Agreement on common principles and rules for the circulation of medical devices (medical products and medical equipment) within the Eurasian Economic Union

(as amended by Protocols of 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 of 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 referred to as medical devices),

taking into account the mutual interest in ensuring guarantees of safety, quality and effectiveness of medical devices for human life and health, environmental protection, property of legal entities and individuals, preventing actions that mislead consumers (users) of medical devices,

recognizing that medical devices are socially significant products,

in order to form a common market for medical devices within the Eurasian Economic Union (hereinafter referred to as the Union),

striving to increase the competitiveness of medical devices manufactured within the Union,

striving to eliminate restrictions on mutual trade,

have agreed as follows:

 

Article 1

Scope of the Agreement

 

1. This Agreement establishes common principles and rules for the circulation of medical devices within the Union in order to form a common market for medical devices.

2. This Agreement applies to legal relations related to the circulation of medical devices intended for circulation within the Union, as well as to medical devices in circulation within the Union.

3. The regulation of the circulation of medical devices within the Union is carried out in accordance with the Treaty on the Eurasian Economic Union of 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 terms shall mean:

"release for circulation of medical devices" - any compensated or uncompensated transfer of medical devices, which 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 trials for the purpose of their subsequent sale and use;

"medical devices" - any instruments, apparatus, 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 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 human body, conducting medical research, restoration, replacement, alteration of the anatomical structure or physiological functions of the body, prevention or termination of pregnancy, and the functional purpose of which is not realized through pharmacological, immunological, genetic or metabolic effects on the human body, but may be supported by medicines;

"circulation of medical devices" - design, development, creation of prototypes, conducting technical trials, research (testing) for the purpose of assessing biological effects, clinical trials, examination of the safety, quality and effectiveness of medical devices, registration, production (manufacturing), storage, transportation, sale, installation, adjustment, use (operation), maintenance, repair and disposal of medical devices.

 

Article 3

Pursuit of a Coordinated Policy in the Field of Circulation of Medical Devices

1. Member states shall form a common market for medical devices within the Union in accordance with the principles specified in Article 31 of the Treaty on the Eurasian Economic Union of May 29, 2014.

2. Member states shall pursue a coordinated policy in the field of circulation of medical devices through:

  a) taking measures necessary to harmonize the legislation of the member states in the field of circulation of medical devices;

  b) establishing common safety and effectiveness requirements for medical devices within the Union;

  c) establishing common rules for the circulation of medical devices in accordance with the recommendations of the International Medical Device Regulators Forum (IMDRF);

  d) defining common approaches to creating a medical device quality assurance system;

  e) harmonizing the nomenclature of medical devices used in the member states with the Global Medical Device Nomenclature;

  f) harmonizing the legislation of the member states in the field of control (supervision) over the circulation of medical devices.

 

3. For the purposes of implementing this Agreement, each member state shall define a government authority (authorities) authorized to carry out and/or coordinate activities in the field of medical device circulation within the territory of the member state (hereinafter referred to as the authorized body), and shall inform other member states and the Eurasian Economic Commission (hereinafter referred to as the Commission) about it.

4. Coordination of activities aimed at harmonizing the legislation of the member states in the field of medical device circulation shall be carried out by the Commission.

5. Harmonization of the legislation of the member states in the field of medical device circulation shall be carried out on the basis of international norms, taking into account the decisions of the Commission in the field of medical device circulation.

6. Authorized bodies shall cooperate in the field of medical device circulation, including by organizing and coordinating research work, scientific and practical conferences, seminars, and other events.

  Authorized bodies shall conduct events for sharing experience and organizing joint training for specialists in the field of medical device circulation.

  Authorized bodies, or organizations acting on their behalf in the member states, shall hold consultations with the participation of Commission representatives, aimed at coordinating the positions of the member states on issues of medical device circulation.

 

Article 4

Registration of Medical Devices

1. The provisions of this Article shall apply to medical devices released for circulation within the Union from the date of entry into force of this Agreement.

2. Medical devices released for circulation within the Union are subject to registration in the manner established by the Commission.

Registration of medical devices is carried out by authorized bodies.

The examination of the safety, quality, and effectiveness of medical devices for the purpose of their registration is 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.

 

3. When carrying out registration, identical requirements are imposed on medical devices manufactured within the Union and imported into the customs territory of the Union from third countries.

4. For the purpose of registering medical devices, technical trials, research (tests) to assess biological effects, clinical trials, tests for type approval of measuring instruments (in relation to medical devices classified as measuring instruments, the list of which is approved by the Commission), and an examination of the safety, quality, and effectiveness of medical devices are conducted.

