BOARD OF THE EURASIAN ECONOMIC COMMISSION

DECISION

dated July 24, 2018 No. 116

ON THE CRITERIA FOR DISTINGUISHING ELEMENTS OF A MEDICAL DEVICE

THAT ARE COMPONENT PARTS OF A MEDICAL DEVICE,

FOR THE PURPOSES OF ITS REGISTRATION

Based on paragraph 2 of Article 3, paragraphs 2 and 4 of Article 4 of the Agreement on Common Principles and Rules for the Circulation of Medical Devices (Medical Devices and Medical Equipment) within the Eurasian Economic Union dated December 23, 2014, and paragraph 11 of the Rules for Registration and Examination of Safety, Quality and Efficacy of Medical Devices, approved by the Decision of the Council of the Eurasian Economic Commission dated February 12, 2016 No. 46, as well as in accordance with paragraph 23 of the list of acts of the Eurasian Economic Commission on the regulation of common markets for medicines and medical devices within the Eurasian Economic Union for 2017–2019 (appendix to the Order of the Council of the Eurasian Economic Commission dated May 17, 2017 No. 15), the Board of the Eurasian Economic Commission has decided:

1. To approve the attached Criteria for distinguishing elements of a medical device that are component parts of a medical device, for the purposes of its registration.
2. This Decision shall enter into force upon the expiration of 30 calendar days from the date of its official publication.

Chairman of the Board

of the Eurasian Economic Commission

T. SARGSYAN

Approved

by the Decision of the Board of the Eurasian Economic Commission

dated July 24, 2018 No. 116

CRITERIA FOR DISTINGUISHING ELEMENTS OF A MEDICAL DEVICE THAT ARE COMPONENT PARTS OF A MEDICAL DEVICE, FOR THE PURPOSES OF ITS REGISTRATION

1. This document establishes the criteria for distinguishing elements of a medical device that are component parts of a medical device, for the purposes of its registration.
2. For the purposes of applying this document, concepts are used that mean the following:

"spare part of a medical device" — a part of a medical device intended to replace the same part that was in operation in order to maintain or restore the serviceability or operability of the medical device;

"main block (part) of a medical device" — a device, other than consumables for a medical device, released into circulation on behalf of the manufacturer of the medical device, not mechanically connected to other main blocks (parts) of the medical device upon delivery of the medical device, and ensuring the functioning of the medical device in accordance with its intended purpose. The main blocks (parts) of a medical device include special software that is a medical device, and may also include other medical devices registered in the established procedure and admitted for circulation within the Eurasian Economic Union, intended in accordance with the documentation of the manufacturer of the registered medical device to ensure its functioning in accordance with its intended purpose;

"component part of a medical device" — a main block (part) of a medical device, an accessory, a component for a medical device, and a consumable material for a medical device.

Other concepts are used in the meanings defined by the Rules for Registration and Examination of Safety, Quality, and Efficacy of Medical Devices, approved by the Decision of the Council of the Eurasian Economic Commission dated February 12, 2016, No. 46.

3. The assignment of an element of a medical device to a component part of a medical device for the purposes of its registration is carried out on the basis of the following criteria:

a) if the element is a device or material consumed during the use of a medical device, ensuring the performance of manipulations in accordance with the functional purpose of the medical device, then such an element is classified as a consumable material for the medical device. At the same time, the use of another medical device, including one registered in the established procedure and admitted for circulation within the Eurasian Economic Union, is permitted as a consumable material for a medical device;

b) if the element is not a device or material consumed during the use of a medical device, ensuring the performance of manipulations in accordance with the functional purpose of the medical device, and is released into circulation within the Eurasian Economic Union on behalf of the manufacturer of the medical device, wherein:

it is not a spare part of the medical device, then such an element is classified as a main block (part) of the medical device;

it is a spare part of the medical device, then such an element is a component for the medical device;

c) if the element is not a device or material consumed during the use of a medical device, ensuring the performance of manipulations in accordance with the functional purpose of the medical device, and is released into circulation within the Eurasian Economic Union not on behalf of the manufacturer of the medical device, but on behalf of the manufacturer of the element, wherein:

it is a medical device, including one registered in the established procedure, admitted for circulation within the Eurasian Economic Union, and intended in accordance with the documentation of the manufacturer of the registered medical device to ensure its functioning in accordance with its intended purpose, then such an element is classified as a main block (part) of the medical device;

it is not a medical device and is specifically intended by its manufacturer for joint use with a medical device, then such an element is classified as an accessory of the medical device;

it is not a medical device and is not specifically intended by its manufacturer for joint use with a medical device, then such an element is classified as a component for the medical device.

4. When assigning an element of a medical device to a component part of a medical device, a standard algorithm is applied in accordance with the scheme according to the appendix. Deviations from this algorithm when identifying the component parts of a medical device must be justified by the applicant in the submitted registration dossier and confirmed during the examination within the framework of the procedure for registration of a medical device and making amendments to the registration dossier.

5. If another medical device is used as a consumable material for a medical device or a main block (part) of a medical device, then it may be registered separately or as a set in the established procedure and admitted for circulation within the Eurasian Economic Union.

Appendix

to the Criteria for distinguishing elements

of a medical device that are

component parts of a medical

device, for the purposes of its registration

SCHEME OF THE STANDARD ALGORITHM APPLIED WHEN ASSIGNING AN ELEMENT OF
A MEDICAL DEVICE TO A COMPONENT PART OF A MEDICAL DEVICE