Recommendation of the Board of the Eurasian Economic Commission dated September 4, 2017 No. 16
"On the Procedure for Forming the List of Standards, the Application of Which on a Voluntary Basis Fully or Partially Ensures Compliance of Medical Devices with the General Requirements for the Safety and Effectiveness of Medical Devices, and with the Requirements for Their Labeling and Operating Documentation"
BOARD OF THE EURASIAN ECONOMIC COMMISSION
RECOMMENDATION
dated September 4, 2017. N 16
ABOUT THE ORDER
FORMATION OF A LIST OF STANDARDS, AS A RESULT OF APPLICATION
WHICH, ON A VOLUNTARY BASIS, FULLY OR PARTIALLY
COMPLIANCE OF MEDICAL DEVICES IS ENSURED
GENERAL REQUIREMENTS FOR THE SAFETY AND EFFECTIVENESS OF MEDICAL
THE REQUIREMENTS FOR THE LABELING AND OPERATIONAL REQUIREMENTS OF PRODUCTS
DOCUMENTATION ON THEM
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, from the date of publication of this Recommendation on the official website of the Eurasian Economic Union, when forming 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 for Safety and Effectiveness of Medical Devices, requirements for their labeling and operational documentation for them, to apply the Procedure according to the Annex.
Chairman of the Board
Eurasian Economic Commission
T. SARKISYAN
appendix
to the Recommendation of the Board
Eurasian Economic Commission
dated September 4, 2017. N 16
ORDER
FORMATION OF A LIST OF STANDARDS, AS A RESULT OF APPLICATION
WHICH, ON A VOLUNTARY BASIS, FULLY OR PARTIALLY
COMPLIANCE OF MEDICAL DEVICES IS ENSURED
GENERAL REQUIREMENTS FOR THE SAFETY AND EFFECTIVENESS OF MEDICAL
THE REQUIREMENTS FOR THE LABELING AND OPERATIONAL REQUIREMENTS OF PRODUCTS
DOCUMENTATION ON THEM
1. This Procedure is developed on the basis of paragraph 2 of Article 3, paragraph 4 of Article 4 and 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 dated December 23, 2014 and in accordance with paragraph 110 of the General Requirements for 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 dated February 12, 2016. N 27 (hereinafter - the General Requirements), in order to ensure the formation of a 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 (hereinafter - the list), and the procedure for amending it.
2. Compliance of medical devices with the General Requirements is ensured by fulfillment of the requirements established by the specified document directly, or the requirements of the standards included in the list.
3. The list shall be developed in the form according to Annex N 1.
4. Formation of the list shall be carried out through inclusion of standards taking into account the following priorities:
a) interstate standards developed on the basis of current versions of international and (or) regional standards;
b) national (state) standards of member states of the Eurasian Economic Union (hereinafter - member states), developed on the basis of current versions of international and (or) regional standards. If there are several national (state) standards developed on the basis of the current version of an international and (or) regional standard, all of them are included in the list;
c) interstate standards developed not on the basis of international and (or) regional standards;
d) national (state) standards of Member States developed not on the basis of international and (or) regional standards.
5. Prior to the development of standards specified in paragraph 4 of this Procedure, containing rules and methods of research (tests) and measurements, necessary to confirm compliance of medical devices with the General Requirements, the list may include methods of research (tests) and measurements, validated and approved in accordance with the legislation of the Member State.
6. In the case of inclusion in the list of national (state) standards of Member States and (or) methods of research (tests) and measurements for these standards and (or) methods in the column of the list "Date of termination of application of the standard", if necessary, the term by which it is necessary to adopt and include in the list of interstate standards for the relevant object of standardization.
Authorized bodies of the Member States, carrying out registration of medical devices (hereinafter - authorized bodies), shall submit to the authorized standardization bodies of the Member States proposals for the development of relevant interstate standards.
7. Authorized bodies send to the Eurasian Economic Commission (hereinafter - the Commission) proposals for inclusion in the list of standards in the form provided by Annex N 1 to the General Requirements, as well as the results of the analysis of compliance of such standards with the objectives of the General Requirements in the form according to Annex N 2.
8. When preparing proposals for inclusion in the list of standards and for amendments thereto, the authorized body:
a) analyze standards to determine whether they can be applied to ensure that the medical device complies with the General Requirements, including taking into account the recommendations of the International Medical Device Regulators Forum (IMDRF);
b) analyzes international experience in the application of standards to ensure the safety and effectiveness of medical devices;
c) select the standards that best meet the objectives of the General Requirements. Compliance with the provisions of the General Requirements may be ensured by applying on a voluntary basis the requirements of the standard in its entirety or one or more sections, paragraphs, subparagraphs of the standard.
9. The Commission shall forward proposals received from the authorized body to other authorized bodies within 5 working days from the date of their receipt.
10. In case of disagreement with the received proposals, the authorized bodies shall send their comments on them to the Commission within 30 working days from the date of their receipt (with justification). In the absence of comments of the authorized body within the specified period, such proposals shall be considered agreed.
These comments of authorized bodies are discussed at a meeting of the working group on the formation of common approaches to the regulation of the circulation of medical devices within the Eurasian Economic Union. The decision on the advisability of including a standard in the list or its exclusion is made by consensus. Based on this decision, the issue of amending the list is considered at a meeting of the Board of the Commission in accordance with the established procedure.
11. When including in the list of the national (state) standard of the Member State, developed on the basis of international and (or) regional standards, the designations of such international and (or) regional standards, as well as the degree of harmonization of the national (state) standard of the Member State with the specified standard shall be additionally indicated.
International or regional standards shall be applied after their adoption as interstate or national (state) standards.
12. Amendments to the list shall be made in the manner provided for the inclusion of the standard in the list or its deletion, in the following cases:
(a) The standard is inconsistent with the objectives of the General Requirements;
b) revocation of the validity of the standard;
c) replacing the standard in the old version with the standard in the current version.
13. Where a new standard replaces a standard in the list and requires a transitional period during which both the replaced and superseded standard may be applied, the relevant information is provided in the list.
In the event that instead of a research (testing) and measurement methodology contained in the list, a standard is included, for the application of which a transitional period is required, during which both the replaced research (testing) and measurement methodology and the standard replacing it may be applied, the relevant information shall be given in the list.
14. Interstate standards, approved from the date of entry into force of this Procedure, shall be included in the list provided that all Member States join them.
15. Authorized bodies on standardization of the Member States shall inform the Commission on termination of interstate and national (state) standards from among those included in the list on their territory.
Annex N 1
to the Procedure for forming the list
standards, as a result of the application
which on a voluntary basis
fully or partially provided
Compliance with medical
of products General safety requirements
and efficacy of medical devices,
labeling requirements
and their operational documentation
(form)
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 the General Requirements
safety and efficacy of medical devices,
requirements for their labeling and operational
documentation on them
