Council of the Eurasian Economic Commission Decision No. 173

Decision of the Board of the Eurasian Economic Commission

of December 22, 2015 N 173

"On Approval of the Rules for Classification of Medical Devices

Depending on the Potential Risk of Use»

(as amended by Decisions of the Board of the Eurasian Economic Commission

of May 23, 2023 N 65, of February 18, 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 for the Circulation of Medical Devices (Medical Products and Medical Equipment) within the Eurasian Economic Union of December 23, 2014, paragraph 23 of Annex N 2 to the Regulations of the Work of the Eurasian Economic Commission, approved by Decision of the Supreme Eurasian Economic Council of December 23, 2014 N 98, and in order to implement Decision of the Supreme Eurasian Economic Council of December 23, 2014 N 109 "On the Implementation of the Agreement on Common Principles and Rules for the Circulation of Medical Devices (Medical Products and Medical Equipment) within the Eurasian Economic Union," the Board of the Eurasian Economic Commission RESOLVES:

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 after 30 calendar days from the date of entry into force of the Agreement on Common Principles and Rules for the Circulation of Medical Devices (Medical Products and Medical Equipment) within the Eurasian Economic Union of December 23, 2014, or from 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 Common Principles and Rules for the Circulation of Medical Devices (Medical Products and Medical Equipment) within the Eurasian Economic Union of December 23, 2014, whichever date is later, but no earlier than after 30 calendar days from the date of official publication of this Decision.

 

Chairman of the Board

of the Eurasian Economic Commission

V. Khristenko

 

APPROVED

by the Decision of the Board

of the Eurasian Economic Commission

of December 22, 2015 N 173

(as amended by the Decision of the Board

of the Eurasian Economic Commission

of May 23, 2023 N 65)

 

RULES

for the classification of medical devices

depending on the potential risk of use

 

(as amended by Decisions of the Board of the Eurasian Economic Commission

of May 23, 2023 N 65, of February 18, 2025 N 18)

 

I. General Provisions

 

1. These Rules have been developed for the purpose of implementing the Agreement on Common Principles and Rules for the Circulation of Medical Devices (Medical Products and Medical Equipment) within the Eurasian Economic Union of December 23, 2014, and establish the procedure for classifying 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 the environment.

2. These Rules apply to medical devices released for circulation within the Eurasian Economic Union.

3. For the purposes of these Rules, the following concepts are used, which mean the following:

"active diagnostic medical devices" - active medical devices intended to present information for the purpose of diagnosing, monitoring treatment, or changing the physiological state, disease state, or congenital defects;

"active medical devices" - medical devices used separately or in combination with other medical devices, the operation of which requires the use of energy other than that produced by a person, or gravity. Medical devices intended to transfer energy or substances from an active medical device to a patient without their significant alteration are not active medical devices;

 

"active therapeutic medical devices" - active medical devices intended to preserve, change, replace, or restore biological functions or structures associated with treatment, alleviation of disease, injury, or disability;

"analyte" - a component of a sample with a measurable property;

"apheresis" - a method of obtaining individual blood components, subdivided into plasmapheresis and cytapheresis;

"implantable medical devices" - invasive medical devices, including those that are partially or completely absorbable in the body, completely inserted into the human body or replacing the epithelial surface or the surface of the eye through surgical intervention and remaining at the insertion site after the surgical procedure, as well as medical devices partially inserted into the human body through surgical intervention and remaining at the insertion site after the surgical procedure for more than 30 days;

"invasive medical devices" - medical devices intended for full or partial insertion into the human body through its surface or through a body orifice;

"artificial intelligence" - a complex of technological solutions that allows simulating the cognitive functions of a person (including self-learning and searching for solutions without a predetermined algorithm), which includes information and communication infrastructure, software (including using machine learning methods), data processing and solution search processes and services;

"medical devices for temporary use" - medical devices intended for continuous use for a certain time (from 60 minutes to 30 days) in accordance with the instructions for use or the operating manual;

"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 operating manual;

"medical devices for short-term use" - medical devices intended for continuous use for no more than 60 minutes in accordance with the instructions for use or the operating manual;

