Decision of the Council of the Eurasian Economic Commission dated February 12, 2016, No. 46

“On the Rules for the Registration and Examination of the Safety,

Quality, and Effectiveness of Medical Devices”

(as amended by the decisions of the Council of the Eurasian Economic Commission dated 24.12.2021 N144, dated 19.05.2022 N 84, dated 30.03.2023 N 50, dated 08.07.2025 N 50)

In accordance with paragraph 2 of Article 31 of the Treaty on the Eurasian Economic Union of May 29, 2014, paragraphs 2 and 4 of Article 4 of the Agreement on Common Principles and Rules for the Circulation of Medical devices (medical devices and medical Equipment) within the framework of the Eurasian Economic Union of December 23, 2014, paragraph 92 of Appendix No. 1 to the Operating Regulations Approved by the Decision of the Supreme Eurasian Economic Council No. 98 of December 23, 2014, and in order to implement the Decision of the Supreme Eurasian Economic Council No. 109 of December 23, 2014 “On the Implementation of the Agreement on Common Principles and Rules for the Circulation of Medical Devices (Medical Devices and Medical Equipment) within the Framework of the Eurasian Economic Union” The Council of the Eurasian Economic Commission DECIDED:

Approve the attached Rules for the registration and examination of the safety, quality, and effectiveness of medical devices (hereinafter referred to as the Rules).

New edition. Decision No. 50 dated 30.03.2023 of the EEC Council

Has become invalid. — Decision of the Council of the Eurasian Economic Commission dated 30.03.2023 No. 50.

To Member States by December 31, 2016:

a) approve the amount of fees (duties) or other mandatory payments provided for in the Rules, taking into account the complexity of the procedures and the volume of work carried out in the reference state and in the recognition states, including in the following cases:

registration of a medical device;

examination of the safety, quality, and effectiveness of a medical device;

making amendments to the registration dossier of a medical device;

issuing duplicate registration certificates;

b) identify the bodies (organizations) responsible for carrying out registration, making amendments to the registration dossier, and performing other procedures related to the registration of medical devices, as provided for in the Rules, and inform the Eurasian Economic Commission about this.

This Decision shall enter into force 10 calendar days after the date of entry into force of the Protocol signed on December 2, 2015, on the accession of the Republic of Armenia to the Agreement on the unified principles and rules for the circulation of medical devices (medical products and medical equipment) within the Eurasian Economic Union, dated December 23, 2014, but not earlier than 10 calendar days after the date of official publication of this Decision.

Члены Совета Евразийской экономической комиссии:

From the Republic of Armenia
V. Gabrielyan

From the Republic of Belarus
V. Matyushevsky

From the Republic of Kazakhstan
B. Sagintayev

From the Kyrgyz Republic
O. Pankratov

From the Russian Federation
I. Shuvalov

Approved

by the Decision of the Council

of the Eurasian Economic Commission

dated February 12, 2016, No. 46

RULES

FOR REGISTRATION AND EXAMINATION OF SAFETY, QUALITY

AND EFFECTIVENESS OF MEDICAL DEVICES

(ed. Decisions of the Council of the Eurasian Economic Commission dated December 24, 2021, No. 144, dated March 30, 2023, No. 50, dated July 8, 2025, No. 50)

General provisions
These Rules are developed in accordance with paragraph 2 of Article 31 of the Treaty on the Eurasian Economic Union of May 29, 2014 and paragraph 2 of Article 4 of the Agreement on Common Principles and Rules for the Circulation of Medical Devices (Medical Devices and Medical Equipment) within the Framework of the Eurasian Economic Union of December 23, 2014 and establish the procedure for examination of the safety, quality and effectiveness of medical devices (hereinafter referred to as the examination), approval of an expert opinion, settlement of disagreements regarding the approval of an expert opinion, making changes to the registration dossier (including in the notification procedure), issuing a duplicate registration certificate of a medical device, approval of an expert opinion on a registered medical device, as well as suspension and termination of the registration of (or) cancellation of the validity (cancellation) of the registration certificate of a medical device within the framework of the Eurasian Economic Union (hereinafter referred to as the Union).

The requirements of these Rules may not apply to medical devices whose need arises or increases in emergency situations, in the context of military operations, in the event of a threat of the spread of new epidemic diseases that pose a danger to others, or in the event of a threat of a shortage or actual shortage of medical devices on the markets of the Union member states (hereinafter referred to as member states) due to the introduction of restrictive economic measures against at least one of the member states. The circulation of such medical devices on the territories of member states is regulated by the legislation of those member states during the period when the specified conditions are in effect and until their consequences are eliminated.

For the purposes of these Rules, the following terms are used to mean the following:

“Safety of medical devices” means the absence of unacceptable risk associated with causing harm to human life, health, or the environment.

“validation” means confirmation by providing objective evidence of compliance with requirements intended for a particular use or application;

“verification” – confirmation based on the submission of objective evidence of compliance with the established requirements;

“state of recognition” – a member state whose authorized body (expert organization) carries out the procedure for approving the expert opinion of the reference state;

“first-party evidence” means evidence materials (documents) of the manufacturer of a medical device (protocols of its own tests (studies), including those issued by testing laboratories (centers) accredited in the national accreditation system of a member state, results of clinical use of a medical device, and other materials).;

“The unified register of medical devices registered within the Eurasian Economic Union” is an electronic database of medical devices registered in accordance with these Rules.

“Applicant” — the manufacturer of the medical device or its authorized representative.

“Quality of a medical device” is the degree to which the совокупности of properties and characteristics of a medical device meet the purpose established by the manufacturer.

“medical devices for in vitro diagnostics” means any instruments, apparatuses, devices, equipment, materials, reagents, calibrators, control materials and other products used for medical purposes separately or jointly, as well as together with accessories and special software necessary for their intended use, and intended by the manufacturer for use in in vitro studies of samples of human biological materials to obtain information about a physiological or pathological condition (congenital pathology, predisposition to a particular clinical condition or disease), compatibility of tissues with a potential recipient, prediction of reactions to therapeutic effects, choice of therapeutic agents and / or control of treatment;

“Model (brand) of a medical device” refers to a specific version of a medical device, characterized by certain design and technological solutions and specific values of the indicators of its intended (functional) purpose.

“accessory” — a product that is not a medical device, intended by its manufacturer for use in conjunction with one or more medical devices when used in accordance with their intended purpose.

“manufacturer of a medical device”, “manufacturer” — a legal entity or an individual registered as an individual entrepreneur, responsible for the development and manufacture of a medical device, making it available for use in its own name, regardless of whether the medical device was developed and (or) manufactured by this person or by another person (persons) on its behalf, and who is liable for the safety, quality and effectiveness of the medical device.

“Production site” is a geographically separate complex designed to carry out the entire process of manufacturing a medical device or its specific stages.

“registration dossier” – a set of documents and materials of the established structure submitted by the applicant during the registration and examination procedures, approval of an expert opinion, making changes to the registration dossier (including in the notification procedure), issuing a duplicate registration certificate for a medical device, approval of an expert opinion for a registered medical device, cancellation (cancellation) of the registration certificate for a registered medical device. certificates of a medical device, as well as originals and / or copies of other documents related to a specific medical device (decisions of authorized bodies (expert organizations), minutes of meetings of the Advisory Committee on Medical Devices under the Board of the Eurasian Economic Commission, documents submitted during the settlement of disputes, reports on the results of production inspection, etc.);

“Registration certificate” is a document of a unified form confirming the fact of registration of a medical device in the territory of one or more member states.

“registration of a medical device”, “registration” – the procedure for issuing a permit by the authorized body of the reference state to put a medical device into circulation on the territory of one or several member states;

“reference state” – a member state chosen by the applicant, whose authorized body (expert organization) performs registration and expertise;

“authorized body” means a public authority of a member State authorized to carry out and / or coordinate activities in the field of circulation of medical devices in the territory of this member State;

“authorized organizations” – organizations included in the unified register of authorized organizations that have the right to conduct research (testing) of medical devices for the purpose of their registration;

“Authorized representative of the manufacturer” means a legal entity or an individual registered as an individual entrepreneur, who are residents of a member state and are authorized by the manufacturer, in accordance with a contract or any other document provided for by the legislation of the member states, to represent its interests and be responsible for the circulation of the medical device within the Union and for complying with the mandatory requirements applicable to medical devices.

Registration of a medical device is a mandatory condition for its release into circulation in the territory of one or more member states and is carried out by the authorized body of the reference state. At the same time, the same requirements apply to medical devices manufactured within the customs territory of the Union and those imported into the customs territory of the Union from third countries.

For the purpose of registering a medical device, an examination is carried out by an expert organization designated by the authorized body of the member state (hereinafter referred to as the expert organization).

The document confirming the fact of registration of a medical device is the registration certificate, drawn up in accordance with the form and rules set out in Appendix No. 1.

The registration certificate is issued for an indefinite period and is valid in the territory of one or more member states.

A registered medical device must comply with the General Requirements for the Safety and Effectiveness of Medical Devices, the requirements for their labeling and operational documentation, as approved by Decision No. 27 of the Council of the Eurasian Economic Commission dated February 12, 2016 (hereinafter referred to as the General Requirements). The manufacturer (or an authorized representative of the manufacturer) is responsible for ensuring that medical devices comply with the General Requirements.

Manufacturers from third countries must appoint an authorized representative of the manufacturer, who will act during the period when the medical device is in circulation within the Union, and must keep the information about such representative of the manufacturer contained in the registration dossier up to date.

The manufacturer ensures the implementation and up-to-date maintenance of the medical device quality management system in accordance with the Requirements for the implementation, maintenance and Evaluation of the medical device quality management system, depending on the potential risk of their use, approved by the Decision of the Council of the Eurasian Economic Commission No. 106 of November 10, 2017 (hereinafter referred to as the Requirements for the Quality Management System)..

Prior to submitting to the authorized body (expert organization) of the reference state an application for an examination of the medical device and an application for the registration of the medical device in accordance with the forms in Appendices No. 2 and 3 (hereinafter referred to as the registration and examination applications), the applicant shall collect evidence of the safety and efficacy of the medical device and prepare the relevant registration dossier.

For the purpose of preparing the registration dossier, the applicant (if necessary):

a) has the right to contact the authorized body (expert organization) to obtain preliminary consultations on issues related to registration and expertise, including on a paid basis, in accordance with the procedure established by the authorized body (expert organization) of the relevant member state.

b) in order to confirm compliance of the medical device with the General Requirements:

Conducts technical tests and tests (studies) to assess the biological effect of the medical device, as well as clinical and clinical‑laboratory tests (studies) of the medical device, or includes the available data (first‑party evidence) in the registration dossier.

Conducts tests for the purpose of approving the type of measuring instruments (for medical devices included in the list of types of medical devices that must be classified as measuring instruments upon registration, as approved by Decision No. 42 of the Council of the Eurasian Economic Commission dated February 12, 2016) in accordance with the procedure established by the legislation of the member state in the field of ensuring the uniformity of measurements, in organizations selected by the applicant and authorized (notified) in accordance with the legislation of the member state to conduct testing of measuring instruments.

c) ensures the conduct of periodic (scheduled) or unscheduled production inspections to assess production conditions and evaluate the manufacturer’s quality management system in accordance with the Quality Management System Requirements.

During registration and expert examination, the authorized bodies (expert organizations) mutually recognize the results of tests (studies) specified in subparagraph “b” of paragraph 10 of these Rules, provided that they are performed in accordance with the Rules for Conducting Technical Tests of Medical Devices, approved by the Decision of the Council of the Eurasian Economic Commission of February 12, 2016 No. 28, the Rules for conducting technical tests of conducting studies (tests) for the purpose of evaluating the biological effect of medical devices, approved by the Decision of the Council of the Eurasian Economic Commission No. 38 of May 16, 2016, or the Rules for Conducting clinical and clinical Laboratory tests (studies) of Medical Devices, approved by the Decision of the Council of the Eurasian Economic Commission No. 29 of February 12, 2016, respectively, and in accordance with the legislation of the member State in the case of tests for the purpose of type approval of measuring instruments.

If necessary, the authorized body (expert organization) may involve external experts in the examination if their specialized knowledge is required to conduct the examination.

Representatives of authorized organizations who conducted the tests (studies) specified in subparagraph “b” of paragraph 10 of these Rules regarding the medical device submitted for examination, as well as representatives of inspection organizations that carried out an assessment of the quality management system (production inspection) of the manufacturer of such a medical device, may not be involved in the examination.

When conducting an examination, the expert must be independent of the body or person who commissioned the examination, the manufacturer, their authorized representative, or any other parties interested in the results of the examination.

If an expert is aware of circumstances that prevent them from being involved in the examination or that do not allow them to comply with the principles of its conduct, they must inform the head of the authorized body (expert organization) of the reference state.

The applicant is responsible for the accuracy of the information provided in the registration dossier.

The documents of the registration dossier are submitted in Russian in electronic form. If the legislation of the reference state does not provide for the possibility of preparing these documents in electronic form, the authorized body (expert organization) of the reference state has the right to request such documents (their copies) in paper form.

If the registration dossier documents are submitted in paper form, the applicant must also submit electronic copies of them in electronic form (in *.pdf format with a text layer that allows text to be selected and copied, as well as searched). Electronic copies of the documents must be submitted in accordance with the classifier of types of documents for the medical device registration dossier, approved by Decision No. 48 of the Board of the Eurasian Economic Commission dated April 3, 2018.

The operating manual or instructions for the use of a medical device, the service manual, and the labeling text of the medical device must be additionally provided in the official language (official languages) of the member states, provided that such requirements are stipulated in the legislation of the member states.

Documents of the registration dossier submitted in a foreign language must be accompanied by a translation into Russian, certified in accordance with the procedure established by the legislation of the relevant state.

When calculating the timeframe for the authorized bodies (expert organizations) to carry out the procedures provided for in these Rules, the following timeframes are not taken into account:

a) the period from the date when the authorized body (expert organization) of the reference state sends a request or notification to the applicant about the need to eliminate the identified violations and (or) submit missing documents, or about the need to submit copies of documents on payment for the procedure for approving an expert opinion in the state (s) of recognition until the day when the authorized body (expert organization) of the reference state receives a response response to such a request or notification;

b) the time required to organize and conduct a production inspection (in the event that a production inspection is carried out as part of the registration and examination procedures);

c) the time period required for sending a report on the results of the inspection of production by the inspecting organization (if its role is not performed by the authorized body (expert organization)) to the authorized body (expert organization) for inclusion in the registration dossier (if the inspection of production is carried out within the framework of registration and expert examination procedures);

d) the period for coordinating with the applicant the need to contact the Advisory Committee on Medical Devices under the Board of the Eurasian Economic Commission (hereinafter referred to as the Advisory Committee).

e) the period required for the authorized body (expert organization) of the reference state to carry out the measures necessary to include a new type of medical device in the Global Medical Device Nomenclature and in the Union’s medical device nomenclature (if, based on the results of the examination, it is determined that it is necessary to contact the Global Medical Device Nomenclature Agency, and provided that there are no comments on the documents contained in the submitted registration dossier, or the comments specified in the request have been addressed).

(subclause ” d ” was introduced by the Decision of the Council of the Eurasian Economic Commission No. 50 of 08.07.2025)

The applicant bears the costs associated with the registration and examination procedures, coordination of the expert conclusion, making amendments to the registration file (including under the notification procedure), issuing a duplicate of the registration certificate, or coordinating the expert conclusion for a registered medical device, in accordance with the legislation of the member state.

