Decision of the Council of the Eurasian Economic Commission of 12.02.2016 N 27 "On approval of the General requirements for the safety and effectiveness of medical devices, requirements for their labeling and operational documentation for them"

13. Requirements for the labeling of medical devices

58. Labeling of a medical device must contain the following information:

1) the name and (or) trade name of the medical device;

2) information required to identify a medical device, as well as information on its purpose (if necessary);

3) information about the manufacturer, including the full and abbreviated (if any) name of the legal entity, location (surname, name, patronymic (if any) and place of residence of an individual registered as an individual entrepreneur), postal address of the manufacturer, country of origin of the medical products. The manufacturer's mailing address may be omitted from the labeling if it is contained in the instructions for use attached to the medical device.

Medical devices manufactured in a state that is not a member of the Union may be subject to additional marking containing information about the authorized representative of a foreign manufacturer, including the full and abbreviated (if any) name of the legal entity, location (surname, name, patronymic (if any) and place of residence of an individual registered as an individual entrepreneur), the mailing address of the authorized representative of the manufacturer. Additional marking should not hide the marking containing information about the manufacturer of the medical device;

4) information on the presence of medicinal products or biological materials in a medical device, as well as nanomaterials, if such nanomaterials are not contained in a bound state that excludes the possibility of their ingestion into the user's body when using the medical device for the intended purpose determined by the manufacturer;

5) the code (number) of the batch or the serial number of the medical device;

6) the period (indicating the year and month) before the expiration of which the medical device can be safely used;

7) the year of manufacture of the medical device, unless a period is specified before the expiration of which the medical device can be safely used. The year of manufacture of a medical device is included in the batch number or serial number, provided that the year of manufacture is easily identifiable as part of such a number;

8) information on the special conditions of storage and (or) handling of a medical device (if necessary);

9) information on the sterility of the medical device (if the medical device is supplied sterile) with an indication of the sterilization method;

10) warning or precautions that are indicated in such a way as to attract the attention of the user or a third party. This information can be minimized if more detailed information is contained in the instructions for use;

11) information on the one-time use of the medical device (if the medical device is intended for one-time use);

12) information on the restoration of the medical device, indicating the number of restoration cycles performed and any restrictions on the number of restoration cycles (if the medical device for single use is refurbished);

13) information on the manufacture of a medical device according to the individual order of the user exclusively for personal use in accordance with the appointment of a medical specialist issued in writing;

14) information on the intended use of the medical device only for clinical trials for registration purposes;

15) information on the intended use of the medical device for exhibition or demonstration purposes only. In this case, the labeling requirements specified in subparagraphs 1 - of this paragraph are not mandatory;

16) information on the inactivation of possible viruses and other infectious agents in a medical device, applied in the form of the inscription "there are no antibodies to HIV 1, 2 and hepatitis C and HBsAg viruses" (if the medical device contains human blood serum (plasma) or elements human tissue).

59. In the event that medical devices or their components intended for the introduction into the body and removal from the human body of medicines, body fluids or other substances, or for the transportation and storage of such means, liquids or substances, contain harmful substances that, depending on their concentrations of carcinogenic, mutagenic or toxic to reproductive function, or contain phthalates, then such medical devices are subject to special labeling. This special marking is applied to the medical device and its packaging, or, if necessary, to the outer packaging used for storing and transporting the medical device.

60. Labeling of sterile and non-sterile medical devices should provide the ability to distinguish between identical or similar types of medical devices released into circulation in a sterile and non-sterile form, and be distinguished so that the user can distinguish a sterile medical device from a non-sterile one by means of marking.

1. A medical device that is put into circulation on the territory of the Russian Federation must comply with the requirements established in Chapter 2 of this Federal Law, provided that it is properly supplied, installed for the purpose of operation and use in accordance with its intended purpose.

2. For each type or model of a medical device, the manufacturer, prior to release into circulation, must create a consolidated technical documentation drawn up in accordance with Appendix 3 to this Federal Law. The manufacturer or his authorized representative must store, update and, upon request, provide this documentation to the bodies exercising state control (supervision) over the fulfillment of the requirements of this Federal Law. This clause does not apply to medical devices for clinical trials or medical trials.

3. On the territory of the Russian Federation, only a medical device that has passed the mandatory confirmation of compliance with the requirements of this Federal Law may be released into circulation and put into operation. Such a medical device must be marked with a mark of circulation in the market.