"medical device intended purpose" - a documented decision of the manufacturer regarding the intended use of a medical device, based on its properties, reflected in the technical specifications, instructions for use, or operating manual;

"nanomaterial" - a material containing particles that are in an unbound state, or particles in the form of aggregates or agglomerates, at least 50 percent of which have sizes in the range of 1 - 100 nm. In this case, aggregates are understood as particles consisting of fused or strongly bound particles, and agglomerates are understood as combinations of weakly bound particles. Nanomaterials also include graphene particles or carbon nanotubes with one or more external dimensions less than 1 nm;

"non-invasive medical devices" - medical devices not intended for full or partial insertion into the human body through its surface or through body orifices;

"non-professional user" - a natural person who does not have specialized education in the relevant field. For a medical device for in vitro diagnostics intended for use outside laboratory conditions, the user of such a medical device will be considered a non-professional user;

"body orifice" - any natural orifice 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 directions;

"surgical invasive medical devices" - invasive medical devices that are fully or partially inserted into the human body through its surface or through a body orifice by surgical intervention or in connection with it.

Other concepts used in these Rules are applied in the meanings defined by the acts of the bodies of the Eurasian Economic Union in the field of circulation of medical devices.

 

II. Classification of Medical Devices,

with the exception of medical devices for in vitro diagnostics

and software that is a medical device

 

1. Classes of medical devices depending on the potential risk of use

 

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.

The assignment of medical devices to classes is based on the following:

Class 1 includes medical devices with a low degree of potential risk of use;

Class 2a includes medical devices with a medium degree of potential risk of use;

Class 2b includes medical devices with a high degree of potential risk of use;

Class 3 includes medical devices with a high degree of potential risk of use.

 

5. When classifying a medical device, the medical device's intended purpose and conditions of use, as well as the following criteria, are taken into account:

 

a) duration of use of the medical device;

b) invasiveness of the medical device;

c) presence of contact of the medical device with the human body or its relationship with it;

d) method of insertion of the medical device into the human body (through a body orifice or surgically);

e) use of the medical device for vital organs and systems (heart, central circulation, central nervous system);

f) use of energy sources.

 

2. Classification of non-invasive medical devices

 

6. Non-invasive medical devices belong to class 1 if paragraphs 7-9 of these Rules do not apply to them, with the exception of subparagraph "a" of paragraph 9 of these Rules.

7. Non-invasive medical devices intended for storing organs, parts of organs, or for storing or introducing into the human body blood, other fluids, gases, vapors, or tissues are classified as class 2a, including in the case of their use in conjunction with active medical devices of class 2a or higher.

8. Non-invasive medical devices intended to change the biological or physicochemical composition and properties of blood, tissues, cells, other physiological fluids, or fluids that must enter the human body are classified as class 2b. If their action consists only of filtering from particles, centrifuge processing, gas or heat exchange, the specified medical devices belong to class 2a.

9. Non-invasive medical devices that come into contact with damaged skin are classified:

a) as class 1 - if they are used as mechanical barriers, for compression, or absorption of exudate;

b) as class 2b - if they are used for wounds that can only be healed by secondary healing;

c) as class 2a - in other cases (including if the medical devices are intended primarily for affecting the microenvironment of wounds).

 

3. Classification of invasive medical devices

 

10. Invasive medical devices (excluding surgical invasive devices), the use of which is associated with body orifices and which are not intended for connection to an active medical device (with the exception of an active medical device of class 1), are classified:

as class 1 - if these are medical devices for short-term use;

as class 2a - if these are medical devices for temporary use. If the specified medical devices are temporarily used in the oral cavity to the pharynx, in the ear canal to the eardrum, or in the nasal cavity, they belong to class 1;

as class 2b - if these are medical devices for long-term use. If the specified medical devices are long-term used in the oral cavity to the pharynx, in the ear canal to the eardrum, or in the nasal cavity and cannot be absorbed by the mucous membrane, they belong to class 2a.

