Decision of the Board of the Eurasian Economic Commission dated December 22, 2015 No. 173

(as amended on February 18, 2025)

"On the Approval of the Rules for the Classification of Medical Devices Depending on the Potential Risk of Use"

BOARD OF THE EURASIAN ECONOMIC COMMISSION

DECISION

dated December 22, 2015 N 173

ON THE APPROVAL OF THE RULES

CLASSIFICATION OF MEDICAL DEVICES DEPENDING ON

FROM THE POTENTIAL RISK OF APPLICATION

List of amending documents

(ed. decisions of the Board of the Eurasian Economic Commission

from 23.05.2023 N 65, from 18.02.2025 N 18)

In accordance with paragraph 2 of Article 31 of the Treaty on the Eurasian Economic Union of May 29, 2014, paragraph 4 of Article 4 of the Agreement on common principles and rules of circulation of medical devices (medical devices and medical equipment) within the Eurasian Economic Union of December 23, 2014, paragraph 23 of Annex N 2 to the Regulations of the Eurasian Economic Commission, approved by the decision of the Supreme Eurasian Economic Council of December 23, 2014 N 98, and in order to implement the decision of the Supreme Eurasian Economic Council of December 23, 2014 N 98
1. To approve the attached Rules for the classification of medical devices depending on the potential risk of use.
2. This Decision shall enter into force 30 calendar days after the date of entry into force of the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices (Medical Devices and Medical Equipment) within the Eurasian Economic Union of December 23, 2014 or 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 Uniform Principles and Rules for the Circulation of Medical Devices (Medical Devices and Medical Equipment) within the Eurasian Economic Union of December 23, 2014.

Chairman of the Board

Eurasian Economic Commission

V. CHRISTENKO

Approved

By decision of the Board

Eurasian Economic Commission

dated December 22, 2015 N 173

RULES.

CLASSIFICATION OF MEDICAL DEVICES DEPENDING ON

FROM THE POTENTIAL RISK OF APPLICATION

List of amending documents

(ed. decisions of the Board of the Eurasian Economic Commission

from 23.05.2023 N 65, from 18.02.2025 N 18)

I. General provisions

1. These Rules are developed in order to implement the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices (Medical Devices and Medical Equipment) within the Eurasian Economic Union of December 23, 2014 and establish the procedure for the classification of medical devices depending on the potential risk of harm, expressed in injury or damage to the health of patients from the use of medical devices, personnel operating medical devices, other persons, public health or environment
2. These Rules shall apply to medical devices put into circulation within the Eurasian Economic Union.
3. For the purposes of these Regulations, the terms used shall mean the following:
"active diagnostic medical devices" means active medical devices intended to provide information for the purpose of diagnosing, monitoring treatment, or modifying a physiologic condition, disease state, or birth defect;
"active medical devices" are medical devices used alone or in combination with other medical devices that require the use of non-human energy or gravity for their action. Medical devices designed to transfer energy or substances from an active medical device to a patient without substantially altering them are not active medical devices;
"active therapeutic medical devices" means active medical devices, intended to preserve, modify, replace, or restore biological functions or structures associated with the treatment, relief of disease, injury, or disability;
"analyte" is a sample component with a measurable property;
"apheresis" is a method of obtaining individual blood components, subdivided into plasmapheresis and cytopheresis;
"implantable medical devices" means invasive medical devices, including medical devices that are partially or fully resorbable in the body, that are fully inserted into the human body or that replace the epithelial surface or surface of the eye through surgical intervention and remain at the site of insertion after a surgical procedure, and medical devices that are partially inserted into the human body through surgical intervention and remain at the site of insertion after a surgical procedure for more than 30 days;
"invasive medical devices" means medical devices designed to be inserted, in whole or in part, into the human body through the surface of the body or through an opening of the body;
"artificial intelligence" - a set of technological solutions that allows imitating human cognitive functions (including self-learning and search for solutions without a predetermined algorithm), which includes information and communication infrastructure, software (including using machine learning methods), processes and services for data processing and search for solutions;
"medical devices for temporary use" - medical devices intended for continuous use for a certain period of time (from 60 minutes to 30 days) in accordance with the instructions for use or operating instructions;
"medical devices for long-term use" - medical devices intended for continuous use for more than 30 days in accordance with the instructions for use or the instruction manual;
"medical devices for short-term use" - medical devices intended for continuous use for not more than 60 minutes in accordance with the instructions for use or the instruction manual;
"medical device intended use" means a manufacturer's documented decision regarding the intended use of a medical device based on its properties as reflected in its technical specifications, instructions for use, or instruction manual;
"nanomaterial" means a material containing particles in an unbound state or particles in the form of aggregates or agglomerates, at least 50 percent of the particles of which have sizes in the range of 1 to 100 nm. Aggregates are defined as particles consisting of fused or strongly bonded particles, and agglomerates as aggregations of loosely bonded particles. Nanomaterials also include graphene particles or carbon nanotubes with one or more external dimensions of less than 1 nm;
"Non-invasive medical devices" means medical devices not intended to be inserted, in whole or in part, into the human body through the surface or openings of the body;
"non-professional user" means a natural person who has no specialized training in the relevant field. For an in vitro diagnostic medical device intended for use outside the laboratory, the user of such a medical device will be considered a lay user;
"body orifice" - any natural opening of the human body, as well as the outer surface of the eyeball or any permanent artificial opening (cavity);
"artificial intelligence technologies" - technologies based on the use of artificial intelligence, including computer vision, natural language processing, speech recognition and synthesis, intelligent decision support and other promising areas;
"surgical invasive medical devices" means invasive medical devices that are inserted, in whole or in part, into the human body through a surface or an opening of the body by or in connection with a surgical procedure.
Other concepts used in these Rules shall be applied in the meanings defined by the acts of the bodies of the Eurasian Economic Union in the sphere of medical devices circulation.

