Agreement on uniform principles and rules

(as amended by Protocols dated December 30, 2021; June 10, 2022; February 13, 2023)

 

The member states of the Eurasian Economic Union, hereinafter referred to as the member states,

based on the Treaty on the Eurasian Economic Union dated May 29, 2014,

recognizing the expediency of pursuing a coordinated policy in the field of circulation of medical devices (medical products and medical equipment) (hereinafter — medical devices),

taking into account the mutual interest in ensuring guarantees of safety, quality and efficacy of medical devices for the life and health of people, protection of the environment, property of legal entities and individuals, and prevention of actions misleading consumers (users) of medical devices,

recognizing that medical devices belong to socially significant products,

for the purpose of forming a common market of medical devices within the framework of the Eurasian Economic Union (hereinafter — the Union),

striving to increase the competitiveness of medical devices produced within the framework of the Union,

striving to eliminate restrictions in mutual trade,

have agreed as follows::

 

Article 1

Scope of the Agreement

1. This Agreement establishes uniform principles and rules for the circulation of medical devices within the framework of the Union for the purpose of forming a common market of medical devices.
2. This Agreement shall apply to legal relations related to the circulation of medical devices intended for circulation within the framework of the Union, as well as to medical devices that are in circulation within the framework of the Union.
3. The regulation of the circulation of medical devices within the framework of the Union shall be carried out in accordance with the Treaty on the Eurasian Economic Union dated May 29, 2014, this Agreement, other international treaties constituting the law of the Union, decisions of the Commission, as well as the legislation of the member states.

 

Article 2

Definitions

For the purposes of this Agreement, the following concepts shall have the following meanings:

“circulation of medical devices” — designing, development, creation of prototypes, technical testing, studies (tests) for the purpose of evaluating biological action, clinical trials, examination of safety, quality and efficacy of medical devices, registration, production (manufacturing), storage, transportation, sale, installation, adjustment, application (operation), technical maintenance, repair and disposal of medical devices;

“medical devices” — any instruments, apparatuses, devices, equipment, materials and other products that are used for medical purposes separately or in combination with each other, as well as with accessories necessary for the use of the said products for their intended purpose (including special software), intended by the manufacturer for the prevention, diagnosis, treatment of diseases, medical rehabilitation and monitoring of the condition of the human body, conducting medical research, restoration, replacement, modification of the anatomical structure or physiological functions of the body, prevention or interruption of pregnancy, and the functional purpose of which is not achieved by pharmacological, immunological, genetic or metabolic action on the human body, but may be supported by medicinal products;

“introduction of medical devices into circulation” — any gratuitous or compensated transfer of medical devices that is carried out for the first time and makes them available for distribution and (or) use, with the exception of the transfer of medical devices for conducting studies (tests) for the purpose of their subsequent sale and use.

 

Article 3

Pursuing a coordinated policy in the field of circulation of medical devices

1. The member states shall form a common market of medical devices within the framework of the Union in accordance with the principles specified in Article 31 of the Treaty on the Eurasian Economic Union dated May 29, 2014.
2. The member states shall pursue a coordinated policy in the field of circulation of medical devices by:
3. a) taking measures necessary for the harmonization of the legislation of the member states in the field of circulation of medical devices;
4. b) establishing common requirements for safety and efficacy of medical devices within the framework of the Union;
5. c) establishing uniform rules for the circulation of medical devices in accordance with the recommendations of the International Medical Device Regulators Forum (IMDRF);
6. d) determining uniform approaches to the creation of a quality assurance system for medical devices;
7. e) harmonizing the nomenclature of medical devices used in the member states with the Global Medical Device Nomenclature;
8. f) harmonizing the legislation of the member states in the field of control (supervision) over the circulation of legal entities and registered as individual entrepreneurs carrying out activities in the field of circulation of medical devices within the framework of the Union, in the manner established by the legislation of the member states.
9. For the purposes of implementing this Agreement, a member state shall designate a state body (bodies) of state power (administration) authorized to carry out and (or) coordinate activities in the field of circulation of medical devices in the territory of the member state (hereinafter — the authorized body) and shall inform the other member states and the Eurasian Economic Commission (hereinafter — the Commission) thereof.
10. Coordination of activities aimed at harmonizing the legislation of the member states in the field of circulation of medical devices shall be carried out by the Commission.
11. The harmonization of the legislation of the member states in the field of circulation of legal entities and registered as individual entrepreneurs carrying out activities in the field of circulation of medical devices within the framework of the Union, in the manner established by the legislation of the member states.
12. For the purposes of implementing this Agreement, a member state shall designate a body (bodies) of state power (administration) authorized to carry out and ( (or) coordinate activities in the field of circulation of medical devices in the territory of the member state (hereinafter — the authorized body) and shall inform the other member states and the Eurasian Economic Commission (hereinafter — the Commission) thereof.
13. Coordination of activities aimed at the harmonization of the legislation of the member states in the amendment of the legislation of the member states in the field of circulation of medical devices shall be carried out by the Commission.
14. The harmonization of the legislation of the member states in the field of circulation of medical devices shall be carried out on the basis of international standards, taking into account the decisions of the Commission in the field of circulation of medical devices.
15. The authorized bodies shall cooperate in the field of circulation of medical devices, including by organizing and coordinating research works, scientific and practical conferences, seminars and other events.

