Recommendation of the Board of the Eurasian Economic Commission dated November 12, 2018 No. 25
(as amended on June 29, 2021)
"On the Criteria for Classifying Products as Medical Devices within the Eurasian Economic Union"
BOARD OF THE EURASIAN ECONOMIC COMMISSION
RECOMMENDATION
dated November 12, 2018 N 25.
ABOUT THE CRITERIA
CATEGORIZATION OF PRODUCTS AS MEDICAL DEVICES WITHIN THE FRAMEWORK OF THE
EURASIAN ECONOMIC UNION
List of amending documents
(ed. Recommendations of the Board of the Eurasian Economic Commission
from 29.06.2021 N 15)
The Board of the Eurasian Economic Commission in accordance with Article 31 of the Treaty on the Eurasian Economic Union of May 29, 2014 and paragraph 2 of Article 3 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,
in order to eliminate differences in the requirements for classifying products as medical devices,
Recommends that member states of the Eurasian Economic Union, upon the expiration of 6 months from the date of publication of this Recommendation on the official website of the Eurasian Economic Union, apply the Criteria for classifying products as medical devices within the Eurasian Economic Union according to the annex.
Chairman of the Board
Eurasian Economic Commission
T. SARKISYAN
appendix
to the Recommendation of the Board
Eurasian Economic Commission
dated November 12, 2018 N 25.
CRITERIA
CATEGORIZATION OF PRODUCTS AS MEDICAL DEVICES WITHIN THE FRAMEWORK OF THE
EURASIAN ECONOMIC UNION
List of amending documents
(ed. Recommendations of the Board of the Eurasian Economic Commission
from 29.06.2021 N 15)
I. General provisions
1. This document has been developed in accordance with Article 31 of the Treaty on the Eurasian Economic Union of May 29, 2014 and paragraph 2 of Article 3 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 and defines the basic principles of attributing products to medical devices within the Eurasian Economic Union (hereinafter - the Union) in cases where this cannot be unambiguously established based on a certain definition of medical devices.
2. This document may be used in the preparation of documents for registration and examination of medical devices in accordance with 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 of February 12, 2016. N 46.
3. The provisions of this document may be followed by manufacturers, authorized representatives of the manufacturer, as well as experts of authorized bodies (expert organizations) of the Union Member States.
II. Concepts and definitions
4. For the purposes of the application of this document, the concepts defined by acts falling within the law of the Union shall be used.
III. Frontier medical devices
5. The intended use of a medical device is one of the main criteria for classifying products as medical devices. The use of a medical device must provide for its medical purpose. Such medical purpose shall be the sole or primary purpose.
1. Perfumery and cosmetic products and means
personal hygiene
6. If products are intended by the manufacturer for medical use, such products may be classified as medical devices. Examples of products that are classified as medical devices:
(a) Devices and devices, breast pumps (breast pumps) designed by the manufacturer for the treatment and prevention of breast diseases and pathologies;
b) warmers and warming elements, whose main purpose is to temporarily reduce and relieve pain;
c) products (diapers, diapers, pads, etc.) for people suffering from diseases of the genitourinary system or other diseases with impaired control of excretory function;
d) lubricant gels, lubricants;
e) laser and photoepilation products.
(item. "e" introduced by the Recommendation of the Board of the Eurasian Economic Commission from 29.06.2021 N 15)
7. If products are intended by the manufacturer to care for skin, hair, nails, lips, external genitals, teeth and oral mucosa, including if the additional purpose of these products is prevention of diseases and (or) age-related changes, such products are not classified as medical devices. Examples of products that do not belong to medical devices:
(a) Diapers, diapers, pads, etc. (except for products specified in subparagraph "c" of paragraph 6 hereof), as well as powder, powders, wipes, wet wipes and other products for children and newborns;
b) bottles, pacifiers, rubber teething products;
c) personal hygiene products for women: pads, tampons, tissues, towels and other personal hygiene products for women;
d) personal hygiene products: antibacterial gels and liquids (sanitizers), paper napkins, wet wipes;
e) tools, materials and products intended by the manufacturer for cosmetic procedures (tattooing, manicure, pedicure, piercing, hair removal, etc.);
(e) Mattress pads;
g) heating tapes and elements, heated baby food bottles;
h) slimming products (tight underwear, clothing, etc.);
(i) Oral cleaning and oral hygiene supplies (tooth and tongue brushes, dental floss, toothpicks, toothpaste, toothpowder, tooth whitening, mouthwash, mouth sprays, etc.);
(ed. Recommendation of the Board of the Eurasian Economic Commission from 29.06.2021 N 15)
(j) General hygiene products: razors, shaving equipment;
(l) Appearance enhancements: wigs for women and men;
m) products for the care of skin, hair, nails, lips, external genitals, teeth and oral mucosa that slow down and/or correct external signs of aging (creams, wipes, masks, body and hair washes, decorative cosmetics, etc.);
(n) Antibacterial soap, gel, mousse, etc.;
(o) Intimate hygiene and external genital skin care products: gels, foams, soaps, creams, deodorants, etc;
(n) Cosmetic patches, cosmetic eye patches;
(p) Products to reduce the external signs of cellulite: creams, gels, oils, scrubs, etc.