4. It is prohibited to put designations, inscriptions or information on the medical device and accompanying documents that may mislead the consumer and (or) other persons. Misleading occurs when:

the medical device is assigned performance properties that it does not have;

the successful result of the application or the complete absence of undesirable consequences is guaranteed with proper and long-term use in the absence of an evidence base;
^

Article 15. Requirement for packaging of medical devices

1. Packaging of a medical device must comply with safety requirements, ensure safety and maintain the functional and operational characteristics of a medical device during its service life (shelf life).

2. The packaging of the medical device should minimize the risk associated with product leakage for persons involved in the transportation, storage and operation of the product.

3. Packaging of a medical device delivered in a sterile state must ensure its sterility upon release into circulation, as well as maintain sterility under the conditions of storage and transportation established by the manufacturer.

4. Packaging of a non-sterile medical device intended for use in a sterile state must ensure its safety at the level of purity established by the manufacturer and minimize the risk of contamination of the medical device after sterilization. The packaging of such a medical device must comply with the sterilization method specified by the manufacturer.

5. Packaging and (or) labeling of medical devices supplied in a sterile or non-sterile state should be different.

6. The inner packaging of light-sensitive products must be made of materials that protect them from direct sunlight.

7. The inner packaging of a radiation hazardous product must be made of material that provides maximum protection.

8. Different outer packaging should be used to pack different components of the reagent kit transported at different temperatures.

9. Packaging of a medical device containing non-inactivated pathogenic biological agents must ensure the safety of the medical device from mechanical damage, the safety of persons in contact with the packaged medical device during transportation, storage and operation, and comply with the requirements of the legislation of the Russian Federation on sanitary and epidemiological welfare. Medical device packaging must be labeled with biohazards.
^

Article 16. Requirements for the labeling of medical devices

1. The manufacturer, supplier or seller is obliged to provide the purchaser with the necessary and reliable information about the medical device, taking into account the level of training and knowledge of potential users. Any restrictions on the use should be indicated on the labeling of the medical device or in the instructions for its operation (use).

2. Information required for the safe use of a medical device must be placed on the device itself and (or) on each of its packaging, or on the group packaging. If individual packaging of each unit of a medical device is not feasible, then the information should be placed on the package insert supplied with one or more medical devices.

3. The information contained in the labeling of a medical device must be presented in Russian. The specified information can be presented additionally in other languages, while its content should be identical to the text in Russian.

4. The text of the marking applied to a medical device or its component must contain in a concise form information that allows to unambiguously identify the properties of the given device indicated by this marking.

5. The text of the marking applied to each unit of the group packaging must contain:

trademark (if any);

service life or shelf life (year, month inclusive);

date of manufacture (year, month);

indication of the sterilization method;

batch number;

batch (batch) code, after the inscription "series" ("batch") or the serial number of the product;

if the device is intended for clinical trials or performance testing, indication, "for clinical trials only" or "for medical trials only"

any special instructions;

any warnings and precautions to be followed, handling notices (if necessary);

the number of consumer packaging units of medical devices in group packaging, reusable containers or shipping containers;

net weight and gross weight on group packaging, reusable containers or transport containers;

net weight of consumer packaging.

6. The text of the marking applied to each unit of consumer (individual packaging) must contain:

trade (if any) and full name of the product;

manufacturer's name and address;

trademark (if any);

if necessary, an indication of the date (year, month inclusive) until which the product is safe;

if the information accompanying the product does not include an indication of the date until which the product is safe, then the indication of the date of manufacture (year, month) may be included in the batch or batch number of the product, or in the serial number of the product);

requirements for storage conditions (if necessary, special conditions for handling the product);

sterile products must have a warning label "STERILE";

indication of the sterilization method;

batch (batch) number of the product or serial number;

an indication that this product is intended for one-time use;

if the product is for individual use, the indication "product for individual use";

if the product is intended for clinical trials or performance testing, the indication “for clinical trials only”, for medical trials only ”;

any special instructions;

any warnings and precautions to be followed;

the intended purpose of the product, the intended user, the type of patients for whom the product is planned to be used (if this is not obvious);

information necessary for the user in order to uniquely identify the medical device and the contents of the package, as well as to take appropriate measures in order to identify any direct risk posed by this device and its components;

market circulation mark;

6.1. For medical devices used for in vitro diagnostics, the text of the labeling of the outer packaging must additionally contain:

the name of the ingredients contained in the package (package contents);

the number of internal packages and their composition in system or non-system units;

a hazard warning sign corresponding to that printed on the inner packaging;

“For in vitro diagnostic use only” warning label;

date of manufacture (year, month);

expiration date (year, month inclusive);

an identification number;

number of determinations (if necessary);

It is allowed to apply the full text of the instructions for use of the product to the outer packaging.