Invasive medical devices (excluding surgically invasive ones) that are used in connection with body orifices and are intended to be connected 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, with the following exceptions:

a) if these medical devices 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 the organs or parts of these systems, they are classified as class 3;

b) if these medical devices are reusable surgical instruments, they are classified as class 1;

c) if these medical devices are intended to transmit energy in the form of ionizing radiation, they are classified as class 2b;

d) if these medical devices are intended to cause a biological effect or dissolve completely or to a significant extent, they are classified as class 2b;

e) if these medical devices are intended for the administration of drugs by non-professional users, they are classified as class 2b.

 

12. Surgical invasive medical devices for temporary use are classified as class 2a, with the following exceptions:

a) if these medical devices are intended for the diagnosis, monitoring, control, or correction of pathologies of the heart or central circulation and are in direct contact with the organs or parts of these systems, they are classified as class 3;

b) if these medical devices are in direct contact with the central nervous system, they are classified as class 3;

c) if these medical devices are intended to transmit energy in the form of ionizing radiation, they are classified as class 2b;

d) if these medical devices are intended to cause a biological effect or dissolve completely or to a significant extent, they are classified as class 3;

e) if these medical devices undergo chemical changes in the human body, they are classified as class 2b (with the exception of medical devices intended for implantation in teeth or for the administration of drugs).

 

13. Implantable medical devices, as well as surgical invasive medical devices for long-term use, are classified as class 2b, with the following exceptions:

a) if these medical devices are intended for implantation in teeth, they are classified as class 2a;

b) if these medical devices are in direct contact with the heart, central circulation, or central nervous system, they are classified as class 3;

c) if these medical devices are intended to cause a biological effect or dissolve completely or to a significant extent, they are classified as class 3;

d) if these medical devices undergo chemical changes in the human body, they are classified as class 3 (with the exception of medical devices intended for implantation in teeth or for the administration of drugs);

e) if these medical devices are active implantable medical devices, including implantable accessories to active implantable medical devices, they are classified as class 3;

f) if these medical devices are breast implants, they are classified as class 3;

g) if these medical devices are total or partial hip, knee, or shoulder joint prostheses, they are classified as class 3;

h) if these medical devices are intervertebral disc prostheses or implantable medical devices that come into contact with the spine, they are classified as class 3.

 

4. Features of the classification of active medical devices

 

14. Active medical devices are classified taking into account the following features: 

  a) Active therapeutic medical devices intended for transmitting energy or energy exchange belong to class 2a. If the transfer of energy to the human body or the exchange of energy with it presents a potential danger due to the characteristic features of medical devices, taking into account the nature, density and location of the energy impact on body parts, these medical devices belong to class 2b (including active medical devices designed to generate ionizing radiation, radiation therapy);

  b) Active medical devices intended to monitor or control active therapeutic medical devices of class 2b belong to class 2b. If active medical devices are intended to monitor or control active implantable medical devices, these medical devices belong to class 3.

 

15. Active diagnostic medical devices belong to class 2a if they are intended for:

  a) Transferring energy absorbed by a person. If the function of the medical device is to illuminate the patient's body in the visible spectrum, such a medical device belongs to class 1;

  b) Presenting the distribution of radiopharmaceutical drugs administered to the human body;

  c) Providing direct diagnosis or monitoring of vital functions of the body. If these medical devices are intended to monitor vital physiological parameters, changes in which could lead to immediate danger to the patient (for example, changes in heart function, respiration, or central nervous system activity), they belong to class 2b.

 

16. Active medical devices that generate ionizing radiation and are intended for radiological diagnostics and therapy, including medical devices for monitoring or controlling such devices, belong to class 2b.

17. Active medical devices intended for introducing into the human body drugs, physiological fluids or other substances and (or) for removing them from the body belong to class 2a. If such introduction (removal) may lead to a potential danger to the patient, taking into account the type of corresponding substances, the part of the body, and the method of application, these medical devices belong to class 2b.

18. Active medical devices to which paragraphs 14–17 of these Regulations do not apply belong to class 1. 

 

5. Specifics of the Classification of Individual Medical Devices

(Effective date is  March 22, 2025)

 

19. Medical devices containing substances that, when used on their own, can be considered medicinal products, as well as products derived from human blood or plasma, and that affect the human body in addition to the effect of the medical device, belong to class 3 (with the exception of antiseptic wipes for treating the hands of medical personnel, surgical and injection sites, which belong to class 2a).

