Medical Device Classification in Russia: Risk Classes & Nomenclature

 

January 12, 2022

BRACE Law Firm ©

Treatment of patients in the modern world is inextricably linked with medicine, its achievements, its development, and its innovations. Medicine, like any area of human activity, does not stand still; it develops, and every year more and more modern technologies appear, allowing for the provision of more qualified medical care to patients. The provision of medical care is accompanied by the constant use of medical devices.

The concept of a medical device is enshrined in Article 38 of Federal Law No. 323-FZ dated November 21, 2011, On the Fundamentals of Health Protection of Citizens in the Russian Federation (the "Law No. 323-FZ"). In accordance with Part 1 of this article, medical devices (the "MD", "medical devices") are any instruments, apparatus, appliances, equipment, materials, and other articles used for medical purposes, alone or in combination, as well as together with other accessories necessary for the application of said devices for their intended purpose, including special software, and intended by the manufacturer (maker) for the prevention, diagnosis, treatment, and medical rehabilitation of diseases, monitoring of the human body state, conducting medical research, restoration, replacement, modification of the anatomical structure or physiological functions of the organism, prevention or termination of pregnancy, the functional purpose of which is not realized by pharmacological, immunological, genetic, or metabolic effects on the human body.

In simple terms, based on this legal norm, MDs are all devices applied for medical purposes to provide medical care to a patient and intended by the manufacturer of these devices as medical.

The list of regulatory documents regulating the procedure for using MDs in our country is very extensive; amendments regarding storage, sale, and use of medical devices are introduced annually into existing documents.

For a device to become a medical one and be applicable in medical organizations, it must undergo state registration in accordance with the Rules for State Registration of Medical Devices, approved by Decree of the Government of the Russian Federation No. 1416 dated December 27, 2012 (the "Rules for State Registration of MD"), Clause 2 of which states that state registration is subject to any instruments, apparatus, appliances, equipment, materials, and other articles used for medical purposes alone or in combination, as well as together with other accessories necessary for the application of said devices for their intended purpose, including special software, and intended by the manufacturer (maker) for the prevention, diagnosis, treatment, and medical rehabilitation of diseases, monitoring of the human body state, conducting medical research, restoration, replacement, modification of the anatomical structure or physiological functions of the organism, prevention or termination of pregnancy, the functional purpose of which is not realized by pharmacological, immunological, genetic, or metabolic effects on the human body.

That is, in essence, based on the above norms, potentially everything used by medical personnel and the medical organization as a whole to provide medical care to a patient, and which is not a drug, can be considered medical devices – this can include syringes, CT and MRI scanners, glass slides, and even software necessary for diagnosing and treating a patient.

On the one hand, only registered MDs are permitted for use in Russia; on the other hand, the use of MDs brought into the territory of the Russian Federation for personal use, for example, prostheses, orthopedic footwear, etc., is also allowed.

Based on Part 5 of Article 38 of the Law No. 323-FZ, the following are not registered in the territory of the Russian Federation:

• Medical devices listed in Clause 11 of Article 4 of the Agreement on Common Principles and Rules for the Circulation of Medical Devices (Medical Devices and Medical Equipment) within the Eurasian Economic Union dated December 23, 2014;
• Medical devices imported into the territory of the Russian Federation for the provision of medical care based on life-saving indications for a specific patient on the basis of a permit from Roszdravnadzor issued in the manner established by the Government;
• Medical devices manufactured in the Russian Federation for export outside the territory of the EAEU and not intended for use in the territory of the EAEU, as well as those manufactured in the Russian Federation for conducting experimental design work, research (trials);
• Medical devices intended for use in the territory of an international medical cluster or in the territories of innovative scientific and technological centers;
• Medical devices representing cases, sets, kits, and first aid kits consisting of registered medical devices (with the exception of medical devices connected to an energy source or equipped with an energy source) and (or) medicinal devices combined by common packaging, provided that the secondary (consumer) packaging or primary packaging of the medicinal device is preserved if secondary (consumer) packaging is not provided, of the manufacturer (maker) of each of the devices and (or) medicinal devices included in said cases, sets, kits, and first aid kits, and provided that its labeling is preserved;
• Medical devices intended for the diagnosis of diseases by conducting studies of human biological material samples outside the human body, manufactured in a medical organization and used in the medical organization that manufactured them.

