Type of medical device. Legislative base of the Russian Federation

Registration N 24852

In accordance with part 2 of article 38 of the Federal Law of November 21, 2011 N 323-FZ "On the basics of protecting the health of citizens in Russian Federation"(Collected Legislation of the Russian Federation, 2011, N 48, Art. 6724) and Decree of the President of the Russian Federation of May 21, 2012 N 636 "On the structure of federal executive bodies" (" Russian newspaper", 2012, N 114) order:

Approve:

nomenclature classification of medical devices by types in accordance with Appendix No. 1;

nomenclature classification of medical devices by classes depending on the potential risk of their use in accordance with Appendix No. 2.

Minister V. Skvortsova

Appendix No. 1

Appendix No. 2

Nomenclature classification of medical devices by classes depending on the potential risk of their use

1. With the nomenclature classification of medical devices by classes, depending on the potential risk of use (hereinafter referred to as the classification of medical devices), medical devices are divided into four classes. Classes are labeled 1, 2a, 2b and 3.

I. Classification of medical devices (except for medical devices for in vitro diagnostics)

2. When classifying medical devices, each medical device can be assigned to only one class:

class 1 - low-risk medical devices;

class 2a - medical devices with medium degree risk;

class 2b - medical products with an increased degree of risk;

class 3 - medical products with a high degree of risk.

3. When classifying medical devices, their functional purpose and conditions of use are taken into account, as well as the following criteria:

duration of use of medical devices;

invasiveness of medical devices;

presence of contact of medical devices with human body or relationship with it;

method of introducing medical devices into the human body (through anatomical cavities or surgically);

the use of medical products for vital organs and systems (heart, central circulatory system, central nervous system);

application of energy sources.

4. When assigning medical devices to classes, depending on the potential risk of use, the following provisions must be taken into account:

4.1. Non-invasive medical devices are in Class 1 if none of the provisions below apply, except for the provisions in 4.4.1.

4.2. Non-invasive medical devices designed to carry or store blood, body fluids or tissues, liquids or gases for the purpose of subsequent infusion, transfusion or introduction into the body, belong to class 2a.

4.3. Non-invasive medical devices intended to change the biological or chemical composition blood, other body fluids, or fluids intended for infusion into the body are in Class 2b. However, in cases where therapeutic effect consists in filtering, centrifuging, gas exchange or heat exchange to change the biological or chemical composition of blood, other body fluids or fluids intended for infusion into the body, medical devices belong to class 2a.

4.4. Non-invasive medical devices that come into contact with damaged skin:

4.4.1. are in class 1 if they are used as mechanical barriers or for compression;

4.4.2. are in class 2b if they are used for wounds that can only be healed by secondary healing;

4.4.3. belong to class 2a if they are used in all other cases (including medical devices that are intended primarily to affect the microenvironment of wounds).

4.5. Invasive medical devices (with the exception of surgical invasive ones), the use of which is associated with anatomical cavities in the human body and which are not intended to be attached to an active medical device:

4.5.1. belong to class 1 if these medical devices are of short-term use (continuous use for no more than 60 minutes);

4.5.2. belong to class 2a if these medical products are of temporary use (continuous use for no more than 30 days), however, in cases where these medical products are temporarily used in the oral cavity up to the pharynx, in ear canal before eardrum or in the nasal cavity, they are in class 1;

4.5.3. belong to class 2b if these medical products are of long-term use (continuous use for more than 30 days), however, in cases where these medical products are used for a long time in the oral cavity up to the pharynx, in the ear canal up to the eardrum or in the nasal cavity and not may be mucosally resorbable, they are class 2a;

4.5.4. all invasive medical devices (with the exception of surgical invasive ones), the use of which is associated with anatomical cavities in the body and which are intended to be attached to an active medical device of class 2a or a higher class, belong to class 2a.