Registration is carried out by the reference state based on the results of the examination and the approval of the expert opinion by the state(s) of recognition.

Authorized bodies (expert organizations) of the recognition states have the right to review the progress of the examination in the reference state and the relevant documents, including documents issued when the applicant submits additional and clarifying information during the registration and examination of a medical device.

Information about medical devices subject to the procedures provided for in these Rules, as well as documents contained in the registration dossier, except for the operational document or instructions for the use of the medical device, the service manual, data on labeling and packaging (full‑color (with color coding indicated) mock‑ups of packages and labels), and the text of the labeling in Russian and the state languages of the member states, is considered confidential information and is available only to the relevant authorized bodies (expert organizations) of the member states.

The inclusion of several models (brands) of a medical device in a single registration certificate, including those belonging to different types of medical devices in accordance with the nomenclature of medical devices used in the Union, is possible provided that these models (brands) meet all the following criteria:

a) The production of models (brands) of the medical device is carried out by a single manufacturer according to the same technical documentation.

b) The models (brands) of the medical device belong to the same class of potential risk of use.

c) The models (brands) of the medical device have the same functional purpose and operating principle.

d) models (brands) of a medical device are designed to determine the presence and / or quantitative content of the same clinically (diagnostically) significant analyte (s) in a biological sample (for medical devices for in vitro diagnostics);

d) The models (brands) of the medical device have various configurations that do not affect the operating principle and functional purpose, which makes it possible to expand or specialize their use for medical purposes (in terms of applicability).

e) The models (brands) of the medical device have different technical parameters (for example, radiation wavelength, light field size, resolution, etc.) that do not affect the operating principle and functional purpose (in terms of applicability).

g) models (brands) of a medical device form a standard-sized (model) a series (for example, they have different dimensions (overall, linear, three-dimensional, etc.), shape, color coding, are made of the same materials, etc.) or are a group of medical device designs (for example, a stationary mobile device (device, system, complex, etc.) with a wall and / or floor mounting mounting, etc.) (if applicable). At the same time, a medical device execution group means products for which one group drawing of parts and (or) one group specification are made;

h) The models (brands) of the medical device have identical characteristics in terms of:

application areas;

invasiveness;

sterility (including taking into account sterilization methods);

frequencies of use (single use, multiple use by one patient, multiple use by multiple patients);

operational and design features;

duration of application;

New edition. Decision No. 50 dated 08.07.2025 of the EEC Council

The uniformity of the materials used in the models (brands) of the medical device and in contact with the human body (in terms of their chemical, toxicological, physical, electrical, morphological, and mechanical properties).

The following is not permitted within the customs territory of the Union:

a) the selection of two or more reference countries for the registration and evaluation of a single medical device;

b) registration of various medical devices under a single name;

c) registration as medical devices of products whose name is contained in the unified register of registered medicines of the Eurasian Economic Union, the procedure for its formation and maintenance being approved by Decision No. 84 of the Council of the Eurasian Economic Commission dated November 3, 2016, or whose name coincides with the name of a dietary supplement, the information about which is contained in the unified register of certificates of state registration of products, the procedure for its formation and maintenance being approved by Decision No. 80 of the Board of the Eurasian Economic Commission dated June 30, 2017. If a medicinal product or a dietary supplement is a component of a medical device, their names may be used in the name of the medical device.

Procedures for the registration and examination of a medical device
To register a medical device, the applicant selects a reference state and at least one recognition state.

The applicant submits the following documents to the authorized body (expert organization) of the reference state:

a) a registration dossier containing applications for registration and examination, as well as documents according to the list in Appendix No. 4;

b) copies of documents confirming payment for the registration and examination procedures in the reference state.

The authorized body (expert organization) of the reference state shall verify the completeness and accuracy of the information contained in the applications for registration and examination, as well as in the documents specified in clause 22 of these Rules, within 7 working days from the date of receipt of the applications and documents.

If applications for registration and examination are submitted in violation of the requirements established by these Rules, or they contain false information, or the documents specified in paragraph 22 of these Rules are not submitted in full, the authorized body (expert organization) of the reference state within 7 working days from the date of receipt of such applications and documents notifies the applicant of the need to eliminate the identified violations and (or) submit missing documents within 30 working days from the date of posting the relevant notification in the information system of the authorized body (expert organization) of the reference state or from the date of sending the notification to the applicant in the manner specified in the applications for registration and examination.

25.If, after 30 working days, the applicant has not eliminated the identified violations and / or submitted missing documents, the authorized body (expert organization) of the reference state within 3 working days decides to return to the applicant applications for registration and examination and documents with justification for the reasons for the return.

Within 3 working days from the date of submission of applications for registration and examination and documents that meet the requirements of these Rules, as well as in case of elimination of detected violations within the time period specified in paragraph 24 of these Rules and (or) submission of documents that meet the requirements of these Rules, the authorized body (expert organization) of the reference state makes a decision on the beginning of registration and examination procedures, and also places in its information system a registration dossier containing applications for registration and examination.

The examination includes (if applicable):

a) an assessment of the correctness of classifying the product as a medical device;

b) an assessment of compliance with the class of potential risk of use of the medical device specified by the applicant, in accordance with the Rules for the Classification of Medical Devices Depending on the Potential Risk of Use, approved by Decision No. 173 of the Board of the Eurasian Economic Commission dated December 22, 2015;

c) assessing the correctness of classifying a medical device (models (brands) of a medical device) as belonging to a specific type of medical device in accordance with the nomenclature of medical devices, the rules for maintaining which are approved by Decision No. 177 of the Board of the Eurasian Economic Commission dated December 29, 2015;

If, based on the results of the examination (provided there are no comments on the documents contained in the submitted registration dossier, or the comments specified in the request have been addressed), it is determined that the Union’s list of medical devices does not include a medical device of the relevant type for the declared medical device (model (brand) of the medical device), the authorized body (expert organization) of the reference state has the right to initiate the procedure for including the new type of medical device in the Global Medical Device Nomenclature and in the Union’s list of medical devices. Within 10 working days from the date of detection of the specified fact, the authorized body (expert organization) of the reference state notifies the applicant about this.

(the paragraph was introduced by the Decision of the Council of the Eurasian Economic Commission No. 50 of 08.07.2025)

d) assessing the compliance of the models (brands) of the medical device (if any) included in a single registration certificate with the criteria established by paragraph 19 of these Rules;

e) analysis and evaluation of evidence documents (materials) confirming that the medical device complies with the General Requirements, including:

Analysis of the information provided by the manufacturer regarding the compliance of the medical device with the General Requirements, including an analysis of the correct identification of the provisions of the General Requirements applicable to the medical device.

Assessment of the compliance of technical test protocols issued by authorized organizations with the Rules for Conducting Technical Tests of Medical Devices.

Assessment of the compliance of research (test) protocols issued by authorized organizations, which are intended to evaluate the biological effects of medical devices, with the Rules for conducting research (tests) to evaluate the biological effects of medical devices.

Analysis of the report on the assessment of the biological effect of a medical device (carried out, among other things, to confirm that the materials that come into contact (interact) with human tissues have been identified (the material brands and their manufacturers are indicated), as well as to confirm the validity of the conclusion that there is no need to conduct studies (tests) to assess the biological effect).

Analysis of the report on clinical evidence of the efficacy and safety of a medical device (carried out to confirm the validity of the choice of methods for proving the clinical efficacy and safety of the medical device, the validity of the data used to prove the clinical efficacy and safety of the medical device, as well as the validity of the conclusion regarding clinical efficacy and safety for all declared indications for use, taking into account the presence or absence of contraindications).

Assessment of the compliance of reports on clinical (clinical‑laboratory) tests (studies) of medical devices with the Rules for Conducting Clinical and Clinical‑Laboratory Tests (Studies) of Medical Devices.

Analysis of the validity of first‑party evidence (if available) to confirm compliance of the medical device with the General Requirements, taking into account the class of potential risk associated with the use of the medical device (for medical devices of classes of potential risk of use 2b and 3, the first‑party evidence must be accompanied by a test (research) programme and a justification of the selected methods).

Analysis of the standards used by the manufacturer in the design and production of a medical device.

Analysis of the safety and efficacy of a medicinal product as part of a medical device, its impact on the functionality of the medical device, and the compatibility of the medicinal product with the medical device (excluding medical devices for in vitro diagnostics). The medicinal product must be registered and approved for use in the country of manufacture of the medicinal product.

New edition. Decision No. 50 dated 08.07.2025 of the EEC Council

Analysis of data on the biological safety of a medical device based on an analysis of all materials of animal or human origin included in the medical device, information on the selection of sources (donors), material selection, processing, storage, testing, validation of testing procedures, as well as the handling of tissues, cells, substances of animal or human origin, cultures of microorganisms and viruses.

Analysis of the procedure and methods of sterilizing a medical device, the materials that justify the sterilization method, the proposed quality control methods, and the determination of residual sterilizing agent when using the chemical sterilization method.

The study of the validity of software based on an analysis of data related to its verification and validation, including information about its development, measures and means to protect against unauthorized access and ensure cybersecurity, testing by the manufacturer, and data on identification and labeling.

Analysis of the report on the stability of the medical device and the validity of the declared shelf life.

Review of the risk analysis report to confirm the completeness of the hazards, hazardous situations, and corresponding risks identified in the report that may be assessed as unacceptable, as well as to confirm the manufacturer’s conclusion regarding the absence of unacceptable risks or the acceptability of risks that were assessed in the risk analysis report as acceptable based on the “risk‑benefit” analysis.

Confirmation, based on the submitted evidence (documents), of the validity of the manufacturer’s assessment regarding the compliance of the medical device with the General Requirements.

Assessment of the compliance of the operational document or instructions for use, or the service manual, with the General Requirements.

Assessment of compliance of the medical device’s labeling with the General Requirements.

analysis of the requirements for the technical characteristics of a medical device;

Assessment of documents confirming the results of tests of medical devices for the purpose of approving the type of measurement instruments (in relation to medical devices included in the list of types of medical devices that must be classified as measurement instruments during their registration).

e) analysis of reports on the results of inspections of the production of a medical device (carried out to confirm that the claimed medical device belongs to the appropriate group (subgroup) of medical devices, taking into account the class of potential risk of use in accordance with Appendix No. 2 to the Requirements for the Quality Management System, as well as to confirm the accuracy of the information about the production sites specified in the applications for registration and examination, which are covered by the report on the results of inspections of the production of a medical device);

g) analysis of data on the certification of the quality management system (if available), including the requirements to which the manufacturer’s quality management system is certified, and information about the certificates (number, date of issue, validity period, name, and information about the accreditation of the certification body);

h) confirmation of the validity of the indication of the production sites for the registered medical device;

i) analysis of data on the development and production of a medical device (flowcharts of production processes, information about the main stages of production, packaging, testing, and the procedure for releasing the final product);

k) analysis of the marketing information provided by the manufacturer;

New edition. Decision No. 50 dated 08.07.2025 of the EEC Council

l) analysis of the information provided by the manufacturer regarding the presence or absence of reports of adverse events (incidents) related to the use of the medical device, recalls of the medical device from the market, safety notifications regarding the medical device, the manufacturer’s approaches to addressing such issues when they arise, a description of the corrective actions taken, as well as an analysis of the relationship between the sales level, the number of adverse events (incidents), and recalls of the medical device from circulation.

m) analysis of the data collection plan for the safety and effectiveness of a medical device at the post‑market stage.

When conducting an examination, if the materials and information contained in the applications for registration and examination and in the documents of the registration dossier are insufficient to make a decision on whether to initiate a production inspection (if it is necessary) or to prepare an expert opinion (if there is no need to conduct a production inspection), the authorized body (expert organization) of the reference state shall send the applicant a corresponding request (indicating the nature of the comments and the ways to eliminate them). The request shall be sent once, using the method specified in the applications for registration and examination.

The applicant is required to submit a response to the request within 60 working days from the date of receipt. If the specified response is not submitted within the required timeframe, the authorized body (expert organization) will make a decision regarding the possibility of registering the medical device based on the documents at its disposal.

If the authorized body (expert organization) of the reference state identifies unreliable data or documents containing text in a foreign language that have not been translated into Russian in accordance with the procedure established by the legislation of the reference state, the authorized body (expert organization) shall, within 2 working days from the date of receipt of such documents, deliver to the applicant, via the method specified in the applications for registration and examination, a decision to return the said documents, along with a justification of the reasons for the return and a notification that the applicant may submit the documents again before the expiration of the period specified in the second paragraph of this clause.

The authorized body (expert organization) of the reference state, within 45 working days from the date it makes a decision to initiate the procedures for registering and examining a medical device, issues an expert conclusion in accordance with Appendix No. 5, or, if it is necessary to conduct a production inspection, decides to initiate the production inspection (provided there are no comments on the documents contained in the submitted dossier or the comments specified in the request have been addressed), and notifies the applicant of the decision made by sending a notification in the manner specified in the applications for registration and examination.

When a decision is made to initiate a production inspection by the authorized body (expert organization) of the reference state, the inspection organization of the reference state conducts the production inspection in accordance with the Requirements for the Quality Management System. The timeframe for organizing and conducting the production inspection should not, in total, exceed 90 working days from the date the authorized body (expert organization) makes the decision to initiate the production inspection.

The report on the results of the production inspection is sent by the inspection organization to the authorized body (expert organization) of the reference state for inclusion in the registration dossier, and to the applicant by registered mail with a delivery notification, or in the form of an electronic document signed with an electronic signature, within 15 working days from the date of completion of the production inspection. In this case, if non‑conformities are identified as a result of the production inspection, the report on the results of the production inspection, supplemented with information on the elimination of the identified non‑conformities, is sent by the inspection organization to the authorized body (expert organization) of the reference state within 15 working days after receiving information from the applicant on the elimination of the non‑conformities or from the date when the deadline for their elimination expires.

If, as a result of the production inspection, changes are made to the documents of the registration dossier for the registered medical device, such documents, drawn up in accordance with Appendix No. 4, are sent by the inspection organization to the authorized body (expert organization) of the reference state.

The authorized body (expert organization) of the reference state shall issue an expert conclusion within 15 working days from the date of receipt of the report on the results of the production inspection, in accordance with Appendix No. 5 to these Rules.

The conclusions contained in the expert report must be unambiguous and clear.

The grounds for the authorized body (expert organization) of the reference state to issue a conclusion refusing to register a medical device are:

a) non-confirmation by the relevant materials and information contained in the registration dossier of the quality, and (or) effectiveness, and (or) safety of the medical device;

b) the risk of harm to the health of citizens and medical workers due to the use of a medical device exceeds the effectiveness of its use;

c) the identification by authorized bodies of state control (supervision) over the circulation of medical devices of false data regarding the efficacy and safety of the medical device, and their discrepancy with the data about the medical device contained in the documents of the registration dossier.

If the expert opinion regarding the possibility of registering a medical device is negative, the authorized body (expert organization) shall, within 10 working days from the date of issuing (receiving) the expert opinion, make a decision to refuse to register the medical device, and issue to the applicant, in the manner specified in the applications for registration and examination, a notification of refusal to register the medical device, including a justification of the reasons for the refusal and an attached copy of the expert opinion of the authorized body (expert organization) of the reference state.

