

II. Information on clinical trials (studies)

1. Are clinical trials (studies) multicenter? __________________________________________________________________________

2. Medical organization (clinical center) (medical organizations (clinical centers)) conducting clinical trials (research), specifying the location address, telephone and fax numbers and e-mail address (if available) _________________________________

3. Details of the regulatory document(s) on the basis of which the medical organization (clinical center) (medical organizations (clinical centers)) is permitted to conduct clinical (trials) of medical devices ________________________________

4. Planned period of time for conducting clinical trials (research) __________________________________________________________________________

5. Data   on the researchers, research coordinator (when available) _________________________________________________________            (surname, first name, patronymic (if available), place of employment, position, academic degree (title) (if any))

6. Purpose and hypotheses of the clinical trial (study) __________________________________________________________________________

7. Number of subjects of clinical trials (studies) (in case of multicenter trials (studies) the number of subjects of clinical trials (studies) in each medical organization (clinical center)) ______________________________________________________

8. Number of samples of the medical device under study and their identification features (make, model, software version, weight, volume, date of production (manufacturing), expiration date (service life), catalog number, factory (serial) number (series number, batch (lot) number), etc.) (if applicable). ______________________________________________________

III. Additional information

1. Surname, first name, patronymic (if any), address, telephone and fax numbers, e-mail address (if any) of the contact person for this application __________________________________________________________________________

2. When re-submitting an application for this medical device, the date and number of the previous application _____________________________________________________

3. Information on a document confirming payment for the performance of actions connected with obtaining an authorization to conduct clinical trials (research) or making an entry in a register in which information is entered on authorizations issued and notifications submitted concerning the conduct of clinical or clinical and laboratory trials (research) of medical devices __________________________________________________________________________

4. Method of receipt of notifications (decisions) from the authorized body (expert organization) of the Eurasian Economic Union member state:  personally signed;  by registered mail with return receipt requested;  electronically via telecommunication channels (when selecting this method, it is necessary to specify the e-mail address(es) to which notifications should be sent);  in the form of an electronic document signed with an electronic digital signature.

I guarantee the accuracy and identity of the information contained in the submitted documents.

Applicant’s signature:

_________________________________________________________________________

(surname, name, patronymic (if any), place of work, position)

Date «__» ___________________

List of attached documents:

1) …2) …

Annex N 9

to the Rules for the Conduct of Clinical

and clinical and laboratory trials

(research) of medical devices

(form)

To the authorized body (expert organization) of a member state of the Eurasian Economic Union

______________________________________

______________________________________

(name of the authorized body (expert organization) of the Eurasian Economic Union member state)

APPLICATION

on obtaining authorization to conduct clinical and laboratory tests (trials) of a medical device (when conducting an interventional clinical efficacy trial)

I. Information about the medical device

1.	Name of medical device
2.	Purpose of medical device
3.	Potential risk class of the medical device

4.	Model (brand) of the medical device, its composition and accessories

N	Name	Manufacturer	Country
1.	Model (brand) of medical device (if available)
2.	Composition (if any)
3.	Accessories (if available)

5.	Manufacturer information

legal form, full name and abbreviated name (if any), country (full name of individual entrepreneur)

registration number, date of registration

address of a legal entity or address of residence of an individual registered in as an individual entrepreneur

business address

Telephone and fax numbers, e-mail address (if available)

Full name and position of the manager

6.	Information about the production site(s)

N	legal form, full name and abbreviated name (if any) (full name of an individual entrepreneur)	number, date and validity of the authorization document (if any)	business address	Telephone and fax numbers, e-mail address (if available)	Full name and position of the manager
1.
…

7.	Information on the manufacturer’s authorized representative (if any)

legal form, full name and abbreviated name (if any), country (full name of individual entrepreneur)

registration number, date of registration

address of a legal entity or address of residence of an individual registered as an individual entrepreneur

business address

Telephone and fax numbers, e-mail address (if available)

Full name and position of the manager

II. Information on clinical and laboratory trials (studies)

1. Are clinical and laboratory trials (studies) multicenter? __________________________________________________________________________

2. Medical organization (clinical center) (medical organizations (clinical centers)) conducting clinical and laboratory trials (research), specifying the location address, telephone and fax numbers and e-mail address (if available) _______________________

3. Details of the regulatory document(s) on the basis of which the medical organization (clinical center) (medical organizations (clinical centers)) is permitted to conduct clinical and laboratory (testing) of medical devices _______________________

4. Planned period of time for conducting clinical and laboratory trials (studies) ____________________________________________________________

5. Data on researchers, research coordinator (if any) ___________________________________________________________ (surname, name, patronymic (if any), place of work, position, academic degree (title) (if any))