The authorized bodies shall hold events for the exchange of experience and the organization of joint training of specialists in the field of circulation of medical devices.

The authorized bodies or organizations of the member states acting on their behalf shall hold consultations with the participation of representatives of the Commission aimed at coordinating the positions of the member states on issues of the circulation of medical devices.

 

Article 4

Registration of medical devices

1. The provisions of this Article shall apply to medical devices introduced into circulation within the framework of the Union from the date of entry into force of this Agreement.
2. Medical devices introduced into circulation within the framework of the Agreement shall be subject to registration in the manner established by the Commission.

Registration of medical devices shall be carried out by the authorized bodies.

The conduct of an examination of safety, quality and efficacy of medical devices for the purposes of their registration shall be carried out by an expert organization determined by the state body of a member state in the field of healthcare, in the manner approved by the Commission.

1. In the course of registration, the same requirements shall apply to medical devices produced within the framework of the Union and imported into the customs territory of the Union from third states.
2. For the purposes of registering medical devices, technical tests, studies (tests) for the purpose of evaluating biological action, clinical trials, tests for the purpose of type approval of measuring instruments (in respect of medical devices that are measuring instruments, the list of which is approved by the Commission) and examination of safety, quality and efficacy of medical devices shall be carried out.

The rules for the classification of medical devices depending on the potential risk of use, the rules for maintaining the nomenclature of medical devices, the general requirements for safety and efficacy of medical devices, the requirements for the operational documentation of medical devices, the rules for conducting studies (tests) of medical devices, the rules for the registration of medical devices (including requirements for the registration dossier, application for registration, grounds and procedure for the suspension or revocation (cancellation) of the registration certificate of a medical device), the rules for conducting an examination of safety, quality and efficacy of medical devices shall be approved by the Commission.

1. The authorized bodies shall determine the list of institutions, organizations and enterprises, including medical institutions and organizations, that have the right to conduct studies (tests) of medical devices for the purpose of their registration (hereinafter — authorized organizations).

The requirements for authorized organizations and the procedure for assessing their compliance with these requirements shall be established by the Articles.

1. The document confirming the fact of registration of a medical device shall be the registration certificate of a medical device, valid within the framework of the Union.

The form of the registration certificate and the rules for filling it out shall be established by the Commission.

The registration certificate shall be valid for an indefinite period.

1. The member states shall create conditions for ensuring the compliance of the methods and conditions for conducting studies (tests) and the comparability of the results of examinations through the application of common requirements for safety and efficacy of medical devices and uniform requirements applied to authorized organizations.
2. The authorized bodies shall mutually recognize the results of studies (tests) and examinations obtained during the performance of medical device registration procedures, provided that they are performed in accordance with the requirements and rules established by the Commission.
3. The resolution of disagreements arising between authorized bodies during the registration of medical devices shall be carried out in the manner established by the corruption of the Commission.
4. The resolution of disagreements arising between authorized bodies during the corruption of medical devices, including rules for the classification of medical devices.
5. A decision of an authorized body to refuse to issue a registration certificate for a medical device may be appealed by the manufacturer of the medical device or its authorized representative in the court of a member state in the manner provided for by the legislation of that member state.
6. Within the framework of the Union, the following medical devices shall not be subject to registration:

