Decision of the Board of the Eurasian Economic Commission dated August 30, 2016 No. 93

(as amended on December 24, 2019)

"On the Technological Documents Regulating Information Interaction in the Implementation, via the Integrated Information System of External and Mutual Trade, of the General Process 'Formation, Maintenance, and Use of the Unified Register of Authorized Organizations of the Eurasian Economic Union Conducting Studies (Tests) of Medical Devices for the Purpose of Their Registration'"

(together with the

"Rules for Information Interaction in the Implementation, via the Integrated Information System of External and Mutual Trade, of the General Process 'Formation, Maintenance, and Use of the Unified Register of Authorized Organizations of the Eurasian Economic Union Conducting Studies (Tests) of Medical Devices for the Purpose of Their Registration',"

"Regulation on Information Interaction Between the Authorized Bodies of the Member States of the Eurasian Economic Union and the Eurasian Economic Commission in the Implementation, via the Integrated Information System of External and Mutual Trade, of the General Process 'Formation, Maintenance, and Use of the Unified Register of Authorized Organizations of the Eurasian Economic Union Conducting Studies (Tests) of Medical Devices for the Purpose of Their Registration',"

"Description of the Formats and Structures of Electronic Documents and Data Used for the Implementation, via the Integrated Information System of External and Mutual Trade, of the General Process 'Formation, Maintenance, and Use of the Unified Register of Authorized Organizations of the Eurasian Economic Union Conducting Studies (Tests) of Medical Devices for the Purpose of Their Registration',"

"Procedure for Accession to the General Process 'Formation, Maintenance, and Use of the Unified Register of Authorized Organizations of the Eurasian Economic Union Conducting Studies (Tests) of Medical Devices for the Purpose of Their Registration'")

BOARD OF THE EURASIAN ECONOMIC COMMISSION

DECISION

dated August 30, 2016. N 93

ABOUT TECHNOLOGY DOCUMENTS,

REGULATING INFORMATION INTERACTION

IN THE IMPLEMENTATION OF THE INTEGRATED INFORMATION SYSTEM

FOREIGN AND MUTUAL TRADE SYSTEMS OF THE COMMON PROCESS

"FORMATION, MAINTENANCE AND USE OF A UNIFIED REGISTER OF

OF AUTHORIZED ORGANIZATIONS OF THE EURASIAN ECONOMIC

OF THE UNION, CARRYING OUT RESEARCH (TESTING)

MEDICAL DEVICES FOR THE PURPOSE OF THEIR REGISTRATION"

List of amending documents

(ed. by the decision of the Board of the Eurasian Economic Commission

dated 24.12.2019 N 226)

In accordance with paragraph 30 of the Protocol on Information and Communication Technologies and Information Interaction within the Eurasian Economic Union (Annex N 3 to the Treaty on the Eurasian Economic Union of May 29, 2014) and guided by the Decision of the Board of the Eurasian Economic Commission of November 6, 2014 N 200, the Board of the Eurasian Economic Commission decided:
1. To approve the attached:
Rules for information interaction in the implementation by means of an integrated information system for foreign and mutual trade of the general process "Formation, maintenance and use of a single register of authorized organizations of the Eurasian Economic Union which carry out research (testing) of medical devices for the purpose of their registration";
Regulations on information interaction between authorized bodies of member States of the Eurasian Economic Union and the Eurasian Economic Commission in the implementation by means of an integrated information system for foreign and mutual trade of the common process "Formation, maintenance and use of a single register of authorized organizations of the Eurasian Economic Union which carry out research (testing) of medical devices for the purpose of their registration";
Description of formats and structures of electronic documents and information used for the implementation by means of the integrated information system for foreign and mutual trade of the general process "Formation, maintenance and use of a unified register of authorized organizations of the Eurasian Economic Union carrying out research (tests) of medical devices for the purpose of their registration";
Procedure for joining the general process "Formation, maintenance and use of of the unified register of authorized organizations of the Eurasian Economic Union which carry out research (tests) on medical devices for the purpose of their registration".
2. To establish that the development of technical schemes of structures of electronic documents and information, provided by the Description approved by this Decision, and ensuring their placement in the register of structures of electronic documents and information used in the implementation of information interaction in the integrated information system of foreign and mutual trade, are carried out by the department of the Eurasian Economic Commission, whose competence includes coordination of work on the creation and development of the integrated information system of the Eurasian Economic Commission.
(3) This Decision shall enter into force upon expiration of 30 calendar days from the date of its official publication.