4.6. Surgical invasive short-term medical devices are in class 2a, but if they:

4.6.1. designed to diagnose, monitor, control or correct pathologies of the heart, the central circulatory system or the central nervous system in direct contact with organs or parts of these systems, they are classified in class 3;

4.6.2. are reusable surgical instruments, then they belong to class 1;

4.6.3. designed to transfer energy in the form of ionizing radiation, they belong to class 2b;

4.6.4. are intended to cause a biological effect, to dissolve completely or to a large extent, then they belong to class 2b;

4.6.5. designed to administer drugs through a dosing system that uses potentially dangerous method introductions, then belong to class 2b.

4.7. Surgical invasive medical devices for temporary use are in class 2a, but if they:

4.7.1. are intended for the diagnosis, observation, control or correction of pathologies of the heart or the central circulatory system in direct contact with organs or parts of these systems, then they belong to class 3;

4.7.2. directly in contact with the central nervous system, then they belong to class 3;

4.7.3. designed to transfer energy in the form of ionizing radiation, they belong to class 2b;

4.7.4. are intended to cause a biological effect, to dissolve completely or in a significant part, then they belong to class 3;

4.7.5. undergo chemical changes in the body or administer drugs, then they belong to class 2b (with the exception of medical devices implanted in the teeth).

4.8. Implantable medical devices, as well as surgical invasive medical devices for long-term use, are classified as class 2b, however, if they:

4.8.1. intended for implantation in the teeth, then they belong to class 2a;

4.8.2. in direct contact with the heart, the central circulatory system or the central nervous system, then they are classified as class 3;

4.8.3. are intended to cause a biological effect or be completely or substantially absorbed, they are classified in class 3;

4.8.4. undergo chemical changes in the body or introduce drugs into the patient's body, then they belong to class 3 (with the exception of medical devices implanted in the teeth).

4.9. Active therapeutic medical devices:

4.9.1. active medical devices that are intended for energy transfer or energy exchange belong to class 2a. However, if the transfer of energy to the human body or the exchange of energy with it is a potential hazard due to the characteristic features of medical devices, taking into account the impact on the parts of the body to which energy is applied (including active medical devices designed to create ionizing radiation, radiotherapy), then they belong to class 2b;

4.9.2. active medical devices intended to control class 2b active therapeutic medical devices belong to class 2b.

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

4.10.1. transfer of energy absorbed by the human body, however, if the function medical device is the illumination of the patient's body in the visible range of the spectrum, then they belong to class 1;

4.10.2. distribution of radiopharmaceutical drugs introduced into the patient's body;

4.10.3. provide direct diagnosis or monitoring of vital body functions, but if they are intended to monitor vital physiological parameters, changes in which could lead to an immediate danger to the patient (for example, changes in heart function, respiration, or activity of the central nervous system), then they are class 2b;

4.10.4. control of active diagnostic medical devices of class 2b belong to class 2b.

4.11. Active medical devices intended for the introduction of drugs, physiological fluids or other substances into the patient's body and (or) their removal from the body belong to class 2a. However, if the method of administration (removal) represents a potential hazard, taking into account the type of substances concerned, the part of the body and the method of application, then they belong to class 2b.

4.12. Other active medical devices are in Class 1.

4.13. Medical devices, the components of which include a substance that is medicinal product or other biologically active agent and affecting human body in addition to exposure to the medical device, are classified in class 3.

4.14. Medical devices designed to control conception or to protect against sexually transmitted diseases are classified in class 2b, but if they are implantable or invasive long-term medical devices, then they are classified in class 3.

4.15. Medical devices intended for disinfection of medical devices belong to class 2a, however, if they are intended for cleaning, washing, disinfection contact lenses, then they belong to class 2b.

4.16. Non-active medical devices used to obtain diagnostic x-rays are in class 2a.

4.17. Medical devices that have been manufactured using dead animal tissue or derived products are in class 3, but if they are intended to come into contact only with intact skin, then they are in class 1.

4.18. Containers for blood, blood products and blood substitutes belong to class 2b.

5. If a medical device is intended to be used in combination with other medical devices, then classes are established for each medical device.

6. If during classification different provisions can be applied to a medical device, then the provisions are applied as a result of which the class of the medical device corresponding to the highest degree of potential risk is established.

7. For special software that is an independent product and used with a medical device, the same class is established as for the medical device itself.