2. Disinfection agents and equipment
8. If products are intended by the manufacturer for medical use, such products may be classified as medical devices. Examples of products that are classified as medical devices:
(a) Air recirculators designed by the manufacturer for air purification in medical organizations (except for administrative and household rooms);
b) equipment designed by the manufacturer for air disinfection in medical organizations (bactericidal lamps, etc.);
(ed. Recommendation of the Board of the Eurasian Economic Commission from 29.06.2021 N 15)
c) equipment designed by the manufacturer for sterilization and disinfection of medical devices in medical organizations;
d) antiseptic wipes for treatment of surgeon's hands, surgical and injection fields;
(item. "d" introduced by the Recommendation of the Board of the Eurasian Economic Commission from 29.06.2021 N 15)
e) sterilization quality control indicators.
(item. "e" introduced by the Recommendation of the Board of the Eurasian Economic Commission from 29.06.2021 N 15)
9. If the products are used for treatment of premises, clothing and equipment for disinfection, disinsection, as well as for air purification and maintenance of a certain microclimate, including in case of their use in medical organizations, such products are not classified as medical devices. Examples of products that do not belong to medical devices:
a) disinfecting solutions, cleaning compositions (except for the means intended by the manufacturer for special treatment of medical devices);
(ed. Recommendation of the Board of the Eurasian Economic Commission from 29.06.2021 N 15)
b) insecticidal products for the treatment of premises against insects;
c) insect repellents (repellent) and acarorepellents to protect against insects;
d) means to control pediculosis (shampoos, lotions, emulsion concentrates, caps or towels and napkins impregnated with a special agent);
e) air recirculators, air ionizers and other air modification equipment intended by the manufacturer for household use.
3. General purpose products
10. If products are used in medical organizations for general purposes and if the purpose of these products does not specify medical use, such products may not be classified as medical devices. Examples of products that do not belong to medical devices:
(a) Monitors, printers, scanners, telephones, fax machines, system units and other organizational equipment, including accessories thereto;
b) televisions;
c) refrigerators for product storage (except for the equipment specified in paragraph 26 hereof).
4. Products for adaptation and rehabilitation of people
handicapped
11. If the products are used for the adaptation and rehabilitation of people with disabilities, such products may be classified as either medical devices or general purpose devices. The determining criteria are the existence of a direct relationship between the corrective effect of the product and the individual needs of the patient, as well as the indication in the purpose of the product on its use for medical purposes. Examples of products that qualify as medical devices:
(a) Accessories and prosthetic limbs;
b) hearing aids and sound amplification devices;
c) orthopedic shoes;
d) orthoses for the back and limbs;
e) walking aids for people with disabilities;
(e) Crutches and canes;
g) wheelchairs;
h) lifting devices to facilitate movement of patients (except for lifting devices specified in subparagraphs "c" and "e" of paragraph 12 of this document);
(i) Voice-forming apparatus.