Chairman of the Board

Eurasian Economic Commission

T. SARKISYAN

Approved

By decision of the Board

Eurasian Economic Commission

dated August 30, 2016. N 93

RULES.

OF INFORMATION INTERACTION IN THE IMPLEMENTATION OF

BY MEANS OF THE INTEGRATED INFORMATION SYSTEM OF THE EXTERNAL

AND RECIPROCAL TRADE OF THE OVERALL PROCESS OF "SHAPING, MAINTAINING

AND USE OF A SINGLE REGISTER OF AUTHORIZED ORGANIZATIONS

OF THE EURASIAN ECONOMIC UNION, CARRYING OUT

CONDUCTING RESEARCH (TRIALS) OF MEDICAL

OF ARTICLES FOR THE PURPOSE OF THEIR REGISTRATION"

List of amending documents

(ed. by the decision of the Board of the Eurasian Economic Commission

dated 24.12.2019 N 226)

I. General provisions

1. These Rules have been developed in accordance with the following acts within the law of the Eurasian Economic Union (hereinafter - the Union):
Treaty on the Eurasian Economic Union of May 29, 2014;
Agreement on Uniform Principles and Rules for the Circulation of Medical Devices (Medical Devices and Medical Equipment) within the Eurasian Economic Union of December 23, 2014;
Decision of the Supreme Eurasian Economic Council of December 23, 2014 N 109 "On the Implementation of the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices (Medical Devices and Medical Equipment) within the Eurasian Economic Union";
Decision of the Council of the Eurasian Economic Commission of February 12, 2016. N 30 "On Approval of the Procedure for the Formation and Maintenance of the Information System in the Field of Circulation of Medical Devices";
Decision of the Board of the Eurasian Economic Commission of November 6, 2014 N 200 "On technological documents regulating information interaction in the implementation of common processes by means of the integrated information system of foreign and mutual trade";
Decision of the Board of the Eurasian Economic Commission of January 27, 2015 N 5 "On Approval of the Rules of Electronic Data Exchange in the Integrated Information System of Foreign and Mutual Trade";
Decision of the Board of the Eurasian Economic Commission of April 14, 2015 N 29 "On the list of common processes within the Eurasian Economic Union and amending Decision of the Board of the Eurasian Economic Commission of August 19, 2014 N 132";
Decision of the Board of the Eurasian Economic Commission of June 9, 2015 N 63 "On the Methodology of Analysis, Optimization, Harmonization and Description of Common Processes within the Eurasian Economic Union".

II. Scope of application

2. These Rules are designed to determine the procedure and conditions for information interaction between participants in the general process "Formation, maintenance and use of a unified register of authorized organizations of the Eurasian Economic Union carrying out research (testing) of medical devices for the purpose of their registration" (hereinafter - the general process), including a description of the procedures carried out within the framework of this general process.
(3) These Rules shall be applied by the participants of the common process when controlling the order of performance of procedures and operations within the common process, as well as when designing, developing and finalizing the components of information systems that ensure the implementation of the common process.

