{"id":2429,"date":"2026-09-01T12:20:04","date_gmt":"2026-09-01T09:20:04","guid":{"rendered":"https:\/\/grandlocus.com\/?post_type=resources&p=2429"},"modified":"2026-09-01T12:20:04","modified_gmt":"2026-09-01T09:20:04","slug":"council-of-the-eurasian-economic-commission-decision-no-26","status":"publish","type":"resources","link":"https:\/\/grandlocus.com\/en\/resources\/council-of-the-eurasian-economic-commission-decision-no-26\/","title":{"rendered":"Council of the Eurasian Economic Commission Decision No. 26"},"content":{"rendered":"

Council of the Eurasian Economic Commission Decision No. 26<\/h3>\n

 <\/p>\n

Decision of the Council of the Eurasian Economic Commission<\/p>\n

Dated February 12, 2016, N 26<\/p>\n

“On a Special Mark of Circulation of Medical Devices on the Market of the Eurasian Economic Union”<\/p>\n

In accordance with paragraph 2 of\u00a0Article 31\u00a0of the Treaty on the Eurasian Economic Union of May 29, 2014, paragraph 4 of Article 7 of the\u00a0Agreement on Common Principles and Rules for the Circulation of Medical Devices (Medical Products and Medical Equipment) within the Eurasian Economic Union of December 23, 2014, paragraph 94 of Annex No. 1 to the Rules of Procedure of the Eurasian Economic Commission, approved by the Decision of the Supreme Eurasian Economic Council of\u00a0December 23, 2014, No. 98, and the Decision of the Supreme Eurasian Economic Council of\u00a0December 23, 2014, No. 109\u00a0“On the Implementation of the Agreement on Common Principles and Rules for the Circulation of Medical Devices (Medical Products and Medical Equipment) within the Eurasian Economic Union,” the Council of the Eurasian Economic Commission RESOLVES:<\/p>\n

1. To approve the attached:<\/p>\n

Image of the special mark of circulation of medical devices on the market of the Eurasian Economic Union;<\/p>\n

Regulations on the special mark of circulation of medical devices on the market of the Eurasian Economic Union.<\/p>\n

2. This Decision shall enter into force after 10 calendar days from the date of entry into force of the\u00a0Protocol\u00a0signed on December 2, 2015, on the accession of the Republic of Armenia to the\u00a0Agreement\u00a0on Common Principles and Rules for the Circulation of Medical Devices (Medical Products 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.<\/p>\n

Members of the Council of the Eurasian Economic Commission:<\/p>\n

From the Republic of Armenia<\/p>\n

V. Gabrielyan<\/p>\n

From the Republic of Belarus<\/p>\n

V. Matyushevsky<\/p>\n

From the Republic of Kazakhstan<\/p>\n

B. Sagintaev<\/p>\n

From the Kyrgyz Republic<\/p>\n

O. Pankratov<\/p>\n

From the Russian Federation<\/p>\n

I. Shuvalov<\/p>\n

APPROVED<\/p>\n

By the Decision of the Council<\/p>\n

of the Eurasian Economic Commission<\/p>\n

dated February 12, 2016, N 26<\/p>\n

REGULATIONS<\/p>\n

ON THE SPECIAL MARK OF CIRCULATION OF MEDICAL DEVICES<\/p>\n

ON THE MARKET OF THE EURASIAN ECONOMIC UNION<\/p>\n

1. These Regulations have been developed in accordance with paragraph 2 of\u00a0Article 31\u00a0of the Treaty on the Eurasian Economic Union of May 29, 2014, paragraph 4 of Article 7 of the Agreement on Common Principles and Rules for the Circulation of Medical Devices (Medical Products and Medical Equipment) within the Eurasian Economic Union of December 23, 2014, and establish the procedure for applying the special mark of circulation of medical devices on the market of the Eurasian Economic Union (hereinafter referred to as the special mark of circulation, medical devices, and the Union, respectively).<\/p>\n

2. The special mark of circulation indicates that the medical device marked with it has undergone the procedure established within the Union for registration and confirmation of compliance with the general requirements for the safety and effectiveness of medical devices and the requirements for the implementation and maintenance of a quality management system for medical devices.<\/p>\n

