In accordance with paragraphs 7 and 44 of the Regulations on the Eurasian Economic Commission (Annex No. 1 to the Treaty on the Eurasian Economic Union (EAEU) of 29 May 2014) and paragraph 34 of the Rules for Registration and Expert Examination of the Safety, Quality and Efficacy of Medical Devices, approved by Decision of the Board of the Eurasian Economic Commission No. 46 of 12 February 2016, the Board of the Eurasian Economic Commission DECIDED:
1. To approve the attached Regulations on the Advisory Committee on Medical Devices.
2. This Decision shall enter into force upon the expiry of 30 calendar days from the date of its official publication.
Chairman of the Board of the
Eurasian Economic Commission T. Sargsyan
Approved
by Decision of the Board of the
Eurasian Economic Commission
of 26 September 2017 No. 123
I. General Provisions
1. The Advisory Committee on Medical Devices (hereinafter — the Committee) is established under the Board of the Eurasian Economic Commission (hereinafter — the Commission) in accordance with paragraphs 7 and 44 of the Regulations on the Eurasian Economic Commission (Annex No. 1 to the Treaty on the Eurasian Economic Union (EAEU) of 29 May 2014).
The Committee is an advisory body of the Commission, providing preparation of proposals, recommendations and consultations on matters related to the circulation of medical devices.
2. In its activities, the Committee shall be guided by the Treaty on the Eurasian Economic Union (EAEU) of 29 May 2014, the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices (medical products and medical equipment) within the Eurasian Economic Union of 23 December 2014, other international treaties and acts comprising the law of the Eurasian Economic Union (hereinafter — the Union), as well as these Regulations.
II. Main Tasks of the Committee
3. The main tasks of the Committee are:
a) resolution of disagreements between the reference state and the recognizing state regarding the approval of the expert conclusion on the evaluation of the safety, quality and efficacy of medical devices during registration (hereinafter — the expert conclusion) in accordance with paragraph 34 of the Rules for Registration and Expert Examination of the Safety, Quality and Efficacy of Medical Devices, approved by Decision of the Board of the EEC No. 46 of 12 February 2016;
b) resolution of disagreements on matters of classifying products as medical devices, as well as classifying medical devices as measuring instruments at the time of their registration;
c) preparation of proposals on improving the legal acts of the Union in the sphere of circulation of medical devices.
III. Composition and Formation Procedure of the Committee
4. The composition of the Committee shall be formed from representatives of the authorized bodies of the EAEU Member States in the field of healthcare (hereinafter respectively — the authorized body, the Member States), as well as expert organizations designated by the authorized bodies to conduct expert examinations of the safety, quality and efficacy of medical devices (hereinafter — the expert organization) (not more than 5 persons per Member State), based on proposals from the Member States.
The composition of the Committee shall be approved by an order of the Board of the Commission.
5. Member States shall promptly inform the Commission of the need to replace representatives of the authorized bodies on the Committee, and shall submit proposals for amendments to its composition.
6. Where necessary, upon proposal of the authorized bodies, representatives of healthcare organizations, expert organizations, the medical device manufacturer, and other specialists (hereinafter — invited persons) may be invited to participate in the consideration of issues discussed at the Committee session.
Upon the proposal of the Chairman of the Committee, officials and staff of the Commission whose competence covers the matters under consideration at the Committee session may participate in such sessions.
7. Sessions of the Committee are chaired and the general management of the Committee's work is carried out by the Member of the Board of the Commission whose competence covers matters related to the circulation of medical devices (hereinafter — the Chairman of the Committee).
8. The Chairman of the Committee shall:
a) direct the activities of the Committee and organize the work to fulfil the tasks assigned to the Committee;
b) approve the agenda of the Committee session and determine the date, time and venue of the session;
c) chair the sessions of the Committee;
d) sign the minutes of the Committee sessions;
e) inform the Board and the Council of the Commission about proposals and recommendations developed by the Committee;
f) appoint the Executive Secretary of the Committee;
g) represent the Committee at sessions of the Board and the Council of the Commission and in relations with other bodies and organizations;
h) perform other functions.