II. Classification of medical devices for in vitro diagnostics

8. When classifying medical devices for in vitro diagnostics (hereinafter referred to as medical devices), each medical device can be assigned to only one class:

class 1 - medical products with low individual risk and low risk to public health;

class 2a - medical devices with a moderate individual risk and / or low risk to public health;

class 2b - medical products with high individual risk and/or moderate risk to public health;

class 3 - medical products with high individual risk and/or high risk to public health.

9. When classifying medical devices into classes, depending on the potential risk of use, the following provisions must be taken into account:

9.1. Medical devices designed to detect infectious agents in blood, blood components, blood derivatives, cells, tissues or organs, in order to assess the possibility of their transfusion or transplantation, medical devices designed to detect infectious agents that can cause diseases that threaten human life , with a high risk of spread and which provide crucial information for a correct diagnosis, are in class 3.

9.2. Medical devices that are used to determine blood groups or tissue types in order to guarantee the immunological compatibility of blood, blood components, cells, tissues or organs that are intended for transfusion or transplantation belong to class 2b, with the exception of ABO systems, Rh systems (C , c, d, e, e), Kell systems, Kidd systems and Duffy systems are classified in class 3.

9.3. Medical devices belong to class 2b if they are intended for the following purposes:

9.3.1. to identify infectious agents of sexually transmitted diseases;

to detect in the cerebrospinal fluid or blood infectious agents with a moderate risk of spread and which provide crucial information for making a correct diagnosis;

9.3.2. to detect the presence of infectious agents when there is a significant risk that an erroneous result may cause death or incapacitation of the patient or fetus being examined;

9.3.3. when screening pregnant women to determine their immune status in relation to infections;

9.3.4. when determining the status infectious disease or immune status if there is a risk that an erroneous result will lead to a therapeutic decision causing imminent danger to the patient's life;

9.3.5. in screening to select patients for elective therapy or for diagnosis (eg, cancer diagnosis);

9.3.6. in genetic testing, when the result of the test leads to a serious interference in a person's life;

9.3.7. to control the levels of drugs, substances or biological components, when there is a risk that an incorrect result will lead to a therapeutic decision that causes a life-threatening situation for the patient;

9.3.8. in the treatment of patients suffering from life threatening infectious disease;

9.3.9. in screening for congenital diseases of the fetus.

9.4. Medical devices intended for testing samples and self-control belong to class 2b, excluding those medical devices whose analysis result does not have a critical medical status or is preliminary, requires comparison with the corresponding laboratory tests, belong to class 2a.

9.5. Medical devices that do not have a measuring function, which, due to their objective properties, can be used as general laboratory ones, 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) belong to class 1 .

9.6. Medical devices not covered by the provisions of paragraphs 9.1 - 9.5 belong to class 2a, including:

9.6.1. medical devices with a measuring function (analyzers) with a non-fixed list of performed laboratory research, which depends on the reagent kits (test systems) used. The interdependence of the analyzer and the reagents used, as a rule, does not allow an analyzer to be evaluated separately, however, this does not affect its assignment to class 2a;

9.6.2. medical devices, in the application of which the therapeutic decision should be made after further research;

9.6.3. medical devices used for monitoring and treatment of oncological diseases.

10. If a medical device is intended to be used in combination with other medical devices, then classes are established for each medical device.

11. Calibration and control materials with quantitatively and qualitatively specified values belong to the same class as the medical devices they are intended to control.

12. For special software that is an independent product and used with a medical device, the same class is established as for the medical device itself.

Mikhail Albertovich, first explain what a nomenclature classifier is and why is it needed at all?

— At the request of Government Decree No. 1416 “On approval of the Rules state registration medical devices”, Federal Law No. 323 FZ “On the Fundamentals of Protecting the Health of Citizens in the Russian Federation”, as well as on behalf of the Chairman of the Government of the Russian Federation Dmitry Medvedev, a nomenclature classifier of medical devices should be developed in Russia.

The document is intended for identification of medical devices during their circulation, for quality monitoring, as well as for cooperation and data exchange between interested parties (including at the international level). To achieve the above goals, the Russian classifier must be harmonized with other classifiers used in the world.

Has the classifier been completed yet?