III. Basic concepts

4. For the purposes of these Regulations, the terms used shall mean the following:
"authorization" - granting a participant in a common process the rights to perform certain actions;
"unified register" means a unified register of authorized organizations of the Union carrying out research (testing) of medical devices for the purposes of their registration, the formation and maintenance of which is carried out by the Eurasian Economic Commission;
"authorized organization" - an institution, organization or enterprise (including a medical institution or organization) that carries out research (testing) of medical devices for the purpose of their registration.
The terms "group of procedures of the common process", "information object of the common process", "performer", "operation of the common process", "procedure of the common process" and "participant of the common process" used in these Rules are used in the meanings defined by the Methodology for the analysis, optimization, harmonization and description of common processes within the Eurasian Economic Union, approved by the Decision of the Board of the Eurasian Economic Commission dated June 9, 2015 N 63.

IV. Basic information on the overall process

5. Full name of the general process: "Formation, maintenance and use of a unified register of authorized organizations of the Eurasian Economic Union carrying out research (testing) of medical devices for the purposes of their registration".
6. Common process code: P.MM.07, version 1.0.1.
(ed. by Decision of the Board of the Eurasian Economic Commission from 24.12.2019 N 226)

1. Purpose and objectives of the overall process

7. The purpose of the common process is to create prerequisites for reducing the costs associated with the exchange of information on authorized organizations of the Union carrying out research (testing) of medical devices for the purpose of their registration by creating a common information space in the sphere of circulation of medical devices.
8. In order to achieve the goal of the overall process, the following tasks must be accomplished:
(a) To create within the framework of the integrated information system for foreign and mutual trade (hereinafter referred to as the integrated system) an information resource containing data on authorized organizations conducting research (testing) of medical devices for the purpose of their registration;
b) to ensure the possibility for authorized bodies of the Union Member States (hereinafter referred to as Member States) to obtain, by means of the integrated system, information from the unified register in electronic form and in automated mode;
c) ensure that interested parties and employees of of the Eurasian Economic Commission (hereinafter - the Commission) can obtain up-to-date, complete and reliable information from the unified register through the use of the Union's information portal;
d) ensure the use of unified classifiers and directories by the authorized bodies of the Member States.

2. Participants in the overall process

9. The list of participants in the overall process is given in Table 1.

Table 1

List of participants in the overall process

Annex N 1

nomenclature sheet

medical devices of the Eurasian

economic union

ORDER

MAINTENANCE OF THE NOMENCLATURE OF MEDICAL DEVICES OF THE EURASIAN UNION

ECONOMIC UNION

I. General provisions

1. This Procedure is developed in accordance with the following acts included in law of the Eurasian Economic Union (hereinafter - the Union):
Decision of the Board of the Eurasian Economic Commission of November 17, 2015 N 155 "On the unified system of normative and reference information of the Eurasian Economic Union";
Decision of the Board of the Eurasian Economic Commission of December 29, 2015 N 177 "On the Rules for Maintaining the Nomenclature of Medical Devices";
Decision of the Board of the Eurasian Economic Commission of September 19, 2017. N 121 "On Approval of the Methodology for the Development, Maintenance and Application of Directories and Classifiers that are Part of the Resources of the Unified System of Normative and Reference Information of the Eurasian Economic Union".

II. Scope of application

2. This Procedure defines the procedures for maintaining the nomenclature of medical devices of the Eurasian Economic Union (hereinafter - the nomenclature).
3 This Procedure shall be applied by the operator, administrator and users of the nomenclature when making changes to individual items of the nomenclature.

III. Basic concepts

4. Concepts used in this Procedure shall be applied in the meanings defined by acts of the Eurasian Economic Commission in the field of medical devices circulation, as well as acts of the Eurasian Economic Commission on the creation and development of the integrated information system of the Union.

