DECISION OF COUNCIL OF THE EURASIAN ECONOMIC COMMISSION

of January 26, 2024 No. 7

About modification of the Decision of Council of the Eurasian economic commission of February 12, 2016 No. 29

According to Item 2 of article 31 of the Agreement on the Eurasian Economic Union of May 29, 2014, items 4 and the 5th article 4 of the Agreement on the single principles and rules of the address of medical products (products of medical appointment and medical equipment) within the Eurasian Economic Union of December 23, 2014 and Items 105 and 106 of appendix No. 1 to the Regulations of work of the Eurasian economic commission approved by the Decision of the Supreme Eurasian economic council of December 23, 2014 No. 98, Council of the Eurasian economic commission DECIDED:

1. Bring in the Decision of Council of the Eurasian economic commission of February 12, 2016 No. 29 "About Rules of carrying out clinical and clinical laboratory testing (researches) of medical products" changes according to appendix.

2. Determine that:

carrying out clinical and clinical laboratory testing (researches) medical products according to the civil agreement signed with the medical organization having the right to carry out such testing (researches), before date of the introduction of this Decision to force is performed according to the Rules of carrying out clinical and clinical laboratory testing (researches) of medical products approved by the Decision of Council of the Eurasian economic commission of February 12, 2016 No. 29, in the edition operating at the time of the conclusion of this agreement;

the reports on clinical and clinical laboratory testing (researches) of medical products issued in the forms provided by the corresponding appendices to Rules of carrying out clinical and clinical laboratory testing (researches) of medical products in the edition operating at the time of the conclusion of the civil agreement are accepted for registration of medical products within the Eurasian Economic Union.

3. This Decision becomes effective after 180 calendar days from the date of its official publication.

Members of council of the Eurasian economic commission:

From the Republic of Armenia

M. Grigoryan

From the Republic of Belarus

I. Petrishenko

From the Republic of Kazakhstan

S. Zhumangarin

From the Kyrgyz Republic

A. Kasymaliyev

From the Russian Federation

A. Overchuk

 

Appendix

to the Decision of Council of the Eurasian economic commission of January 26, 2024 No. 7

The changes made to the Decision of Council of the Eurasian economic commission of February 12, 2016 No. 29

1. The paragraph one of Item 2 after words of "the implanted medical products" to add with words "(except for medical products for diagnostics of in vitro and the software which is medical product)", after the word "registration" to add with the words "if it is not proved that clinical efficiency and safety of the declared medical product can be confirmed with different way".

2. The rules of carrying out clinical and clinical laboratory testing (researches) of medical products approved by the specified Decision to state in the following edition:

"Are approved by the Decision of Council of the Eurasian economic commission of February 12, 2016 No. 29
(in edition of the Decision of Council of the Eurasian economic commission of January 26, 2024 No. 7)

Rules of carrying out clinical and clinical laboratory testing (researches) of medical products

I. General provisions

1. These rules are developed according to Item 2 of article 31 of the Agreement on the Eurasian Economic Union of May 29, 2014, items 4 and the 5th article 4 of the Agreement on the single principles and rules of the address of medical products (products of medical appointment and medical equipment) within the Eurasian Economic Union of December 23, 2014 and establish within the Eurasian Economic Union (further – the Union) rules of carrying out clinical and clinical laboratory testing (researches) of medical products.

2. For the purposes of these rules concepts which mean the following are used:

"anolyte" – test component with measurable property;

"analytical efficiency of medical product for diagnostics of in vitro" – capability of medical product for diagnostics of in vitro to reveal presence or to determine content of specific anolyte in biological test;

"biological reference population" – homogeneous population of the individuals who are in well certain state of health or disease;

"the brochure of the researcher" – summary statement of the up-to-date clinical and not clinical information about the examinee (researched) medical product relating to clinical testing (research) or clinical laboratory testing (research) (when performing intervention clinical trial of efficiency);

"the chief researcher" – the qualified person responsible for carrying out clinical or clinical laboratory testing (research). If testing (research) is carried out by team of researchers, the head of this team is the chief researcher;

"double blind method" – the procedure of clinical testing (researches) in which the subjects of testing (researches) and researchers participating in obtaining and processing of primary data are not informed on the actual application to subjects of testing (researches) of impact of medical product;

"design of clinical testing (research)" – methodology of carrying out clinical testing (research) with participation of the person as the subject of testing (research) by means of which it is planned to obtain statistically mathematical evidences of clinical safety and efficiency of the examinee (researched) medical product, including use of control groups of subjects of testing (research), and (or) distribution of subjects of testing (researches) on groups in a random way, and (or) use of unary or double blind method, and also the choice of the main and additional final points;

"additional final point" – the indicator (indicators) used for check of additional hypothesis of clinical testing (research);

