Decision of the Board of the Eurasian Economic Commission dated April 3, 2018 No. 46
“On the Nomenclature of Medical Devices of the Eurasian Economic Union”
(together with the “Nomenclature Passport of Medical Devices of the Eurasian Economic Union”)
BOARD OF THE EURASIAN ECONOMIC COMMISSION
DECISION
dated April 3, 2018 N 46.
ABOUT THE NOMENCLATURE
MEDICAL DEVICES OF THE EURASIAN ECONOMIC UNION
In accordance with Article 31 of the Treaty on the Eurasian Economic Union of May 29, 2014, paragraphs 4 and 7 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 Regulations on the unified system of normative and reference information of the Eurasian Economic Union, approved by Decision of the Board of the Eurasian Economic Commission of November 17, 2015 N 155, as well as the Rules for maintaining the nomenclature of the
1. To approve the attached passport of the nomenclature of medical devices of the Eurasian Economic Union.
2. To apply the nomenclature of medical devices of the Eurasian Economic Union (hereinafter — the nomenclature) in accordance with the passport approved by this Decision.
3. To include the nomenclature in the resources of the unified system of normative and reference information of the Eurasian Economic Union.
4. Establish that:
nomenclature shall apply from the date of entry into force of this Decision;
the use of nomenclature codes is mandatory when implementing common processes within the Eurasian Economic Union in the sphere of medical devices circulation.
5. 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 April 3, 2018 N 46.
PASSPORT
OF THE NOMENCLATURE OF MEDICAL DEVICES OF THE EURASIAN UNION
ECONOMIC UNION
| N n/a | Element designation | Description |
| 1 | 2 | 3 |
| 1 | Code | 0__ |
| 2 | Type | 2 — classifier |
| 3 | Name | Nomenclature of medical devices of the Eurasian Economic Union |
| 4 | Abbreviation | NMI |
| 5 | Designation | EC 0_-201 (ed. 1). |
| 6 | Details of the act on adoption (approval) of the directory (classifier) | Decision of the Board of the Eurasian Economic Commission of April 3, 2018 N 46 |
| 7 | Date of enactment (start of application) of the directory (classifier) | 20 г. |
| 8 | Details of the act on termination of reference (classifier) application | — |
| 9 | Date of termination of reference (classifier) application | — |
| 10 | Operator(s) | RU, Federal Service for Supervision in the Sphere of Healthcare |
| 11 | Assignment | The nomenclature is intended for systematization of information on types of medical devices, including taking into account classification features of medical devices |
| 12 | Annotation (scope of application) | is used to form registration dossiers for a medical device, to control the circulation of medical devices, and to ensure information interaction, including in the implementation of common processes |
| 13 | Keywords | medical devices, nomenclature, type of medical device, classification feature of medical devices |
| 14 | Sphere in which the powers of the bodies of the Eurasian Economic Union are exercised | technical regulation |
| 15 | Use of international (interstate, regional) classification | 1 — the classifier is harmonized with international (interstate, regional) classifiers and (or) standards: Global Medical Device Nomenclature, maintained by the Global Medical Device Nomenclature Agency; ISO 15225:2010 «Medical devices. Quality management. Data structure of medical devices nomenclature» Harmonization method: 4 — Establishing a match with a trusted source |
| 16 | Availability of state directories (classifiers) of the Eurasian Economic Union member states | 1 — the classifier has analogs in member states of the Eurasian Economic Community economic union: in the Russian Federation — Order of the Ministry of Health of the Russian Federation dated June 6, 2012 N 4n «On Approval of the Nomenclature Classification of Medical Devices». |
| 17 | Method of systematization (classification) | 1 is ordinal; in accordance with ISO 15225:2010 «Medical devices. Quality management. Data structure of medical devices nomenclature». The signs of systematization (classification) of types of medical devices are classification features of medical devices depending on their purpose and (or) device |
| 18 | Methodology | The nomenclature shall be maintained in electronic form in accordance with the procedure according to Annex N 1 |
| 19 | Structure | structure and requisite composition of nomenclature (composition of nomenclature fields, fields of their values and rules of formation) are given in the description according to Appendix N 2 |
| 20 | Degree of data confidentiality | information from the nomenclature refers to publicly available information |
| 21 | Established periodicity of review | undetermined |
| 22 | Changes | — |
| 23 | Reference to detailed information from the directory (classifier) | detailed information from the nomenclature is published on the information portal of the Eurasian Economic Union |
| 24 | Method of presentation of information from the directory (classifier) | publication on the information portal of the Eurasian Economic Union |
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
| Name of requisite | Props value area | Rules for forming the value of a requisite | Mn. |
| 1. Information on the type of medical device | is determined by the value areas of the nested requisites | is determined by the rules of formation of nested details | 1..* |
| 1.1 Medical device type code | normalized character string. Template: \d{6} | the code designation is generated by the operator | 1 |
| 1.2 Name of the type of medical device | a string of characters. Min. length: 1. Max. length: 500 | is formed in the form of a word combination in the Russian language | 1 |
| 1.3 Description of the type of medical device | a string of characters. Min. length: 1. Max. length: 4000 | is formed in the form of arbitrary text | 1 |
| 1.4 Commentary. | a string of characters. Min. length: 1. Max. length: 4000 | is formed in the form of arbitrary text | 0..1 |
| 1.5 Synonym code | normalized character string. Template: \d{6} | code designation of the synonym in accordance with the classification of types of medical devices of the Eurasian Economic Union | 0..* |