- Currently, the draft nomenclature classifier is posted on the official website of Roszdravnadzor for public discussion. To date, we have received proposals and comments from the professional community on 884 of its positions, in accordance with which the specialists of the Service are working to correct the list of types of medical devices and their descriptions.

Are there differences between Russian and international nomenclature classification?

- When developing the document, the English version of the classifier, the most common in the world, was taken as a basis. In general, the structure and approaches to the formation of the Russian nomenclature classification do not differ from the principles used in other countries. But since not all products included in the nomenclature of the GMDN Agency (Global Medical Device Nomenclature - an organization that compiles an international classifier) are medical Russian legislation, the Russian classifier will include only those types of products that are called "medical" in accordance with Federal Law No. 323 "On the Fundamentals of Protecting the Health of Citizens in the Russian Federation".

Also, in the Russian version, the codes used will also differ. Under the terms of the memorandum signed between Roszdravnadzor and the GMDN Agency, codes other than GMDN must be used in our country. According to the agreement, a six-digit code will be used in the Russian-language nomenclature. At the same time, I want to emphasize that for data exchange between countries, Roszdravnadzor has a list of code matches.

Can we say that the developed classifier is a complete document that interested parties will use for the next 5-10 years?

— Currently, the list of medical products includes a little more than 20 thousand types of items. But it is constantly changing and supplementing, which allows you to maintain it in up to date and harmonize with the nomenclature classification adopted in most countries, which, by the way, is updated up to several times a week.

Roszdravnadzor, which is entrusted with the authority to organize the maintenance of the classifier, will make all changes and additions to it in a timely manner. We have reached an agreement with the GMDN Agency to provide updates to the international classification on a monthly basis.

It should be emphasized that the dynamic nature of the list of types of medical devices does not allow fixing it at a specific moment. In this regard, we have identified only the main - relatively stable - groups and subgroups of medical devices. Specific types of medical devices (more than 20,000) included in these subgroups will be posted on the Roszdravnadzor website.

Despite the obvious need for such a document for the Russian market of medical devices, some experts frighten the professional community with the coming "collapse" associated, in their opinion, with the adoption of the Russian classifier. Do you think their fears are justified?

“Of course not justified. These are just frightening forecasts that have no basis and are not supported by facts. The fact is that the issues of creating a classifier and the basic principles of its use were repeatedly discussed at meetings of the Coordinating Council in the field of circulation medicines and medical devices at the Ministry of Health of Russia, where, by the way, representatives of the professional and medical community have always been present. All their proposals were included in the draft classifier. Therefore, to say that the interested parties did not take part in this process, and the introduction of the classifier for them is a complete surprise, at least, is not correct.

I also want to assure the professional community that the adoption of the classification will not lead to an increase in the number of refusals to register. In case of an incorrect indication of the type of medical device in the application, Roszdravnadzor will independently determine and indicate this type, and during registration will enter it into the state register of medical devices.

How much will this service cost applicants?

“They don’t have to pay anything. Russian codes will be assigned during the registration process, and those who have previously registered medical devices will go through the procedure within the service automatically. I note that abroad the applicant separately pays for the procedure for assigning a number.

The number assigned to a medical device will remain with it forever, or will it need to be changed over time?

— The assigned number will not change for the entire period of circulation of the medical device. Newly developed ones will be added and the numbers of obsolete species will be removed.

EAT. ASTAPENKO, Ph.D., Head of Organization Department state control and registration of medical devices of Roszdravnadzor, V.S. ANTONOV, Ph.D., assistant CEO, Federal State Budgetary Institution "CMIKEE" of Roszdravnadzor, MM. SUKHANOVA, Deputy Head of the Department for the Organization of State Control and Registration of Medical Devices of Roszdravnadzor

The article is devoted practical application nomenclature classification of medical devices by type. The goals and objectives of the nomenclature classification of medical devices are described. The structure of the type of medical product is given.

Currently, the Russian Federation is working to improve the regulatory legal acts in the field of circulation of medical devices, aimed at harmonizing Russian and international legislation, the prerequisites for which were the entry of the Russian Federation in 2013 into the number of participants in the International Medical Devices Regulators Forum (IMDRF).