  Rules for the classification of medical devices depending on the potential risk of use, rules for maintaining the nomenclature of medical devices, general requirements for the safety and effectiveness of medical devices, requirements for operational documentation of medical devices, rules for conducting trials of medical devices, rules for the registration of medical devices (including requirements for the registration dossier, application for registration, grounds and procedure for suspension or cancellation (annulment) of a medical device registration certificate), rules for conducting examinations of the safety, quality, and effectiveness of medical devices are approved by the Commission.

 

5. Authorized bodies define a list of institutions, organizations, and enterprises, including medical institutions and organizations, authorized to conduct trials of medical devices for the purpose of their registration (hereinafter referred to as authorized organizations).

  Requirements for authorized organizations and the procedure for assessing their compliance with these requirements are established by the Commission.

 

6. The document confirming the fact of medical device registration is a medical device registration certificate, valid within the Union.

  The form of the registration certificate and the rules for its completion are established by the Commission.

  The registration certificate is perpetual.

 

7. Member states create conditions to ensure the conformity of methods and conditions for conducting trials and the comparability of examination results through the application of common safety and effectiveness requirements for medical devices and uniform requirements for authorized organizations.

8. Authorized bodies mutually recognize the results of trials and examinations obtained during the medical device registration procedures, provided that they are performed in accordance with the requirements and rules established by the Commission.

9. The settlement of disputes arising between authorized bodies during the registration of medical devices is carried out in the manner established by the Commission.

10. A decision by an authorized body to refuse to issue a medical device registration certificate may be appealed by the legal manufacturer of the medical device or its authorized representative in a court of a member state in the manner provided for by the legislation of that member state.

11. Within the Union, the following medical devices are not subject to registration:

a) imported by individuals into the customs territory of the Union and intended for personal use;

b) manufactured in the territory of a member state according to individual patient orders exclusively for personal use and for which special requirements are imposed in accordance with a prescription issued by a medical professional;

c) imported into the customs territory of the Union for use by employees of diplomatic missions and consular offices;

d) imported into the customs territory of the Union to provide medical assistance to passengers and crew members of vehicles, train crews, and drivers of vehicles that have arrived in the territory of the Union;

e) imported into the customs territory of the Union to provide medical assistance to participants in international cultural, sporting events and participants in international expeditions, as well as for holding exhibitions;

f) imported into the customs territory of the Union for conducting trials, including for scientific purposes;

g) imported into the customs territory of the Union as humanitarian aid in cases determined by the legislation of the member states.

 

Article 5

Release of Medical Devices into Circulation within the Union

1. The manufacturer or its authorized representative is responsible for the release of a medical device into circulation within the Union.

 

2. The release of a medical device into circulation within the Union is prohibited if:

  a) there is an official notification from the authorized body, 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;

  b) the service life (shelf life) of the medical device has expired;

  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

Manufacturing of Medical Devices

1. The legal manufacturer of medical devices intended for circulation within the Union ensures the implementation and maintenance of a medical device quality management system. Requirements for the implementation, maintenance, and assessment of medical device quality management systems, depending on the potential risk of their use, are established by the Commission.

2. The manufacturer establishes and maintains an up-to-date system for collecting and analyzing data on the use of medical devices, tracking, and identifying adverse effects of medical devices during operation.

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

  In case of identification of non-compliance of medical devices with the general safety and effectiveness requirements for medical devices, or receipt of information about facts and circumstances that pose a threat to human life or health, the authorized body shall notify the authorized bodies of other member states within 5 days and take measures to prevent the circulation of such medical devices in its territory.

 

3. In the event of the cessation of medical device manufacturing, the manufacturer or its authorized representative is obliged, within 30 calendar days from the date of the decision to cease medical device manufacturing, to submit relevant information to the authorized body that issued the medical device registration certificate.

 

Article 7

Labeling of Medical Devices

 

1. Medical devices that have undergone the registration and conformity assessment procedures established within the Union, confirming compliance with the general safety and effectiveness requirements for medical devices, and the requirements for implementing and maintaining a medical device quality management system, shall be subject to mandatory labeling with a special circulation mark for medical devices on the Union market (hereinafter – special circulation mark) before being released into circulation within the Union.

2. The manufacturer or its authorized representative bears responsibility for the unjustified labeling of a medical device with the special circulation mark.

3. If an authorized body determines that the labeling of a medical device with the special circulation mark is being used unjustifiably by any manufacturer or its authorized representative, it shall inform the authorized bodies of other member states and the Commission about this violation and take necessary measures to withdraw such medical device from circulation in its territory and hold the responsible party accountable.