If the expert opinion regarding the possibility of registering a medical device is positive, the authorized body (expert organization) of the reference state shall, within 5 working days from the date of issuance of the expert opinion, post the registration dossier and this expert opinion in its information system, and notify the applicant of the need to submit copies of documents confirming payment for the procedure of approving the expert opinion in the state (states) of recognition within 30 calendar days from the date such notification is sent to the applicant by the method specified in the applications for registration and examination.

The applicant notifies the authorized bodies (expert organizations) of the reference state and the state(s) of recognition about the payment for the approval procedures within the timeframe established by paragraph 36 of these Rules.

The approval of the expert conclusion is the basis for making a decision on the registration of a medical device in the state of recognition and is issued by the authorized body (expert organization) of the state of recognition in the form of a conclusion confirming the approval (or non‑approval) of the expert conclusion in accordance with Appendix No. 6 (hereinafter referred to as the confirmation of approval (or non‑approval) of the expert conclusion).

The approval of the expert opinion by the authorized body (expert organization) of the state of recognition is carried out in accordance with Section III of these Rules.

Provided that there are no disagreements between the reference state and the state(s) of recognition regarding the approval of the expert opinion, the authorized body (expert organization) of the reference state:

a) within 10 working days from the date of receipt from all authorized bodies (expert organizations) of the states of recognition of confirmation of approval of the expert opinion or from the date of expiration of the period established for the provision of the specified confirmation by the states of recognition (provided that the applicant submitted copies of documents on payment for the approval procedure to the authorized body (expert organization) of the reference state in the states of recognition and translations of the operating document or instructions for use of the medical device, the service manual and the marking text into the state languages of the states of recognition (if necessary)), decides on the registration of the medical device and places in the unified register of medical devices registered within the Union, information about the medical device provided for by creating and maintaining an information system;

b) within 10 working days from the date of the decision to register the medical device, it issues and provides the applicant with the registration certificate and the appendix thereto, using the method specified in the application for the registration of the medical device.

Failure to obtain approval of the expert opinion of the authorized body (expert organization) of the reference state in one of the recognition states is grounds for refusing to register a medical device in the territory of that recognition state.

If there is a state (s) of recognition, whose authorized body (expert organization) has not approved the expert opinion, the authorized body (expert organization) of the reference state, within 10 working days from the date of receipt from all authorized bodies (expert organizations) of the recognition confirmation of approval (non-approval) of the expert opinion, or from the date of expiration of the term of validity of the expert opinion. the deadline set for granting the specified confirmation by the States of recognition (provided that the applicant submitted to the authorized body (expert organization) of the reference state copies of documents on payment for the procedure for approving an expert opinion in the States of recognition and translations of the operational document or instructions for use of a medical device, service manual and marking text into the state languages of the States of recognition (if necessary)), taking into account the nature of the identified comments, performs one of the following actions::

a) sends the applicant a notification about the need to coordinate the application with the Advisory Committee to resolve disagreements regarding the coordination of the expert opinion, attaching a copy (copies) of the confirmation of coordination (or non‑coordination) of the expert opinion. If the applicant does not respond within 15 working days from the date of receipt of the relevant notification, the application to the Advisory Committee is considered non‑coordinated.

b) If the competent authority (expert organization) of the recognition state agrees with the conclusions regarding the impossibility of registering the medical device, it makes a decision to refuse to register the medical device. In this case, the competent authority (expert organization) of the reference state, within 10 working days from the date of the decision to refuse to register the medical device, issues and provides to the applicant, in the manner specified in the applications for registration and examination, a notification of refusal to register the medical device (including a justification of the reasons for the refusal and attached copies of the expert conclusion and confirmation of the non‑approval of the expert conclusion).

The authorized body (expert organization) of the reference state shall, within 3 working days from the date of receiving the applicant’s response regarding the appeal to the Advisory Committee to resolve disagreements regarding the expert opinion:

a) applies to the Advisory Committee in accordance with Section IV of these Rules (provided the applicant has agreed to submit an application to the Advisory Committee);

b) makes a decision on the registration of a medical device without indicating in the registration certificate the state (states) of recognition whose authorized body (expert organization) has not approved the expert conclusion (in the event that the applicant does not agree with the submission to the Advisory Committee). In this case, the authorized body (expert organization) of the reference state shall, within 10 working days from the date of the decision to register the medical device:

places in the unified register of medical devices registered within the Union, the information about the medical device provided for in the Procedure for the Formation and Maintenance of the Information System;

It prepares and issues to the applicant, using the method specified in the application for registration of the medical device, the registration certificate and the appendix to it.

III. Procedure for approving the expert conclusion

The procedure for approving an expert conclusion is carried out in relation to an expert conclusion that has been drawn up in accordance with the following procedures:

a) the procedures for registering and reviewing a medical device in accordance with Section II of these Rules;

b) the procedure for making changes to the registration dossier in accordance with Section V of these Rules;

c) the procedure for approving an expert opinion on a registered medical device in accordance with Section VIII of these Rules.

The applicant shall ensure, within the timeframe agreed upon with the authorized body (expert organization) of the recognition state and not exceeding the period specified in paragraph 50 of these Rules, that the authorized body (expert organization) of the reference state and the recognition state receives translations of the operating document or instructions for the use of the medical device, the service manual, and the labeling text into the official language of the recognition state (if the recognition state’s legislation contains relevant requirements).

During the procedure for approving the expert conclusion, the authorized body (expert organization) of the state of recognition assesses the completeness and sufficiency of the data confirming the safety, quality, and effectiveness of the medical device, as well as the accuracy of the translation of the operational document or instructions for using the medical device, the service manual, and the labeling text into the official language of the state of recognition (if necessary).

If necessary, the authorized bodies (expert organizations) of the recognition states may submit their comments and proposals to the authorized body (expert organization) of the reference state using the means of the Union’s integrated information system (hereinafter referred to as the integrated system) before that authorized body (expert organization) issues an expert opinion.

During the coordination of the expert conclusion, the authorized bodies (expert organizations) of the member states may interact with each other in order to resolve any issues that arise.

If there are disagreements between the reference state and the state(s) of recognition regarding the approval of the expert opinion, the authorized body (expert organization) of the reference state shall make a decision based on the expert opinion and confirmation of the disagreement regarding the approval of the expert opinion, including taking into account the results of resolving disagreements regarding the approval of the expert opinion within the framework of the Advisory Committee (if an appeal is made to the Advisory Committee).

The authorized body (expert organization) of the state of recognition reviews the expert opinion within 30 working days, starting from one of the following dates:

During the procedures for registering and examining a medical device — from the date the notification regarding the payment for the approval procedures is received by the authorized bodies (expert organizations) of the reference state and the state (states) of recognition.

During the procedure for making changes to the registration dossier — from the date when the authorized body (expert organization) of the reference state places the registration dossier containing the application for making changes to the registration dossier in its information system.

When carrying out the procedure for approving an expert opinion on a registered medical device, it begins from the date when the authorized body (expert organization) of the reference state places the registration dossier containing the application for approval of the expert opinion on the registered medical device in its information system.

At the same time, the condition for calculating the specified period is the presence of funds in the account of the authorized body (expert organization) of the state of recognition, which were received as a result of the applicant’s payment for the procedure of coordination of the expert opinion in the state of recognition in full.

Based on the results of reviewing the expert conclusion, the authorized body (expert organization) of the recognition state shall send to the authorized body (expert organization) of the reference state confirmation of the approval (or non‑approval) of the expert conclusion (with a justification) using the means of the integrated system (including confirmation of the correctness of the translation of the operational document or instructions for the use of the medical device, the service manual, and the labeling text into the state languages of the recognition states in accordance with the legislation of the member states).

If the State of Recognition fails to submit confirmation of the approval (or non‑approval) of the expert opinion within the timeframe established by paragraph 50 of these Rules, the expert opinion shall be considered approved, provided that the applicant has submitted to the authorized bodies (expert organizations) of the reference State and the State of Recognition translations of the operating document or instructions for the use of the medical device, the service manual, and the labeling text into the official language of the State of Recognition (if the legislation of the State of Recognition contains the relevant requirements).

Within the framework of the procedures for registration and examination of a medical device, in accordance with Section II of these Rules, the grounds for the state’s refusal to recognize an expert opinion are:

a) the grounds provided for in paragraph 34 of these Rules;

b) the applicant’s failure to submit, within the agreed timeframe, a translation of the operational document or instructions for use of the medical device, the service manual, and the labeling text into the official language of the state of recognition (if necessary);

c) the absence of recognition of funds received as a result of the applicant’s payment for the expert opinion approval procedure in full, in the account of the authorized body (expert organization) of the state.

Within the framework of the procedure for approving an expert conclusion for a registered medical device in accordance with Section VIII of these Rules, the grounds for the state’s refusal to approve the expert conclusion are those provided for in paragraph 54 of these Rules.

Within the framework of the procedure for making amendments to the registration dossier, in accordance with Section V of these Rules, the grounds for the state’s refusal to approve the expert conclusion are:

a) the grounds provided for in paragraph 79 of these Rules;

b) the absence of translations of the operational document or instructions for the use of the medical device, the service manual, and the labeling text into the official language of the state of recognition (if necessary).

Settlement of disagreements regarding the coordination

of the expert opinion

If there is no consensus on the issue of agreeing on the expert opinion issued as part of the procedures for registering and reviewing a medical device in accordance with Section II of these Rules, disagreements shall be resolved by submitting a request from the authorized body (expert organization) of the reference state to the Advisory Committee.

The authorized body (expert organization) of the reference state, in agreement with the applicant, submits a statement to the Advisory Committee regarding the need to consider the disagreements (including information about the subject of the disagreements and the results of the negotiations and consultations held). Any materials supporting the position of the authorized body (expert organization) of the reference state on the subject of the disagreements may be attached to the statement.

After receiving the application and the materials attached to it from the authorized body (expert organization) of the reference state, the Advisory Committee requests materials from the authorized bodies (expert organizations) of the recognition states that confirm their position on the subject of disagreement.

The Advisory Committee shall send a notification about the holding of a meeting to resolve disagreements to the authorized bodies (expert organizations) of the reference state and the states of recognition after they have submitted the relevant materials.

The organization and conduct of the meeting to resolve disagreements are ensured by the Advisory Committee. The meeting is attended by members of the Advisory Committee who are representatives of the authorized bodies (expert organizations). If necessary, at the suggestion of the authorized bodies, representatives of healthcare organizations, expert organizations, manufacturers, and other specialists may be invited to participate in the consideration of the issue being discussed at the Advisory Committee meeting.

Based on the results of the Advisory Committee meeting, a decision is adopted, which is of a recommendatory nature.

The timeframe for resolving disagreements regarding the approval of an expert opinion must not exceed 30 working days from the date the authorized body (expert organization) of the reference state submits the relevant application and materials to the Advisory Committee.

Within 3 working days from the date of receipt of the minutes of the meeting of the Advisory Committee for the Settlement of Disputes, the authorized body (expert organization) of the reference state, based on the recommendations of the Advisory Committee, shall make a decision regarding the possibility of registering the medical device.

If the decision made in accordance with paragraph 63 of these Rules is positive, the authorized body (expert organization) of the reference state shall, within 3 working days from the date of its adoption:

a) places in the unified register of medical devices registered within the Union the information about the medical device, as provided for in the Procedure for the Formation and Maintenance of the Information System;

b) issues the registration certificate and the annex to it (indicating the states of recognition whose authorized bodies (expert organizations) have approved the expert opinion) and issues them to the applicant in the manner specified in the application for the registration of the medical device.

c) if, following the results of the meeting of the Consultative Committee of the state (s) of recognition, the authorized body (expert organization) of which has not agreed on an expert opinion, sends the applicant a notification of the decision of the authorized body (expert organization) of the state of recognition (with a copy of the confirmation of non-agreement of the expert opinion and other documents), solutions (protocol records) Of the Advisory Committee).

If the decision made in accordance with paragraph 63 of these Rules is negative, the authorized body (expert organization) of the reference state shall, within 3 working days from the date of its adoption, issue and provide to the applicant, in the manner specified in the applications for registration and examination, a notification of refusal to register the medical device (with a justification of the reasons for the refusal and the attachment of copies of the expert opinion, confirmation of the non‑consent with the expert opinion, and the decision (protocol record) of the Advisory Committee.

Procedure for making changes to the registration dossier
The applicant must initiate the procedure for making such changes to the registration dossier within 90 calendar days from the date of making amendments to the documents contained in the registration dossier.

Changes to the registration dossier that require registration of a new medical device include:

a) changes that entail a change in the functional purpose and (or) principle of operation of a medical device;

b) including information about the models (brands) of a registered medical device that do not meet the criteria for including several models (brands) of a medical device in a single registration certificate in accordance with paragraph 19 of these Rules;

c) changes that entail a simultaneous alteration of information about the manufacturer and the production site (production sites) in relation to the information specified in the registration certificate issued as part of the registration and examination procedures for the medical device, except for information about the organizational and legal form, address, reorganization, and other information contained in the statutory documents.

In the event of making changes that entail a modification of the operational document or the instructions for use of the medical device, the service manual, and the labeling text, the release into circulation of medical devices that comply with the documents and information from the registration dossier prior to the amendments being made is permitted within 180 calendar days from the date these amendments are made. It is permitted to simultaneously release into circulation medical devices with an operational document or instructions for the use of the medical device, a service manual, and labeling text that comply with the documents and information from the registration dossier both before and after the amendments are made.

The procedure for making amendments to the registration dossier (except for amendments for which a notification procedure is provided) requires the coordination of an expert opinion with the states of recognition specified in the registration certificate, in accordance with the procedure established in Section III of these Rules.

For the purpose of making changes to the registration dossier, the applicant submits the following documents and information to the authorized body (expert organization) of the reference state:

a) an application for making changes to the registration dossier (in hard copy and (or) in electronic form) in accordance with Annex No. 7 (hereinafter referred to in this section as the application for making changes);

b) a copy of the document confirming the authority of the manufacturer’s authorized representative (if available);

c) documents and information on relevant changes, including documents confirming the changes and indicating that the introduction of these changes does not entail changes in the properties and characteristics of the medical device that affect its safety, quality and effectiveness, or improves its properties and characteristics with the same functional purpose and (or) principle actions of a medical device;

d) copies of documents confirming payment for the procedure to amend the registration dossier in the reference state and for the procedure to coordinate the expert opinion in the state(s) of recognition, as well as for the issuance of a registration certificate in the reference state (if necessary);

e) the original registration certificate (duplicate);

f) inventory of documents.

The authorized body (expert organization) of the reference state shall verify the completeness and accuracy of the information contained therein within 7 working days from the date of receipt of the application for amendments, as well as the documents and information specified in paragraph 70 of these Rules.

If the application for amendments is submitted in violation of the requirements of these Rules and (or) contains false information and (or) the documents and information specified in paragraph 70 of these Rules are not submitted in full, the authorized body (expert organization) of the reference state within 7 working days from the date of receipt of such amendments. application, documents and information notifies the applicant of the need to eliminate the identified violations and (or) submit missing documents within 30 working days from the date of posting the relevant notification in the information system of the authorized body (expert organization) of the reference state or from the date of sending the notification to the applicant in the manner specified in the application for amendments.

If, after 30 working days, the applicant has not eliminated the identified violations and /or submitted missing documents, the authorized body (expert organization) of the reference state within 3 working days decides to return the application for amendments and documents (with justification of the reasons for the return).