On November 4, 2012, the order of the Ministry of Health of Russia dated 06.06.2012 No. 4n "On approval of the nomenclature classification of medical devices" came into force. Appendix No. 1 of this document determined the structure of the nomenclature classification of medical devices by type (hereinafter referred to as the Nomenclature Classification), but in practice it has not found its application. In connection with the foregoing, as well as on the basis of instructions from the Chairman of the Government of the Russian Federation D.A. Medvedev to develop and approve a classifier of medical devices based on the international nomenclature of medical devices, the Ministry of Health of Russia, together with Roszdravnadzor, worked on the development of a Russian nomenclature classifier of medical devices.

Classification is understood as a multi-stage division of the logical volume of a concept or any set of units into a system of subordinate concepts or classes of objects. The ultimate goal of the classification is to determine the place in the system of any unit, and thereby establish the presence of some links between them.

The main problem that arises when creating a logical, consistent, universal system for identifying medical devices is to compare medical and technical criteria. Based on world practice, it can be concluded that the identification of medical devices is possible only when using a multidimensional criteria structure.

Currently, the Global Medical Device Nomenclature (GMDN) (hereinafter referred to as the Global Nomenclature, GMDN), developed by the non-governmental organization GMDN Agency (Great Britain) and used in 65 countries of the world, is becoming increasingly important in world practice. To date, the above nomenclature contains about 22,000 types of medical devices. In the European database of medical devices EUDAMED, as part of the product data, the code of the type of the Global Nomenclature is entered. In April 2012, an agreement was reached between GMDN and the International Organization for Standardization of Health Terminology (IHTSDO) to use the Global Medical Device Nomenclature as the basis for the Standardized Clinical Terminology (SNOMED CT) section. In accordance with the IMDRF documents, the GMDN nomenclature is integrated into international project unique medical device identification (UDI).

At the same time, it should be noted that the nomenclature classification of medical devices by type is aimed primarily at:

For the identification of medical devices under state and interstate control of their quality, efficiency and safety;
- for the identification of medical devices when they are included in the standards and procedures for the provision medical care;
- for planning the equipment of medical institutions, taking into account the types medical activities, as well as for use by ministries of health and other executive authorities for various purposes.

Based on the foregoing, the development of the nomenclature classification of medical devices by type was carried out on the basis of the GMDN Global Nomenclature of Medical Devices, taking into account its adaptation to Russian legislation in the field of circulation of medical devices, for which, on May 26, 2014, an agreement was signed between Roszdravnadzor and the GMDN Agency on the transfer of access rights and how to use the global international nomenclature of medical devices.

The fundamental regulatory legal act regulating relations arising in the field of protecting the health of citizens in the Russian Federation is the Federal Law of November 21, 2011 No. 323-FZ “On the Basics of Protecting the Health of Citizens in the Russian Federation” (hereinafter - Law No. 323-FZ). Article 38 of this law defines medical devices, regulates the procedure for their registration, circulation, classification (including by types and classes, depending on the potential risk of their use), import, maintenance of the State Register of medical devices and organizations (individual entrepreneurs), engaged in the production and manufacture of medical devices.

In connection with the development and implementation of the nomenclature classification of medical devices by type on the territory of the Russian Federation and in pursuance of the provisions of Art. 38 of Law No. 323-FZ, amendments were made to the following regulatory legal acts:

Decree of the Government of the Russian Federation of December 27, 2012 No. 1416 “On Approval of the Rules for the State Registration of Medical Devices”;
- Order of the Ministry of Health of the Russian Federation dated 06.06.2012 No. 4n "On approval of the nomenclature classification of medical devices" (hereinafter - Order No. 4n).

Thus, since July 29, 2014, in connection with the entry into force of the Decree of the Government of the Russian Federation of July 17, 2014 No. 670 “On Amendments to the Rules for the State Registration of Medical Devices”, Roszdravnadzor has been empowered to ensure the organization of work on the formation and maintenance of the nomenclature classification of medical devices according to types, and from January 06, 2015, by order of the Ministry of Health of the Russian Federation of September 25, 2014 No. 557n "On Amendments to Appendix No. 1 to the Order of the Ministry of Health of the Russian Federation of June 6, 2012 No. 4n" On Approval of the Nomenclature Classification of Medical Devices " nomenclature classification of medical devices by type.