II. Classification of medical devices, except for

medical devices for in vitro diagnostics and program

of a medical device that is a medical device

1. Classes of medical devices depending on

from the potential risk of application

4. Medical devices, depending on the potential risk of use, are divided into 4 classes: 1, 2a, 2b and 3.
Each medical device can only be assigned to one class.
Classification of medical devices is based on the following:
Class 1 includes medical devices with a low potential risk of use;
Class 2a includes medical devices with a medium potential risk of use;
Class 2b includes medical devices with an increased potential risk of use;
Class 3 includes medical devices with a high potential risk of use.
5. When classifying a medical device, the purpose of the medical device and the conditions of use shall be taken into account, as well as the following criteria:
(a) The duration of use of the medical device;
b) the invasiveness of the medical device;
c) the presence of contact or relationship of the medical device with the human body;
d) the method of insertion of the medical device into the human body (through a body orifice or surgically);
e) use of a medical device for vital organs and systems (heart, central circulation, central nervous system);
(e) Application of energy sources.

2. Classification of non-invasive medical devices

6. Non-invasive medical devices shall be classified as Class 1 unless paragraphs 7 to 9 of this Regulation apply, with the exception of subparagraph "a" of paragraph 9 of this Regulation.
7. Non-invasive medical devices intended for the storage of organs, parts of organs or for the storage or administration of blood, other liquids, gases, vapors or tissues into the human body shall be classified as Class 2a, including when used in conjunction with active medical devices of Class 2a or higher.
8. Non-invasive medical devices designed to alter the biological or physicochemical composition and properties of blood, tissues, cells, other physiological fluids or fluids to be delivered to the human body are classified as Class 2b. If their action consists only in filtration from particles, centrifuge treatment, gas or heat exchange, the said medical devices are classified as Class 2a.
9. Non-invasive medical devices that come in contact with injured skin include:
(a) To Class 1 if they are used as mechanical barriers, for compression or absorption of exudate;
b) to class 2b - if they are used for wounds that can only be treated by secondary healing;
c) to class 2a - in other cases (including if medical devices are intended primarily to affect the microenvironment of wounds).