For the provision of medical care to patients, there are procedures, standards of medical care, and clinical guidelines that provide for the use of MDs having registration certificates. For the procurement of MDs, as a rule, the availability of a registration certificate is prescribed in the procurement documentation; acceptance of medical devices without such is not performed by the customer due to the impossibility of its further use in the absence of a registration certificate.

Often, difficult moments arise in determining whether a device is medical or not. Such a situation usually arises when a device looks like a medical one and in most cases even has instructions for use, however, when studying the manufacturer's instructions, it happens that it is not specifically written that the device is medical, or it is written, for example, "for scientific purposes". Such a device cannot be used to provide medical care to a patient; this would be a violation of treatment standards and protocols.

The use of devices in a medical organization for the provision of a medical service is possible only if they are of medical purpose; for example, gloves can be both medical and household, however, when providing medical care, only the use of medical gloves is possible.

Assignment to Medical Devices during their State Registration

Registration of medical devices is a state procedure, the purpose of which is to permit the release of high-quality and safe devices onto the Russian market.

Part 4 of Article 38 of the Law No. 323-FZ establishes that the circulation of medical devices registered in the manner established by the Government by the federal executive body authorized by it is permitted in the territory of the Russian Federation. In accordance with Clause 5.5 of the Regulation on the Federal Service for Surveillance in Healthcare, approved by Decree of the Government of the Russian Federation No. 323 dated June 30, 2004, state registration of medical devices is carried out by the Federal Service for Surveillance in Healthcare (Roszdravnadzor).

To eliminate chaos in the issue of use and registration of medical devices, there is a State Register of MDs and their manufacturers, the maintenance of which is entrusted to Roszdravnadzor. The maintenance of the state register of medical devices and their manufacturers is carried out on the basis of the Rules for Maintaining the State Register of Medical Devices and Organizations (Individual Entrepreneurs) Engaged in the Deviceion and Manufacture of Medical Devices, approved by Decree of the Government of the Russian Federation No. 615 dated June 19, 2012. However, from March 1, 2022, Decree of the Government of the Russian Federation No. 1650 dated September 30, 2021, On Approval of the Rules for Maintaining the State Register of Medical Devices and Organizations (Individual Entrepreneurs) Engaged in the Deviceion and Manufacture of Medical Devices, on Amending the List of Regulatory Legal Acts and Groups of Regulatory Legal Acts of the Government of the Russian Federation, Regulatory Legal Acts... enters into force, and the maintenance of the register of medical devices will be carried out based on the new legal document.

The State Register of Medical Devices, in accordance with Clause 7 of Decree of the Government of the Russian Federation No. 615 dated June 19, 2012, contains the following information:

a) Name of the medical device;

b) Date of state registration of the medical device and its registration number, validity period of the registration certificate;

c) Purpose of the medical device established by the manufacturer;

d) Type of medical device in accordance with the nomenclature classification of medical devices approved by the Ministry of Health of the Russian Federation</u>;

e) Class of potential risk of application of the medical device in accordance with the nomenclature classification of medical devices approved by the Ministry of Health of the Russian Federation;

f) Code of the All-Russian Classifier of Devices for the medical device;

g) Name and location of the organization – applicant for the medical device;

h) Name and location of the organization – manufacturer (maker) of the medical device or surname, first name, patronymic (if any), place of residence of the individual entrepreneur – manufacturer (maker) of the medical device;

i) Address of the place of deviceion or manufacture of the medical device;

j) Information on interchangeable medical devices.

In accordance with current legislation, information from the state register of medical devices and organizations engaged in the deviceion and manufacture of medical devices is classified as open data and is published in the public domain.