(item. "and" introduced by the Recommendation of the Board of the Eurasian Economic Commission from 29.06.2021 N 15)
12. If there is no direct relationship between the corrective effect of the product and the individual needs of the patient and (or) if the purpose of the product does not specify its use for medical purposes, such products may not be classified as medical devices, but are defined as a general-purpose product. Examples of products that do not belong to medical devices:
(a) Sound equipment for people suffering from various types of dementia, for visually impaired people, audible crossing signals, audible orientation signals (the equipment can be used both at home and in public places);
b) special equipment for baths and showers for people with disabilities (chairs, seats and other devices);
c) stair elevators and elevator trucks for raising wheelchairs;
d) portable ramps and rehabilitation devices;
e) special gangways and elevators for baths and swimming pools for people with disabilities;
(e) Door and wall adaptations for persons with disabilities;
g) tactile transition signals and yellow circles.
5. Products for sports and therapeutic physical training
13. If the main purpose of sports and physical therapy products is their use for medical purposes as prescribed by the manufacturer, such products may be classified as medical devices. Examples of products that are classified as medical devices:
(a) Cooling (heating) packs, patches, bandages to reduce pain;
b) cryotherapy equipment;
c) bandages, bandages, dressings, elastic bandages and tapes designed by the manufacturer for the recovery and treatment of sprained muscles or ligaments;
d) equipment, simulators designed by the manufacturer for stress tests, the main indication for the use of which is the measurement of physiological functions of the human body (with the function of measuring pressure, pulse and breathing tests) (if the information obtained during the use of these products is intended for diagnosis and decision-making on the treatment of the disease).
14. Products for sports and therapeutic exercise are in most cases not classified as medical devices, including if their functional characteristics imply their use for medical purposes. Examples of products that do not qualify as medical devices:
a) treadmills, exercise machines with heart rate measurement function used in gyms and fitness clubs;
b) wristbands and bracelets that measure the number of steps walked and (or) heart rate;
c) tapes, expanders designed by the manufacturer for training and stretching muscles.
6. Personal protective equipment
15. Where personal protective equipment is intended by the manufacturer to protect patients or medical personnel and is used for medical purposes, such personal protective equipment may be classified as medical devices. Examples of personal protective equipment that qualify as medical devices:
(a) Medical masks and medical respirators designed to limit the transmission of infectious agents;
(ed. Recommendation of the Board of the Eurasian Economic Commission from 29.06.2021 N 15)
b) surgical and examination gloves;
c) shoe covers designed by the manufacturer to prevent cross-contamination in a health care organization;
(item. "c" in edition of Recommendation of the Board of the Eurasian Economic Commission from 29.06.2021 N 15)
d) products for protection of patients or medical personnel from radiation used in medical organizations during radiation diagnostics or radiation therapy;
(ed. Recommendation of the Board of the Eurasian Economic Commission from 29.06.2021 N 15)
e) mouth guards used in dental practice or for the treatment of sleep apnea;
(e) Protective goggles used during medical procedures;
g) clothing for medical personnel and patients used during medical procedures;
(ed. Recommendation of the Board of the Eurasian Economic Commission from 29.06.2021 N 15)
h) surgical linens (including sheets, diapers, covers used in surgical areas);
(item. "h" in edition of Recommendation of the Board of the Eurasian Economic Commission from 29.06.2021 N 15)
(i) Zero refraction soft contact lenses.
16. Examples of personal protective equipment that are not medical devices:
a) masks and respirators for respiratory protection against aerosols, vapors and gases of hazardous and harmful substances, which are not intended by the manufacturer for medical use, including those intended for work in harmful conditions of production, emergency situations;
(ed. Recommendation of the Board of the Eurasian Economic Commission from 29.06.2021 N 15)
b) gloves and other products used also for household purposes (cleaning, cleaning) (e.g. shoe covers, caps used in administrative and household premises);
c) products for protection against chemical and physical factors, including radiation, intended by the manufacturer for use at work or at home;
(ed. Recommendation of the Board of the Eurasian Economic Commission from 29.06.2021 N 15)
d) mouth guards designed by the manufacturer to protect the teeth during sports;
e) products for eye protection against dust, computer and sun radiation (safety glasses, sunglasses);
(ed. Recommendation of the Board of the Eurasian Economic Commission from 29.06.2021 N 15)
(e) Special clothing and special footwear that are not intended by the manufacturer for medical use.
17. Excluded. - Recommendation of the Board of the Eurasian Economic Commission from 29.06.2021 N 15.
7. Software
18. Software is a medical device if it meets all of the following criteria:
(a) Software is a computer program or program modules, regardless of the hardware platform used, and regardless of how the software is hosted and accessed;
b) the software is not an integral part of another medical device;
c) the software is intended by the manufacturer to provide medical care;
d) the result of the software action is the interpretation of data in automatic mode, including the use of artificial intelligence technologies, or according to the parameters specified by the medical worker, affecting clinical decision-making, of the data set.