According to order No. 4n, the Nomenclature classification contains ( picture):

Numerical designation of the type of medical product -- six-digit identification unique record number;
- name of the type of medical product;
- description of the type of medical device.

The type name is not a standardized name for a particular medical device, but defines a type or species group, which is a collection of products that have the same or similar purpose and device (design).

The description of the type of medical device is formed on the basis of 6 classification features of the formation of the type of medical device: scope, invasiveness, sterility, frequency of use, design features and operational features, which makes it possible to unambiguously refer the medical device to the type of the Nomenclature Classification.

The nomenclature classification of medical devices by type is formed by groups and subgroups and posted on the official website of Roszdravnadzor www.roszdravnadzor.ru in the Electronic Services section.
The name and description of the type of medical device may be changed over time, which is associated with an increase in the requirements for detailing a particular type, or the emergence of fundamentally new types of medical devices may occur, which requires constant updating of the Nomenclature Classification. In this regard, Roszdravnadzor updates the data of the Nomenclature Classification of Medical Devices by Type at least once a month with the posting of these changes on the official website of Roszdravnadzor. Taking into account the fact that the type of medical device is also reflected in the corresponding entry of the State Register of Medical Devices and Organizations (Individual Entrepreneurs) engaged in the production and manufacture of medical devices, Roszdravnadzor also intends to notify the relevant manufacturers of medical devices about the changes that have occurred, the codes of which have been changed due to updating the Nomenclature Classification.

Thus, the introduction into Russian practice of the nomenclature classification of medical devices, harmonized with the international one, was a significant step towards the modernization of legislation in the field of circulation of medical devices. If initially the main area of its application was considered to be the identification of medical devices in the monitoring of adverse events, then at present the use of nomenclature classification is relevant in various fields associated with the protection of the health of the population of the Russian Federation.

The nomenclature classification of medical devices by type is placed on the CD attached to the journal.

Instructions for searching for species in the nomenclature classification of medical devices by type

The nomenclature classification of medical devices by type (hereinafter referred to as the nomenclature classification) was approved by Order of the Ministry of Health of the Russian Federation dated June 6, 2012 No. 4n "On Approval of the Nomenclature Classification of Medical Devices".

The nomenclature classification is placed in in electronic format on the official website of the Federal Service for Surveillance in Healthcare in the information and telecommunications network "Internet".

The nomenclature classification contains:

Numerical designation of the type of medical device - a six-digit identification unique record number presented on the website in the first column of the table (column "Code"),

Name of the type of medical device (column "Name"),

Description of the type of medical device (column "Description").

The search for a species is carried out primarily by name. To clarify the attribution, a search is used for the description of the type, which contains a description of the properties and classification features of the medical device.

It is possible to search for a species in the nomenclature classification in the following ways:

The search for a word or part of a word in the name of a species is performed by placing the word or part of it in the name search string.

The line "Advanced search" allows you to navigate:

By type code;

By a word or part of a word in the species description;

By the word or part of the word in the title of the section.

On the left side of the page there is a list of sections and subsections, which allows you to select the types contained in this section (subsection). One view can belong to several sections (subsections). If you cannot find a view by keyword, it is recommended that you carefully review the views included in the corresponding section. This allows you to pick up additional keywords to search for the species.

Simultaneous use of search by name and description, or simultaneous search by name and selection of the appropriate section (subsection) allows you to narrow down the search of the desired type.

Search example.

Product name: Cobalt-chromium coronary stents.

Step 1.

Enter the word "stent" in the search bar by name. In the table, 174 records of types containing words that include this combination of letters are selected.

Step 2

To narrow the search, you can simultaneously enter a part of the word "coronary" in the "Advanced search" in the "Description" line. 14 records selected, 6 of them various kinds(some species are repeated, as they belong to several subsections).

Step 3

Viewing the displayed views allows you to select the desired view:

218190 "Stent for coronary arteries bare metal."