DECISION OF BOARD OF THE EURASIAN ECONOMIC COMMISSION

of December 22, 2015 No. 173

About approval of Rules of classification of medical products depending on potential risk of use

According to Item 2 of article 31 of the Agreement on the Eurasian Economic Union of May 29, 2014, item 4 of 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, Item 23 of appendix No. 2 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 for the purpose of execution of 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" the Board of the Eurasian economic commission solved No. 109:

1. Approve the enclosed Rules of classification of medical products depending on potential risk of use.

2. This Decision becomes effective after 30 calendar days from the effective date 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 or from the effective date 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 depending on what date is later, but not earlier than after 30 calendar days from the date of official publication of this Decision.

Approved by the Decision of Board of the Eurasian economic commission of December 22, 2015 No. 173

Rules of classification of medical products depending on potential risk of use

I. General provisions

1. These rules are developed for the purpose of 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 of December 23, 2014 and establish procedure for classification of medical products depending on potential risk of the harming which is expressed in injuring or drawing damage to health of patients from use of medical products, the personnel operating medical products, other persons, to public health or the environment.

2. These rules extend to the medical products released within the Eurasian Economic Union.

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

"active diagnostic medical products" - the active medical products intended for submission of information for the purpose of diagnosis, control of treatment or change of physiological condition, condition of disease or birth defects;

"active medical products" - the medical products applied separately or in combination with other medical products which action requires energy use, excellent from made by the person or gravity. The medical products intended for transmission of energy or substances from active medical product to the patient without their essential change are not active medical products;

"active therapeutic medical products" - the active medical products intended for preserving, change, replacement or recovery of the biological functions or structures connected with treatment, simplification of disease, wound or disability;

"anolyte" - test component with measurable property;

"aferez" - the method of receipt of separate components of blood subdivided into plasmapheresis and cytapheresis;

"the implanted medical products" - the invasive medical products including in parts or in full resolving in organism, which are completely entered into body of the person or replacing the epithelial surface or the surface of eye by means of surgical intervention and remaining in injection site after the surgical procedure and also the medical products which are partially entered into body of the person by means of surgical intervention and remaining in injection site after the surgical procedure more than 30 days;

"invasive medical products" - the medical products intended for complete or partial introduction in body of the person through its surface or through body opening;

"artificial intelligence" - the complex of technology solutions allowing to imitate cognitive functions of the person (including self-training and finding solutions without in advance set algorithm) who includes information and communication infrastructure, the software (including with use of methods of machine training), processes and services for data processing and finding solutions;

"medical products for temporary use" - the medical products intended for continuous use during certain time (from 60 minutes to 30 days) according to the application instruction or the operation manual;

"medical products for prolonged use" - the medical products intended for continuous use within more than 30 days according to the application instruction or the operation manual;

"medical products for short-term use" - the medical products intended for continuous use within no more than 60 minutes according to the application instruction or the operation manual;

"purpose of medical product" - the documentary decision of the producer concerning target use of medical product based on its properties reflected in technical characteristics, the application instruction or the operation manual;

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