Decision of the Board of the Eurasian Economic Commission dated February 12, 2016 No. 26

"On the Special Mark of Circulation of Medical Devices on the Market of the Eurasian Economic Union"

(together with the "Regulation on the Special Mark of Circulation of Medical Devices on the Market of the Eurasian Economic Union")

COUNCIL OF THE EURASIAN ECONOMIC COMMISSION

DECISION

dated February 12, 2016. N 26

SPECIAL MARK

OF MEDICAL DEVICES ON THE EURASIAN MARKET

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 of circulation of medical devices (medical devices and medical equipment) within the Eurasian Economic Union of December 23, 2014, paragraph 94 of Annex N 1 to the Regulations of the Eurasian Economic Commission, approved by Decision of the Supreme Eurasian Economic Council of December 23, 2014 N 98, and Decision of the Supreme Eurasian Economic Council of December 23, 2014 N 109 "On the re
1. To approve the attached:
image of the special mark of medical devices circulation 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 upon expiration of 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 Uniform Principles and Rules of Circulation of Medical Devices (Medical Devices and Medical Equipment) within the Eurasian Economic Union of December 23, 2014, but not earlier than upon expiration of 10 calendar days from the date of official publication of this Decision.

Members of the Council of the Eurasian Economic Commission:

Approved

By decision of the Council

Eurasian Economic Commission

dated February 12, 2016. N 26

PROPOSAL.

ON THE SPECIAL MARK FOR MEDICAL DEVICES ON THE MARKET

EURASIAN ECONOMIC UNION

1. These Regulations are 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 Uniform Principles and Rules of Circulation of Medical Devices (Medical Devices and Medical Equipment) within the Eurasian Economic Union of December 23, 2014, and establishes the procedure for the application of a special mark of circulation of medical devices in the market of the Eurasian Economic Union (hereinafter, respectively, special mark of circulation, medical devices, Union).
2. The special circulation mark indicates that the medical device marked with it has passed the registration procedure established within the Union and confirmation of compliance with the general requirements for safety and effectiveness of medical devices and the requirements for implementation and maintenance of the quality management system for medical devices.
3 The abbreviation "EAU" stands for Eurasian Conformity.
4. Marking of a medical device with a special circulation mark shall be carried out by the manufacturer of this medical device or its authorized representative.
5. Marking with a special circulation mark shall be carried out before the medical device is put into circulation within the Union.

Approved

By decision of the Council

Eurasian Economic Commission

dated February 12, 2016. N 26

PICTURE.

SPECIAL MARK OF MEDICAL DEVICES ON THE MARKET

EURASIAN ECONOMIC UNION

I. Description of the image of the special mark

of medical devices on the Eurasian market

economic union

The image of the special mark of circulation of medical devices on the market of the Eurasian Economic Union (hereinafter - the special mark of circulation) is the outline of a square with the abbreviation "EAU" inscribed in it centered on the vertical axis of symmetry, which is formed by a combination of three stylized letters of the Latin alphabet "E", "A" and "C", graphically executed with the use of right angles, having the same height and width, and repeats the exact proportions of the square on a light (Fig. 1) or contrasting (Fig. 2) background.

Fig. 1

Fig. 2

The image of the special handling sign shall be monochromatic and contrast with the color of the surface to which it is applied.
The width of the "EAC" abbreviation element line is equal to the width of the square contour line.
In the lower part of the contour is opened, in the opening is inscribed the inscription "MED", which is an abbreviation of the word "medical". The inscription consists of three letters of the Latin alphabet "M", "E", "D", centered on the vertical axis of symmetry. The width of the line of elements of the inscription "MED" is 1/2 of the width of the contour of the square. The horizontal axis of symmetry of the inscription "MED" coincides with the horizontal axis of symmetry of the width of the lower contour of the square.

II. Dimensions and proportions of the special sign of circulation

An image of the special circulation sign on a scale grid with dimensions and proportions is shown in Figure 3.

Fig. 3

The basic proportions of the special address mark on the scale grid are: vertical dimension H - 30a, horizontal dimension B - 28a, where "a" is the dimensioning module.
The size of the special reversal sign when scaled is determined by the proportional change in the values of H and B.
The permissible minimum value of dimension B is 6 mm.