9. The Chairman of the Committee shall have the right to request from authorized bodies and Committee members materials and information on matters within the competence of the Committee.
10. The Deputy Chairman of the Committee shall be appointed from among the heads of the structural unit of the Commission whose competence covers matters related to the circulation of medical devices.
11. The Deputy Chairman of the Committee shall perform the functions of the Chairman of the Committee as provided for in paragraph 8 of these Regulations in the absence of the Chairman of the Committee or upon his/her instruction.
12. The Executive Secretary of the Committee shall be appointed from among the staff of the Commission.
Information on the appointment of the Executive Secretary of the Committee shall be recorded in the minutes of the Committee session.
13. The Executive Secretary of the Committee shall:
a) ensure the preparation of the draft agenda of the Committee session based on proposals from the authorized bodies, the Chairman and members of the Committee, and submit it for approval to the Chairman of the Committee;
b) send to the Committee members the draft agenda of the Committee session and related materials;
c) inform Committee members of the date, time and venue of the Committee session;
d) monitor the preparation and submission of materials for the draft agenda and the Committee session;
e) maintain the minutes of the Committee session and submit them for signature to the Chairman of the Committee;
f) organize the preparation and distribution to Committee members of the final documents prepared on the basis of the Committee session;
g) monitor the implementation of the procedural decisions of the Committee.
IV. Operating Procedure of the Committee
14. Sessions of the Committee shall, as a rule, be held monthly.
15. The draft agenda of the Committee session shall be formed on the basis of proposals from the authorized bodies, the Chairman and members of the Committee.
16. Proposals for the formation of the draft agenda of the Committee session and related materials shall be submitted by the authorized bodies to the Executive Secretary of the Committee (in electronic or paper form) no later than 20 calendar days before the date of the Committee session. Proposals received later shall be included in the agenda of the next Committee session.
The Chairman and members of the Committee who have submitted proposals for inclusion in the agenda of the Committee session shall ensure the submission to the Executive Secretary of the Committee of relevant materials on those matters.
On matters requiring urgent consideration, the Chairman and members of the Committee may, directly at the Committee session, propose the inclusion of an additional item in the agenda of the Committee session.
Authorized bodies and Committee members who have submitted proposals for including matters in the agenda of the Committee session shall ensure the submission to the Executive Secretary of the Committee of materials on those matters (in electronic or paper form).
17. When forming the agenda of the Committee session, priority shall be given to matters relating to the resolution of disagreements arising during the registration and expert examination of the safety, quality and efficacy of medical devices.
18. Materials on agenda items of the Committee session shall include:
a) an application (on letterhead) from the authorized body of the reference state indicating the need to consider disagreements regarding the expert conclusion, with specification of information about the subject of the disagreements and the outcome of negotiations and consultations;
b) written consent from the applicant (the manufacturer who is a resident of a Member State, or its authorized representative) to provide access for the authorized bodies (expert organizations) of Member States not designated by it as the reference state or the recognizing state to the registration dossier and materials generated during the expert examination in the reference state, including the correspondence between the applicant and the authorized body (expert organization) of the reference state on matters of addressing deficiencies, and the documents submitted by the applicant during the registration and expert examination of medical devices;
c) materials substantiating the positions of the authorized bodies of the reference state and the recognizing states on the agenda items of the Committee session;
d) a background note on the matter under consideration (if necessary);
e) a draft of the document proposed for consideration (if necessary);
f) reference and analytical materials (if necessary);
g) draft procedural decisions and recommendations for the Commission (if necessary).
19. The Committee shall take necessary measures to protect the confidentiality of the information submitted, in accordance with the legislation of the Member States.
20. No later than 2 working days from the date of receipt from the authorized body of the reference state of the application referred to in sub-paragraph (a) of paragraph 18 of these Regulations and the accompanying materials, the Executive Secretary of the Committee shall send to the authorized bodies of the recognizing states, in electronic form via telecommunications channels, a request for the submission of materials confirming their position on the agenda items of the Committee session.
