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 Article 31 of 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, 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 December 23, 2014, No. 98, and the Decision of the Supreme Eurasian Economic Council of December 23, 2014, No. 109 "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:

1. To approve the attached:

Image of the special mark of circulation of medical devices on the market of the Eurasian Economic Union;

Regulations on the special mark of circulation of medical devices on the market of the Eurasian Economic Union.

2. This Decision shall enter into force after 10 calendar days from the date of entry into force of the Protocol signed on December 2, 2015, on the accession of the Republic of Armenia to 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, but not earlier than after 10 calendar days from the date of official publication of this Decision.

Members of the Council of the Eurasian Economic Commission:

From the Republic of Armenia

V. Gabrielyan

From the Republic of Belarus

V. Matyushevsky

From the Republic of Kazakhstan

B. Sagintaev

From the Kyrgyz Republic

O. Pankratov

From the Russian Federation

I. Shuvalov

APPROVED

By the Decision of the Council

of the Eurasian Economic Commission

dated February 12, 2016, N 26

REGULATIONS

ON THE SPECIAL MARK OF CIRCULATION OF MEDICAL DEVICES

ON THE MARKET OF THE EURASIAN ECONOMIC UNION

1. These Regulations have been developed in accordance with paragraph 2 of Article 31 of 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).

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.

3. The abbreviation "EAC" means Eurasian Conformity.

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.

5. Marking with the special mark of circulation shall be carried out before the release of the medical device for circulation within the Union.

APPROVED

By the Decision of the Council

of the Eurasian Economic Commission

dated February 12, 2016, N 26

IMAGE

OF THE SPECIAL MARK OF CIRCULATION OF MEDICAL DEVICES

ON THE MARKET OF THE EURASIAN ECONOMIC UNION

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

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).

(Fig. 1) or contrasting background (Fig. 2).

The image of the special mark of circulation must be monochrome and contrast with the color of the surface on which it is applied.

The line width of the elements of the "EAC" abbreviation is equal to the line width of the square outline.

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 ½ 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.

II. Dimensions and Proportions of the Special Mark of Circulation

The image of the special mark of circulation on a scaled grid with dimensions and proportions indicated is presented in Figure 3.

The main proportions of the special mark of circulation on a scaled grid: the vertical size H is 30a, the horizontal size B – 28a, where "a" is the size-forming module.

The dimensions of the special mark of circulation when scaling are determined by a proportional change in the values of H and B.

The permissible minimum value for size B is 6 mm.