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DECISION OF COUNCIL OF THE EURASIAN ECONOMIC COMMISSION

of February 12, 2016 No. 27

About approval of General requirements of safety and efficiency of medical products, requirements to their marking and operational documentation on them

According to Item 2 of article 31 of the Agreement on the Eurasian Economic Union of May 29, 2014, Item 2 of Article 3, item 4 of Article 4 and item 4 of article 7 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 104, and the Decision of the Supreme Eurasian economic council of December 23, 2014 No. 109 "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 the 108 and 109 appendices 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,:

1. Approve the enclosed General requirements of safety and efficiency of medical products, requirements to their marking and operational documentation on them.

2. 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.

Members of council of the Eurasian economic commission:

from the Republic of Armenia

 

V. Gabriyelyan

from the Republic of Belarus

V. Matyushevsky

from the Republic of Kazakhstan

B. Sagintayev

from the Kyrgyz Republic

O. Pankratov

from the Russian Federation

I. Shuvalov

Approved by the Decision of Council of the Eurasian economic commission of February 12, 2016 No. 27

General requirements of safety and efficiency of medical products, requirements to their marking and operational documentation on them

I. General provisions

1. These General requirements are developed according to Item 2 of article 31 of the Agreement on the Eurasian Economic Union of May 29, 2014, Item 2 of Article 3, item 4 of Article 4 and item 4 of article 7 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 general requirements of safety and efficiency of medical products, and also requirements to marking and operational documentation on the medical products released within the Eurasian Economic Union (further - the Union).

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

"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 user without their essential change are not active medical products. The independent software is considered as active medical product;

"safety of medical product" - lack of the unacceptable risk connected with damnification of life, to health of the person, and also the environment;

"application instruction" - the operational documentation containing information provided by the producer to the user concerning appointment, proper and safe use of medical product which can include including the operation manual, technique of medical application, the passport, the form, instructions for installation, adjustment, maintenance, repair, transportation, storage, utilization of medical product;

"medical products for diagnosis of invitro" - 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 invitro 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;

"unfavorable event (incident)" - any defect and (or) deterioration in characteristics, either violation of functioning of medical product, or insufficiency or incorrectness of accompanying information (documentation) on medical product, or the side effect which is not specified in application instructions which directly or indirectly brought or could lead to death or serious aggravation of symptoms of health of users or the third parties (at the same time the serious aggravation of symptoms of health is understood as life-threatening disease, permanent defeat of function of organism or irreversible damage of structure of body, the condition requiring medical or surgical intervention for the purpose of prevention of life-threatening disease, either permanent defeat of function of organism, or irreversible damage of structure of body, the condition requiring hospitalization or significant increase in term of stay in hospital of already hospitalized patient functional violation at fruit, his death, congenital anomaly or birth trauma);

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