3. The abbreviation “EAC” means Eurasian Conformity.<\/p>\n

4. The marking of a medical device with the special mark of circulation shall be carried out by the legal manufacturer of this medical device or its authorized representative.<\/p>\n

5. Marking with the special mark of circulation shall be carried out before the release of the medical device for circulation within the Union.<\/p>\n

APPROVED<\/p>\n

By the Decision of the Council<\/p>\n

of the Eurasian Economic Commission<\/p>\n

dated February 12, 2016, N 26<\/p>\n

IMAGE<\/p>\n

OF THE SPECIAL MARK OF CIRCULATION OF MEDICAL DEVICES<\/p>\n

ON THE MARKET OF THE EURASIAN ECONOMIC UNION<\/p>\n

Description of the Image of the Special Mark of Circulation of Medical Devices on the Market of the Eurasian Economic Union Image of the Special Mark of Circulation of Medical Devices on the Market of the Eurasian Economic Union<\/p>\n

The image of the special mark of circulation of medical devices on the market of the Eurasian Economic Union (hereinafter referred to as the special mark of circulation) is a square outline with the abbreviation “EAC” inscribed in it, centered along the vertical axis of symmetry. The abbreviation is formed by the combination of three stylized letters of the Latin alphabet “E,” “A,” and “C,” graphically executed using right angles, having the same height and width, and repeating the exact proportions of the square on a light background (Fig. 1) or a contrasting background (Fig. 2).<\/p>\n

(Fig. 1) or contrasting background (Fig. 2).<\/p>\n

\"\"<\/a>\"\"<\/a><\/p>\n

The image of the special mark of circulation must be monochrome and contrast with the color of the surface on which it is applied.<\/p>\n

The line width of the elements of the “EAC” abbreviation is equal to the line width of the square outline.<\/p>\n

The outline is open at the bottom, and the inscription “MED,” which is an abbreviation of the word “medical,” is inscribed within the opening. The inscription consists of three letters of the Latin alphabet “M,” “E,” “D,” centered along the vertical axis of symmetry. The line width of the elements of the “MED” inscription is \u00bd the width of the square outline. The horizontal axis of symmetry of the “MED” inscription coincides with the horizontal axis of symmetry of the width of the lower square outline.<\/p>\n

II. Dimensions and Proportions of the Special Mark of Circulation<\/p>\n

The image of the special mark of circulation on a scaled grid with dimensions and proportions indicated is presented in Figure 3.<\/p>\n

\"\"<\/a><\/p>\n

The main proportions of the special mark of circulation on a scaled grid: the vertical size H is 30a, the horizontal size B \u2013 28a, where “a” is the size-forming module.<\/p>\n

The dimensions of the special mark of circulation when scaling are determined by a proportional change in the values of H and B.<\/p>\n

The permissible minimum value for size B is 6 mm.<\/p>\n","protected":false},"excerpt":{"rendered":"

Council of the Eurasian Economic Commission Decision No. 26   Decision of the Council of the Eurasian Economic Commission Dated February 12, 2016, N 26 “On a Special Mark of Circulation of Medical Devices on the Market of the Eurasian Economic Union” In accordance with paragraph 2 of\u00a0Article 31\u00a0of the Treaty on the Eurasian Economic […]<\/p>\n","protected":false},"featured_media":2424,"template":"","categories":[25],"class_list":["post-2429","resources","type-resources","status-publish","has-post-thumbnail","hentry","category-regulatory-framework-en"],"_links":{"self":[{"href":"https:\/\/grandlocus.com\/en\/wp-json\/wp\/v2\/resources\/2429","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/grandlocus.com\/en\/wp-json\/wp\/v2\/resources"}],"about":[{"href":"https:\/\/grandlocus.com\/en\/wp-json\/wp\/v2\/types\/resources"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/grandlocus.com\/en\/wp-json\/wp\/v2\/media\/2424"}],"wp:attachment":[{"href":"https:\/\/grandlocus.com\/en\/wp-json\/wp\/v2\/media?parent=2429"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/grandlocus.com\/en\/wp-json\/wp\/v2\/categories?post=2429"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}