Situations occur where it is difficult to find out whether a device is medical or not. This is due to the complexity of determining the purpose of the device or the complexity of determining its mechanism of action. In such a case, controversial issues regarding the classification of a device as medical are considered at a meeting of a special commission of Roszdravnadzor, when qualified specialists are involved and a decision is made on recognizing the device as medical.

Verification of the Classification of a Device as a Medical Device

When purchasing a medical device, a consumer should check in the State Register of Medical Devices whether the MD is registered and permitted for use in the territory of the RF. This information can be found on the Roszdravnadzor website in the "Medical Devices" section. It is important to remember that the State Register of Medical Devices and Organizations is the only official register and source of official information.

Having studied the information in the register, employees of a medical organization can check the supplier of medical devices, see the period the MD has been on the market, etc. This stage – conducting an MD check – is very important, because if a patient experiences adverse consequences after medical intervention and it is established that medical manipulations were performed using an unregistered medical device, then liability arises for the medical organization, which can be both administrative (Article 6.28 of the Code of Administrative Offenses of the RF) and criminal (for example, Article 238.1 of the Criminal Code of the RF).

Information on the availability of a registration certificate for an MD should be checked before purchasing the MD, or the presence of a registration certificate should be indicated as a mandatory condition in the procurement documentation if the medical organization is budgetary and the MD procurement is carried out on the basis of Federal Law No. 44-FZ dated April 5, 2013, On the Contract System in the Sphere of Procurement of Goods, Works, Services for Provision of State and Municipal Needs (the "Law No. 44-FZ"). Sometimes data in the State Register of MDs can be difficult to find. This is due to the fact that the manufacturer may send the medical organization a general name for the MD, and it turns out that seemingly this MD is not in the State Register. However, during the procurement of MDs, it is necessary to request full names or article numbers from the manufacturer to identify the presence or absence of this medical device in the State Register.

In the "Medical Devices" section, Roszdravnadzor publishes information letters about the withdrawal from the market or suspension of circulation of certain medical devices; this should also be remembered and this information used.

When providing medical services, a medical organization must accurately identify the medical device used in accordance with the standards of medical care. In the modern world, there are more than 500 thousand names of medical devices; their manufacturers give names to their devices based on their own considerations. However, they strive to ensure that the name of the medical device makes it roughly clear what its purpose, area of application, and technical features are. But in most cases, given the huge variety of purposes, operating principles, and technical variants of medical devices, this is far from always understandable by the brand name. Therefore, the global medical community tries to simplify the choice of MD for the future consumer (buyer) as much as possible; for this purpose, registries of medical devices are being developed and maintained in many countries.

To simplify the classification of a device as medical, it is important to apply the criteria for classifying devices as medical:

• Mechanism of action. Usually distinguishes the device from medicinal devices.
• The manufacturer must not just indicate that the device is medical, but also substantiate that the purpose of using this device will be carried out for medical purposes.

Potential Risk Class of Medical Device Application

In accordance with Part 2 of Article 38 of the Law No. 323-FZ, medical devices are divided into classes depending on the potential risk of their application and into types in accordance with the nomenclature classification of medical devices. The nomenclature classification of medical devices is approved by the authorized federal executive body.

Order of the Ministry of Health of Russia No. 4n dated June 6, 2012, On Approval of the Nomenclature Classification of Medical Devices is intended to determine not only the class of the medical device but also the degree of risk. This information is important both for medical personnel and for manufacturers, distributors of MDs, including specialists procuring MDs to ensure the uninterrupted operation of a medical organization. All medical devices are divided depending on the degree of potential risk of their application for medical purposes into four risk classes: low, medium, increased, and high degree of risk.

