Many manufacturers and distributors are wondering whether their device, apparatus, or equipment is a medical device in Russia. This is a fairly common but tricky question. To answer this, let us start by analyzing what the Russian legislator implies by this concept.
According to the Art. 38 of the Federal Law No. 323-FZ, dated 21.11.2011 “On the fundamentals of protecting the health of citizens of the Russian Federation”, medical devices are instruments, apparatus, devices, equipment, materials, and other products used for medical purposes separately or in combination with each other, as well as together with other accessories required for the use of these devices for their intended purpose, including special software, and intended by the manufacturer for the prevention, diagnosis, treatment, and medical rehabilitation of diseases, monitoring the condition of the human body, conducting medical research, restoration, replacement, change in anatomical structures or physiological functions of the body, prevention or termination of pregnancy, and the functional purpose of which is not realized through pharmacological, immunological, genetic, or metabolic effects on the human body.
The official definition tells us the main criteria for classifying products as medical.
Criteria for classification as medical devices
One of the important criteria for answering this question is the list of possible uses of the device:
During development of technical and operational documentation for the device, the manufacturer should pay special attention to reflecting those properties and characteristics that allow for the realization of the medical purpose of the device. These properties and characteristics should be identified, assessed, and documented as fully and objectively as possible.
A medical device is not merely intended for medical purposes. It should have those properties and characteristics that fulfill the medical purpose in the declared application area. In addition to the fact that these properties are objectively present, they need to be reflected in the technical and operational documentation for the medical device.
These properties should be confirmed at the stage of registration of the medical device as part of confirmation of the quality, effectiveness and safety of the device. Otherwise, the device is not medical. That is why one should be very careful when describing the intended use of the device and formulating the technical aspects and properties that define the device as medical.
To determine whether their product is medical, many applicants use the nomenclature classification of medical devices. Currently, the nomenclature classifier on the official website of Roszdravnadzor in the Services section contains about thirty thousand entries describing type codes. When using the classifier, applicants are searching for a medical device type code that is most suitable for their product by description.
This approach is justified in most cases. However, it can fail in some situations. The reason is that type codes describe the types of medical devices only. Thus, first one still has to determine whether the product is a medical device, and only then determine its type, not vice versa.
If one does this in incorrect order, errors can occur when a non-medical product may be mistaken for a medical device. Thus, X-ray diagnostic systems, biochemical analyzers, and urine analyzers for veterinary medicine can easily comply with the description of the nomenclature classification code, if one does not take into account their veterinary purpose.
The main criterion for classifying a product as a medical device is its intended purpose. Let us look at the example of contact lenses.
| wdt_ID | Product type | Medical device | Non-medical product | Explanation |
|---|---|---|---|---|
| 1 | Contact lenses | Corrective contact lens with visible light filter. A soft ophthalmic lens designed to be worn directly on the cornea and adjacent limbal sclera of the eye region to correct refractive errors (e.g. nearsightedness, farsightedness), selectively tinted to filter specific wavelengths of light in the visible spectrum to improve vision (e.g. for sports, color blindness); the device is designed to be removed before bed, every evening | Contact lens colored/tinted/ limbal/decorative. Used to change the color of the iris | In case of the non-medical product, there is no medical purpose, i.e. the lenses do not correct vision |
The next criterion for classifying a product as medical is the mode of action. As follows from the definition, the mode of action should not be realized through pharmacological, immunological, genetic, or metabolic effects. Otherwise, we are not dealing with a medical device.
These effects usually pertain to medicinal products (drugs). The line between medical devices and medicinal products is often very thin, which requires special attention from market participants.
Let us give simple examples that clearly illustrate how to draw this line. The table shows the differences in the effects of a medical device and a medicinal product.