 

20. Medical devices intended for contraception or for protection against sexually transmitted diseases belong to class 2b. If these medical devices are implantable or invasive medical devices for long-term use, they belong to class 3.

21. Medical devices intended for disinfecting invasive medical devices, as well as for cleaning, rinsing, disinfecting, or hydrating contact lenses, belong to class 2b. Other medical devices intended for disinfecting or sterilizing medical devices belong to class 2a.

22. Medical devices intended for recording images obtained from X-ray, magnetic resonance imaging (MRI), ultrasound, and other diagnostic equipment belong to class 2a.

23. Medical devices that have been manufactured using devitalized tissues or cells of animal origin or their derivatives belong to class 3. If these medical devices are intended to come into contact only with the intact surface of the skin, they belong to class 1.

24. Blood bags (polymer containers) belong to class 2b.

25. Medical devices containing a nanomaterial belong to class 3. If the nanomaterial is in an isolated or bound state, preventing its entry into the patient's or user's body, such a medical device belongs to class 1.

26. Medical devices intended for apheresis, including sets, connectors, and solutions, belong to class 3.

27. If a medical device is intended for use in combination with another medical device, the provisions of these Regulations apply separately to each medical device.

28. If, considering the information provided by the manufacturer regarding the medical device, several clauses of these Regulations are applicable, the clause that establishes the medical device's class corresponding to the greatest degree of potential risk of use applies.

 

6. Algorithm for Performing Classification of Medical Devices Depending on the potential risk of use

 

29. When classifying medical devices, the applicability of all provisions of these Regulations regarding the classification of medical devices is assessed.

30. The classification of medical devices (except for in vitro diagnostic medical devices and software that is a medical device) depending on the potential risk of use is carried out in accordance with the algorithm according to Appendix N 1.

 

III. Classification of Medical Devices for In Vitro Diagnostics, excluding software that is a medical device

 

1. Classes of Medical Devices for In Vitro Diagnostics depending on the potential risk of use

 

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 medical device for in vitro diagnostics can only be assigned to one class.

The assignment of medical devices for in vitro diagnostics to classes is based on the following:

Class 1 includes medical devices for in vitro diagnostics with a low degree of potential risk of use for an individual and a low degree of potential risk of use for public health.

Class 2a includes medical devices for in vitro diagnostics with a moderate degree of potential risk of use for an individual and a low degree of potential risk of use for public health.

Class 2b includes medical devices for in vitro diagnostics with a high degree of potential risk of use for an individual and/or a moderate degree of potential risk of use for public health.

Class 3 includes medical devices for in vitro diagnostics with a high degree of potential risk of use for an individual and a high degree of potential risk of use for public health.

 

32. When classifying a medical device for in vitro diagnostics, the following criteria are considered:

  a) The intended purpose of the medical device for in vitro diagnostics and the indications for its use, as stated by the manufacturer.

  b) The technical, scientific, or medical knowledge of the intended user (non-professional or professional).

  c) The importance of the information for diagnosis (sole determining factor or one of several), taking into account the presence of signs and symptoms of the disease, condition, or other clinical information that the physician may be guided by.

  d) The impact of the result (true or false) on the health of an individual and/or on public health.

 

2. Specifics of the Classification of Medical Devices for In Vitro Diagnostics depending on the potential risk of use

 

33. If, considering the information provided by the manufacturer regarding the medical device for in vitro diagnostics, several clauses of these Regulations are applicable, the clause that establishes the medical device for in vitro diagnostics’ class corresponding to the greatest degree of potential risk of use applies.

34. Calibration and control materials with quantitatively and qualitatively specified values belong to the same class as the reagent (reagent kit) for in vitro diagnostics, for use with which they are intended.

 

3. Classification of Medical Devices for In Vitro Diagnostics

 

35. Medical devices for in vitro diagnostics intended to detect infectious agents in blood, blood components, blood derivatives, cells, tissues, or organs for the purpose of assessing the possibility of their transfusion or transplantation, as well as medical devices for in vitro diagnostics intended to detect infectious agents that lead to long-term disability or death, with a high or suspected high risk of spread, belong to class 3.