(item 18 in edition of Recommendation of the Board of the Eurasian Economic Commission from 29.06.2021 N 15)
19. Examples of methods and techniques used in software functions that are not data interpretation:
(a) Displaying data received from the medical device, including in a specified format;
b) calculation according to the given formulas;
c) translation between units of measurement;
d) construction of statistical reports and graphs;
e) a raster or vector image editor;
f) signaling of deviations in the data, provided that it is possible to display the source data and provided that the parameters for signaling deviations are set by the user;
g) functions of creating screen forms, business processes, reporting and other views that are used to automate business processes of a medical organization in the course of software operation.
(item 19 in edition of Recommendation of the Board of the Eurasian Economic Commission from 29.06.2021 N 15)
20. Examples of software (including examples of functions, dataset sources, purposes, platforms, ways of presenting access, etc.) that relate to medical devices:
(a) Software for physician viewing of a customized anatomical 3D model based on computed tomography images that meets the following criteria:
interpretation function - calculation of the distance between two points of the anatomical 3D model;
the source of the data set is a CT scanner;
intended for use by radiologists, including in emergency care;
hardware platform - smartphone or tablet;
the method of providing access is the app store;
b) medical decision support software for stroke that meets the following criteria:
interpretation function - differentiation between ischemic and hemorrhagic stroke based on diagnostic images;
the source of the data set is a CT or MRI scanner;
intended for use by intensive care physicians, neurosurgeons and neurologists in neuroresuscitation and vascular centers, including emergency care;
hardware platform - any with web-browser support;
method of providing access - Internet site under SaaS licensing model;
c) software to assist the physician in the diagnosis of malignant neoplasms that meets the following criteria:
interpretation function - construction of a map of pathological changes on the skin surface, calculation of their fractal dimension to estimate the degree of probability of their malignancy;
the source of the dataset is health care providers by taking pictures with the built-in camera of a smartphone;
intended for use by dermatovenerology physicians at initial appointments;
hardware platform is a smartphone;
method of providing access - the developer's website;
d) software to assist the physician in the diagnosis of tuberculous or viral meningitis in children that meets the following criteria:
interpretation function - analyzing cerebrospinal fluid spectroscopy data to diagnose tuberculous or viral meningitis in children;
the source of the data set is a spectrograph;
intended for use by a medical laboratory technician;
hardware platform - personal computer;
method of providing access - purchase of license and electronic media;
(e) Medical decision support software for colorectal cancer risk assessment that meets the following criteria:
interpretation function - assessment of the risk of developing colorectal cancer based on the available data on a high-risk patient when developing his/her individualized plan of preventive measures;
the source of the dataset is health care providers and diagnostic equipment;
intended for use by physicians of various specialties at primary or follow-up appointments;
hardware platform - personal computer;
method of providing access - purchase of license and electronic media;
(e) Software to assist the physician in the diagnosis of arrhythmias that meets the following criteria:
interpretation function - analyzing heart rhythm data to diagnose arrhythmias;
data set source - pulse oximeters with wireless data transmission interface;
intended for use by physicians of any specialty, including emergency care;
hardware platform is a smartphone;
the method of providing access is the app store;
g) software to assist the physician in planning surgical techniques that meets the following criteria:
interpretation function - building and visualizing a customized anatomical 3D model based on CT images, used to determine catheter placement locations on the inner part of the bronchial tree and in the lung tissue or to place markers in soft lung tissue;
the source of the data set is a CT scanner;
intended for use by surgeons (thoracic surgery, radiosurgery);
hardware platform - personal computer;
method of providing access - purchase of the right to use the program with the possibility of downloading the distribution from the developer's website;
h) software to assist the physician in performing morphometric measurements that meets the following criteria:
interpretation function - image recognition and morphometry of cytological and histological preparations;
the source of the dataset is digital microscopes;
intended for use by laboratory technicians;
hardware platform - personal computer;
method of providing access - purchase of the right to use the program for an unlimited period of time with the possibility of downloading the distribution from the developer's site;
(i) Remote health monitoring software for elderly patients with comorbid chronic diseases that meets the following criteria:
