BOARD OF THE EURASIAN ECONOMIC COMMISSION
DECISION
dated July 24, 2018 No. 123
ON THE CRITERIA FOR INCLUDING IN ONE REGISTRATION CERTIFICATE SEVERAL MODIFICATIONS OF A MEDICAL DEVICE, BELONGING TO ONE TYPE OF MEDICAL DEVICE IN ACCORDANCE WITH THE NOMENCLATURE OF MEDICAL DEVICES APPLIED IN THE EURASIAN ECONOMIC UNION
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 14 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 21 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:
- To approve the attached Criteria for including in one registration certificate several modifications of a medical device, belonging to one type of medical device in accordance with the nomenclature of medical devices applied in the Eurasian Economic Union.
- 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. 123
CRITERIA FOR INCLUDING IN ONE REGISTRATION CERTIFICATE SEVERAL MODIFICATIONS OF A MEDICAL DEVICE, BELONGING TO ONE TYPE OF MEDICAL DEVICE IN ACCORDANCE WITH THE NOMENCLATURE OF MEDICAL DEVICES APPLIED IN THE EURASIAN ECONOMIC UNION- This document establishes the criteria for including in one registration certificate several modifications of a medical device, belonging to one type of medical device in accordance with the nomenclature of medical devices applied in the Eurasian Economic Union.
- For the purposes of applying this document, concepts are used that are defined by the Rules for Maintaining the Nomenclature of Medical Devices, approved by the Decision of the Board of the Eurasian Economic Commission dated December 29, 2015, No. 177, the Rules for Conducting Clinical and Clinical-Laboratory Trials (Studies) of Medical Devices, approved by the Decision of the Council of the Eurasian Economic Commission dated February 12, 2016, No. 29, and 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.
- The inclusion in one registration certificate of several modifications of a medical device, belonging to one type of medical device in accordance with the nomenclature of medical devices applied in the Eurasian Economic Union, is possible provided that these modifications meet all the following criteria:
a) the production of the modifications of the medical device is carried out by one manufacturer of the medical device according to one technical documentation;
b) the modifications of the medical device belong to the same potential risk class of application;
c) the presence and (or) quantitative content in a biological sample of the same clinically (diagnostically) significant analyte (analytes) (for in vitro diagnostic medical devices);
d) the modifications of the medical device have different configurations that do not affect the operating principle and functional purpose, which allows ensuring the expansion or specialization of their application for medical purposes (as applicable);
e) the modifications of the medical device have different technical parameters (for example, radiation wavelength, size of the light field, resolution, etc.) that do not affect the operating principle and functional purpose (as applicable);
f) the modifications of the medical device form a standard size range (for example, have different sizes (overall, linear, volumetric, etc.), shape, color coding, etc.) or are a group of execution of a medical device (for example, a stationary mobile apparatus (device, system, complex, etc.) with wall and (or) floor mounting, etc.) (as applicable). At the same time, a group of execution of a medical device is understood as devices for which one group drawing of parts and (or) one group specification are executed.