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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.

Chairman of Board of the Eurasian economic commission

V. Khristenko

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 degree of potential risk of harming health of patients, the personnel operating medical products, and other persons.

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. The independent software is considered as active medical product;

"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;

"harm" - injuring or drawing damage to health of the person, to the equipment or the environment;

"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;

"medical products for temporary use" the medical products intended for continuous use from 60 minutes to 30 days according to the application instruction or the operation manual;

"medical products for diagnosis of in vitro" - any tools, devices, devices, the equipment, materials, reagents, calibrators, control materials and other products applied in the medical purposes separately or in combination among themselves and also together with the accessories necessary for use of the specified products to destination (including the special software), and information of rather physiological or pathological condition, inborn pathology, predisposition to certain clinical condition or disease, compatibility of fabrics with the potential recipient intended by the producer for use in case of the researches in vitro of samples of biological materials of the person for obtaining, forecasting of reactions to therapeutic impacts, the choice of therapeutic means and (or) control of treatment;

"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;

"nanomaterial" - material which contains the particles which are in untied condition or particles in the form of aggregates or is agglomerate and in which at least 50 percent of particles have the sizes in the range 1... 100 nanometers. At the same time aggregates are understood as the particles consisting from alloyed or firmly bound particles, as agglomerates - associations of poorly bound particles. Particles of graphene or carbon nanotubes with one or several external dimensions less than 1 nanometer also belong to nanomaterials;

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