Within 3 working days from the date of submission of the application for amendments, documents and information that meet the requirements of these Rules, and also in the event that the identified violations are eliminated within 30 days and (or) documents that meet the requirements of these Rules are submitted, the authorized body (expert organization) of the reference state makes a decision to initiate the procedure for amending the registration dossier and posts the registration dossier containing the application for amendments and documents confirming the amendments in its information system.

During the examination, if the materials and information contained in the application for amendments and the documents confirming the amendments are insufficient, the authorized body (expert organization) of the reference state shall send the applicant a corresponding request (indicating the comments and ways to resolve them). The request shall be sent to the applicant once, using the method specified in the application for amendments.

The applicant shall submit a response to the request within 60 working days from the date of its receipt. If a response is not submitted within the specified period, the authorized body (expert organization) of the reference state shall make a decision based on the documents at its disposal.

If the authorized body (expert organization) of the reference state identifies false information or documents in the documents submitted by the applicant in response to the request, compiled or containing text in a foreign language without a certified translation into Russian in accordance with the procedure established by the legislation of the member State, the authorized body (expert organization) of the reference state within 2 working days from the date on the day of receipt of such documents, hand over to the applicant, in the manner specified in the application for amendments, the decision to return the specified documents (with justification of the reasons for the return and notification of the possibility of re-submission of documents before the expiration of the period specified in paragraph two of paragraph 75 of these Rules).

The authorized body (expert organization) of the reference state conducts an examination and issues an expert opinion in accordance with Appendix No. 8 within 30 working days from the date of the decision to initiate the procedure for making changes to the registration file.

The conclusions contained in the expert report must be unambiguous and clear.

The grounds for the authorized body (expert organization) of the reference state to prepare an expert opinion stating that it is impossible to make changes to the registration dossier are:

a) the unreliability of the information provided to substantiate the introduction of changes (including that identified during the exercise of state control (supervision) by authorized bodies over the circulation of medical devices);

b) the absence in the documents submitted by the applicant of information confirming that the changes made to the documents contained in the registration dossier do not entail changes to the properties and characteristics of the medical device that affect its safety, quality and effectiveness, or that they improve the properties and characteristics while maintaining the functional purpose and (or) operating principle of the medical device;

c) the need to carry out a new registration of the medical device in accordance with paragraph 67 of these Rules.

The authorized body (expert organization) of the reference state, within 10 working days from the date of issuing (receiving) an expert opinion on the impossibility of making changes to the registration dossier, decides to refuse to make these changes, draws up and issues to the applicant a notification of refusal to make changes to the registration dossier in the manner specified in the application for making changes. dossier (with justification of the reasons for refusal and attachment of a copy of the expert opinion of the authorized body (expert organization) of the reference state and the original (duplicate) registration certificate.

After an expert opinion has been issued in the reference state regarding the possibility of making changes to the registration dossier, the authorized body (expert organization) of the reference state places the registration dossier containing the application for amendments and the expert opinion in its information system.

In the absence of recognition by the state (states), the authorized body (expert organization) of the reference state shall, within 10 working days from the date of issuance of the expert opinion on the possibility of making changes to the registration dossier:

a) makes a decision to make changes to the registration dossier and publishes in the unified register of medical devices registered within the Union information about the amendments made to the registration dossier in accordance with the Procedure for the Formation and Maintenance of the Information System, as well as scanned copies of the documents to which the amendments have been made.

b) within 10 working days from the date of making a decision on making changes to the registration dossier, notify the applicant about it in the manner specified in the application for making changes, and also in case of making changes to the registration certificate and (or) its annex, draw up and issue to the applicant in the manner specified in the application for making changes, reissued documents the registration certificate and its annex with the same number (indicating the date of making the corresponding changes) and returns the previously issued registration certificate and its annex with a note about their invalidity (indicating the date).

If there is a state (states) of recognition and provided there are no disagreements between the authorized body (expert organization) of the reference state and the authorized body (expert organization) of the state (states) of recognition regarding the approval of the expert opinion, the authorized body (expert organization) of the reference state:

a) within 10 working days from the date of receipt from the authorized bodies (expert organizations) of all states of recognition of confirmation of approval of the expert opinion or from the date of expiration of the period provided for in paragraph 50 of these Rules (provided that the applicant submitted to the authorized body (expert organization) of the reference state a translation of the operational document or instructions for state languages of the states of recognition (if necessary)), makes a decision on making changes to the registration dossier and places in the unified register of medical devices registered within the Union, information on making changes to the registration dossier in accordance with the Procedure for Forming and maintaining the information system, as well as information on the use of medical devices in accordance with the Procedure for scanned copies of documents that have been modified;

b) within 10 working days from the date of making a decision on making changes to the registration dossier, notify the applicant about it in the manner specified in the application for making changes, and also in case of making changes to the registration certificate and (or) its annex, draw up and issue to the applicant in the manner specified in the application for making changes, reissued documents the registration certificate and its annex with the same number (indicating the date of making the corresponding changes) and returns the previously issued registration certificate and its annex with a note about their invalidity (indicating the date).

Disagreement between the expert opinion of the authorized body (expert organization) of the reference state and the recognition state is grounds for excluding information about that state from the registration certificate.

If the authorized body (expert organization) of the recognition state has not agreed on the expert conclusion, and the authorized body (expert organization) of the reference state agrees with the conclusions of the authorized body (expert organization) of the recognition state regarding the impossibility of making changes to the registration dossier, the authorized body (expert organization) of the reference state:

a) within 10 working days from the date of receipt from the authorized bodies (expert organizations) of all states of confirmation of the approval (or non‑approval) of the expert conclusion, or from the date of expiration of the period provided for in paragraph 50 of these Rules, a decision is made to refuse to make amendments to the registration file.

b) Within 10 working days from the date of the decision to refuse to make amendments to the registration dossier, the authority shall prepare and issue to the applicant, via the method specified in the application for amendments, a notification of refusal to make amendments to the registration dossier (including a justification of the reasons for the refusal, as well as an attachment containing a copy of the expert opinion of the authorized body (expert organization) of the reference state, a copy (copies) of the confirmation of approval (or non‑approval) of the expert opinion, and the original (or duplicate) of the registration certificate).

If the authorized body (expert organization) of the recognition state has not approved the expert opinion, and the authorized body (expert organization) of the reference state disagrees with the conclusions of the authorized body (expert organization) of the recognition state regarding the impossibility of making changes to the registration dossier, the authorized body (expert organization) of the reference state:

a) within 10 working days from the date of receipt from the authorized bodies (expert organizations) of all recognition states of confirmation of the approval (or non‑approval) of the expert opinion, or from the date of expiration of the period established for the recognition states to provide such confirmation (provided that the applicant has submitted to the authorized body (expert organization) of the reference state a translation of the operating document or instructions for the use of the medical device, the service manual, and the labeling text into the official languages of the recognition states (if necessary)):

It makes a decision to make changes to the registration file and to exclude information about the state (states) of recognition from the registration certificate, if the authorized body (expert organization) has not agreed on the expert opinion.

publishes in the unified register of medical devices registered within the framework of the Union information about amendments to the registration dossier in accordance with the Procedure for the formation and maintenance of the information system, as well as scanned copies of the documents to which amendments have been made.

b) within 10 working days from the date of the decision to make changes to the registration dossier:

Notifies the applicant of the amendments made to the registration dossier and of the exclusion of information about the state (states) of recognition from the registration certificate, for which the authorized body (expert organization) has not approved the expert conclusion, in the manner specified in the application for amendments (with an attached copy of the confirmation of non‑approval of the expert conclusion).

It prepares and issues to the applicant, in the manner specified in the application for making amendments, a reissued registration certificate and its appendix, from which the information about the state (states) of recognition whose authorized body (expert organization) has not approved the expert conclusion has been removed, and to which amendments have been made in accordance with the application for making amendments, while preserving the previous number (indicating the date when the relevant amendments were made).

Returns to the applicant, in the manner specified in the application for amendments, the previously issued registration certificate and its appendix, with a note indicating their invalidity (including the date).

Procedure for making changes to the registration dossier

on a notification basis

The procedure for making amendments to the registration dossier on a notification basis is applied in the following cases:

a) The changes concern the validity periods of the documents contained in the registration dossier (updating the documents in the registration dossier by the applicant).

b) Changes are made by the manufacturer of medical devices of potential risk class 1 or non‑sterile medical devices of potential risk class 2a, which have undergone an assessment of the medical device quality management system (including the design and development processes of medical devices) in accordance with the Quality Management System Requirements.

c) The changes concern the following information about the manufacturer of the medical device or its authorized representative:

name of the legal entity (full and abbreviated (if any), including brand names), address of the location or address of the place of business;

surname, first name, patronymic (if any), residential address of the individual entrepreneur or address of the place where the business is carried out, and details of the document удостоверяющего identity.

d) changes to the name of a medical device, including the trademark and other means of identification;

e) The changes consist in excluding information about the model (brand) of the medical device from the registration certificate.

In order to make changes to the registration dossier on a notification basis, the applicant submits the following documents and information to the authorized body (expert organization) of the reference state:

a) application for making changes to the registration dossier in a notification procedure (on paper and (or) in electronic form) in accordance with Annex No. 9 (hereinafter referred to in this section as the application for making changes);

b) a copy of the document confirming the authority of the manufacturer’s authorized representative (if an authorized manufacturer’s representative is present);

c) documents and information on relevant changes, including documents confirming the changes and indicating that the introduction of these changes does not entail changes in the properties and characteristics of the medical device that affect its safety, quality and effectiveness, or improves its properties and characteristics with the same functional purpose and (or) principle actions of a medical device;

d) reports on the results of initial, periodic (scheduled) and unscheduled inspections of production (in the case provided for in subparagraph “b” of paragraph 87 of these Rules);

д) копии документов, подтверждающих оплату процедуры внесения изменений в регистрационное досье в уведомительном порядке в референтном государстве, а также выдачи регистрационного удостоверения в референтном государстве (при необходимости);

е) оригинал регистрационного удостоверения (дубликат) (в случае необходимости внесения в него изменений);

ж) опись документов.

The application for amendments and the documents confirming the amendments (including reports on the results of production inspections) are posted by the authorized body (expert organization) of the reference state in its information system, with access granted only to the authorized bodies (expert organizations) of the reference state and the state (states) of recognition.

The authorized body (expert organization) of the reference state shall, within 7 working days from the date of receipt of the application for amendments, as well as the documents and information specified in paragraph 88 of these Rules, verify the completeness and accuracy of the information contained therein (including the validity period of the reports on the results of the production inspection).

If the application for amendments is submitted in violation of the requirements of these Rules, contains false information and (or) the documents and information specified in paragraph 88 of these Rules are not submitted in full, the authorized body (expert organization) of the reference state within 7 working days from the date of receipt of such applications, documents and information notifies the applicant of the need to eliminate the identified violations and (or) submit missing documents within 30 working days from the date of posting the relevant notification in the information system of the authorized body (expert organization) of the reference state or from the date of sending the notification to the applicant in the manner specified in the application for amendments.

If, after 30 working days, the applicant has not eliminated the identified violations and /or submitted missing documents, the authorized body (expert organization) of the reference state within 3 working days decides to return the application for amendments and documents (with justification of the reasons for the return).

Within 3 working days from the date of submitting an application for amendments, documents and information that meet the requirements of these Rules, as well as in case of elimination of detected violations within the time period established by paragraph 91 of these Rules and (or) submission of documents that meet the requirements of these Rules, the authorized body (expert organization) of the reference state makes a decision on the beginning of the procedure for making changes to the registration dossier in a notification manner and places in its information system the registration dossier containing the application for making changes.

If the validity period of the report on the results of the production inspection has expired (in the case provided for in subparagraph “b” of paragraph 87 of these Rules), the application for amendments will not be accepted, and amendments to the registration file will be carried out in accordance with the procedure provided for in Section V of these Rules.

Amendments to the registration file are made through a notification procedure by the authorized body (expert organization) of the reference state within 15 working days from the date of the decision to initiate the procedure for making amendments to the registration file through a notification procedure.

The procedure for making changes to the registration file on a notification basis does not require coordination with the states of recognition. Therefore, the states of recognition are not indicated in the application for making changes.

If the amendments concern the information contained in the registration certificate, the authorized body of the reference state shall issue a new registration certificate while retaining the previous number (indicating the date on which the relevant amendments were made).

The grounds for the authorized body (expert organization) of the reference state to make a decision to refuse to make amendments to the registration file on a notification basis are:

a) the unreliability of the information provided to substantiate the introduction of changes under the notification procedure (including the expiration of the validity period of the report on the results of the production inspection);

b) the submitted documents and information do not comply with clause 88 of these Rules;

c) the need to carry out a new registration of the medical device in accordance with paragraph 67 of these Rules;

d) the inconsistency of the proposed changes with the cases specified in clause 87 of these Rules.

Уполномоченный орган (экспертная организация) референтного государства в течение 5 рабочих дней со дня принятия решения об отказе во внесении изменений в регистрационное досье в уведомительном порядке оформляет и выдает заявителю способом, указанным в заявлении о внесении изменений, уведомление об отказе во внесении изменений в регистрационное досье в уведомительном порядке с обоснованием, а также возвращает заявителю способом, указанным в заявлении о внесении изменений, ранее выданные регистрационное удостоверение (дубликат) и приложение к нему в случае их предоставления.

The authorized body of the reference state, within 5 working days from the date of the decision to make changes to the registration file, shall, in accordance with the notification procedure:

a) publishes in the unified register of medical devices registered within the framework of the Union information about amendments to the registration dossier in accordance with the Procedure for the formation and maintenance of the information system, as well as scanned copies of the documents to which amendments have been made.

b) prepares and issues to the applicant, in the manner specified in the application for amendments, a notification regarding the amendments to the registration file in a notification procedure, as well as, if necessary, a reissued registration certificate and its appendix, preserving the previous number (indicating the date on which the relevant amendments were made).

c) returns to the applicant, in the manner specified in the application for amendments, the previously issued registration certificate (duplicate) and its appendix, with a note indicating their invalidity (with the date), if they have been provided.

VII. Procedure for issuing a duplicate

of the registration certificate

In case of loss (damage) of the registration certificate, the applicant has the right to apply to the authorized body of the reference state with an application for issuing a duplicate of the registration certificate (in hard copy and (or) in electronic form)in accordance with Annex No. 10.

In the event of damage to the registration certificate, the damaged registration certificate must be attached to the application for the issuance of a duplicate registration certificate.

Within 5 working days from the date of receipt of the application for the issuance of a duplicate registration certificate, the authorized body of the reference state shall issue a duplicate registration certificate on a separate form and deliver it to the applicant in the manner specified in the application for the issuance of a duplicate registration certificate.

If the submitted application for the issue of a duplicate registration certificate is not properly executed and (or) it contains false information, the authorized body of the reference state draws up a decision to refuse to issue a duplicate registration certificate.

VIII. Procedure for coordinating the expert opinion

on a registered medical device

The procedure for registering a medical device registered in accordance with these Rules in Member States not specified in the registration certificate is carried out by coordinating the expert opinion with the authorized bodies (expert organizations) of these Member States. Based on the results of the coordination, the authorized body of the reference state issues a registration certificate indicating all recognition states whose authorized bodies (expert organizations) have coordinated the expert opinion.