IV. Principles of nomenclature maintenance

5. The nomenclature is formed on the basis of information included in the Global Nomenclature of Medical Devices. Decisions to exclude certain types of medical devices from the nomenclature may be made by the working group to coordinate work on the creation and maintenance of the nomenclature of medical devices of the Eurasian Economic Union, established by the order of the Board of the Eurasian Economic Commission of July 26, 2016. N 109 (hereinafter - the working group).
6. Interaction between the operator and the administrator shall be carried out in accordance with the contract between them (hereinafter referred to as the contract).
7. The liability of the operator and the administrator shall be determined by acts falling within the law of the Union and by contract.
8. Informing users of the nomenclature, as well as authorized bodies (organizations) of the Union Member States about changes made to the nomenclature shall be carried out using the means of the Union's information portal upon publication of such changes.
9. Information from the nomenclature for publication on the Union's information portal shall be submitted by the operator in the form of a set of XML documents in accordance with the description of the structure and requisite composition of the nomenclature of medical devices of the Eurasian Economic Union (Annex N 2 to the passport of the nomenclature of medical devices of the Eurasian Economic Union, approved by the Decision of the Board of the Eurasian Economic Commission of April 3, 2018 N 46). The package of documents to be transferred includes:
a file containing information on classification features of medical devices without specifying types of medical devices (hereinafter - features file);
a file containing information on types of medical devices and their links with classification features of medical devices (hereinafter - file of types of medical devices).

V. Description of activities required for the conduct of

and application of nomenclature

10. The following activities shall be performed to maintain and apply the nomenclature:
initial filling of nomenclature;
periodic updating of information from the nomenclature;
exclusion of types of medical devices from the nomenclature by decision of the working group;
use of the nomenclature when performing procedures related to the registration of medical devices.

1. Primary filling of nomenclature

11. Primary filling of the nomenclature is performed 1 time after the entry into force of the Decision of the Board of the Eurasian Economic Commission of April 3, 2018 N 46.
12. The period of performance of measures for initial filling of the nomenclature shall be determined by the terms and conditions of the contract.
13. The operator shall form a package of documents containing the information from the nomenclature that is up-to-date at the time of transfer in accordance with paragraph 9 of this Procedure and send it to the administrator.
14. The administrator confirms the receipt and successful processing of information from the nomenclature by sending the operator a processing protocol in Russian. If there are no errors, the administrator accepts the submitted information and ensures its publication on the Union's information portal not later than 3 working days from the date of receipt.
15. If there are errors, the operator eliminates the errors and repeats the process of transferring XML documents containing nomenclature information to the administrator.
16. The result of the measure is the publication of the nomenclature on the Union's information portal.

2. Periodic updating of information from the nomenclature

17. The operator shall update the information from the nomenclature at least once a month, not later than 5 working days from the beginning of the month. If there are no changes during the month, the operator shall notify the administrator about it.
18. The operator shall form a package of documents containing information on changed nomenclature items in accordance with paragraph 9 of this Procedure and send it to the administrator.
19. The feature file is formed in accordance with the following rules:
in case of adding new classification attributes of medical devices, information on the new position with the indication of its start date and blank expiration date shall be entered into the attributes file;
in case of changes in the classification features of medical devices, information on the current position with the indication of its expiration date, as well as a new version of the position with the indication of its start date and a blank expiration date shall be entered into the features file;
in case of exclusion of classification attributes of medical devices from the nomenclature, the attributes file shall include information on the current position with indication of its expiration date.
20. The file of types of medical devices shall be formed in accordance with the following rules:
in case of addition of new types of medical devices, information on the new item is entered into the file of types of medical devices with the indication of its start date and a blank expiration date;
in case of changes in the types of medical devices, information on the current position with the indication of its expiration date, as well as a new version of the position with the indication of its start date and a blank expiration date shall be entered into the file of types of medical devices;
in case of exclusion of types of medical devices from the nomenclature, the file of types of medical devices shall include information on the current position with indication of its expiration date, as well as details of the protocol of the working group, according to which the type of medical device was excluded from the nomenclature (if any).
21. The administrator confirms the receipt and successful processing of information from the nomenclature by sending the operator a processing protocol in Russian. If there are no errors, the administrator accepts the submitted information and ensures its publication on the Union's information portal not later than 3 working days from the day of receipt.
22. If there are errors, the operator eliminates the errors and repeats the process of transferring XML documents containing nomenclature information to the administrator.
23. The result of the measure is the publication of the updated nomenclature on the Union's information portal.