interpretation function - automatic detection of pathological changes in blood pressure and heart rate, signs of rhythm disturbance with subsequent notification of persons monitoring and (or) caring for the patient, based on the data collected and received on the central server in automatic mode;
dataset source - tonometers with wireless data interface;
intended use by a medical professional;
hardware platform - personal computer;
method of providing access - purchase of the right to use the program with the possibility of downloading the distribution from the developer's website;
j) software for the development of an individual rehabilitation program that meets the following criteria:
interpretation function - predicting and assessing the extent of the intended outcome based on available patient data;
the source of the dataset is health care providers and diagnostic equipment;
intended for use by rehabilitation physicians;
hardware platform - personal computer;
method of providing access - purchase of license and electronic media from the developer;
(k) Prescription software to calculate a bolus dose of insulin for a diabetic patient at high risk of hypoglycemia based on carbohydrate intake, expected physical activity, and pre-meal blood glucose levels that meets the following criteria:
interpretation function - prandial insulin dose selection;
the source of the data set is the patient and the diagnostic equipment;
intended use by the patient as prescribed by the attending physician;
hardware platform - any with web-browser support;
method of providing access - internet site under SaaS licensing model;
(m) Radiology image archiving and transmission system software for image acquisition, storage, transmission, processing (image quality change, compression) and viewing by a physician that meets the following criteria:
interpretation function - determination of morphometric indices of the image;
the source of the dataset is various types of radiation diagnostic equipment;
intended use by physicians to provide medical care;
hardware platform - personal computer;
method of providing access - purchase of license and electronic media from the developer.
(item 20 in edition of Recommendation of the Board of the Eurasian Economic Commission from 29.06.2021 N 15)
21. Examples of software that is not related to medical devices:
(a) Software designed to automate the administrative and economic activities of a medical organization;
b) software, including mobile applications, designed by the manufacturer for the purposes of promoting a healthy lifestyle and for forming in people a responsible attitude to the preservation and promotion of health, maintenance of active longevity, which, among other things, measures (calculates) the number of steps, walking (running) speed, pulse rate, amount of spent and (or) consumed calories (liquid), weight, body mass index, etc.;
c) medical information systems of a medical organization, laboratory information systems, software for maintaining electronic medical records, image archiving and transmission systems, if such software does not contain data interpretation functions;
d) software, including software updates, used to control the medical device and monitor its performance;
e) software that uses data from one or more medical devices but is not intended to provide medical care. For example, software that encrypts and/or aggregates data (including patient data) from one or more medical devices for further transmission;
f) software for exchange of text and (or) voice messages, electronic documents, photographic images, video and audio recordings (streams) and other data between a medical worker and a patient, their registration, storage and providing access to them when providing medical care, including with the use of telemedicine technologies, or for making an appointment;
g) software for recording, planning and controlling the implementation of routine maintenance and scheduled repair of medical devices;
h) software intended for use by an unlimited number of users for educational, popular science, reference and information purposes, including for selection of a medical specialist, for reminding (controlling) the need to take a medicinal product, providing information from the general characteristics of the medicinal product and instructions for medical use.
(item 21 in edition of Recommendation of the Board of the Eurasian Economic Commission from 29.06.2021 N 15)
22 - 25. Excluded. - Recommendation of the Board of the Eurasian Economic Commission from 29.06.2021 N 15.
8. Packaging and storage equipment for medical devices
and other products
26. If the equipment is intended by the manufacturer to store medical devices and other medical products (medicines, etc.) that require special storage conditions, such products may be classified as medical devices. Examples of products that are classified as medical devices:
(a) Equipment for the storage and transportation of biological fluids and materials having a temperature maintenance regime and other special storage conditions;
b) equipment designed by the manufacturer for storage of medical products, having a temperature maintenance regime and other special storage conditions;
c) packaging for sterilization of medical devices used in medical institutions;
(subp. "c" introduced by the Recommendation of the Board of the Eurasian Economic Commission from 29.06.2021 N 15)
d) devices (injectors) for the administration of medicines available in replaceable cartridges.