4. Requirements for the labeling of medical devices, the image of the special circulation mark, and the regulation on the special circulation mark shall be approved by the Commission.

5. The unified mark for product circulation on the Union market shall not apply to medical devices.

 

Article 8

Control over the Circulation of Medical Devices and Monitoring of the Safety, Quality, and Effectiveness of Medical Devices

 

1. Control over the circulation of medical devices shall be exercised over legal entities and individuals registered as sole proprietors, engaged in activities in the field of medical device circulation within the Union, in the manner established by the legislation of the member states.

2. Rules for monitoring the safety, quality, and effectiveness of medical devices shall be established by the Commission.

3. In the event of identifying the circulation within the Union of medical devices that pose a danger to human life and/or health, or of substandard, counterfeit, or falsified medical devices, the authorized body shall, within 5 days after establishing such fact, notify the authorized bodies of other member states and send relevant information to the Commission, and shall also be entitled to take measures, in the manner established by the Commission, to suspend or prohibit the use of the specified medical devices and withdraw them from circulation.

 

4. Upon identifying facts affecting issues of safety, quality, and effectiveness of medical devices, the authorized body shall inform the legal manufacturer of medical device or its authorized representative and may request additional information about the medical device from them.

5. The authorized body shall be entitled to:

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

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

  cancel the validity (annul) the medical device registration certificate issued by it.

  The grounds and procedure for suspending or canceling the validity (annulling) of a medical device registration certificate shall be determined by the rules for medical device registration, approved by the Commission.

  The authorized body shall immediately inform the authorized bodies of other member states, the manufacturer or its authorized representative, and the Commission about the suspension or cancellation of the validity (annulment) of a medical device registration certificate, as well as about sending a notification regarding the need for additional examination of the medical device.

 

Article 9

Information System in the Field of Medical Device Circulation

 

1. In order to ensure conditions for the circulation of safe, high-quality, and effective medical devices within the Union, the Commission shall form and maintain an information system in the field of medical device circulation (hereinafter - information system), which is part of the integrated information system of the Union and includes:

  a) a unified register of medical devices registered within the Union;

  b) a unified register of authorized organizations;

  c) a unified information database for monitoring the safety, quality, and effectiveness of medical devices.

 

2. The procedure for forming and maintaining the information system shall be established by the Commission.

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

 

3. The information included in the information system shall be posted on the official website of the Commission on the information and telecommunication network "Internet".

 

Article 10

Confidentiality of Information

 

1. Authorized bodies and the Commission shall take necessary measures to protect confidential information, including personal data, received and transmitted by them within the framework of this Agreement.

2. Transfer to third parties of confidential information received by an authorized body and (or) the Commission in accordance with this Agreement requires the prior consent of the person who provided this information.

3. Information and data contained in a medical device registration certificate cannot be classified as confidential information.

 

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

 

Transitional Period

 

Until December 31, 2025, an application for examination or registration of a medical device may be submitted in accordance with the legislation of the member state. If an application for examination or registration of a medical device is submitted in accordance with the legislation of the member state before December 31, 2025, registration of the medical device may be carried out in accordance with the legislation of the member state. (as amended by Protocols of June 10, 2022, February 13, 2023)

A medical device registered in accordance with the legislation of the member state is released for circulation in the territory of that member state until the expiration of the documents confirming the fact of its registration, and circulates only in the territory of that member state.

A medical device registered in accordance with the legislation of a member state (with the exception of a medical device for which a perpetual document confirming the fact of its registration has been issued) may be re-registered (the document confirming the fact of its registration may be reissued) in accordance with the legislation of the member state, if a corresponding application is submitted before December 31, 2026.

 

It is permissible to make changes to the registration documents of a medical device registered in accordance with the legislation of a member state (with the exception of changes requiring a new registration in accordance with the procedure provided for in paragraph 2 of Article 4 of this Agreement), if a corresponding application is submitted before December 31, 2026.

 

Article 12

Procedure for Resolving 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 of May 29, 2014.

 

Article 13

Amendments to 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 be an integral part of this Agreement.

 

Article 14

Entry into Force of the Agreement

 

1. This Agreement shall enter into force on the date of receipt by the depositary of the last written notification from the member states of the completion of the internal 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 is part of the law of the Union.

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

The original copy of this Agreement shall be kept by the Eurasian Economic Commission, which, as the depositary of this Agreement, shall send a certified copy of it to each member state.

 

For the Republic of Belarus 

For the Republic of Kazakhstan 

For the Russian Federation