| wdt_ID | Product type | Medical device | Medicinal product | Explanation |
|---|---|---|---|---|
| 1 | Nasal decongestant | Saline solution for rinsing the nose, sterile. A sterile, water-based (such as isotonic or hypertonic mineral-enriched purified seawater) saline solution designed to penetrate, rinse, empty, and moisten the nasal passages and sinuses | Nasal spray with xylometazoline. 0.1% solution of xylometazoline hydrochloride in water. Vasoconstrictor for local use in ENT practice. Alpha adrenergic agonist. When applied to the mucous membranes, it causes vasoconstriction, as a result of which local hyperemia and swelling are reduced. Makes nasal breathing easier during rhinitis | In case of the medical device, nasal congestion is eliminated physically by rinsing. In case of the medicinal product – through the pharmacological effect of an active substance that affects the metabolism of the nasal mucosa cells |
| 2 | Anti-burn agent | Anti-burn gel. A substance intended for application directly to minor burns or sunburns. Typically developed to protect against infection, minimize injury and skin damage, relieve pain, moisturize and cool the burnt area, and prevent the burn from spreading. Typically available in sachets, bottles, or containers for dispensing as a gel or spray and used by emergency medical services and intensive care units, but can also be used at home | Anti-burn 5% dexpanthenol cream. Cream for external use. Dexpanthenol in skin cells quickly turns into pantothenic acid, which is a component of coenzyme A and plays an important role in both the formation and healing of damaged skin. Stimulates skin regeneration, normalizes cellular metabolism | The gel provides physical protection for the damaged skin area. The main effect of the medicinal cream is pharmacological |
| 3 | Agent for reducing/relieving pain and muscle tension | Anesthetic gel with a cooling effect. A substance (e.g. pure alcohol, herbal extract) that is applied externally and relieves muscle and joint pain (e.g. caused by stress, burns, injury) with a cooling effect on the skin through evaporation, the substance affects the epidermis only | Ointment containing capsaicin, ethyl nicotinate, ethyl glycol salicylate. It has a local irritating, analgesic, and dissolving effect. Contains substances that cause prolonged expansion of superficial blood vessels in the area of application, increase skin temperature, and cause a feeling of warmth. The effect is associated with the irritating and distracting effects of capsaicin, the analgesic and anti-inflammatory activity of glycol salicylate, and the dissolving ability of ethyl nicotinate | The effect of the gel is realized via physical evaporation, the effect of the ointment – pharmacologically |
| 4 | Eye drops | Eye lubricant. A substance intended to provide additional lubrication/moisturization to the eyes to relieve dryness, fatigue, irritation, and/or eye strain caused by the dry eye syndrome, age-related/hormonal changes (menopause) or external factors (for example, due to the use of medications, pollution, computer use, air conditioning, allergies); some types can additionally be used to keep contact lenses moist while wearing | Medicines in the form of eye drops. - Antiseptic and anti-inflammatory drops eliminate redness, soothe and stabilize condition of the tissues of the anterior parts of the eyes. - Antiallergic medicines are used to relieve allergic symptoms. - Medicines for improving metabolic processes, used for age-related dystrophic changes in the eyes, as well as for cataracts. - Antibacterial and antiviral medicines, used during treatment of eye diseases of viral and bacterial origin. - Medicines for the glaucoma (mitotic) treatment, intended to lower intraocular pressure. - Vasoconstrictor medicines, used to reduce swelling and hyperemia of the mucous membrane of the eye | The medical device helps maintain the natural functions of tissues. Medicines have a wide range of pharmacological and metabolic effects |
| 5 | Wound healing cream | Skin product with osmotic properties, non-sterile, antibacterial. A non-sterile substance (e.g. cream, impregnated material) intended for topical application to the skin and containing components (e.g. hyaluronic acid) intended to accelerate wound healing and re-epithelialization of the skin, primarily through osmotic properties; the product absorbs and retains water to create a moist environment; also contains antibacterial substances. It can be used to treat superficial and/or deep wounds (e.g. scratches, lacerations, burns, surgical wounds, bedsores, ulcers) | Medicine for wound healing for external use. It has fibrinolytic, anti-inflammatory, antithrombotic, and keratolytic effects. It stimulates cellular regeneration without hyperplasia. Inhibits the proliferation of keloid fibroblasts | See the line above |
More questions arise when trying to distinguish between a medicinal product and a medical device that contains an active substance registered as a medicinal product. In these cases, the determining factor is also the mode of action, namely which of them is the main component and which is the auxiliary one. Let us look at a few illustrative examples.
Thus, the distinction “medical device or medicinal product” is determined mainly by the mode of action and the features of its implementation when used as intended.
What software is classified as medical?
A large number of questions arise when considering the issue of classifying software as a medical device. Difficulties arise, among other things, because this is not yet a fully developed area from a regulatory point of view. Until recently, there was no unified approach even among the expert organizations of Roszdravnadzor. Not long ago, the legislator issued Methodological recommendations on the procedure for examining the quality, effectiveness and safety of medical products (in terms of software) for state registration within the national system.
These recommendations define the criteria according to which software is considered a medical device. Criteria for classifying software as a medical device include:
That means a software medical device has an interpretation function. For this criterion, it is obvious that based on the quality, efficiency and safety of the software, it is regarded as an independent medical device.
Here are some examples of software that is not a medical device:
This means that if software:
then this software is not a medical device!
What furniture is classified as medical?
This question has recently become increasingly relevant. Thus, the Federal Antimonopoly Service (FAS) of the Russian Federation issued a warning to Roszdravnadzor with a requirement to review the approach to registering medical furniture before December 1, 2020. The warning was issued after an appeal to the Federal Antimonopoly Service by a furniture manufacturer. They tried to register the filing cabinet as medical furniture but received a refusal from Roszdravnadzor. The regulator cited the fact that the filing cabinet is not a medical device.
At the same time, the state register of medical devices contains examples of similar furniture from other manufacturers, which have already received registration certificates.
In the warning, the FAS pointed out to the regulator the need to cancel the registrations of previously registered furniture if it does not have medical properties. This is especially true for cabinets that do not differ functionally and in purpose from office cabinets: a filing cabinet, a wardrobe, chairs and armchairs, benches and banquettes without special functions, etc.