3. Classification of invasive medical devices

10. Invasive medical devices (except surgical invasive medical devices), the use of which involves bodily orifices and which are not intended to be attached to an active medical device (except a Class 1 active medical device), include:
Class 1 - if they are medical devices for short-term use;
Class 2a if they are medical devices for temporary use. If these medical devices are used temporarily in the oral cavity up to the pharynx, in the ear canal up to the tympanic membrane or in the nasal cavity, they are classified as Class 1;
Class 2b - if they are medical devices for prolonged use. If these medical devices are used for long term use in the oral cavity up to the pharynx, in the ear canal up to the tympanic membrane or in the nasal cavity and cannot be absorbed by the mucous membrane, they are classified as Class 2a.
Invasive medical devices (except surgical invasive medical devices) whose use involves body openings and which are designed to be attached to an active medical device of Class 2a or higher are classified as Class 2a.
11. Surgical invasive medical devices for short-term use are classified as Class 2a, except as follows:
(a) If the medical devices in question are intended for the diagnosis, monitoring, control or correction of pathologies of the heart, central circulation or central nervous system and are in direct contact with organs or parts of these systems, they shall be classified as Class 3;
b) if the specified medical devices are reusable surgical instruments, they shall be classified as Class 1;
c) if the specified medical devices are intended to transmit energy in the form of ionizing radiation, they shall be classified as Class 2b;
d) if the medical devices in question are intended to cause a biological effect or to be absorbed completely or substantially, they are classified as Class 2b;
e) if the specified medical devices are intended for the administration of medicines by non-professional users, they shall be classified as Class 2b.
12. Surgical invasive medical devices for temporary use are classified as Class 2a, except as follows:
(a) If the medical devices in question are intended for the diagnosis, monitoring, control or correction of pathologies of the heart or central circulation and are in direct contact with organs or parts of these systems, they shall be classified as Class 3;
b) if the specified medical devices are in direct contact with the central nervous system, they are classified as Class 3;
c) if the specified medical devices are intended to transmit energy in the form of ionizing radiation, they shall be classified as Class 2b;
d) if the medical devices in question are intended to cause a biological effect or to be absorbed completely or substantially, they are classified as Class 3;
e) if the said medical devices undergo chemical changes in the human body, they are classified as Class 2b (except for medical devices intended for implantation in teeth or for the administration of medicines).
13. Implantable medical devices as well as surgical invasive medical devices for long-term use are classified as Class 2b, except as follows:
(a) If the medical devices in question are intended for implantation in teeth, they shall be classified as Class 2a;
b) if said medical devices are in direct contact with the heart, central circulation or central nervous system, they are classified as Class 3;
c) if the medical devices in question are intended to cause a biological effect or to be absorbed completely or substantially, they are classified as Class 3;
d) if the said medical devices undergo chemical changes in the human body, they shall be classified as Class 3 (except for medical devices intended for dental implantation or for the administration of medicines);
e) if the specified medical devices are active implantable medical devices, including implantable accessories for active implantable medical devices, they are classified as Class 3;
(e) If the medical devices in question are breast implants, they are class 3;
g) if the specified medical devices are total or partial hip, knee or shoulder prostheses, they are classified as Class 3;
h) if the specified medical devices are intervertebral disc prostheses or implantable medical devices that come in contact with the spine, they are classified as Class 3.

4. specifics of classification of active medical devices

14. Active medical devices shall be classified taking into account the following features:
(a) Active therapeutic medical devices intended for energy transfer or energy exchange are classified as Class 2a. If energy transfer to or energy exchange with the human body poses a potential hazard due to the characteristic features of medical devices, taking into account the nature, density and location of energy impact on body parts, the said medical devices shall be referred to class 2b (including active medical devices intended to create ionizing radiation, radiation therapy);
b) Active medical devices intended to control or manage active therapeutic medical devices of Class 2b are classified as Class 2b. If the active medical devices are intended to control or manage active implantable medical devices, the said medical devices are classified as Class 3.
15. Active diagnostic medical devices are classified as Class 2a if they are intended for:
(a) The transmission of energy absorbed by a person. If the function of the medical device is to illuminate the patient's body in the visible spectrum, the medical device is classified as Class 1;
(b) Representations of the distribution of radiopharmaceuticals administered to the human body;
c) providing direct diagnosis or monitoring of vital bodily functions. If the medical devices in question are intended to monitor vital physiological parameters, changes in which could result in an immediate danger to the patient (e.g. changes in heart function, respiration or central nervous system activity), they are classified as Class 2b.
16. Active medical devices generating ionizing radiation and intended for radiological diagnostics and therapy, including medical devices for controlling or managing such devices, are classified as Class 2b.
17. Active medical devices intended for administration of medicinal preparations, physiological fluids or other substances into the human body and (or) for their excretion from the body shall be classified as Class 2a. If such administration (excretion) may result in a potential hazard for the patient, taking into account the type of the relevant substances, part of the body and the method of application, the said medical devices shall be referred to class 2b.
18. Active medical devices to which paragraphs 14 to 17 of this Regulation do not apply shall be class 1.

5. Peculiarities of classification of certain medical devices

Clause 19 (in edition of Decision of the EEC Collegium from 18.02.2025 N 18) does not apply to relations on registration of medical devices, if applications for registration, examination, amendments to the dossier, harmonization of the expert opinion were submitted before 22.03.2025.

