BOARD OF THE EURASIAN ECONOMIC COMMISSION

RECOMMENDATION

dated September 4, 2017. N 17

ABOUT THE LIST

STANDARDS, AS A RESULT OF THE APPLICATION OF WHICH ON A VOLUNTARY BASIS

BASED IN WHOLE OR IN PART ON COMPLIANCE WITH THE

COMPLIANCE OF MEDICAL DEVICES WITH GENERAL REQUIREMENTS

SAFETY AND EFFICACY OF MEDICAL DEVICES,

REQUIREMENTS FOR THEIR LABELING AND OPERATIONAL

DOCUMENTATION ON THEM

List of amending documents

(ed. recommendations of the Board of the Eurasian Economic Commission)

from 08.06.2021 N 10, from 27.06.2023 N 15, from 11.02.2025 N 2)

The Board of the Eurasian Economic Commission on the basis of paragraph 2 of Article 3, paragraph 4 of Article 4 and 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 and in accordance with paragraph 110 of the General requirements for the safety and effectiveness of medical devices, requirements for their labeling and operational documentation for them, approved by the Decision of the Council of the Eurasian Economic Commission of February 12, 2016. N 27, recommends that member states of the Eurasian Economic Union:
after 6 months from the date of publication of this Recommendation on the official website of the Eurasian Economic Union for the purpose of registration of medical devices in accordance with the Rules for Registration and Examination of Safety, Quality and Effectiveness of Medical Devices, approved by the Decision of the Council of the Eurasian Economic Commission dated February 12, 2016. N 46, to apply the list of standards, as a result of the application of which on a voluntary basis fully or partially ensures compliance of medical devices with the General requirements of safety and effectiveness of medical devices, requirements for their labeling and operational documentation for them, according to the Annex;
to inform the authorized bodies of the member states of the Eurasian Economic Union from the date of publication of this Recommendation on the official website of the Eurasian Economic Union about the need to work out the conformity assessment bodies (testing laboratories (centers)) of the member states on the issue of updating the scope of accreditation taking into account the standards included in the list.

Chairman of the Board

Eurasian Economic Commission

T. SARKISYAN

appendix

to the Recommendation of the Board

Eurasian Economic Commission

dated September 4, 2017. N 17

LIST

STANDARDS, AS A RESULT OF THE APPLICATION OF WHICH ON A VOLUNTARY BASIS

BASED IN WHOLE OR IN PART ON COMPLIANCE WITH THE

COMPLIANCE OF MEDICAL DEVICES WITH GENERAL REQUIREMENTS

THE SAFETY AND EFFICACY OF MEDICAL DEVICES,

REQUIREMENTS FOR THEIR LABELING AND OPERATIONAL

DOCUMENTATION ON THEM

List of amending documents

(ed. recommendations of the Board of the Eurasian Economic Commission)

from 08.06.2021 N 10, from 27.06.2023 N 15, from 11.02.2025 N 2)