36. Medical devices for in vitro diagnostics used for determining blood groups or for determining group incompatibility of mother and fetus blood or tissue types for the purpose of ensuring immunological compatibility of blood, blood components, cells, tissues or organs intended for transfusion or transplantation, belong to class 2b, with the exception of those used for determining antigens or antibodies of the AB0 system (A (AB01), B (AB02), AB (AB03)), Rhesus system (Rh1 (D), Rh2 (C), Rh3 (E), Rh4 (c), Rh5 (e) and weak or partial Rh (D)), Kell system (Kell (K)), Kidd system (JK1 (Jka), JK2 (Jkb)) and Duffy system (FY1 (Fya), FY2 (Fyb)), which belong to class 3.

37. Medical devices for in vitro diagnostics belong to class 2b if they are intended for:

  a) Detecting infectious agents of sexually transmitted diseases;

  b) Detecting infectious agents with a moderate risk of spread in cerebrospinal fluid or blood;

  c) Detecting infectious agents when there is a risk that an erroneous test result could cause death or loss of capacity of the examined patient, fetus, or embryo, or offspring of the patient;

  d) Screening pregnant women to determine their immune status in relation to infections;

  e) Determining the status of an infectious disease or immune status when there is a risk that an erroneous result will lead to a therapeutic decision causing disability or the inevitable occurrence of a life-threatening situation for the patient or his offspring;

  f) Screening, diagnosis, or staging of oncological diseases;

  g) Genetic testing;

  h) Monitoring levels of drugs, substances, or biological components when there is a risk that an incorrect result will lead to a therapeutic decision causing the occurrence of a life-threatening situation for the patient or his offspring;

  i) Assessing the condition of patients suffering from life-threatening conditions or diseases;

  j) Screening for congenital diseases of the fetus or embryo;

  k) Screening for congenital diseases in newborns when there is a risk that failure to detect and treat such diseases may lead to life-threatening situations or disability;

  l) Screening for selecting patients for selective therapy and management as companion diagnostics.

 

38. Medical devices for in vitro diagnostics intended for use by non-professional users belong to class 2b. If the result of the analysis obtained using these medical devices for in vitro diagnostics does not have a critical medical status or is preliminary and requires subsequent comparison with relevant laboratory tests, such medical devices belong to class 2a. If these medical devices for in vitro diagnostics are intended for the purposes specified in paragraphs 35 and 36 of these Regulations, such medical devices belong to class 3.

39. Medical devices for in vitro diagnostics that do not have a measuring function, by their objective properties can be used as general laboratory equipment, 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 collecting and storing biological samples belong to class 1.40. Medical devices for in vitro diagnostics to which paragraphs 35-39 of these Regulations do not apply, including those for the diagnosis of rarely encountered infectious agents when there is no risk that an erroneous result could cause disability or death of the patient, control materials without quantitatively or qualitatively specified values, analytical instruments (analyzers) with a measuring function with a non-fixed list of performed laboratory tests that depends on the applied reagent kits (test systems), belong to Class 2a. The interdependence of the instrument and the reagents used generally does not allow the instrument to be evaluated separately, but this does not affect its classification as Class 2a. 

 

4. Algorithm for Performing Classification of Medical Devices for In Vitro Diagnostics depending on the Potential Risk of Use

 

41. The classification of medical devices for in vitro diagnostics (except for software that is a medical device) depending on the potential risk of use is carried out in accordance with the algorithm according to Appendix N 2.

42. Examples of the classification of medical devices for in vitro diagnostics (except for software that is a medical device) depending on the potential risk of use are given in Appendix N 3.

 

IV. Classification of Software that is a Medical Device

 

1. Classes of Software that is a Medical Device, depending on the Potential Risk of Use

 

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 assigned to one class.

The assignment of software to classes is based on the following:

Class 1 includes software with a low degree of potential risk of use.

Class 2a includes software with a moderate 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 class of potential risk of use to software is carried out in accordance with this paragraph, regardless of the class of potential risk of use of the medical device in combination with which it is used.