(item. "d" introduced by the Recommendation of the Board of the Eurasian Economic Commission from 29.06.2021 N 15)
27. Packaging and equipment for storage of medical devices and other products (medicines, etc.) that do not require special storage conditions do not belong to medical devices. Examples of products that do not belong to medical devices:
(a) Bags for first aid kits (first aid kits, bags and cases for emergency medical aid, cases for storage and transportation of drugs, medicines and items that do not require special storage conditions, etc.);
b) cases for glasses, cases for lenses;
c) cases for devices (injectors) for the administration of medicines produced in replaceable cartridges.
28. Do not apply to medical devices:
a) primary, intermediate and secondary (consumer) packaging of medicinal products, including primary packaging of a medicinal product that is a means of administration (e.g., multi-dose syringe pen with a fixed cartridge, prefilled syringe);
b) dosing device (dispenser) and (or) device for dissolution (dilution) of the medicinal product (e.g. adapter, dosing syringe, dosing cap, dosing spoon) enclosed in the secondary (consumer) package of the medicinal product;
c) sachets or tablets with desiccant enclosed in primary or secondary (consumer) packaging of the medicinal product.
(item 28 in edition of Recommendation of the Board of the Eurasian Economic Commission from 29.06.2021 N 15)
9. Physiotherapy equipment and products
domestic use
29. Where the main purpose of a product is physiotherapy, it is not a natural resource and at the same time it is intended by the manufacturer for use only in a medical organization or as prescribed by a doctor, such products may be classified as medical devices. An example of products that are classified as medical devices is physiotherapy equipment intended by the manufacturer for the prevention and treatment of various diseases.
30. Examples of products that do not qualify as medical devices:
(a) Peloids, mineral waters, stone therapy stones and other natural resources;
b) cedar barrels, infrared saunas and other products for general tonic purposes.
10. Furniture
31. If furniture is used in a special medical room (treatment room, operating room, etc.) and (or) is subjected to a certain type of treatment, such products may be classified as medical devices. Examples of products that are classified as medical devices:
(a) Medical couches;
b) special furniture, including anesthesiologist's tables, procedure tables, racks (racks) for infusions, etc...;
(item. "b" in edition of Recommendation of the Board of the Eurasian Economic Commission from 29.06.2021 N 15)
c) massage tables;
d) operating tables;
e) functional medical beds;
(e) Medical chairs (dental, gynecological, dialysis, donor, etc.).
(item. "e" introduced by the Recommendation of the Board of the Eurasian Economic Commission from 29.06.2021 N 15)
32. If furniture is not used in a special medical room (treatment room, operating room, etc.) and is not used for medical purposes in accordance with the main purpose, such products cannot be classified as medical devices. Examples of products that do not belong to medical devices:
(a) Desk;
b) office chairs;
c) sofa, chairs, banquettes and other furniture used in the patient waiting room;
d) cabinet for storage of medical products that do not require special storage conditions;
e) furniture for dining rooms in medical organizations.
11. medical devices containing the following
medicinal products
33. Where products contain medicinal products and their primary action is not by pharmacological, immunological, genetic or metabolic action, but by physical or mechanical action, such products may be classified as medical devices. Examples of products that qualify as medical devices:
(a) Highly elastic materials with viscoelastic properties containing hyaluronic acid and its salts and other components;
b) deleted. - Recommendation of the Board of the Eurasian Economic Commission from 29.06.2021 N 15;
c) drug-coated stents and other implantable devices in which the antiproliferative or other pharmacological action of the drug is secondary to the mechanical restoration of the lumen of a vessel or other part of the body achieved by the stent or other implantable device;
d) nasal and throat irrigation products, including those containing substances whose main purpose is not accomplished by pharmacological, immunological, genetic or metabolic action;
e) medical devices in various forms of release (e.g. solutions, drops, sprays, powders, pastes, gels, etc.), including those containing medicinal products, the main purpose of which is not carried out through pharmacological, immunological, genetic or metabolic effects on the human body;
f) dressings (including napkins), bandages, wound dressings, including those containing drugs, antiseptics (including alcohols) and (or) other substances, the main purpose of which is not realized through pharmacological, immunological or metabolic effects;
g) media, solutions for transportation of organs and tissues that do not have metabolic effects;
h) eye drops, moisturizing solutions for irrigation of the eye, including those containing substances whose main purpose is not carried out by pharmacological, immunological or metabolic action;
(i) Hemostatic sponges, which do not contain substances involved in thrombosis and have a hemostatic effect by mechanically preventing bleeding;
j) concentrates, solutions for hemodialysis;
l) deleted. - Recommendation of the Board of the Eurasian Economic Commission from 29.06.2021 N 15;
(m) Hyaluronic acid products (e.g. for intra-articular, intradermal administration, etc.);
n) deleted. - Recommendation of the Board of the Eurasian Economic Commission from 29.06.2021 N 15.