19. Medical devices containing substances which, when used on their own, may be regarded as medicines or as products derived from human blood or plasma, and which affect the human body in addition to the effects of the medical device, are classified as Class 3 (except antiseptic wipes for the treatment of hands of medical personnel, operating and injection fields, which are classified as Class 2a).
(in edition of the decision of the Board of the Eurasian Economic Commission from 18.02.2025 N 18)
20. Medical devices intended to control conception or to protect against sexually transmitted diseases are classified in class 2b. If these medical devices are implantable or invasive medical devices for prolonged use, they are classified as Class 3.
21. Medical devices intended for disinfection of invasive medical devices, as well as for cleaning, rinsing, disinfecting, hydrating contact lenses are classified as Class 2b. Other medical devices intended for disinfection or sterilization of medical devices belong to class 2a.
22. Medical devices designed to register images from X-ray, magnetic resonance, ultrasound and other diagnostic devices are classified as Class 2a.
23. Medical devices which have been manufactured using dead animal tissues or cells or derivatives thereof are classified as Class 3. If said medical devices are intended to come into contact only with the intact surface of the skin, they shall be classified as Class 1.
24. Blood bags (polymer containers) belong to class 2b.
25. Medical devices incorporating a nanomaterial are classified as Class 3. If the nanomaterial is in an isolated or bound state that prevents it from entering the body of the patient or user, the medical device is classified as Class 1.
26. Medical devices intended for apheresis, including kits, connectors and solutions are classified as Class 3.
27. Where a medical device is intended to be used in combination with another medical device, the provisions of this Regulation shall apply separately to each medical device.
28. If, taking into account the information provided by the manufacturer, several paragraphs of these Regulations are applicable to medical device, the paragraph according to which the class of medical device corresponding to the highest degree of potential risk of use is established shall be applied.

6. Algorithm for classification of medical devices

depending on the potential risk of application

29. In classifying medical devices, the applicability of all provisions of these Regulations relating to the classification of medical devices shall be assessed.
30. Classification of medical devices (except for medical devices for in vitro diagnostics and software that is a medical device) depending on the potential risk of use shall be carried out in accordance with the algorithm according to Annex N 1.



See Methodological Recommendations on the classification of medical devices for in vitro diagnostics depending on the potential risk of use for the purposes of their registration within the EAEU.

III. Classification of medical devices for diagnostics

in vitro, with the exception of software,

of a medical device

1. Classes of medical devices for in vitro diagnostics

depending on the potential risk of application

31. Medical devices for in vitro diagnostics, depending on the potential risk of use, are divided into 4 classes: 1, 2a, 2b and 3.
Each in vitro diagnostic medical device can be assigned to only one class.
Classification of medical devices for in vitro diagnostics is based on the following:
Class 1 includes in vitro diagnostic medical devices with a low potential risk of use to the individual and a low potential risk of use to public health;
Class 2a includes in vitro diagnostic medical devices with a medium potential risk of use to the individual and a low potential risk of use to public health;
Class 2b includes in vitro diagnostic medical devices with a high potential risk of use for an individual and/or a medium potential risk of use for public health;
Class 3 includes in vitro diagnostic medical devices with a high potential risk of use to the individual and a high potential risk of use to public health.
32. The following criteria shall be considered when classifying an in vitro diagnostic medical device:
(a) The intended use of the in vitro diagnostic medical device and the indications for its use as specified by the manufacturer;
b) the technical, scientific or medical knowledge of the intended user (lay or professional);
c) the importance of the information to the diagnosis (single determinant or one of several), taking into account the presence of signs and symptoms of the disease, condition, or other clinical information that may guide the physician;
d) the impact of the outcome (true or false) on individual health and/or public health.

2 Peculiarities of classification of medical devices

for in vitro diagnostics depending on potential

application risk

33. If, taking into account the information submitted by the manufacturer, several paragraphs of this Regulation are applicable to the in vitro diagnostic medical device, the paragraph according to which the class of the in vitro diagnostic medical device corresponding to the highest degree of potential risk of use is established shall be applied.
34. Calibration and control materials with quantitative and qualitative set points are of the same class as the in vitro diagnostic reagent (reagent kit) for use with which they are intended.