 

2. Classification of Software

 

44. The classification of software (excluding software using artificial intelligence technologies) is carried out on the basis of the type of information presented based on an assessment of the impact of the results of the software on medical decision-making and the conditions of use of the software and is presented in the table.

Table  

 

45. Software using artificial intelligence technologies belongs to class 3.

46. Assigning conditions of use of software depending on its intended purpose to one of the categories is carried out in accordance with the following criteria:

a) The conditions of use of the software belong to category "A" if the software is intended:

To provide emergency medical care (in case of sudden acute illnesses, conditions, exacerbation of chronic diseases that pose a threat to the patient's life);

For use in surgical intervention and/or complex therapy, or to determine the need for their implementation;

For the diagnosis and/or treatment of a disease or diseases or conditions of a patient with a high risk to public health, and/or with a high individual risk;

 

  b) The conditions of use of the software belong to category "B" if the software is intended:

To provide urgent medical care (in case of sudden acute illnesses, conditions, exacerbation of chronic diseases without obvious signs of threat to the patient's life);

To provide medical care without surgical intervention;

For the diagnosis and treatment of a disease or diseases or conditions of a patient with a moderate risk to public health;

 

  c) The conditions of use of the software belong to category "C" if the software is intended:

To provide planned medical care (in the implementation of preventive measures, in the presence of diseases and conditions that do not pose a threat to the patient's life, do not require emergency and urgent medical care, and the postponement of which for a certain time will not lead to a deterioration in the patient's condition, a threat to his life and health);

For providing medical care using non-invasive methods and/or for use in long-term care;

For the diagnosis or treatment of a disease or diseases or conditions of a patient with a low risk to public health.

 

47. The use of software in conditions related to categories "A" and "B" is possible only by a healthcare professional who has undergone the necessary training in its use. The use of software in conditions related to category "C" is possible both by a healthcare professional and by a patient or other individual as prescribed and/or under the supervision of a healthcare professional.

 

48. Assigning information, depending on the impact of the results of the software on medical decision-making, to one of the types is carried out in accordance with the following criteria:

  a) The first type of information includes information that does not require clarification and/or supplementation for making a reasoned clinical (medical) decision and indicates the need for immediate and timely action;

  b) The second type of information includes information that requires clarification and/or supplementation for making a reasoned clinical (medical) decision;

  c) The third type of information includes information that does not indicate the need for immediate action.

 

3. Specifics of the Classification of Software depending on the Potential Risk of Use

 

49. If, when assigning software to a class depending on the potential risk of use, a combination of different types of information obtained using this software and/or categories of conditions in which it is used is possible, then the class of software is established that corresponds to the greatest degree of potential risk of use.

50. Examples of the classification of software depending on the potential risk of use are given in Appendix N 4.

 

 

Appendix N 1

to the Rules for Classification

of Medical Devices depending

on the Potential Risk of Use

 

ALGORITHM

for performing the 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

 

 

  

_________________

* Rules for the classification of medical devices based on the potential risk of use.

  Note:

  To classify a medical device, it is necessary to answer the question that allows the medical device to be assigned to the corresponding class, and then proceed to the item indicated next to the class designation. If several points of the Rules are applicable, the class of the medical device shall be the class corresponding to the highest degree of potential risk of use.

 

Appendix N 2

to the Rules for the classification

of medical devices based

on the potential risk of use

ALGORITHM

for conducting the classification of medical device

for in vitro diagnostics (excluding software that is a medical device) based

on the potential risk of use

________________

* Rules for the classification of medical devices based on the potential risk of use.

 Appendix N 3

 to the Rules for the classification

of medical devices based

on the potential risk of use

EXAMPLES

of the classification of in vitro diagnostic medical devices

(excluding software that is a medical device)

based on the potential risk of use

 

Appendix N 4
to the Rules for the classification
of medical devices based
on the potential risk of use

 

EXAMPLES
of the classification of software that is a
medical device, based on the potential risk
of use  

________________

* Excluding software that utilizes artificial intelligence (AI) technologies.

Appendix N 1

to the Rules for the classification

of medical devices base

 on the potential risk of use