3. exclusion of types of medical devices from the nomenclature

as decided by the working group

24. If the working group decides to exclude certain types of medical devices from the nomenclature, the responsible secretary of the working group shall send to the operator an extract from the relevant minutes of the working group meeting not later than 5 working days from the date of signing of the minutes.
25. The operator shall take into account the directed changes as part of the next package of changes sent to the administrator as part of the periodic update of the nomenclature.
26. The result of the measure is the receipt by the operator of a notification on the need to exclude certain types of medical devices from the nomenclature.

4. using nomenclature when performing procedures,

related to the registration of medical devices

27. Information from the nomenclature shall be used in the performance of procedures provided for by 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 (hereinafter - registration procedures).
28. Where there is no relevant information in the nomenclature, the applicant submitting to the authorized body of a Member State of the Union an application for registration procedures shall use text fields to describe the new items.
29. Information on a new type of medical device shall be transmitted to the operator by the applicant in the manner determined by the operator.
30. The Operator shall ensure that the application for inclusion of a new type of medical device is sent to the Agency of the Global Nomenclature of Medical Devices (hereinafter referred to as the Agency) in accordance with the regulations on interaction between the Operator and the Agency.
31. The decision on inclusion of a new type of medical device in the Global Nomenclature of Medical Devices shall be made by the Agency.
32. Information on the adopted decision is transmitted by the Agency to the operator in accordance with the regulations on interaction between the operator and the Agency.
33. The result of the measure on the use of the nomenclature in the course of registration procedures is the inclusion of a new type of medical device in the nomenclature within the framework of periodic updating of information from it on the basis of the Agency's decision on inclusion of this new type of medical device in the Global Nomenclature of Medical Devices or notification of the applicant on impossibility of inclusion of a new type of medical device in the nomenclature due to the Agency's negative decision.

Annex N 2

nomenclature sheet

medical devices of the Eurasian

economic union

DESCRIPTION

STRUCTURE AND REQUISITE COMPOSITION OF THE MEDICAL NOMENCLATURE

PRODUCTS OF THE EURASIAN ECONOMIC UNION

1. This Description establishes the requirements for the structure of the nomenclature of medical devices of the Eurasian Economic Union (hereinafter - the nomenclature), including determining the structure and requisite composition of the nomenclature, areas of requisite values and rules of their formation.
2. The structure and requisite composition of the nomenclature is a combination of the structure of the classifier of types of medical devices of the Eurasian Economic Union and the structure of the directory of classification features of medical devices depending on their purpose and (or) device, given in Tables 1 and 2, in which the following fields (columns) are formed:
"Props value area" - text explaining the meaning (semantics) of the prop;
"Rules for forming the value of a requisite" a text specifying the purpose of a requisite, defining the rules of its formation (filling), or a verbal description of possible values of the requisite;
"Mn." - multiplicity of the requisite (mandatory (optional) and number of possible repetitions of the requisite).
The following designations are used to indicate the plurality of details of the data being transmitted:
1 - the prop is mandatory, repetitions are not allowed;
n - this requisite is mandatory and must be repeated n times (n > 1);
1..* - the requisite is mandatory, can be repeated without restrictions;
n..* - this requisite is mandatory and must be repeated at least n times (n > 1);
n..m - the requisite is mandatory, must be repeated at least n times and not more than m times (n > 1, m > n);
0..1 - the requisite is optional, repetitions are not allowed;
0..* - the requisite is optional, can be repeated without restrictions;
0..m - the prop is optional, can be repeated not more than m times (m > 1).

Table 1

Structure and requisite composition of the classifier of types

medical devices of the Eurasian Economic Union