6. Objectives and hypotheses of the trial (research) _________________________________

7. Number of subjects of clinical and laboratory trials (studies) (in case of multicenter trials (studies), the number of subjects of clinical and laboratory trials (studies) in each medical organization (clinical center)) __________________________________________

8. Number of samples of the medical device under study and their identification features (make, model, software version, weight, volume, date of production (manufacturing), expiration date (service life), catalog number, factory (serial) number (series number, batch (lot) number), etc.) (if applicable). ______________________________________________________________________________________

III. Additional information

1. Surname, first name, patronymic (if any), address, telephone and fax numbers, e-mail address (if any) of the contact person for this application __________________________________________________________________________

2. When re-submitting an application for this medical device, the date and number of the previous application _____________________________________________________

3. Information on a document confirming payment for the performance of actions connected with obtaining an authorization to conduct clinical and laboratory tests (investigations) or making an entry in a register in which information is entered on authorizations issued and notifications submitted concerning the conduct of clinical or clinical and laboratory tests (investigations) of medical devices ______________________________________________________________

4. Method of receipt of notifications (decisions) from the authorized body (expert organization) of a member state of the Eurasian Economic Union:  personally signed;  by registered mail with return receipt requested;  electronically via telecommunication channels (when selecting this method, it is necessary to specify the e-mail address(es) to which notifications should be sent);  in the form of an electronic document signed with an electronic digital signature.

I guarantee the accuracy and identity of the information contained in the submitted documents.

Applicant’s signature:

_________________________________________________________________

(surname, name, patronymic (if any), place of work, position)

Date «__» __________________________

List of attached documents:

1) …2) …

Annex N 10

to the Rules for the Conduct of Clinical

and clinical and laboratory trials

(research) of medical devices

(form)

________________________________________________________________________________

(name of the authorized body (expert organization) of the Eurasian Economic Union member state)

APPROVED

__________________________
(full name of the head of the authorized body (expert organization) of the Eurasian Economic Union member state, signature, stamp)

«__» _________________ 20__ г.

EXPERT OPINION

the possibility (impossibility) to conduct clinical or clinical-laboratory (in case of interventional clinical efficacy study) trials (studies) of a medical device

N _____ dated «__» _____________ 20__.

I. General information about the medical device

1. Number and date of registration of an application for authorization to conduct a clinical or clinical-laboratory (in the case of an interventional clinical efficacy trial) trial (research) of a medical device ___________________________________________________________________

2. Name of medical device _____________________________________

3. Medical device manufacturer, country ______________________________

4. Authorized representative of the manufacturer (if any) __________________________________________________________________________

5. Production site(s), country __________________________________________________________________________

6. Scope and purpose _______________________________________

7. Potential risk class of the medical device __________________________________________________________________________

8. Medical device models (brands), their composition and accessories __________________________________________________________________________

9. Main technical characteristics of the medical device (model (brand) of the medical device (if any)) ________________________________________

II. Results of expert review to determine the possibility (impossibility) of conducting clinical or clinical-laboratory (in case of interventional clinical efficacy study) tests (trials) of a medical device

1- Assessing whether the product is correctly categorized as a medical device ______________________________________________________

2 Assessment of compliance with the class of potential risk of use of a medical device specified by the applicant in accordance with the Rules for the classification of medical devices depending on the potential risk of use, approved by Decision of the Board of the Eurasian Economic Commission of December 22, 2015 N 173 ______________________________________.

3 Assessment of the possibility of conducting clinical or clinical-laboratory tests (trials) of the declared models (brands) of a medical device under one program of clinical or clinical-laboratory tests (trials) __________________________________________________________________________

4. analysis of the submitted documents, including in part:

compliance of documents with the established requirements ________________________confirmation (non-confirmation) by the relevant information contained in the submitted documents of the admissibility of risks associated with clinical or clinical-laboratory (when conducting an interventional clinical efficacy trial) trials (studies) ____________________________________________________________determining the sufficiency (insufficiency) of evidence on the safety of a medical device ______________________________________________________

III. General conclusion on the possibility (impossibility) to conduct clinical or clinical-laboratory (in case of interventional clinical efficacy study) trials (studies) of a medical device

____________________________________________________________________________________

He is warned about the responsibility for the reliability of the information stated in the expert report on the possibility (impossibility) of conducting clinical or clinical-laboratory (in the case of interventional clinical efficacy studies) trials (research) of a medical device.

____________________________________________________________________________________

(signature, surname, name, patronymic (if any) of the expert, position, academic degree (title) (if any))

____________________________________________________________________________________