| 1.6. pattern qualifier pointer | normalized character string. Template: \d{1,2} | code designation is formed according to the following rules: the number of initial characters of the name of the type of medical device used to search for preferred types of medical devices of the Eurasian Economic Union starting with the same characters is specified not filled in for preferred types of medical devices of the Eurasian Economic Union | 0..1 |
| 1.7 Code of classification feature of medical devices | normalized character string. Template: \d{6} | the code designation of the classification feature of medical devices to which the type of medical device belongs in accordance with the directory of classification features of medical devices of the Eurasian Economic Union is indicated | 0..* |
| 1.8 Information on the directory (classifier) record | is determined by the value areas of the nested requisites | is determined by the rules of formation of nested details | 1 |
| 1.8.1 Effective date | date designation in accordance with GOST ISO 8601-2001 in the format YYYYY-MM-DD | corresponds to the start date specified in the act of the Eurasian Economic Union authority | 1 |
| 1.8.2 Information on the act regulating the beginning of validity of the directory (classifier) record | is determined by the value areas of the nested requisites | is determined by the rules of formation of nested details | 0..1 |
| *.1 Type of act | normalized character string. Template: \d{5} | code designation of the act in accordance with the classifier of types of normative legal acts of international law | 1 |
| *.2. Act number | a string of characters. Min. length: 1. Max. length: 50 | corresponds to the number of the act of the Eurasian Economic Union authority | 1 |
| *.3. Date of the act | date designation in accordance with GOST ISO 8601-2001 in the format YYYYY-MM-DD | corresponds to the date of adoption of the act of the Eurasian Economic Union body | 1 |
| 1.8.3 Expiration date | date designation in accordance with GOST ISO 8601-2001 in the format YYYYY-MM-DD | corresponds to the expiration date specified in the act of the Eurasian Economic Union authority | 0..1 |
| 1.8.4 Information on the act regulating the expiration of the directory (classifier) record | is determined by the value areas of the nested requisites | is determined by the rules of formation of nested details | 0..1 |
| *.1 Type of act | normalized character string. Template: \d{5} | code designation of the act in accordance with the classifier of types of normative legal acts of international law | 1 |
| *.2. Act number | a string of characters. Min. length: 1. Max. length: 50 | corresponds to the number of the act of the Eurasian Economic Union authority | 1 |
| *.3. Date of the act | date designation in accordance with GOST ISO 8601-2001 in the format YYYYY-MM-DD | corresponds to the date of adoption of the act of the Eurasian Economic Union body | 1 |
Table 2
Structure and requisite composition
of the directory of classification features of medical devices
depending on their purpose and (or) device
| Name of requisite | Props value area | Rules for forming the value of a requisite | Mn. |
| 1. Information on the classification feature of medical devices | is determined by the value areas of the nested requisites | is determined by the rules of formation of nested details | 1..* |
| 1.1 Code of classification feature of medical devices | normalized character string. Template: \d{6} | the code designation is formed using a sequential coding method | 1 |
| 1.2 Name of classification feature of medical devices | normalized character string. Min. length: 1. Max. length: 500 | is formed in the form of a word combination in the Russian language | 1 |
| 1.3 Code of the specified classification feature of medical devices | code designation of the specified classification feature of medical devices | 0..* | |
| 1.4 Commentary. | normalized character string. Min. length: 1. Max. length: 4000 | is formed in the form of arbitrary text | 0..1 |
| 1.5 Information on the directory (classifier) record | is determined by the value areas of the nested requisites | is determined by the rules of formation of nested details | 1 |
| 1.5.1 Effective date | date designation in accordance with GOST ISO 8601-2001 in the format YYYYY-MM-DD | corresponds to the start date specified in the act of the Eurasian Economic Union authority | 1 |
| 1.5.2 Information on the act, regulating the beginning of validity of the directory (classifier) record | is defined by the value areas of the nested details | is determined by the rules of formation of nested details | 0..1 |
| *.1 Type of act | normalized character string. Template: \d{5} | code designation of the act in accordance with the classifier of types of normative legal acts of international law | 1 |
| *.2. Act number | a string of characters. Min. length: 1. Max. length: 50 | corresponds to the number of the act of the Eurasian Economic Union authority | 1 |
| *.3. Date of the act | date designation in accordance with GOST ISO 8601-2001 in the format YYYYY-MM-DD | corresponds to the date of adoption of the act of the Eurasian Economic Union body | 1 |
| 1.5.3 Expiration date | date designation in accordance with GOST ISO 8601-2001 in the format YYYYY-MM-DD | corresponds to the expiration date specified in the act of the Eurasian Economic Union authority | 0..1 |
| 1.5.4 Information on the act regulating the expiration of the directory (classifier) record | is determined by the value areas of the nested requisites | is determined by the rules of formation of nested details | 0..1 |
| *.1 Type of act | normalized character string. Template: \d{5} | code designation of the act in accordance with the classifier of types of normative legal acts of international law | 1 |
| *.2. Act number | a string of characters. Min. length: 1. Max. length: 50 | corresponds to the number of the act of the Eurasian Economic Union authority | 1 |
| *.3. Date of the act | date designation in accordance with GOST ISO 8601-2001 in the format YYYYY-MM-DD | corresponds to the date of adoption of the act of the Eurasian Economic Union body |