The applicant submits the following documents (copies of documents) to the authorized body (expert organization) of the reference state:

a) a registration dossier containing an application for approval of an expert opinion for a registered medical device (with an indication of the state (s) of recognition not specified in the registration certificate) (on paper and (or) in electronic form) in accordance with Annex No. 11 (hereinafter referred to in this section as an application for approval of an expert opinion) and documents according to the list according to appendix No. 12;

b) copies of documents confirming payment for the issuance of a new registration certificate in the reference state (if the relevant requirements are met);

c) copies of documents confirming payment for the procedure of approving the expert conclusion in the state (states) of recognition specified in the application for approval of the expert conclusion.

The authorized body (expert organization) of the reference state shall verify the completeness and accuracy of the information contained in the expert conclusion and the documents specified in paragraph 106 of these Rules within 7 working days from the date of receipt of the application for approval of the expert conclusion and the documents.

If the application for approval of an expert opinion is submitted in violation of the requirements of these Rules, contains false information and (or) the documents specified in paragraph 106 of these Rules are not submitted in full, the authorized body (expert organization) of the reference state within 7 working days from the date of receipt of such applications and documents notifies the applicant’s request to eliminate the identified violations and (or) submit missing documents within 30 working days from the date of posting the relevant notification in the information system of the authorized body (expert organization) of the reference state or from the date of sending the notification to the applicant in the manner specified in the application for approval of the expert opinion.

If, after 30 working days, the applicant has not eliminated the identified violations and /or submitted missing documents, the authorized body (expert organization) of the reference state within 3 working days decides to return the application for approval of the expert opinion and documents (with justification of the reasons for the return).

Within 3 working days from the date of submission of the application for approval of the expert conclusion and documents meeting the requirements of these Rules, as well as in the event of eliminating the identified violations within the timeframe established by paragraph 108 of these Rules and (or) submitting documents meeting the requirements of these Rules, the authorized body (expert organization) of the reference state shall make a decision to carry out the procedure for approving the expert conclusion for the registered medical device and shall place the registration dossier containing the application for approval of the expert conclusion in its information system.

The coordination of the expert conclusion by the states of recognition specified in the statement on the coordination of the expert conclusion is carried out in accordance with paragraphs 46, 48–52 and 54 of these Rules.

Failure to obtain approval of the expert conclusion in one of the recognition states specified in the application for approval of the expert conclusion is grounds for refusing to market the medical device in that recognition state.

Within 10 working days from the date of receipt from all authorized bodies (expert organizations) of the recognition states specified in the application for approval of the expert opinion, confirmation of approval (non-approval) of the expert opinion, or from the date of expiration of the period established by paragraph 50 of these Rules, the authorized body (expert organization) of the reference state makes a decision on the issue of reissued registration certificate (if there are states of recognition whose authorized bodies (expert organizations) have agreed on an expert opinion) or on refusal to issue a reissued registration certificate (if there are no states of recognition whose authorized bodies (expert organizations) have agreed on an expert opinion).

Within 10 working days from the date of the decision to issue a reissued registration certificate, the authorized body (expert organization) of the reference state:

The entity places in the unified register of medical devices registered within the framework of the Union information about the states of recognition specified in the application for approval of the expert conclusion, the authorized bodies (expert organizations) of which approved the expert conclusion, as well as scanned copies of documents to which amendments have been made, in accordance with the Procedure for the Formation and Maintenance of the Information System.

It prepares and issues to the applicant, in the manner specified in the application for approval of the expert conclusion, a reissued registration certificate and its appendix, retaining the previous number (indicating all states of recognition whose authorized bodies (expert organizations) approved the expert conclusion, and the dates when the relevant changes were made).

returns to the applicant, via the method specified in the application for approval of the expert opinion, the previously issued registration certificate (duplicate) and its appendix, with a note indicating their invalidity (including the date).

The applicant is issued a notification by the method specified in the application for approval of the expert conclusion, informing them of the refusal to register the medical device by the state of recognition specified in the application for approval of the expert conclusion, along with a copy of the confirmation that the expert conclusion was not approved by the authorized body (expert organization) of the specified state (if there is a state of recognition whose authorized body (expert organization) did not approve the expert conclusion).

Within 10 working days from the date of the decision to refuse to issue a reissued registration certificate, the authorized body (expert organization) of the reference state:

returns to the applicant, in the manner specified in the application for approval of the expert conclusion, the previously issued registration certificate (duplicate) and the appendix to it.

The applicant is issued a notification of refusal to register the medical device by the state of recognition specified in the application for approval of the expert conclusion, using the method indicated in the application for approval of the expert conclusion. The notification includes a copy of the confirmation that the expert conclusion was not approved by the authorized body (expert organization) of the specified state, as well as the original (or duplicate) registration certificate.

Procedure for suspending or revoking

(canceling) the registration certificate

The suspension of the registration certificate is carried out by the authorized body of the reference state in the following cases:

a) based on the results of monitoring the safety, quality, and effectiveness of medical devices in the post‑registration period — if a potential serious threat to human health is identified;

b) based on the results of state control (supervision) over the circulation of medical devices — if there is information about facts and circumstances that pose a threat to the life and health of citizens and medical workers during the use and operation of medical devices.

c) the absence of current information about the manufacturer’s authorized representative in the registration dossier (for manufacturers from third countries).

The decision to suspend the registration certificate (with the reasons, date, and duration of the suspension) is made by the authorized body of the reference state in accordance with the legislation of that state.

The suspension period for the registration certificate cannot exceed 6 months, and the sale and use of such medical devices in the reference state and the state(s) of recognition are not permitted.

The authorized body of the reference state, within 5 working days from the date of making a decision to suspend the registration certificate, enters relevant information into the unified register of medical devices registered within the Union, and informs the authorized bodies of the recognition states and the Eurasian Economic Commission about this using the integrated system tools, as well as the applicant by sending a notification signature, or sending a notification by registered mail with a notification of delivery, or sending it in electronic form or in the form of an electronic document signed with an electronic signature (indicating the reasons, date and term of suspension of the registration certificate, as well as the need for the applicant to eliminate the circumstances that led to the suspension of the registration certificate).

Within the period established by the authorized body of the reference state, the applicant is obliged to eliminate the circumstances that led to the suspension of the registration certificate and to notify this authorized body in writing (with the attachment of supporting documents). Based on the review of the documents submitted by the applicant, the authorized body of the reference state makes a decision on the resumption or cancellation (annulment) of the registration certificate (indicating the date of resumption or cancellation (annulment) of the registration certificate).

The authorized body of the reference state shall, within 5 working days from the date of the decision to renew the registration certificate, enter the relevant information into the unified register of medical devices registered within the Union, and shall notify the applicant of the decision in person, against signature, or send the notification by registered mail with a delivery notification, or transmit it electronically or in the form of an electronic document signed with an electronic signature.

The decision to reinstate the registration certificate is made in accordance with the legislation of the reference state and comes into force on the date of its adoption.

If the applicant fails to eliminate the circumstances that led to the suspension of the registration certificate within the prescribed period, the authorized body of the reference state shall, within 3 working days from the date the specified period expires, make a decision to revoke (annul) the registration certificate (with a justification).

The authorized body of the reference state shall immediately enter the relevant information into the unified register of medical devices registered within the Union and shall notify the applicant of the revocation (cancellation) of the registration certificate by delivering the notification in person to the applicant against signature, or by sending the notification by registered mail with a delivery notification, or by sending it electronically or in the form of an electronic document signed with an electronic signature.

The grounds for the authorized body of the reference state to make a decision to revoke (annul) the registration certificate or to cancel the registration of a medical device (models (brands) of a medical device, the information about which is provided in the registration certificate) are:

a) submission by the manufacturer of an application for revocation (cancellation) of the registration certificate (in hard copy and (or) in electronic form) in accordance with Appendix No. 13;

b) identifying cases where the applicant has provided false information that could not have been detected during the registration of the medical device (including during the exercise of state control (supervision) by the authorized bodies over the circulation of medical devices);

c) a court decision of a member state that has entered into legal force, revoking (annulling) the registration certificate or canceling the registration of a medical device (models (brands) of a medical device, the information about which is provided in the registration certificate);

d) submission by the authorized body, based on the results of state control (supervision) over the circulation of medical devices, of information about facts and circumstances that pose a threat to the life and health of citizens and medical workers during the use and operation of a medical device.

e) loss of the medical device status due to amendments to the acts that are part of the Union’s law, or on the basis of a decision by the Advisory Committee following the work to resolve disagreements regarding the classification of products as medical devices.

An application to revoke (annul) a registration certificate may be submitted by an authorized representative of the manufacturer, provided that the following conditions are simultaneously met:

a) the presence in the registration dossier of an up‑to‑date document confirming the authority of the manufacturer’s authorized representative, or the submission of such a document to the authorized body of the reference state together with an application for the revocation (cancellation) of the registration certificate;

b) submission to the authorized body of the reference state, together with the application for the revocation (cancellation) of the registration certificate, of a document issued by the manufacturer, certified in accordance with the established procedure, confirming their intention to revoke (cancel) the registration certificate.

If an application to revoke (annul) a registration certificate is submitted in violation of the requirements of these Rules, or if the documents are not submitted in full or contain false information, the authorized body of the reference state shall, within 7 working days from the date of receipt of such application and documents, make a decision to return them (indicating the reasons for the return).

The authorized body of the reference state shall, within 7 working days from the date of occurrence of one of the grounds specified in paragraph 123 of these Rules, make a decision to revoke (annul) the registration certificate or to cancel the registration of the medical device (models (brands) of the medical device, the information about which is provided in the registration certificate).

The authorized body of the reference state within 5 working days from the date of making a decision to cancel the validity (cancellation) of the registration certificate or to cancel the registration of a medical device (models (brands) of a medical device, information about which is provided in the registration certificate):

a) publishes in the unified register of medical devices registered within the Union information on the revocation (cancellation) of the registration certificate or on the cancellation of the registration of a medical device (models (brands) of a medical device, the information about which is provided in the registration certificate);

b) notifies the applicant of the cancellation (annulment) of the registration certificate by delivering the notification in person against signature, or by sending it by registered mail with a notification of delivery, or by sending it electronically or in the form of an electronic document signed with an electronic signature.

c) notifies the applicant of the cancellation of the registration of the medical device (models (brands) of the medical device, the information about which is provided in the registration certificate) and of the need to make changes to the registration dossier regarding the exclusion of these medical devices (models (brands) of the medical device) by delivering the notification in person against signature, or by sending it by registered mail with a notification of delivery, or by sending it electronically or in the form of an electronic document signed with an electronic signature.

Appendix No. 1

to the Rules for Registration and Examination

of the Safety, Quality, and Effectiveness

of Medical Devices

FORM OF THE REGISTRATION CERTIFICATE

OF A MEDICAL DEVICE AND THE RULES FOR FILLING IT OUT

Form of the registration certificate for a medical device

The emblem of the Eurasian Economic Union	(1)

EURASIAN ECONOMIC UNION	(2)
	(3)
(name of the authorized body of the reference state)

REGISTRATION CERTIFICATE OF A MEDICAL DEVICE	(4)
MI-XY-Z dated “___” ____________ 20__	(5)

In accordance with		(6)
	(the number and date of the order issued by the authorized body of the reference state regarding the registration of the medical device.)
the present registration certificate of the medical device has been issued:
		(7)
(manufacturer’s name and location)
		(8)
(The name of the production site (including its actual address) or a reference to the annex, if two or more production sites are specified.)
		(9)
(The name of the manufacturer’s authorized representative in the territories of the member states of the Eurasian Economic Union, including its location.)
the fact that		(10)
	(name of the medical device)
the class of potential risk of using a medical device:		(11)
Registered and permitted for release into circulation in the territory of the following member states of the Eurasian Economic Union.
		(12)
(The name of the reference state and the state(s) of recognition.)
The models (brands) of the medical device, their composition, accessories, and production facilities are listed in the appendix (if available) to
According to the registration certificate for the medical device for __ p.		(13)
The annex is an integral part of this registration certificate for the medical device..
The validity period of the medical device registration certificate:
unlimited		(14)
Date of registration of the medical product: “___” ___________ 20__ г.		(15)
The number and date of the order issued by the authorized body of the reference state regarding the amendments to the registration certificate of the medical device:
“___” ___________ 20__. N		(16)

(Full name of the head (authorized person) of the authorized body)
	М.П.	(17)
(signature)
	N _____	(18)

APPENDIX TO THE REGISTRATION CERTIFICATE OF A MEDICAL DEVICE	(1)
МИ-XY-Z от “__” _________ 20__ .	(2)

N п/п	Name
1.	Model (brand) of the medical device (if available)
2.	Composition
3.	Accessories (if available)
	(3)

N п/п	Names and actual addresses of production sites
1.	…
…	…
	(4)


(Full name of the head (authorized person) of the authorized body)
	М.П.	(5)
(signature)
	Sheet ___	(6)
	N _____	(7)

Rules for filling out the registration certificate

for a medical device

The registration certificate for a medical device (hereinafter referred to as the registration certificate) is completed by the authorized body of the reference state in Russian using electronic printing devices, and, if the legislation of the reference state contains the relevant requirement, in the official language of that state.

The registration certificate is completed in Russian and in the official language of the reference state on different sides of the registration certificate.

The registration certificate is classified as a document of strict accountability and is printed on a form that is produced using printing methods and has security levels in accordance with the legislation of the reference state.

If necessary, the manufacturer’s name, its location (the address of the legal entity, the place of residence of an individual registered as an individual entrepreneur), and product information (model, brand, article number, etc.) may be indicated using letters from the Latin alphabet.

The names of the manufacturer, the manufacturer’s authorized representative, and the production sites are indicated in the registration certificate in the following sequence:

a) for residents of the member states of the Eurasian Economic Union (hereinafter referred to, respectively, as member states, the Union):

business and legal form;

full name (for legal entities, it is indicated in quotation marks);

abbreviated name (in parentheses) (if available);

name of the state;

b) for non‑residents of member states:

full name;

business and legal form;

abbreviated name (in parentheses) (if available);

name of the state (in Russian and / or in the official language of the reference state).

Banking details are separated by commas.

The address is indicated in the registration certificate in the following sequence:

the name of the street (including the element of the urban road network), the house number, the room number (if applicable);

the name of the settlement (with indication of its type);

name of the district;

the name of the region (area, territory) (with indication of the type);

postal code;

post office box number (if available);

name of the state.

For non‑residents of member states, the address is indicated using letters of the Latin alphabet.

Banking details are separated by commas.

The information about the manufacturer and the manufacturer’s authorized representative, as specified in the registration certificate, the operating document, or the instructions for use of the medical device, the service manual, as well as in the text of the medical device’s labeling, must be identical and correspond to the information specified in the document or in the data confirming the registration of the manufacturer and the authorized representative as a legal entity or an individual entrepreneur.

All fields of the registration certificate must be filled in (the original registration certificate does not have field numbers).

The registration certificate indicates:
a) in field 1 — the Union’s emblem;
b) in field 2 — an inscription written in one line:

“EURASIAN ECONOMIC UNION”

c) in field 3 — the full name of the authorized body of the reference state;
d) in field 4 — an inscription written in one line:

“REGISTRATION CERTIFICATE OF A MEDICAL DEVICE”

e) in field 5 — the registration certificate number and the date of its issuance.

The registration certificate number is formed in the following order::

МИ	–	Х	Y	–	Z	,
1		2	3		4	,

where:

element 1-medical device;

Element 2 — a 2‑character alphabetic code of the reference state in accordance with the international standard ISO 3166‑1.