12. Products for in vitro diagnostics
34. The attribution of products intended by the manufacturer for laboratory use to medical devices for in vitro diagnostics is carried out in accordance with the definition of medical devices for in vitro diagnostics established by acts of the Eurasian Economic Commission. Examples of products that are classified as in vitro diagnostic medical devices:
(a) Hematocrit centrifuge, centrifuge for cytology studies;
(ed. Recommendation of the Board of the Eurasian Economic Commission from 29.06.2021 N 15)
b) deleted. - Recommendation of the Board of the Eurasian Economic Commission from 29.06.2021 N 15;
c) vials and containers for the collection of human biological material;
d) antigen- or antibody-sorbed plates for the detection of various diseases or pathological conditions, blood groups and Rh factor;
(ed. Recommendation of the Board of the Eurasian Economic Commission from 29.06.2021 N 15)
e) genetic tests intended by the manufacturer to diagnose human genetic disorders and diseases and to identify predisposition to them;
(e) Nutrient media that are specifically designed and intended to provide information relating to a physiological or pathological condition using biological material derived from human beings;
(subp. "e" introduced by the Recommendation of the Board of the Eurasian Economic Commission from 29.06.2021 N 15)
g) reagent kits intended for the isolation of nucleic acids (DNA and/or RNA) from biological material obtained from a human being and subsequent use in combination with a medical device for in vitro diagnostics for the detection of a specific analyte.
(subp. "g" introduced by the Recommendation of the Board of the Eurasian Economic Commission from 29.06.2021 N 15)
35. In case the products do not have specific characteristics that make possible their special purpose for in vitro medical diagnostic tests, such products cannot be referred to in vitro diagnostic medical devices and are general laboratory products. Examples of products that do not belong to medical devices for in vitro diagnostics:
(a) Reagent kits intended by the manufacturer for sanitary and hygienic and sanitary-epidemiological research, quantitative and qualitative research in environmental objects, cosmetic, chemical, food products and food raw materials (e.g., for the detection of infectious agents, heavy metals, etc.);
b) standard samples, international reference materials and materials intended by the manufacturer for external quality control;
c) reagent kits intended by the manufacturer for forensic or law enforcement use;
d) articles, including equipment, measuring instruments and reagents, intended by the manufacturer for use in research and development;
(item. "d" in edition of Recommendation of the Board of the Eurasian Economic Commission from 29.06.2021 N 15)
e) centrifuges, pumps, stirrers, scales, pipettes, incubators, microtomes, sterilizers for laboratory equipment, apparatus for paraffin waxing, microscopes, shakers, laminar flow cabinets, etc. - in case the purpose does not specify that the products are specifically designed for medical use;
(e) Pipettes, filters and other consumables for general purposes (disposable and reusable pipettes, plastic pipettes, Pasteur pipettes, etc.);
g) plastic and glass tubes and vials;
h) empty immunoassay plates, empty petri dishes, etc.;
(i) General laboratory, non-specialized washing solutions for laboratory equipment, cell culture medium, various general buffer solutions, paints, chemical reagents, etc.;
(ed. Recommendation of the Board of the Eurasian Economic Commission from 29.06.2021 N 15)
(j) DNA and RNA isolation kits that provide only for the isolation of a nucleic acid sample without necessarily being intended to be used in combination with an in vitro diagnostic medical device intended by the manufacturer for the detection of a specific analyte;
(k) Blood, plasma, rabbit, calf, lamb, horse and other animal serum, nutrient media without specific medical use and other nutritional supplements or ancillary tests (e.g. indole formation test, oxidase test, hydrogen sulphide formation test, Voges-Proskauer test).
(item. "l" introduced by the Recommendation of the Board of the Eurasian Economic Commission from 29.06.2021 N 15)