1. a) imported by individuals into the customs territory of the Union and intended for personal use;
2. b) manufactured on the territory of a member state according to individual orders of patients exclusively for personal use and to which special requirements are applied in accordance with the appointment issued by a medical worker;
3. c) imported into the customs territory of the Union for use by employees of diplomatic missions and consular offices;
4. d) imported into the medical territory of the Union for the provision of medical care to passengers and crew members of transport vehicles, train crews and drivers of transport vehicles that have arrived in the territory of the Union;
5. e) imported into the customs territory of the Union for the commission of medical care to participants in international cultural and sports events and participants in international expeditions, as well as for holding exhibitions;
6. f) imported into the customs territory of the Union for conducting studies (tests), including for scientific purposes;
7. g) imported into the customs territory of the Union as humanitarian aid in cases determined by the legislation of the member states.

Article 5

Introduction of medical devices into circulation within the framework of the Union

1. The manufacturer or its authorized representative shall be responsible for the introduction of a medical device into circulation within the framework of the Union.
2. It shall be prohibited to introduce a medical device into circulation within the framework of the Agreement, if:

1. a) there is an official notification from the authorized body, the manufacturer and (or) its authorized representative that the circulation of the medical device has been suspended, or it has been withdrawn from circulation, or it has been recalled by the manufacturer;
2. b) the service life (shelf life) of the medical device has expired;
3. c) the medical device is not registered in the established manner (with the exception of medical devices not subject to registration in accordance with paragraph 11 of Article 4 of this Agreement).

 

Article 6

Production of medical devices

1. The manufacturer of medical devices intended for circulation within the
2. The manufacturer shall create and maintain a system for collecting and analyzing data on the use of medical devices, tracking and identifying adverse effects of medical devices during operation.

The manufacturer shall submit to the authorized bodies reports based on the experience of clinical use of certain types of medical devices of a high class of potential risk of use, in the manner established by the Commission.

In the event that non-compliance of medical devices with the general requirements for safety and efficacy of medical devices is identified or information is received about facts and circumstances that create a threat to the life or health of people, the authorized body shall, within a 5-day period, notify the authorized bodies of other member states thereof and take measures to prevent the circulation of such medical devices in the territory of its state.

1. In the event of termination of production of a medical device, the manufacturer or its authorized representative shall, within 30 calendar days from the date of the decision to terminate the production of the medical device, submit the relevant information to the authorized body that issued the registration certificate for the medical device.

 

Article 7

Marking of medical devices

1. Medical devices that have passed the registration and conformity assessment procedures established within the framework of the Union — to the general requirements for safety and efficacy of medical devices, the requirements for the implementation and maintenance of the quality management system of medical devices — shall, before being introduced into circulation within the framework of the Union, be subject to mandatory marking with a special mark of circulation of a medical device on the market of the Union (hereinafter — the special mark of circulation).
2. Responsibility for the unjustified marking of a medical device with the special mark of circulation shall be borne by the manufacturer or its authorized representative.
3. If the authorized body establishes that the marking of a medical device with the special mark of circulation is used by any manufacturer or its authorized representative without justification, it shall inform the authorized bodies of other member states and the Commission of this violation and take the necessary measures to withdraw such medical device from circulation in the territory of its state and to hold the guilty party liable.
4. The requirements for the marking of medical devices, the image of the special mark of circulation and the provision on the special mark of circulation shall be approved by the Commission.
5. Marking with the uniform mark of circulation of products on the market of the Union shall not be applied to medical devices.

 

Article 8

Control over the circulation of medical devices and monitoring of safety, quality and efficacy of medical devices

1. Control over the circulation of medical devices shall be carried out in respect of legal entities and individuals registered as individual entrepreneurs carrying out activities in the field of circulation of numbered devices within the framework of the Union, in the manner established by the legislation of the member states.
2. The rules for conducting monitoring of safety, quality and efficacy of medical devices shall be established by the Commission.
3. In the event that the fact of circulation within the framework of the Union of medical devices that pose a danger to life and (or) health of people, defective, counterfeit or falsified medical devices is established, the authorized body shall, within a 5-day period after the establishment of such fact, notify the authorized bodies of other member states thereof and send the relevant information to the Commission, and shall also have the right to take, in the manner established by the Commission, measures to suspend or prohibit the use of the said medical devices and to withdraw them from circulation.
4. Upon the identification of facts affecting the issues of safety, quality and efficacy of medical devices, the authorized body shall inform the manufacturer of the medical device or its authorized representative thereof and shall have the right to request from him additional information about the medical device.
5. The authorized body shall have the right to:

conduct an additional examination of safety, quality and efficacy of the medical device taking into account the identified negative consequences of its use in the cases provided for by the legislation of the member state;

suspend the validity of the registration certificate of a medical device issued by it;

revoke (cancel) the registration certificate of a medical device issued by it.

