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

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 prescription and medical equipment) within the Eurasian Economic Union of December 23, 2014, 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, and the Decision of the Supreme Eurasian economic council of December 23, 2014 "About implementation of the Agreement on the single principles and rules of the address of medical products (products of medical prescription and medical equipment) within the Eurasian Economic Union" Council of the Eurasian economic commission solved No. 109:

1. Approve the enclosed Rules of carrying out clinical and clinical laboratory testing (researches) of medical products.

2. Determine that for medical products of classes of potential risk of use 3, 2b and the implanted medical products clinical testing (researches) for the purpose of registration shall be carried out in the form of multicenter testing (researches) and correspond to one of the following conditions:

a) clinical testing (researches) are carried out according to the legislation of state members of the Eurasian Economic Union and in their territories till January 1, 2022 (by date of the last visit of the last patient or subject of testing (research)) or continued to be carried out as of 1 yanvarya2022 (in case of complete set of patients);

b) clinical testing (researches) are carried out in the territories of the states which are not members of the Eurasian Economic Union till January 1, 2022 (by date of the last visit of the last patient or subject of testing (research)) or continued to be carried out as of January 1, 2022 (in case of complete set of patients) according to recommendations of the International forum of regulators of medical products (IMDRF);

c) clinical testing (researches) initiated after January 1, 2022 are carried out according to the right of the Eurasian Economic Union, at the same time one of clinical testing (researches) is carried out in one of state members of the Eurasian Economic Union.

3. This Decision becomes effective after 10 calendar days from the effective date of the Protocol signed on December 2, 2015 on accession of the Republic of Armenia to the Agreement on the single principles and rules of the address of medical products (products of medical prescription and medical equipment) within the Eurasian Economic Union of December 23, 2014, but not earlier than after 10 calendar days from the date of official publication of this Decision.

Approved by the Decision of Council of the Eurasian economic commission of February 12, 2016 No. 29

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 prescription 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 diagnosis of invitro" - capability of medical product for diagnosis of invitro to reveal presence or to determine content of specific anolyte in biological test;

"audit of clinical testing (researches)" - systematic and independent verification of documentation, the actions connected with carrying out testing (research), and activities of the parties participating in carrying out clinical testing (research) medical product which is carried out for confirmation of accomplishment of actions of the estimated testing (research), the fact of carrying out clinical testing (research), and also for assessment of conformity of procedures of collection, data analysis and the reporting to requirements of the program of clinical testing (research), standard operational procedures and requirements of the legislation of state members of the Union;

"the brochure of the researcher" - summary statement of the up-to-date clinical and not clinical information about the researched medical product relating to clinical testing (research);

"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 use 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 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 testing (research) on behalf of the potential subject of testing (research);

"applicant" - legal entity or physical person, responsibility for its organization and (or) financing being the initiator of clinical testing (research) and bearing;

"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);

"inspection of clinical testing (research)" - the action of authorized bodies consisting in official check of documentation, the equipment, other materials concerning clinical testing (research) of the medical products which are in the research center, rooms of the applicant, and also in other organizations concerning testing (research), according to the procedure, established by the legislation of state members of the Union and international treaties and acts constituting the right of the Union;

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

"the ispytuyemy (researched) medical product" - medical product which during clinical testing (research) or clinical laboratory testing (researches) for medical products for diagnosis of invitro is estimated regarding safety and (or) efficiency;

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