3. Classification of medical devices for diagnostics

in vitro

35. In vitro diagnostic medical devices intended for the detection of infectious agents in blood, blood components, blood derivatives, cells, tissues or organs for the purpose of assessing the feasibility of transfusion or transplantation, and in vitro diagnostic medical devices intended for the detection of infectious agents that cause long-term disability or death, with a high or suspected high risk of spread, are classified in Class 3.
36. In vitro diagnostic medical devices used for determining blood groups or for determining maternal and fetal blood group incompatibility or tissue types in order to guarantee immunological compatibility of blood, blood components, cells, tissues or organs intended for transfusion or transplantation, are class 2b, except for those used to determine antigens or antibodies of the AB0 system (A (AB01), B (AB02), AB (AB03)), Rh1 (D), Rh2 (C), Rh3 (E), Rh4 (c), Rh5 (e) and weak or partial Rh (D)), Kell systems (Kell (K)), Kidd systems (JK1 (Jka), JK2 (Jkb)), and Duffy systems (FY1 (Fya), FY2 (Fyb)), which are class 3.
37. Medical devices for in vitro diagnostics are classified as Class 2b if they are intended for:
(a) Identification of infectious agents of sexually transmitted diseases;
b) detection of infectious agents with a moderate risk of spread in cerebrospinal fluid or blood;
c) detection of infectious agents where there is a risk that an erroneous test result could cause death or incapacitation of the subject patient, fetus or embryo, or the patient's offspring;
d) screening in pregnant women to determine their immune status in relation to infections;
e) determination of infectious disease status or immune status when there is a risk that an erroneous result will lead to a therapeutic decision causing disability or an imminent life-threatening situation for the patient or his or her offspring;
(e) Screening, diagnosis or staging of cancer;
g) genetic testing;
h) controlling levels of drugs, substances or biological components where there is a risk that an incorrect result will lead to a therapeutic decision causing a life-threatening situation for the patient or his or her offspring;
(i) Assessment of patients with life-threatening conditions or diseases;
j) screening for congenital diseases of the fetus or embryo;
(k) Screening for congenital diseases in newborn children where there is a risk that failure to detect and treat such diseases could lead to life-threatening situations or disability;
(m) Screening to select patients for selective therapy and management as a companion diagnostic.
38. In vitro diagnostic medical devices intended for use by non-professional users are classified as Class 2b. If the result of the analysis obtained with the use of the specified in vitro diagnostic medical devices is not of critical medical status or is preliminary and requires subsequent comparison with appropriate laboratory tests, such medical devices shall be classified as Class 2a. If the specified in vitro diagnostic medical devices are intended for the purposes specified in paragraphs 35 and 36 of this Regulation, such medical devices shall be classified as Class 3.
39. Medical devices for in vitro diagnostics, which have no measuring function, by their objective properties can be used as general laboratory devices, but have special characteristics, according to which they are intended by the manufacturer for use in in vitro diagnostic procedures (without specifying specific types of laboratory tests (analytes)), as well as containers for collection and storage of bioassay samples belong to Class 1.
40. Medical devices for in vitro diagnostics, to which paragraphs 35 - 39 of this Regulation do not apply, including those for diagnostics of rarely occurring infectious agents in the absence of the risk that an erroneous result may cause disability or death of the patient, control materials without quantitatively or qualitatively specified values, analytical instruments (analyzers) with measuring function with an unfixed list of performed laboratory tests, which depends on the used reagent sets (test systems), on the test results, on the test results, on the test results, on the test results, on the test results, on the test results, on the test results. The interdependence of the instrument and the reagents used, as a rule, does not allow the instrument to be evaluated separately, but this does not affect its classification as Class 2a.

4 Algorithm for the classification of medical devices

for in vitro diagnostics depending on potential

application risk

41. Classification of medical devices for in vitro diagnostics (except for software that is a medical device) depending on the potential risk of use shall be carried out in accordance with the algorithm according to Annex N 2.
42. Examples of classification of medical devices for in vitro diagnostics (except for software, which is a medical device) depending on the potential risk of use are given in Annex N 3.

IV. Classification of software that is

medical device

1. Classes of software that are medical

the product, depending on the potential risk of application

43. Software that is a medical device (hereinafter referred to as software), depending on the potential risk of use, is divided into 4 classes: 1, 2a, 2b and 3.
Each software can only be categorized in one class.
Classification of software is based on the following:
Class 1 includes software with a low potential risk of application;
Class 2a includes software with a medium degree of potential risk of use;
Class 2b includes software with an increased degree of potential risk of use;
Class 3 includes software with a high degree of potential risk of use.
The assignment of a potential application risk class to software shall be made in accordance with this paragraph regardless of the potential application risk class of the medical device with which it is used.

2. Classification of software

44. Classification of software (except for software with application of artificial intelligence technologies) is carried out on the basis of the type of information provided based on the assessment of the impact of the obtained results of the software operation on medical decision making and conditions of the software application and is given in the table.

Table