DECISION OF BOARD OF THE EURASIAN ECONOMIC COMMISSION

of December 22, 2015 №174

About approval of Rules of carrying out monitoring of safety, quality and efficiency of medical products

According to Item 2 of article 31 of the Agreement on the Eurasian Economic Union of May 29, 2014, Item 2 of article 8 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, Item 25 of appendix №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 №98, and for the purpose of execution of the Decision of the Supreme Euroasian economic council of December 23, 2014 №109 "About implementation 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" the Board of the Euroasian economic commission decided:

1. Approve the enclosed Rules of carrying out monitoring of safety, quality and efficiency of medical products.

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 appointment 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 appointment 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 №174

Rules of carrying out monitoring of safety, quality and efficiency of medical products

1. These rules are developed according to Item 2 of article 31 of the Agreement on the Eurasian Economic Union of May 29, 2014 and Item 2 of article 8 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 procedure for carrying out monitoring of safety, quality and efficiency of medical products (further - monitoring).

2. The purposes of carrying out monitoring are safety of users, preservation and promotion of health of the population, improvement of quality of delivery of health care, identification and prevention of the side effects and undesirable reactions which are not specified in the instruction for application or the operation manual on medical product (further - the instruction for application), unfavorable events (incidents), the address of the medical products which are not conforming to the general requirements of safety and efficiency of medical products, requirements to their marking and operational documentation approved by the Eurasian economic commission on them.

3. Monitoring includes collection, registration, information analysis about unfavorable events (incidents) and adoption of relevant decisions.

4. Monitoring is based on:

a) the analysis of messages on unfavorable events (incidents) at all stages of the address of the medical products within the Eurasian Economic Union (further - the Union) received:

from users of medical products; from producers of medical products;

when implementing of state members of the Union by authorized bodies of the state control (supervision) of the address of medical products;

b) the analysis of periodic reports on safety and clinical efficiency of medical products of class of potential risk of application 3, and also the medical products of classes of potential risk of application implanted into human body 26 and 3 at post-registration stage, the medical products received from producers or from their authorized representatives;

c) to system of collection and data analysis of the producer of medical products about safety and efficiency of medical products at post-sale stage and carrying out corrective actions according to the requirements to implementation, maintenance and assessment of quality management system of medical products depending on potential risk of application approved by the Eurasian economic commission.

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

"corrective action" - action taken by the producer of medical products for the purpose of elimination of the reason of the found discrepancy or undesirable event;

"corrective action on safety of medical product" - the action taken by the producer of medical products for the purpose of decrease in risk of death or serious deterioration in the state of health of users or the third parties, connected using medical product. 

Such actions can include:

return of medical product to the producer of medical products or to his authorized representative;

modification of medical product (upgrade according to the changes in design of medical product made by the producer of medical products, change of instructions for application, updating of the software of medical product);

replacement of medical product;

withdrawal of medical product from the address;

destruction of medical product;

informing on actions of users of medical products if the medical product is withdrawn from circulation, but is available probability of its use;

"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 the instruction for application which directly or indirectly brought or could lead to death or serious deterioration in the state of health of users or the third parties (at the same time serious deterioration in the state 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 patrimonial injury);

"undesirable event" - any undesirable medical event, not predicted disease either damage or undesirable clinical signs (including the laboratory indicators other than regulation) at users or the third parties connected using medical product;

Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info