Element 3 — a 2‑character alphabetic code for the recognition states in accordance with the international standard ISO 3166‑1 (the codes for the recognition states that have confirmed the agreement of the expert opinion are indicated).

Element 4 — a 6‑digit serial number of the registration certificate assigned by the authorized body of the reference state (assigned automatically from the unified register of medical devices registered within the Union, the procedure for creating and maintaining which is approved by Decision No. 12 of February 2016 of the Council of the Eurasian Economic Commission, and remains unchanged when the medical device is used within the Union).

e) in field 6 — the number and date of the order issued by the authorized body of the reference state regarding the registration of the medical device;

g) in field 7 — the full name and location (address of the legal entity) — for a legal entity, or the surname, first name, patronymic (if any), and place of residence — for an individual registered as an individual entrepreneur.

h) in field 8 — the names and actual addresses of the production sites that carry out the entire production process of the medical device or its specific stages. If there are two or more production sites, it is permissible to indicate information about them in the appendix to the registration certificate.

i) in field 9 — the full name of the manufacturer’s authorized representative in the territories of the member states, its location (the address of the legal entity) — for a legal entity, or the surname, first name, patronymic (if any), place of residence — for an individual registered as an individual entrepreneur. If there is no authorized representative of the manufacturer in the territory of a member state (if the manufacturer is a resident of the member states), a dash is entered in this field.

k) in field 10 — the full name of the medical device, including the trademark and other means of individualization (if any), which must correspond to the name specified in the expert report.

l) in field 11 — the class of potential risk associated with the use of the medical device, confirmed during the examination of the medical device;

m) in field 12 — the names of the reference state and the state(s) of recognition (indicated separated by commas);

n) in field 13 — the number of sheets in the appendix to the registration certificate (filled in if an appendix is present);

o) in field 14-indicate the words “Validity period of the medical device registration certificate: unlimited”;

p) In field 15 — the date of registration of the medical device, which is indicated in a word‑and‑number format: the day — in two Arabic numerals (in quotation marks), the month — in words, the year — in four Arabic numerals (with the abbreviated year indicator “г.”).

p) In field 16, the date of the last amendment to the registration certificate is indicated in a word‑and‑number format: the day is indicated using two Arabic numerals (in quotation marks), the month is indicated in words, and the year is indicated using four Arabic numerals (with the abbreviated year designation “г.”). This field is filled in when amendments are made to the registration file, resulting in the issuance of a new registration certificate with the same number and the indication of the number of the relevant order approving the amendments.

c) in field 17 — the position, signature, surname, first name, and patronymic (if available) of the head (authorized person) of the authorized body that issued the registration certificate, certified with the seal of that authorized body (if available). The use of a facsimile instead of a signature is not permitted;

t) in field 18 — the typographic number, series, and serial number of the registration certificate form, which is assigned during its manufacture.

If there is information about the models (brands) of the medical device, their composition and accessories, or about two or more production sites, an appendix to the registration certificate must be completed; this appendix is an integral part of the registration certificate. Each sheet of the appendix must be numbered. The appendix to the registration certificate shall contain the following:

a) in field 1 — an inscription written in 2 lines:

“APPENDIX TO THE REGISTRATION CERTIFICATE

OF A MEDICAL DEVICE”;

b) in field 2 — the registration certificate number;

c) in field 3 — models (brands) of the medical device, their composition and accessories (if available);

d) in field 4 — the names and actual addresses of the production sites that carry out the entire production process of the medical device or its specific stages (if it is necessary to provide information about two or more production sites);

e) in field 5 — the position, signature, surname, first name, patronymic (if available) of the head (authorized person) of the authorized body that issued the registration certificate, certified with the seal of the authorized body (if available). The use of a facsimile in place of a signature is not permitted.

e) in field 6, the number of the appendix sheet is indicated;

g) in field 7 — the typographic number assigned during the production of the appendix form.

When filling out the registration certificate and (or) its annex, the indication of information not provided for in these Rules, as well as the use of abbreviations of words (except for generally accepted ones) and correction of the text are not allowed.

In the event of loss or damage to the registration certificate, the authorized body of the reference state issues a duplicate of this registration certificate. At the same time, the following notes are made in the upper right corner of the registration certificate: “Duplicate issued on “__” ______ 20__” and “The original registration certificate for the medical device is declared invalid.”

Appendix No. 2

to the Rules for Registration and Examination

of the Safety, Quality, and Effectiveness

of Medical Devices

FORM OF THE APPLICATION FOR THE EXAMINATION OF A MEDICAL DEVICE

(в ред. Решения Совета Евразийской экономической комиссии от 24.12.2021 N 144)

	To the authorized body (expert organization) of the member state of the Eurasian Economic Union.

	(name of the reference State)

	(Name of the State(s) of recognition)

APPLICATION FOR EXAMINATION OF A MEDICAL DEVICE

(full and abbreviated (if any), including the corporate name of the person on whose behalf the registration is made (manufacturer (authorized representative of the manufacturer), the organizational and legal form of the legal entity)

hereby requests an examination of a medical device:

Name of the medical device

Purpose of the medical device

Is it a medical device for in vitro diagnostics?

Yes

The scope of application of the medical device (in accordance with the classifier of areas of medical application of medical devices, approved by Decision No. 62 of the Board of the Eurasian Economic Commission dated April 16, 2019).

The potential risk class of the medical device’s use.

Should a production inspection be carried out (indicated if the registered medical device is a medical device of potential risk class 1 or a non‑sterile medical device of potential risk class 2a, and a primary production inspection has not been carried out previously)?

Yes

Code of the type of medical device (according to the nomenclature of medical devices of the Eurasian Economic Union, the rules for maintaining which are approved by Decision No. 177 of the Board of the Eurasian Economic Commission dated December 29, 2015)

Does the medical device contain a medicinal product?

Yes

Model (brand) of the medical device, its composition and accessories.

Name

Manufacturer

Country

Model (brand) of the medical device (if available)

Composition (if available)

Accessories (if available)

10.

Shelf life (warranty period) of operation

11.

Storage conditions

12.

Registration in the country of manufacture and in other countries.

Country name

N of the medical device registration certificate (if available)

Date of issue

Validity period

…

13.

Production

completely in this production

partially in this production

completely on another production site

14.

Manufacturer Information

The legal form, full name and short name (if available), country, (full name of the individual entrepreneur)

registration number and date

location (address of the legal entity, address of residence of the individual entrepreneur)

actual addressс

phone and fax numbers, email address (if available)

Full name and position of the manager, full name and position of the contact person

15.

Information about the production site (production sites)

The legal form, full name and short name (if available), country, (full name of the individual entrepreneur)

registration number and date

actual addressс

phone and fax numbers, email address (if available)

Full name and position of the manager, full name and position of the contact person

…

16.

Information about the manufacturer’s authorized representative (if available)

The legal form, full name and short name (if available), country, (full name of the individual entrepreneur)

registration number and date

location (address of the legal entity, address of residence of the individual entrepreneur)

actual addressс

phone and fax numbers, email address (if available)

Full name and position of the manager, full name and position of the contact person

17.

Information about the document confirming payment for the examination procedures of the medical device.

18.

The method for receiving notifications (decisions) from the authorized body (expert organization) of the reference state:

personally under the signature

by registered mail with a delivery notification;

in electronic form via telecommunications channels (if you choose this method, you must specify the email address(s) to which the notifications should be sent).

in the form of an electronic document signed with an electronic signature

I guarantee the accuracy and identity of the information contained in the registration dossier and the application

Date of application

, full name and position of the head of the manufacturer (authorized representative of the manufacturer)

Signature, seal of the manufacturer (authorized representative of the manufacturer)

Appendix No. 3

to the Rules for Registration and Examination

of the Safety, Quality and Effectiveness

of Medical Devices

APPLICATION FORM

FOR REGISTRATION OF A MEDICAL DEVICE

	To the authorized body of the member state of the Eurasian Economic Union

	(name of the reference state)

	(the name of the state (states) of recognition)

APPLICATION

for the registration of a medical device

full and abbreviated (if any), including the company name, names of the person on whose behalf registration is performed (manufacturer (authorized representative of the manufacturer), legal form of the legal entity

hereby requests registration of a medical devic

Name of the medical device

Purpose of the medical device

Is the medical device intended for in vitro diagnostic use?

Yes

Class of potential risk associated with the use of the medical device

Yes

Does the medical device contain a medicinal product?

Yes

Model (brand) of the medical device, its composition and accessories.

Name

Manufacturer

Country

Model (brand) of the medical device (if available)

Composition (if available)

Accessories (if available)

10.

Manufacturer Information

The legal form, full name and short name (if available), country, (full name of the individual entrepreneur)

registration number and date

location (address of the legal entity, address of residence of the individual entrepreneur)

actual addressс

phone and fax numbers, email address (if available)

Full name and position of the manager, full name and position of the contact person

11.

Information about the production site (production sites)

The legal form, full name and short name (if available), country, (full name of the individual entrepreneur)

registration number and date

location (address of the legal entity, address of residence of the individual entrepreneur)

actual addressс

phone and fax numbers, email address (if available)

…

12.

Information about the authorized representative of the manufacturer (if available)

The legal form, full name and short name (if available), country, (full name of the individual entrepreneur)

registration number and date

location (address of the legal entity, address of residence of the individual entrepreneur)

actual addressс

phone and fax numbers, email address (if available)

Full name and position of the manager, full name and position of the contact person

13.

Information about the document confirming payment for the registration procedures of a medical device. Method of obtaining notifications (decisions) from the authorized body (expert organization) of the reference state:

14.

in person, against signature;

by registered mail with a delivery notification;

in electronic form via telecommunications channels (if you choose this method, you must indicate the email address(es) to which the notifications should be sent);

in the form of an electronic document signed with an electronic signature.

15.

The method for obtaining a registration certificate for a medical device and its appendix:

The method for obtaining a registration certificate for a medical device and its appendix

in paper form, in person;

in paper form, sent by registered mail with a delivery notification.

I guarantee the accuracy and identity of the information contained in the registration dossier and the application

Date of application

full name and position of the head of the manufacturer (authorized representative of the manufacturer)

Signature, seal of the manufacturer (authorized representative of the manufacturer)

Appendix No. 4

to the Rules for Registration and Examination

of the Safety, Quality and Effectiveness

of Medical Devices

LIST OF DOCUMENTS REQUIRED FOR REGISTRATION OF A MEDICAL DEVICE

(ed. Decisions of the Council of the Eurasian Economic Commission dated 08.07.2025 No. 50)