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

• Class 1 – medical devices with a low degree of risk. For example, medical clothing (gowns, shoe covers, masks, gloves), limb immobilization devices (splints, bandages, casts, corsets), bags for medical waste, recirculator irradiators.
• Class 2a – medical devices with a medium degree of risk. For example, ultrasound machines, endoscopes, sterile syringes, needles, cannulas, dental materials, contact lenses, sterile surgical instruments, autoclaves and sterilizers, medical monitors, incubators for newborns, cosmetology massage equipment, multifunctional cosmetology devices, tonometers.
• Class 2b – medical devices with an increased degree of risk. For example, MRI, anesthesia-respiratory apparatus and ventilators, X-ray tomographs, fluorographs, surgical lasers, dental implants, implants for osteosynthesis of limb bones (titanium plates, screws, pins), non-absorbable suture materials, infusion pumps, pulse oximeters.
• Class 3 – medical devices with a high degree of risk. For example, pacemakers, coronary stents, materials for bone tissue replacement, absorbable suture materials, intradermal hyaluronic or collagen implants, intraocular lenses, implantable electrodes, medical devices with a medicinal device. Details play a large role in classification, due to which similar devices may receive a different class.

Nomenclature Classification of Medical Devices and Their Types

The existing nomenclature classification of medical devices and codes of types of medical devices in the Russian Federation is approved by Order of the Ministry of Health of the Russian Federation No. 4n dated June 6, 2012. The nomenclature classification is posted in electronic form on the official website of the Federal Service for Surveillance in Healthcare in the information and telecommunications network "Internet". Assignment of a type is performed based on information presented in the registration documentation for the medical device.

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").

Also, the nomenclature classification is formed by groups and subgroups. They perform an auxiliary function, serving for navigation when searching for types. Each group is subdivided into subgroups. Various groups include from 5 to 56 subgroups. One type may belong to several groups (subgroups).

The name of the type is not a standardized name of a specific medical device but determines the type or species group, which represents a collection of devices having the same or similar purpose and device (design).

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

Searching for a type in the nomenclature classification can be carried out in the following ways:

Search by word or part of a word in the type name is performed by placing the word or its part in the name search bar.

The "Advanced search" bar allows navigation:

• By type code;
• By word or part of a word in the type description;
• By word or part of a word in the section title.

On the left side of the page, there is a list of sections and subsections, which allows selecting types contained in this section (subsection). One type may belong to several sections (subsections). If it is not possible to find a type by keyword, it is recommended to carefully review the types included in the relevant section. This allows selecting additional keywords to search for the type.

Simultaneous use of search by name and description, or simultaneous search by name and selection of the relevant section (subsection) allows narrowing the search for the required type.

In accordance with Order of the Ministry of Health of the Russian Federation No. 4n dated June 6, 2012, the nomenclature classification of medical devices contains information about the types themselves, as well as a set of classification features associated with each type.

Types in the nomenclature classification are presented by a six-digit type number and type name. The use of a six-digit numerical type identifier allows using the sixth digit for additional detailing of the type based on the needs of domestic healthcare. In the international classification, a five-digit number is used.

Classification features of types are presented by four groups:

• 1st group – purpose of medical devices, 39 features, encoded by three-digit numerical codes;
• 2nd group – features regarding sterility of medical devices, 5 features, encoded by two-digit numerical codes;
• 3rd group – technologies of application of medical devices, 8 features, encoded by two-digit numerical codes;
• 4th group – areas of medical application, 32 features, encoded by two-digit numerical codes.

Classification features play a large role in organizing and classifying types; the nomenclature of medical device types in the RF should continue to be built as a computer database, regularly updated, with user access on the Internet.

The MD nomenclature classifier is a constantly developing system; development goes both in breadth (several hundred new types appear every year due to the emergence of fundamentally new medical devices and increased requirements for detailing a specific type) and in depth – specific models, information on risk classes, standard specifications, subtypes of interchangeable medical devices can be further linked to types of medical devices.

In our country, the classification of MDs looks as follows:

• Anesthesiology and respiratory medical devices.
• Auxiliary and general hospital medical devices.
• Gastroenterological medical devices.
• Medical devices for obstetrics and gynecology.
• In vitro diagnostic medical devices.
• Medical devices for manipulation/restoration of human tissues/organs.
• Medical devices for otorhinolaryngology.
• Medical devices for plastic surgery and cosmetology.
• Neurological medical devices.
• Orthopedic medical devices.
• Ophthalmic medical devices.
• Radiological medical devices.
• Rehabilitation and adapted medical devices for the disabled.
• Cardiovascular medical devices.
• Dental medical devices.
• Urological medical devices.
• Physiotherapy medical devices.
• Surgical instruments/systems and concomitant medical devices.
• Endoscopic medical devices.
• Software that is a medical device.