The grounds and procedure for the suspension or revocation (cancellation) of the registration certificate of a medical device shall be determined by the rules for the registration of medical devices approved by the Commission.

Of the suspension or revocation (cancellation) of the registration certificate of a medical device, as well as of the sending of a notification of the need to conduct an additional examination of the medical device, the authorized body shall immediately inform the authorized bodies of other member states, the manufacturer or its authorized representative, and the Commission.

 

Article 9

Information system in the field of circulation of medical devices

1. For the purpose of ensuring conditions for the circulation of safe, high-quality and effective medical devices within the framework of the Agreement, the Commission shall form and maintain an information system in the field of circulation of medical devices (hereinafter — the information system), which is part of the integrated information system of the Union and includes:

1. a) a unified register of medical devices registered within the framework of the Union;
2. b) a unified register of authorized organizations;
3. c) a unified information database for monitoring safety, quality and efficacy of medical devices.

1. The procedure for the formation and maintenance of the information system shall be established by the Commission.

The authorized bodies shall submit to the Commission the necessary information for the formation of the information system.

1. The information included in the order of inclusion in the information system shall be posted on the official website of the Commission in the information and telecommunications network “Internet”.

 

Article 10

Confidentiality of information

1. The authorized bodies and the Commission shall take the necessary measures to protect confidential information received and transmitted by them within the framework of this Agreement, including personal data.
2. For the transfer of confidential information obtained by an authorized body and (or) the Commission in accordance with this Agreement to third parties, the prior consent of the person who provided such information is required.
3. Information and data contained in the registration certificate of a medical device may not be classified as confidential information.

 

Article 11 (as amended by Protocol dated December 30, 2021)

Transitional period

Until December 31, 2025, an application for the examination or registration of a medical device may be submitted in the manner provided for by the legislation of a member state. If an application for the examination or registration of a medical device is submitted in the manner provided for by the legislation of a Agreement, the registration of a medical device may be carried out in the manner provided for by the legislation of the member state. (as amended by Protocols dated June 10, 202 amendment)

A medical device registered in the manner provided for by the legislation of a member state shall be introduced into circulation in the territory of that member state until the expiry of the validity of the documents confirming the fact of its registration, and shall circulate only in the territory of that member state.

A medical device registered in the amendment of the legislation of a member state (with the exception of a medical device in respect of which an open-ended document confirming the fact of its registration has been issued), may be re-registered (the document confirming the fact of registration may be re-issued) in the manner provided for by the legislation of the member state, in the case of submission of a relevant application before December 31, 2026.

It is permitted to make amendments to the registration documents of a medical device registered in the manner provided for by the legislation of a member state (with the exception of amendments requiring new registration in accordance with the procedure provided for in paragraph 2 of Article 4 of this Agreement), in the case of submission of a relevant application before December 31, 2026.

 

Article 12

Procedure for the resolution of disputes

Disputes related to the interpretation and (or) application of this Agreement shall be resolved in the manner determined by Article 112 of the Treaty on the Eurasian Economic Union dated May 29, 2014.

 

Article 13

Amendment of the Agreement

By mutual consent of the member states, amendments may be made to this Agreement, which shall be formalized by separate protocols and shall constitute an integral part of this Agreement.

 

Article 14

Entry into force of the Agreement

1. This Agreement shall enter into force from the date of receipt by the depositary of the last written notification of the completion by the member states of the internal state procedures necessary for its entry into force, but not earlier than January 1, 2016.
2. This Agreement is an international treaty concluded within the framework of the Union and forms part of the law of the Union.

Done in the city of Moscow on December 23, 2014, in a single original copy in the Russian language.

The original copy of this Agreement is deposited with the Eurasian Economic Commission, which, being the depositary of this Agreement, shall send a certified copy thereof to each member state.

For the Republic of Belarus For the Republic of Kazakhstan For the Russian Federation