N п/п	Name of the document	A medical device of the class of potential risk of use				Medical device for in vitro diagnostics	Note
N п/п	Name of the document	1	2а	2б	3	Medical device for in vitro diagnostics	Note
1.	Statement	+	+	+	+	+	In accordance with the forms provided for in Appendices No. 2 and 3 to the Rules for the Registration and Examination of the Safety, Quality and Effectiveness of Medical Devices, approved by Decision No. 46 of the Council of the Eurasian Economic Commission dated February 12, 2016.
2.	Power of attorney from the manufacturer authorizing the representation of interests during registration (if necessary). Manufacturer’s agreement with the manufacturer’s authorized representative, or a copy thereof (if the manufacturer has an authorized representative). If the manufacturer’s authorized representative is not a resident of the reference state, a copy of the document confirming the registration of the manufacturer’s authorized representative as a legal entity or an individual entrepreneur must be attached.	+	+	+	+	+	Certified in accordance with international certification standards or certification standards established by the legislation of the reference state.
3.	Statement	+	+	+	+	+	The copy is certified in accordance with international certification standards or the certification standards established by the legislation of the reference state.
4.	A copy of the permit document granting the right to manufacture in the country of origin, with an attachment (if available)	+	+	+	+	+	It is certified in accordance with international certification standards or the certification standards established by the legislation of the reference state.
5.	A copy of the document or information confirming the manufacturer’s registration as a legal entity or an individual entrepreneur.	+	+	+	+	+	The copy of the document is certified in accordance with international certification standards or the certification standards established by the legislation of the reference state; the information is certified by the manufacturer.
6.	A copy of the certificate of compliance of the quality management system with the requirements of ISO 13488 standard or the relevant regional or national (state) standard of the member state of the Eurasian Economic Union (hereinafter referred to, respectively, as the member state, the Union), issued in the name of the manufacturer of medical devices (production site) (if available).	+	+	+	+	+	It is certified in accordance with international certification standards or the certification standards established by the legislation of the reference state.
7.	Declaration of conformity of the medical device with the mandatory requirements of states that are not members of the Union (for example, directives or regulations of the European Union), or an equivalent document (if available), or a copy of such documents.	+	+	+	+	+	the copy is certified by the manufacturer (authorized representative of the manufacturer)
8.	Copy of the registration certificate of the medical device (free sale certificate, export certificate (except for medical devices first manufactured on the territory of a member state)) issued in the country of manufacture (if available).	+	+	+	+	+	It is certified in accordance with international certification standards or the certification standards established by the legislation of the reference state.
9.	Information on registration in other countries, with reference to the current sources of such information, and an electronic file containing such information, or a copy of the document certifying the registration of the medical device in other countries (if available)	+	+	+	+	+	certified by the manufacturer (authorized representative of the manufacturer)
10.	Data on labeling and packaging (full‑color (with color coding indicated) mock‑ups of packages and labels), labeling text in Russian and the state languages of the member states (if necessary). Labeling text in the state languages of the recognition states may be submitted after a positive expert opinion has been issued.	+	+	+	+	+	certified by the manufacturer (authorized representative of the manufacturer)
11.	Information about development and production: production process diagrams, main production stages, packaging, testing, and the procedure for releasing the final product.	+	+	+	+	+	certified by the manufacturer (authorized representative of the manufacturer)
12.	Information about the manufacturer: name, type of activity, legal address, form of ownership, management structure, list of departments and subsidiaries involved in the production of the medical device being registered, including their status and authority.	+	+	+	+	+	certified by the manufacturer (authorized representative of the manufacturer)
13.	Marketing information (history if the device has been on the market for more than 2 years) (if available).	–	–	+	+	+ (except for the class 1 and 2а)	certified by the manufacturer (authorized representative of the manufacturer)
14.	Reports of adverse events (incidents) and recalls (information is not provided for newly developed and designed medical devices):	+	+	+	+	+ (except for the class 1)	certified by the manufacturer (authorized representative of the manufacturer)
(in ed. Decisions of the Council of the Eurasian Economic Commission dated от 08.07.2025 N 50)
	A list of adverse events (incidents) related to the use of the product, along with the time period during which these events (incidents) occurred.
(in ed. Decisions of the Council of the Eurasian Economic Commission dated от 08.07.2025 N 50)
	If there are too many adverse events (incidents), it is necessary to provide brief overviews of each type of event and indicate the total number of events of each type that have been reported.
	a list of reviews from the medical device market and/or explanatory notices and a description of the approach to addressing these problems and their solutions by manufacturers in each of these cases
	description of the analysis and/or corrective actions taken in response to these cases
15.	List of standards used by the manufacturer in the design and production of the medical device (indicating the names and designations of the standards)	+	+	+	+	+	certified by the manufacturer (authorized representative of the manufacturer)
16.	Information on the compliance of the medical device with the General Requirements for the Safety and Effectiveness of Medical Devices, the requirements for their labeling and operational documentation, approved by Decision No. 27 of the Council of the Eurasian Economic Commission dated February 12, 2016 (hereinafter referred to as the General Requirements), with the attachment of documents referenced in the specified information	+	+	+	+	+	certified by the manufacturer (authorized representative of the manufacturer)
17.	Document establishing the requirements for the technical characteristics of the medical device	+	+	+	+	+	certified by the manufacturer (authorized representative of the manufacturer)
18.	Protocols of technical tests conducted to prove the compliance of a medical device with General Requirements, test programs, or copies of these documents and (or) documents containing evidence from the first party	+	+	+	+	+ (with the exception of reagents, reagent kits, control materials, calibrators, washing solutions, and culture media)	certified by the manufacturer (authorized representative of the manufacturer) copies of protocols are certified by the testing laboratory (center) or in accordance with the standards of certification established by the legislation of the reference state; copies of programs are certified by the testing laboratory (center) or the manufacturer (authorized representative of the manufacturer); documents containing evidence of the first party are certified by the manufacturer.
19.	Report on the assessment of the biological effect of the medical device (if necessary)	+	+	+	+	–	certified by the manufacturer (authorized representative of the manufacturer)
20.	Protocols of studies (tests) to assess the biological effect of the medical device, conducted to prove compliance of the medical device with the General Requirements (if necessary), research (test) programs, or copies of the specified documents	+	+	+	+	–	Copies of the protocols and programs are certified by the testing laboratory (center) or in accordance with the certification standards established by the legislation of the reference state.
21.	Report on clinical evidence of the efficacy and safety of the medical device, or a copy thereof	+	+	+	+	+	certified by the manufacturer (authorized representative of the manufacturer)
(in ed. Decisions of the Council of the Eurasian Economic Commission dated 08.07.2025 N 50)
22.	A report on a clinical trial (study) of a medical device or a report on a clinical and laboratory test (study) of a medical device for in vitro diagnostics (or a copy thereof) (as applicable)	+	+	+	+	+	A copy of the report is certified by a medical organization (clinical center) or in accordance with the certification requirements established by the legislation of the reference state.
(in ed. Decisions of the Council of the Eurasian Economic Commission dated 08.07.2025 N 50)
23.	Risk analysis and management report, or a copy thereof.	+	+	+	+	+	a copy of the report is certified by the manufacturer (authorized representative of the manufacturer)
24.	Data on medicinal products included in the medical device (composition of the medicinal product, quantity, data on the compatibility of the medicinal product with the medical device, registration of the medicinal product in the country of manufacture)	+	+	+	+	–	a copy of the report is certified by the manufacturer (authorized representative of the manufacturer)
25.	Data on biological safety (as applicable)	+	+	+	+	+	a copy of the report is certified by the manufacturer (authorized representative of the manufacturer)
(in the ed. Decisions of the Council of the Eurasian Economic Commission dated 08.07.2025 N 50)
26.	Data on the sterilization procedure, including information on process validation, test results for the presence of microorganisms (degree of biological load), pyrogenicity, sterility (if necessary), with a description of the test methods, and data on packaging validation (for sterile products).	+	+	+	+	+	certified by the manufacturer (authorized representative of the manufacturer)
27.	Information about special software (if available): the manufacturer’s information on software validation.	+	+	+	+	+	certified by the manufacturer (authorized representative of the manufacturer)
28.	Stability study report or a copy thereof (if the report is submitted in a foreign language, with the results and conclusions of the studies translated into Russian) — for products with a shelf life.	+	+	+	+	+	The copy of the report is certified by the manufacturer (or the manufacturer’s authorized representative); the original is signed by the manufacturer.
29.	An operational document or an instruction for the use of a medical device in Russian and the state languages of the member states (if necessary). An operational document or an instruction for the use of a medical device in the state languages of the recognition states may be submitted after a positive expert opinion has been issued. A service manual — in the event that the data is not available in the operational documentation (if available). This document in the state languages of the recognition states may be submitted after a positive expert opinion has been issued. A report on the results of the inspection of the production of a medical device, or a copy thereof (if available).	+	+	+	+	+	certified by the manufacturer (authorized representative of the manufacturer)
30.	Data on the sterilization procedure, including information on process validation, test results for the presence of microorganisms (degree of biological load), pyrogenicity, sterility (if necessary), with a description of the test methods, and data on packaging validation (for sterile products).	+	+	+	+	+	certified by the manufacturer (authorized representative of the manufacturer)
31.	Information about special software (if available): the manufacturer’s information on software validation.	+	+	+	+	+	a copy of the report is certified by the inspection organization or the manufacturer (authorized representative of the manufacturer)
32.	Plan for collecting and analyzing data on the safety and effectiveness of medical devices at the post‑market stage.	+	+	+	+	+	certified by the manufacturer (authorized representative of the manufacturer)
33.	Documents confirming the results of testing medical devices for the purpose of approving the type of measuring instruments (for medical devices included in the list of types of medical devices subject to classification as measuring instruments during their registration, as approved by Decision No. 42 of the Council of the Eurasian Economic Commission dated 12 February 2016), or copies thereof.	+	+	+	+	+	Copies of the documents are certified by an organization authorized (notified) in accordance with the legislation of the member state to conduct tests of measuring instruments, or in accordance with the certification standards established by the legislation of the reference state.
34.	Photographic images of the general appearance of the medical device and its accessories (if available) (size not less than 180 mm × 240 mm).	+	+	+	+	+	they are certified by the manufacturer (an authorized representative of the manufacturer)
35.	Documents confirming the quality of the medicinal product, biological material and other substances that are part of the medical device and come into contact with the human body in accordance with the intended use of the medical device, and are intended for use only in accordance with the intended use of the medical device as defined by the manufacturer, and issued in accordance with the legislation of the country of origin of the medicinal product, biological material and other substance, or their copies (where applicable).	+	+	+	+	–	copies of the documents are certified by the manufacturer (authorized representative of the manufacturer)
36.	Other documents provided by the applicant.	+	+	+	+	+	copies of the documents are certified by the manufacturer (authorized representative of the manufacturer)
37.	Inventory (in the case of submitting the registration file in paper form)	+	+	+	+	+	certified by the manufacturer (authorized representative of the manufacturer)

Appendix No. 5

to the Rules for Registration and Examination

of the Safety, Quality, and Effectiveness

of Medical Devices

EXPERT REPORT

ON THE ASSESSMENT OF THE SAFETY, QUALITY, AND EFFECTIVENESS

OF A MEDICAL DEVICE

(ed. Decisions of the Council of the Eurasian Economic Commission dated 08.07.2025 No. 50)

(the name of the authorized body (expert organization) of the reference state)

	APPROVE

	(Full name of the head of the authorized body (expert organization), signature, seal)
	“__” ____________ 20__ .

EXPERT REPORT

on the assessment of the safety, quality, and effectiveness

of a medical device

N _____ от “___” ___________ 20__ .

General information about the medical device:

a) the number and date of registration of applications for the examination of a medical device and for the registration of a medical device;

b) name of the medical device;

c) manufacturer of the medical device, country;

d) production site(s), country;

e) authorized representative of the manufacturer (if available);

f) scope and purpose;

g) the type of medical device in accordance with the nomenclature of medical devices of the Eurasian Economic Union, the rules for maintaining which are approved by Decision No. 177 of the Board of the Eurasian Economic Commission dated December 29, 2015;

h) the class of potential risk associated with the use of the medical device;

and) the composition of the medical device (model (brand) of the medical device (if available)) and its accessories (if available);

k) the main technical characteristics of the medical device (the model (brand, type) of the medical device (if available)).

Results of the safety, quality, and effectiveness assessment of the medical device (in terms of applicability):

a) assessment of the correctness of classifying the product as a medical device;

b) assessment of compliance with the class of potential risk of use of the medical device specified by the applicant, in accordance with the Rules for Classifying Medical Devices Depending on the Potential Risk of Use, approved by Decision No. 173 of the Board of the Eurasian Economic Commission dated December 22, 2015;

c) assessment of the correctness of classifying a medical device (models (brands) of a medical device) as a specific type of medical device in accordance with the nomenclature of medical devices of the Eurasian Economic Union, the rules for maintaining which are approved by Decision No. 177 of the Board of the Eurasian Economic Commission dated December 29, 2015;

d) assessment of compliance of models (brands) of medical devices (if any) included in one registration certificate with the criteria established by item 19 of 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 No. 46 of February 12, 2016;

e) analysis and assessment of evidence documents (materials) confirming that the medical device complies with the General Requirements for the Safety and Effectiveness of Medical Devices, the requirements for their labeling and the operational documentation for them, as approved by Decision No. 27 of the Council of the Eurasian Economic Commission dated February 12, 2016 (hereinafter referred to as the General Requirements):

Assessment of the compliance of technical test protocols issued by authorized organizations with the Rules for Conducting Technical Tests of Medical Devices, approved by Decision No. 28 of the Council of the Eurasian Economic Commission dated February 12, 2016.

Assessment of the compliance of research (test) protocols for assessing the biological effects of medical devices, issued by authorized organizations, with the Rules for conducting research (tests) to assess the biological effects of medical devices, approved by Decision No. 38 of the Council of the Eurasian Economic Commission dated May 16, 2016.

Assessment of compliance of reports on clinical (clinical‑laboratory) trials (studies) of medical devices with the Rules for Conducting Clinical and Clinical‑Laboratory Trials (Studies) of Medical Devices, approved by Decision No. 29 of the Council of the Eurasian Economic Commission dated February 12, 2016.

Analysis of the standards used by the manufacturer in the design and production of a medical device.

New edition. Decision No. 50 dated 08.07.2025 of the EEC Council

Analysis of data on the biological safety of a medical device based on an analysis of all materials of animal or human origin included in the medical device, as well as information about the selection of sources (donors), material selection, processing, storage, testing, validation of testing procedures, and the handling of tissues, cells, substances of animal or human origin, and cultures of microorganisms and viruses.

Analysis of the report on the stability of the medical device and the justification of the declared shelf life.

Confirmation, based on the submitted evidence (documents), of the validity of the manufacturer’s assessment regarding the compliance of the medical device with the General Requirements.

Assessment of compliance of the operational document or instructions for use, or the service manual, with the General Requirements.

Assessment of compliance of the medical device’s labeling with the General Requirements.

analysis of the requirements for the technical characteristics of a medical device;

evaluation of documents confirming the results of testing of medical devices for the purpose of approving the type of measuring instruments (in relation to medical devices included in the list of types of medical devices to be classified as measuring instruments during their registration, approved by Decision of the Council of the Eurasian Economic Commission No. 42 of February 12, 2016);

e) analysis of reports on the results of inspections of medical device production (carried out to confirm that the declared medical device corresponds to the group (subgroup) of medical devices, taking into account the class of potential risk of use in accordance with Appendix No. 2 to the Requirements for the Implementation, Maintenance and Assessment of the Quality Management System for Medical Devices Depending on the Potential Risk of Their Use, approved by Decision No. 106 of the Council of the Eurasian Economic Commission dated November 10, 2017, as well as to confirm the accuracy of the information about the production sites specified in the applications for registration and examination, which are covered by the report on the results of the inspection of medical device production);

g) analysis of data on the certification of the quality management system (if available), including the requirements to which the manufacturer’s quality management system is certified, and information about the certificates (number, date of issue, validity period, name, and information about the accreditation of the certification body);

h) confirmation of the validity of the indication of the production sites for the registered medical device;

i) analysis of data on the development and production of a medical device (diagrams of production processes, main stages of production, packaging, testing, and the procedure for releasing the final product);

k) analysis of the marketing information provided by the manufacturer;

New edition. Decision No. 50 dated 08.07.2025 of the EEC Council

l) analysis of the information provided by the manufacturer regarding the presence or absence of reports of adverse events (incidents) related to the use of the medical device, recalls of the medical device from the market, safety notifications regarding the medical device, the manufacturer’s approaches to addressing such issues when they arise, a description of the corrective actions taken, as well as an analysis of the relationship between the sales level, the number of adverse events (incidents), and recalls of the medical device from circulation.

m) analysis of the data collection plan for the safety and effectiveness of a medical device at the post‑market stage.

General conclusion on the confirmation (or non‑confirmation) of the safety, quality and effectiveness of the medical device, and a recommendation on the possibility (or impossibility) of registering the medical device.

I have been informed of the responsibility for the accuracy of the information presented in the expert report on the assessment of the safety, quality, and effectiveness of the medical device.


(Full name of the expert, position, academic degree (title) (if any))		(signature)

Appendix No. 6

to the Rules for Registration and Examination

of the Safety, Quality, and Effectiveness

of Medical Devices

CONCLUSION

ON THE CONFIRMATION OF AGREEMENT (DISAGREEMENT) OF THE EXPERT

CONSENSUS ON THE RESULTS OF THE SAFETY, QUALITY

AND EFFECTIVENESS EXAMINATION OF A MEDICAL DEVICE OF A MEMBER STATE

OF THE EURASIAN ECONOMIC UNION, WHICH CARRIES OUT

THE REGISTRATION OF THE MEDICAL DEVICE

((name of the authorized body (expert organization) of the state of recognition))

	APPROVE

	(Full name of the head of the authorized body (expert organization), signature, seal)
	“__” ____________ 20__ .

CONCLUSION

on the confirmation of the approval (or non‑approval) of the expert

opinion of the member state of the Eurasian Economic

Union that carries out the registration of a medical device,

based on the results of the examination of the safety, quality

and effectiveness of the medical device

N ______ от “___” ___________ 20__ .

The name of the authorized body (expert organization) of the member state of the Eurasian Economic Union that carries out the registration of the medical device (hereinafter referred to as the reference state).

The date when the expert opinion was posted in the information system of the authorized body (expert organization) of the reference state.

The number of the expert opinion.

The name of the medical device (including the model (brand) of the medical device, its composition, and accessories).

Manufacturer of the medical device (full and abbreviated names, legal form of the legal entity, location (address of the legal entity, place of residence of the individual registered as an individual entrepreneur)).

Production sites (full and abbreviated names, legal form of the legal entity, actual address).

Authorized representative of the manufacturer (full and abbreviated names, legal form of the legal entity, location (address of the legal entity, place of residence of an individual registered as an individual entrepreneur)) (if available).

The applicant.

Analysis of the expert opinion submitted by the authorized body (expert organization) of the reference state, based on the results of the examination of the safety, quality and effectiveness of the medical device, as well as the compliance of the documents in the registration dossier with the established requirements.

Confirmation of the correctness of the translation of the operational document or instructions for the use of a medical device, the service manual, and the text on the labeling of the medical device into the state language in accordance with the requirements of the legislation of the member state of the Eurasian Economic Union (if applicable).

The results of the examination (the conclusions regarding individual aspects of the expert report are indicated).

Conclusion (the overall conclusion is stated; if the expert opinion is not consistent, the reasons for this are to be provided).

Information about the experts (full name, academic degree (title) (if available), place of employment, and position).

I have been warned about the responsibility for the accuracy of the information contained in the conclusion confirming the approval (or non‑approval) of the expert opinion of the reference state based on the results of the examination of the safety, quality, and effectiveness of the medical device..