Each section has its own subsections, and then there is coding of each medical device in accordance with the nomenclature classification.

Thus, any medical device is subject not only to registration in the state register of MDs but also to mandatory classification for the convenience of its application by end consumers, medical personnel, pharmacists, etc.

Also, 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 the human body or interconnection with it;
• Method of introducing medical devices into the human body (through anatomical cavities or surgically);
• Use of medical devices for vital organs and systems (heart, central circulatory system, central nervous system);
• Use of energy sources.

If a medical device is intended for use in combination with other medical devices, classes are established for each medical device. In the event that different provisions can be applied to a medical device during classification, provisions are applied that result in the establishment of the class of the medical device corresponding to the highest degree of potential risk.

Borderline cases occur when it is quite difficult to apply a particular criterion and classify a device as medical, and it is necessary to determine the boundary between a medical device and a medicinal device. For example, plasters vary; there is a variant where this device is qualified as both medical and pharmacological. The mechanism of action of the device plays a role for differentiation. For example, in the case of wound closure, protection from external influence, the device is medical, and, for example, when the purpose of the plaster includes the delivery of a medicinal device into the body – the plaster will be a medicinal device. Subtleties of differentiating such devices are common, and determining the mechanism of action of the device and its purpose is very important for correct classification.

Or, for example, medical and non-medical devices, although they perform the same action functionally. Such an example was considered above when comparing household and medical gloves; seemingly the same device, but it is impossible to apply household gloves for the provision of a medical service.

Interchangeable Medical Devices

Medical devices may be recognized as interchangeable if they are comparable in functional purpose, qualitative and technical characteristics, and are capable of replacing each other. This legal norm is applied in most cases for the medical personnel of a medical organization, as well as for procurement activities carried out within the framework of the Law No. 44-FZ.

Interchangeability of MDs is necessary in modern medicine; this is due to the fact that not every MD can be purchased quickly and on time, and subsequently provide a high-quality medical service, therefore, interchangeability of medical devices is the possibility of replacing a medical device with another without deteriorating its qualitative characteristic. At the same time, the replaced MD must have equivalence of the following features:

• Purpose;
• Qualitative characteristics;
• Technical characteristics.

Falsified, Counterfeit, Substandard, and Unregistered Medical Devices

For medical organizations purchasing MDs, interchangeability is of great importance; this is connected not only with the possibility of timely provision of a medical service but also with the effective use of budget funds.

However, when purchasing medical devices, one should not forget that the market for falsified, substandard, and counterfeit MDs does not stand still.

In accordance with Part 12 of Article 38 of the Law No. 323-FZ, a falsified medical device is a medical device accompanied by false information about its characteristics and (or) manufacturer (maker). In accordance with Part 13 of the above-named norm, a substandard medical device is a medical device that does not meet the requirements for safety and efficacy of medical devices, requirements for their labeling, normative, technical, and operational documentation, and which cannot be safely used for its intended purpose established by the manufacturer (maker). In accordance with Part 14, a counterfeit medical device is a medical device circulating in violation of civil legislation.

There are very many orders and regulatory acts regulating issues of liability for the use of medical devices, including those listed above. Employees of medical organizations must know and observe the main ones.

Terminology regarding the use of MDs is prescribed quite thoroughly so that medical workers, in order to properly interpret certain situations and avoid unnecessary problems with law enforcement agencies, must know the correct terminology and apply it in their work.

For violation of the circulation of medical devices, medical workers may face criminal and administrative liability.