21. The authorized bodies of the recognizing states shall respond to the request specified in paragraph 20 of these Regulations no later than 10 working days from the date of receipt of such request.
22. No later than 5 working days before the date of the Committee session, the Executive Secretary of the Committee shall send to the Committee members the approved agenda of the Committee session and related materials, including in electronic form via email distribution (with the exception of documents containing information classified as state secrets or restricted-access information in accordance with the legislation of the Member States).
23. Sessions of the Committee shall, as a rule, be held at the premises of the Commission.
Upon proposal of the Chairman or members of the Committee, sessions may be held in videoconference format.
A session of the Committee may be held in any of the Member States by decision of the Chairman of the Committee, taken on the basis of proposals from the authorized bodies (expert organizations).
In such a case, the hosting authorized body (expert organization) shall ensure all necessary conditions for the organization and conduct of the Committee session.
24. Sessions of the Committee shall be held when a quorum is present, constituting no less than two thirds of the total number of Committee members, including no less than 1 representative from each Member State.
Committee members shall participate in sessions personally, with no right of substitution.
In exceptional circumstances where a Committee member's attendance at a session is not possible, he/she shall have the right, no later than 2 working days before the date of the Committee session, to submit to the Chairman of the Committee his/her position on the matters under consideration in writing and/or to send an authorized official of the authorized body to participate in the Committee session without voting rights.
25. Decisions of the Committee on the resolution of disagreements regarding the classification of products as medical devices, as well as classifying medical devices as measuring instruments at the time of their registration, shall be adopted by consensus; on other matters — by simple majority of votes of the Committee members participating in the session. In voting, regardless of the number of Committee members from each Member State, each Member State shall have 1 vote.
Committee members shall participate in the voting. Voting shall be conducted without the presence of invited persons.
26. The results of the Committee session shall be recorded in the minutes, which shall reflect the positions of the Committee members.
27. The minutes shall be signed by the Chairman of the Committee, as a rule, on the day the Committee session concludes, after being initialled by the Committee members who participated in the session.
In the case of a session held in videoconference format, the Executive Secretary of the Committee shall ensure the distribution of the draft minutes of the Committee session to the Committee members who participated in the session via email.
Committee members shall have the right, within 2 working days from the date of distribution by the Executive Secretary of the Committee of the draft minutes, to submit to the Executive Secretary their proposals on the draft via email.
The Executive Secretary of the Committee shall, within 2 working days from the date of receipt of proposals from the Committee members, ensure the revision of the minutes taking into account the proposals received, and its submission for signature to the Chairman of the Committee.
In the case of a session held in videoconference format, the minutes of the Committee session shall be signed by the Chairman of the Committee within 7 working days from the date of the Committee session.
If a Committee member has a dissenting opinion on a matter under consideration by the Committee, it shall be set out in writing and annexed to the minutes of the Committee session.
28. Within 1 working day from the date of signing of the minutes of the Committee session by the Chairman of the Committee, the Executive Secretary of the Committee shall send a copy of the minutes to Committee members in electronic form via telecommunications channels. Invited persons may, by decision of the Chairman of the Committee, be sent a copy of the minutes or an extract therefrom in electronic form via telecommunications channels.
29. Minutes of Committee sessions shall be kept in the structural unit of the Commission whose competence covers matters related to the circulation of medical devices.
30. Authorized bodies shall, within the time limits established by the minutes of the Committee session, inform the Chairman of the Committee about the implementation of the Committee's recommendations and proposals on matters of classifying products as medical devices, as well as classifying medical devices as measuring instruments at the time of their registration.
31. Organizational and technical support for the activities of the Committee shall be provided by the Commission.
Expenses related to the participation of Committee members and representatives of authorized bodies (expert organizations) in Committee sessions shall be borne by the authorized bodies (expert organizations) that have sent them.
Expenses related to the participation of invited persons shall be borne by such persons themselves.