(Full name of the expert))		(signature)

Appendix No. 7

to the Rules for Registration and Examination

of the Safety, Quality and Effectiveness

of Medical Devices

FORM OF THE STATEMENT

ON AMENDMENTS TO THE REGISTRATION FILE

OF A MEDICAL DEVICE

	To the authorized body of the member state of the Eurasian Economic Union

	(name of the reference state)

	(the name of the state (the names of the states) of recognition)

STATEMENT

on making changes to the registration dossier

of a medical device

(full and abbreviated (if available), including the corporate name, of the entity on whose behalf the amendments are being made (manufacturer (authorized representative of the manufacturer), legal form of the legal entity)

hereby requests to make changes to the registration dossier of the medical device

1. Name of the medical device
2. Manufacturer of the medical device (full and abbreviated names, legal form of the legal entity, location (address of the legal entity, place of residence of the individual registered as an individual entrepreneur)
3. Production facilities (full name, address)
4. Authorized representative of the manufacturer (if available) (full and abbreviated names, legal form of the legal entity, location (address of the legal entity, place of residence of the individual registered as an individual entrepreneur)
5. Class of potential risk associated with the use of the medical device
6. Code of the type of medical device (in accordance with the nomenclature of medical devices of the Eurasian Economic Union, the rules for maintaining which are approved by Decision No. 177 of the Board of the Eurasian Economic Commission dated December 29, 2015)
7. Number of the registration certificate for the medical device of the Eurasian Economic Union
8. Information about the documents confirming payment for the procedure to amend the registration file in the reference state and the procedure for согласование of the expert opinion in the recognition states, as well as for the issuance of a registration certificate for the medical device in the reference state (if necessary).
9. The method of receiving notifications (decisions) from the authorized body (expert organization) of the reference state.		in person, against signature
		by registered mail with a delivery notification
		in electronic form (if you choose this method, you must specify the email address(s) to which the notifications should be sent)
		in the form of an electronic document signed with an electronic signature
10. The method of obtaining the registration certificate of a medical device and (or) its annex (if the changes made will result in a change in the registration certificate of a medical device and (or) its annex), as well as a previously issued registration certificate of a medical device and (or) its annex with a note on their invalidity		on paper, in person
		on paper, sent by registered mail with a delivery notification

due to the following changes:

Changes made to the registration dossier of a medical device
N п/п	Editorial before changes made.	Changes being made.
1.	…	…

Making changes to the registration dossier does not entail changes to the properties and characteristics that affect the safety, quality, and effectiveness of the medical device.

I guarantee the accuracy of the information provided.

I guarantee the preservation of the declared safety and effectiveness characteristics of the medical device throughout its service life, provided that the conditions for use, transportation, and storage of the medical device are observed in accordance with the manufacturer’s requirements.


(date of submission of the application)

(full name and position of the manufacturer’s head (authorized representative of the manufacturer))		(signature, manufacturer’s (manufacturer’s authorized representative’s) seal)

Appendix No. 8

to the Rules for Registration and Examination

of the Safety, Quality, and Effectiveness

of Medical Devices

EXPERT OPINION

ON THE POSSIBILITY (IMPOSSIBILITY) OF MAKING CHANGES

TO THE REGISTRATION FILE OF A MEDICAL DEVICE

((he name of the authorized body (expert organization) of the reference state))

	APPROVE

	((Full name of the head of the authorized body (expert organization), signature, seal),
	“__” ____________ 20__

EXPERT CONSULTATION

on the possibility (or impossibility) of making changes

to the registration dossier of a medical device

N _____ от “___” _____________ 20__ .

Name of the medical device.
Manufacturer of the medical device (full and abbreviated names, legal form of the legal entity, location (address of the legal entity, place of residence of an individual registered as an individual entrepreneur)).
Authorized representative of the manufacturer (full and abbreviated names, legal form of the legal entity, location (address of the legal entity, place of residence of the individual registered as an individual entrepreneur)) (if available).
Production facilities (full and abbreviated names, legal form of the legal entity, actual address).
Scope of application and purpose.
Type of medical device in accordance with the nomenclature of medical devices.

products of the Eurasian Economic Union, the rules for which are approved by Decision No. 177 of the Board of the Eurasian Economic Commission dated December 29, 2015.

The class of potential risk associated with the use of the medical device.
The registration certificate number of the medical device.
The date of issuance of the registration certificate of the medical device.
Changes made:

The data entered into the registration file during registration.	Changes being made.	Applicant’s justification for making the changes.

Analysis and assessment of data justifying the introduction of changes.
Conclusion on the possibility (or impossibility) of introducing changes to the registration dossier of the medical device (in the event of a negative conclusion — with a justification of the reasons).


(Full name of the expert, position, academic degree (title) (if any))		(signature)

Appendix N 9

to the Rules for Registration and Examination

of the Safety, Quality, and Effectiveness

of Medical Devices

FORM OF THE STATEMENT

ON AMENDING THE REGISTRATION FILE OF A MEDICAL

DEVICE IN A NOTIFICATORY PROCEDURE

To the authorized body of the member state

of the Eurasian Economic Union

(name of the reference State)

STATEMENT

on making amendments to the registration dossier of a medical device

in a notification procedure

(full and abbreviated (if available), including the corporate name, of the person on whose behalf the amendments are being made (manufacturer (authorized representative of the manufacturer), organizational and legal form of the legal entity)

hereby requests that amendments be made to the registration dossier of the medical device in a notification procedure

1. Name of the medical device
2. Manufacturer of the medical device (full and abbreviated names, legal form of the legal entity, location (address of the legal entity, place of residence of the individual registered as an individual entrepreneur)
3. Production facilities (full name, address)
4. Authorized representative of the manufacturer (if available) (full and abbreviated names, legal form of the legal entity, location (address of the legal entity, place of residence of the individual registered as an individual entrepreneur)
5. Class of potential risk associated with the use of the medical device
6. Code of the type of medical device (in accordance with the nomenclature of medical devices of the Eurasian Economic Union, the rules for maintaining which are approved by Decision No. 177 of the Board of the Eurasian Economic Commission dated December 29, 2015)
7. Number of the registration certificate for the medical device of the Eurasian Economic Union
8. Information about documents confirming payment for the procedure to amend the registration dossier in a notification procedure in the reference state, as well as the issuance of a registration certificate for the medical device in the reference state (if necessary).
9. The method of receiving notifications (decisions) from the authorized body (expert organization) of the reference state.		in person, against signature
		by registered mail with a delivery notification
		in electronic form (if you choose this method, you must specify the email address(s) to which the notifications should be sent)
		in the form of an electronic document signed with an electronic signature
10. The method of obtaining the registration certificate of a medical device and (or) its annex (if the changes made will result in a change in the registration certificate of a medical device and (or) its annex), as well as a previously issued registration certificate of a medical device and (or) its annex with a note on their invalidity		on paper, in person
		on paper, sent by registered mail with a delivery notification
Information to be provided when making changes by the manufacturer of medical devices of potential risk class 1 and non‑sterile medical devices of potential risk class 2a, which have undergone an assessment of the quality management system for medical devices, including design and development processes, in accordance with the Requirements for the Implementation, Maintenance and Assessment of the Quality Management System for Medical Devices, depending on the potential risk of their use, approved by Decision No. 106 of the Council of the Eurasian Economic Commission dated 10 November 2017:
11. Report number on the results of the initial production inspection
12. Name of the inspection organization that conducted the initial production inspection
13. Report number on the results of the periodic (planned) production inspection (if available)
14. Name of the inspection organization that conducted the periodic (planned) production inspection

due to the following changes:

Changes made to the registration dossier of a medical device
N п/п	Editorial before changes made.	Changes being made.
1.	…	…

Making changes to the registration dossier does not entail changes to the properties and characteristics that affect the safety, quality, and effectiveness of the medical device.

I guarantee the accuracy of the information provided.

I guarantee that the declared safety and effectiveness characteristics of the medical device will be maintained throughout its service life, provided that the conditions for operation, transportation, and storage of the medical device are observed in accordance with the manufacturer’s requirements.


(date of application)

(Full name and position of the manufacturer’s head (authorized representative of the manufacturer))		(signature, manufacturer’s (manufacturer’s authorized representative’s) seal)

Appendix No. 10

to the Rules for the Registration and Examination

of the Safety, Quality, and Effectiveness

of Medical Devices

ФОРМА ЗАЯВЛЕНИЯ О ВЫДАЧЕ ДУБЛИКАТА РЕГИСТРАЦИОННОГО УДОСТОВЕРЕНИЯ МЕДИЦИНСКОГО ИЗДЕЛИЯ

To the authorized body

of the member state of the Eurasian Economic Union

(name of the reference state)

STATEMENT

on the issuance of a duplicate registration certificate for a medical device

1. The registration certificate number of the medical device.
2. The name of the medical device (indicating the model (brand) of the medical device, its composition and accessories — as an appendix to the application, certified with the seal and signature of the manufacturer of the medical device).
I. Information about the manufacturer of the medical device
3. The legal form and full name of the legal entity, or the surname, first name, and patronymic (if available) of the individual registered as an individual entrepreneur.
4. The abbreviated name of the legal entity (if available).
5. The trade name of the legal entity (if available).
6. Location (the address of the legal entity, the place of residence of the individual registered as an individual entrepreneur).
7. Phone number.
8. The email address of the legal entity or the individual registered as an individual entrepreneur (if available).
9. Taxpayer identifier
10. Production sites (full name, address)
II. Information about the authorized representative of the manufacturer (if available)
11. The organizational and legal form and the full name of the legal entity, or the surname, first name, and patronymic (if any) of the individual registered as an individual entrepreneur.
12. The abbreviated name of the legal entity (if any)
13. The trade name of the legal entity (if any)
14. Location (the address of the legal entity, the place of residence of the individual registered as an individual entrepreneur)
15. Phone number
16. Email address of the legal entity or individual registered as an individual entrepreneur (if available)
17. Taxpayer identifier
III. Other information
18. The method for receiving notifications (decisions) from the authorized body (expert organization) of the reference state.		in person, against signature
		by registered mail with a delivery notification
		in electronic form (if you choose this method, you must specify the email address(s) to which the notifications should be sent)
		in the form of an electronic document signed with an electronic signature
19. The method for obtaining a duplicate of the registration certificate for a medical device.		on paper, in person
		on paper, sent by registered mail with a delivery notification
20. Grounds for issuing a duplicate.		loss of the registration certificate
		damage to the registration certificate
21. Information about the document confirming payment for the issuance of a duplicate (date and number of the payment order).


(date of application)

(Full name and position of the manufacturer’s head (authorized representative of the manufacturer))		(signature, manufacturer’s (manufacturer’s authorized representative’s) seal))

Appendix N 11

to the Rules for the Registration and Examination

of the Safety, Quality and Effectiveness

of Medical Devices

FORM OF THE STATEMENT

ON THE CONSULTATION OF THE EXPERT OPINION

ON A REGISTERED MEDICAL DEVICE

	To the authorized body (expert organization) of the member state of the Eurasian Economic Union

	(name of the reference state)

	(the name of the state (the names of the states) of recognition not specified in the registration certificate of the medical device)

STATEMENT

on the coordination of an expert conclusion regarding a registered medical device

(full and abbreviated names (if any), including the company name, of the person on whose behalf the application is submitted (manufacturer (authorized representative of the manufacturer), legal form of the legal entity)

The undersigned hereby requests the procedure for согласование of the expert opinion on the registered medical device.:

1. Name of the medical device
2. Details of the registration certificate for the medical device
3. Class of potential risk associated with the use of the medical device
4. Code for the type of medical device (in accordance with the nomenclature of medical devices of the Eurasian Economic Union, the rules for maintaining which are approved by Decision No. 177 of the Board of the Eurasian Economic Commission dated December 29, 2015)
5. Full name and country of origin of the manufacturer, including the location (address of the legal entity, place of residence of an individual registered as an individual entrepreneur)
6. Full names of the production sites, including the address.
7. Name of the manufacturer’s authorized representative in the territories of the member states of the Eurasian Economic Union, including the location (address of the legal entity, place of residence of an individual registered as an individual entrepreneur).
8. Information about the document confirming payment for the issuance of the registration certificate in the reference state (if necessary).
9. Information about the document confirming payment for the procedure of coordination of the expert conclusion for the registered medical device in the state (states) of recognition.
10. The method for receiving notifications (decisions) from the authorized body (expert organization) of the reference state:		in person, against signature
		by registered mail with a delivery notification
		in electronic form (if you choose this method, you must specify the email address(s) to which the notifications should be sent)
		in the form of an electronic document signed with an electronic signature
11. The method for obtaining a registration certificate for a medical device and its appendix.:		on paper, in person
		on paper, sent by registered mail with a delivery notification

I guarantee the accuracy and authenticity of the information contained in the statement..


(date of application submission)

(Full name and position of the head of the manufacturer (authorized representative of the manufacturer))		(signature, seal of the manufacturer (authorized representative of the manufacturer))

Appendix No. 12

to the Rules for the Registration and Examination

of the Safety, Quality, and Effectiveness

of Medical Devices

LIST

OF DOCUMENTS REQUIRED FOR THE PROCEDURE

OF APPROVAL OF AN EXPERT REPORT FOR A REGISTERED

MEDICAL DEVICE

Document name:	Note
1. Application for approval of an expert conclusion for a registered medical device.	in the form prescribed by Appendix No. 11 to the Rules for the Registration and Examination of the Safety, Quality, and Effectiveness of Medical Devices, approved by Decision No. 46 of the Council of the Eurasian Economic Commission dated February 12, 2016.
2. Manufacturer’s agreement with the manufacturer’s authorized representative or a copy thereof (if the manufacturer has an authorized representative).	The copy is certified in accordance with international certification standards or the certification standards established by the legislation of the reference state.
3. Power of attorney from the manufacturer or the manufacturer’s authorized representative authorizing representation during the procedure for approving an expert conclusion for a registered medical device (if necessary).	in accordance with international certification standards or certification standards established in accordance with the legislation of a member state of the Eurasian Economic Union
4. Labeling and packaging data approved at the time of registration of a medical device, taking into account the changes made to the registration dossier of a medical device (full-color (with color coding) layouts of packages and labels), labeling text in the official languages of the states of recognition indicated in the application for approval of an expert opinion on a registered medical device) (if necessary)	certified by the manufacturer (or the manufacturer’s authorized representative)
5. An operational document or instructions for the use of the medical device, a service manual approved during the registration of the medical device, taking into account the amendments made to the registration dossier of the medical device, in the official languages of the states of recognition specified in the application for approval of the expert conclusion on the registered medical device (if necessary).	certified by the manufacturer (or the manufacturer’s authorized representative)
6. The registration certificate of the medical device of the Eurasian Economic Union or its duplicate.

Appendix No. 13

to the Rules for Registration and Examination

of the Safety, Quality and Effectiveness

of Medical Devices

FORM OF THE STATEMENT

ON THE REVOCATION (CANCELLATION) OF THE REGISTRATION

CERTIFICATE OF A MEDICAL DEVICE

To the authorized body

of the member state of the Eurasian Economic Union

(name of the reference state)

STATEMENT

on the revocation (cancellation) of the registration certificate for a medical device

hereby requests that the registration certificate for the medical device be revoked (the registration certificate for the medical device be annulled)

(the name of the medical device (including the model (brand) of the medical device, its composition, and accessories))

(the date of registration of the medical device and the registration certificate number of the medical device)

due to
	(specify the reason)

(date of application)

(Full name and position of the manufacturer’s head (authorized representative of the manufacturer))		(signature, manufacturer’s (manufacturer’s authorized representative’s) seal)

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Decision of the Council of the Eurasian Economic Commission dated February 12, 2016, No. 46