To make it easier for you to determine whether your furniture classifies as medical, we prepared a table with descriptions of the types of medical furniture.
| wdt_ID | Type code | Name of medical furniture | Description of the type code |
|---|---|---|---|
| 1 | 116920 | Massage table/couch, without power supply, portable | Manually adjustable, portable table designed for use in various complementary therapies (e.g. massage, acupuncture, aromatherapy, reflexology, kinesiotherapy). Typically consists of a folding frame (deck with legs) with a flat deck surface, with the manually adjustable upper section. The table height can also be manually adjusted to fixed positions (i.e. to set the initial height, but the table is not fully adjustable). It may have a hole for the face (the patient, while lying on his stomach, lowers his head into this hole), a headrest and armrests. Typically, this device is called a massage/therapy table, couch or bed. |
| 2 | 116940 | Massage table/couch, with power supply | Mains-powered (AC) table used in various complementary therapies (e.g. massage, acupuncture, aromatherapy, reflexology, kinesiotherapy). Typically it consists of a frame with a flat deck surface, the upper section of which can be manually adjusted to a raised position. The height of the table is adjusted by an electric drive. It may have a hole for the face (the patient, while lying on his stomach, lowers his head into this hole), a headrest and armrests. Typically, this device is called a massage table, couch or bed. |
| 3 | 116990 | Massage table/couch, without power supply, non-portable | Manually adjustable, portable table designed for use in various complementary therapies (e.g. massage, acupuncture, aromatherapy, reflexology, kinesiotherapy). Typically consists of a non-folding frame (non-portable) with a flat deck surface, possibly with a head section, a headrest, a face hole (the patient, while lying on his stomach, lowers his head into this hole) and/or armrests; positions of these components, including the height of the platform, is manually adjusted. Typically, this device is called a massage/therapy table, couch or bed. |
| 4 | 126100 | Patient table for planar tomography X-ray system, without power supply | Device that is part of a diagnostic X-ray system. It is a table without an electric drive, with a fixed deck position or the possibility of its mechanical positioning and/or table height adjustment, for example, by pneumatic control, magnetic locks, handles, or lever mechanisms; the device is specifically designed to support and position the patient during planar tomographic examinations. This can be a stationary or mobile unit made of radiolucent materials with a low X-ray attenuation coefficient. |
| 5 | 126110 | Patient table for planar X-ray tomography system, with power supply | Device that is part of a diagnostic X-ray system. It is a powered/programmable table with electronic and/or software control for deck height adjustment and positioning; the device is specifically designed to position and support the patient during planar tomographic examinations. This can be a stationary or mobile unit made of radiolucent materials with a low X-ray attenuation coefficient. |
As can be seen in the type codes descriptions, they always include the medical purpose of the device. Therefore, for products that can be used both as a medical device and a non-medical product, technical and operational documentation has to contain information confirming that they belong to medical devices. For example, a dentist stool may not be visually different from a standard stool.
However, a dentist stool has to provide freedom of action for the dentist, i.e. have vertical and horizontal adjusters, the ability to rotate 270 degrees, the design of the back support should allow using it as lateral or abdominal support for the dentist. In addition, the materials from which the stool is made should be resistant to treatment with rather aggressive disinfectants.
The conformity assessment of furniture that is not a medical device is carried out in the form of certification or declaration, depending on its purpose.
Is the UV-recirculator a medical device?
In the Russian Federation, UV-recirculators are classified as medical devices. They have a separate type code of the medical device: 131980. The description of the medical device type says:
At the same time, in the EU, the latest edition of the manual on borderline cases (Manual on borderline and classification in the community regulatory framework for medical devices, version 1.22) states that these devices do not have a medical effect and therefore do not classify as medical devices. Even though they reduce the level of microorganism contamination in the air of medical institutions.
This example smoothly leads us to the next question.
Does a product classify as medical in Russia if it does not classify as such in the country of origin and vice versa?
Sometimes questions arise when trying to register medical devices of foreign origin. In the country of manufacture, these devices are considered medical, but in Russia they are not, and vice versa. For example, electric toothbrushes are a medical device in the USA, while in Russia they classify as ordinary household appliances with a hygienic function.
In the European Union, a teeth whitening kit is not considered a medical device, while in Russia more than a dozen devices are registered under the corresponding type code.
For controversial cases, the EU publishes a special guide to borderline cases (Borderline Manual), which directly classifies certain controversial devices as medical. This guide contains many “borderline” examples and provides arguments in favor of one or another decision to classify (or not classify) a device as medical.
In Russia, unfortunately, there are no such regulatory documents. Therefore, each specific case is unique and requires an in-depth study of the product properties to answer the question correctly.
Conclusion
It is worth noting that the position of Roszdravnadzor regarding the classification of products as medical devices can change. Thus, packaging for medicinal products used to be classified as a medical device. Currently, it is an integral part of the medicinal product and therefore is not a separate medical device.
Not so long ago, cabinets for clothes and patient records also classified as medical devices and easily passed the state registration procedure. Now such products are regarded by the regulator as non-medical.
So, we looked at the criteria for classifying products as medical devices and saw what defines the answer to the question “is the product a medical device?”. However, the cases presented in the article are not exhaustive. If you still are uncertain of whether your device is medical or not, you can send us information about it. We will carefully study all the primary information and accurately determine if it classifies as a medical device.