"legal representative" – physical person or legal entity which according to the legislation of state member of the Union has the right to give the informed consent on participation in clinical or clinical laboratory (when performing intervention clinical trial of efficiency) testing (research) on behalf of the potential subject of testing (research);

"applicant" – the producer of medical product or its authorized representative;

"the individual registration card" – the document intended for entering into it by all provided program of testing (research) of information on each subject of testing (research);

"intervention clinical trial of efficiency" – research of clinical efficiency of medical product for diagnostics of in vitro which results influence decisions on maintaining the patient and (or) are used under management of treatment for goal achievement of clinical trial;

"informed consent" – the written instrument in which the subject of testing (research) or its legal representative confirms voluntary consent to participation in clinical or clinical laboratory (when performing intervention clinical trials of efficiency) testing (researches) based on the complete information provided to it about clinical or clinical laboratory testing (research);

"the ispytuyemy (researched) medical product" – medical product which during clinical testing (research) or clinical laboratory testing (researches) for medical products for diagnostics of in vitro is estimated regarding safety and (or) efficiency;

"researcher" – the team member of the researchers appointed by the chief researcher for implementation of the main procedures connected with clinical or clinical laboratory testing (research), or for decision making, connected with clinical or clinical laboratory testing (research), and submitting to the chief researcher;

"clinical laboratory testing (researches) of medical product for diagnostics of in vitro" – systematic testing (researches) of analytical characteristics and where it is applicable, clinical efficiency, carried out for the purpose of establishment or confirmation of conformity of medical product for diagnostics of in vitro to the appointment established by the producer;

"clinical efficiency of medical product for diagnostics of in vitro" – capability of medical product for diagnostics of in vitro to show the results correlating with specific clinical or physiological condition in target population in case of its application by the intended user;

"clinical data" – the data on safety and (or) efficiency received in case of clinical application of medical product. Clinical data can be obtained by search in scientific literature of data on medical product, from experience of clinical application of medical product, as a result of clinical or clinical laboratory testing (researches), by means of application of several of the specified methods or otherwise. Clinical data are also the data on safety and (or) efficiency received in case of clinical application of medical products which equivalence to the considered medical product can be proved;

"the clinical proof of efficiency and safety of medical product" – set of the clinical data confirming clinical efficiency and safety of medical product in case of its proper use, established by the producer, and their assessment;

"the clinical proof of efficiency and safety of medical product for diagnostics of in vitro" – data set, confirming scientific justification of anolyte, analytical efficiency and clinical efficiency of medical product for diagnostics of in vitro in case of its proper use, established by the producer, and their assessment;

"clinical testing (research) of medical product" – any testing (research) with participation of the person as the subject of testing (research) conducted for the purpose of studying of safety and (or) efficiency of the examinee (researched) medical product;

"committee on ethics" – independent expert body which is effective according to these rules and the legislation of state member of the Union and considers questions of providing the rights, safety and health protection of subjects of testing (researches);

"control medical product" – the product used in clinical testing (research) for comparison with the examinee (researched) medical product;

"coordinator-researcher" – the researcher appointed the applicant and who is responsible for coordination of work during multicenter clinical (clinical laboratory) testing (research);

"the medical organization (clinical center)" – the organization acting as the research center when carrying out clinical (clinical laboratory) testing (researches);

"multicenter testing (research)" – clinical (clinical laboratory) testing (research) which is carried out in two and more medical organizations (clinical centers) for the single program of testing (research);

"monitoring of clinical (clinical laboratory) testing (research)" – the activities connected with observation of the course of clinical (clinical laboratory) testing (research) for check that this the carried-out testing (research) register the report on monitoring is created according to the program of testing (research), documentary procedures and these rules;

"scientific justification of anolyte" – communication of anolyte with clinical or physiological condition of human body;

"unary blind method" – the procedure of clinical testing (researches) in which subjects of testing (researches) are not informed on the actual application of impact of medical product to them;

"the main final point" – the indicator (indicators) used for check of main hypothesis of clinical testing (research);

"the report on clinical laboratory testing (research) of medical product" – the written description of clinical laboratory testing (research) of medical product with use of the tests and samples including received by genetically engineered method, combining clinical laboratory and statistical descriptions, data presentation and their analysis in the established form;

"the report on clinical testing (research) of medical product" – the written description of clinical testing (research) of medical product with participation of the person as the subject of testing (research) combining clinical and statistical descriptions, data presentation and their analysis in the established form;

"primary data" – any information in the form of original records or verified copies of original records about the clinical facts, observations and other events during clinical (clinical laboratory) testing (researches), necessary for monitoring and assessment of results of clinical (clinical laboratory) testing (researches);

"the intended user" – the special group (groups) of persons designated in the accompanying documentation to medical product which can apply medical product according to its appointment;

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