In particular, Article 238.1 of the Criminal Code of the Russian Federation on the circulation of falsified, substandard, unregistered medicinal devices, medical devices, and falsified biological supplements implies serious penalties. For example, for the deviceion, sale, or import into the territory of Russia of falsified, substandard, unregistered medical devices, if these acts are committed by a group of persons, imprisonment for a term of 5 to 8 years is provided, and the fine can reach up to 3 million. Cases of forgery of documents for medical devices are often found in judicial practice, which falls under Article 327.2 of the Criminal Code of the Russian Federation Forgery of Documents for Medicinal Devices or Medical Devices, or Packaging of Medicinal Devices or Medical Devices. For manufacture for the purpose of use or sale or use of knowingly forged documents for medical devices, imprisonment of up to 3 years may be threatened; if the same acts are committed by an organized group, then the term of imprisonment is from 5 to 10 years.

Considering the importance of using high-quality and safe medical devices, administrative liability in the sphere of circulation of medical devices has been introduced in Russia. Article 6.28 of the Code of Administrative Offenses of the Russian Federation Violation of Established Rules in the Sphere of Circulation of Medical Devices is most often applied to medical organizations, which entails the imposition of an administrative fine on citizens in the amount of 2,000 to 4,000 rubles; on officials – from 5,000 to 10,000 rubles; on legal entities – from 30,000 to 50,000 rubles. Article 6.33 of the Code of Administrative Offenses of the Russian Federation Circulation of Falsified, Counterfeit, Substandard and Unregistered Medicinal Devices, Medical Devices and Circulation of Falsified Biologically Active Supplements is also applied, which entails the imposition of sufficiently large penalties. For example, for the deviceion, sale, or import of counterfeit, falsified, or substandard medical devices, a fine of 1,000,000 to 5,000,000 rubles and administrative suspension of activity for a period of up to 90 days may be imposed on a medical organization; if the same actions were committed using mass media or information and telecommunications networks, including the Internet, then the fine amount already varies from 2,000,000 to 6,000,000 rubles.

Criminal liability under Part 1 of Article 238.1 of the Criminal Code of the Russian Federation for the illegal import into the territory of the RF of unregistered medicinal devices or medical preparations will occur only if the person pursues a special goal – the sale of imported means and preparations (under other conditions).

If acts in relation to medicinal devices, medical devices, or biologically active supplements are committed not on a large scale, i.e., in an amount less than 100 thousand rubles, the guilty persons may be held administratively liable under Article 6.28 of the Code of Administrative Offenses of the Russian Federation for violation of established rules in the sphere of circulation of medical devices, under Article 6.33 of the Code of Administrative Offenses of the Russian Federation for the circulation of falsified, counterfeit, substandard unregistered medicinal devices, medical devices and circulation of falsified biologically active supplements, under Article 14.4.2 of the Code of Administrative Offenses for violation of legislation on the circulation of medicinal devices.

Considering that the MD market is replenished annually with hundreds of new medical devices, employees of medical organizations should more carefully verify their suppliers and supplied medical devices in order to avoid not only liability for the use of low-quality, falsified MDs when providing medical care to a patient but also a lawsuit from the patient himself. Because liability for poor-quality provision of a medical service is provided not only within the framework of the Law of the Russian Federation On Protection of Consumer Rights, but also criminal liability for improper performance by medical workers of professional duties in accordance with the Criminal Code of the Russian Federation for improper performance of their professional duties upon the occurrence of death by negligence due to improper performance by a person of their professional duties (Part 2 of Article 109 of the Criminal Code of the Russian Federation), infliction of grievous bodily harm by negligence committed due to improper performance by a person of their professional duties (Part 2 of Article 118 of the Criminal Code of the Russian Federation), HIV infection (Article 122 of the Criminal Code of the Russian Federation), failure to provide aid to a sick person (Article 124 of the Criminal Code of the Russian Federation), negligence (Article 293 of the Criminal Code of the Russian Federation).

Considering the above, it should be noted that there are a very large number of questions arising when determining an item as a medical device or not. There are also many questions regarding the qualification of a medical device and its assignment to a particular group, type, and risk class. If it is impossible for the manufacturer to independently determine to which type a particular medical device belongs, this issue can be resolved by contacting Roszdravnadzor.