It is allowed to apply on the outer packaging other special information that is not of an advertising nature, as well as pictograms and holograms.

6.2. For medical devices used for in vitro diagnostics, the labeling text applied to the inner packaging must contain:

trade (if any) or full or abbreviated name of the product;

full or abbreviated name of the organization - manufacturer;

batch number;

shelf life;

hazard warning sign (if any);

requirements for storage and transportation conditions (if necessary);

It is allowed to apply machine-readable markings on the inner packaging or on the label of the inner packaging, outer packaging and shipping container of medical devices.

6.3. Products containing human blood serum (plasma) or elements of human tissue must have an indication of their inactivation, and the inscription “antibodies to HIV 1, 2 and hepatitis C virus and HBsAg are absent” applied using a cliché or printed method.

6.4. On the packaging of products intended for self-testing, the following inscriptions are applied: “For self-testing”, “Keep out of the reach of children”, “Dispensed without a prescription”.

7. Labeling of medical devices put into circulation in sterile or non-sterile form should help the user to reliably distinguish between these devices.

The marking carries very important information for the consumer, which, first of all, defines all the necessary data for the safe and effective use of the product. Correct labeling is extremely important for several reasons. So, non-compliance with the requirements for it can lead to stoppage / suspension of customs clearance of goods, loss of VAT preferences. Since regulatory authorities first of all pay attention to the information that accompanies the product, incorrect registration of such can lead to various consequences, up to the suspension of the certificate of state registration of products. And at the stage of its circulation on the market, non-compliance with labeling requirements can lead to misuse of the product and cause consumer complaints. Therefore, it is very important to understand in advance what the concept of “proper labeling of medical devices” means.

In this issue, the main difficulty lies in the fact that currently the legislation of Ukraine does not contain a definition of the term “proper labeling of medical devices”. This publication will discuss the mandatory requirements for such labeling, as well as what it is only recommended to display on the label of a medical device, how to properly develop labeling, taking into account all legislative, regulatory and legal acts, relevant regulatory documents. In addition, the stages of approval of the labeling sample will be highlighted.

Unlike packaging of a medicinal product, which is subject to mandatory approval during registration, labeling of medical devices and equipment remains at the discretion of the manufacturer and his representative, who, of course, must adhere to the legislation of Ukraine.

At the stage of registration of medical devices during the technical examination, not the layouts of the marking, but only its main elements are agreed upon (Fig. 1).

Requirements for the labeling of medical devices are contained in a number of laws, regulations of the Cabinet of Ministers of Ukraine and standards. Among them there are documents that are binding:

• Law of Ukraine dated 03.07.2012 No. 5029-VI "On the principles of state language policy";
• n and others.

Non-binding regulatory legal acts:

• technical regulations regarding medical devices, medical devices for diagnostics in vitro, active implantable medical devices, approved by the relevant decrees of the Cabinet of Ministers of Ukraine;
• GSTU EN 980: 2007 "Graphic symbols for the labeling of medical devices";
• GSTU 3798-98 (IEC 60601-1: 1988) "Medical electrical equipment. Part 1. General safety requirements (for active products) ", etc.

Non-binding regulatory legal acts contain recommendatory requirements that become mandatory for specific products after the manufacturer declares their compliance.

The most important requirements

These include the identity of the information on the labeling of the product and in the certificate of its state registration. The Resolution of the Cabinet of Ministers of Ukraine No. 1497 stipulates that "the import into the customs territory, the sale and use of medical devices in Ukraine is permitted only after their state registration." The certificate of state registration contains information on the name of the product, manufacturer, as well as its address. In addition, the product catalog number may be included in this document. During customs clearance and market surveillance, a check is carried out as to whether the product is properly registered: the information provided in the certificate is compared with the data on the label and in the accompanying documentation. In the event of any discrepancy, it may be difficult to prove that the product is registered.

Thus, it is necessary to make sure that the information on the labeling fully corresponds to that indicated in the registration certificate. This applies to the name of the product, the name and address of the manufacturer, the country of origin, as well as the catalog number, if any. It is important to pay attention to this aspect even at the stage of state registration of products, when preparing an application, as well as an attachment to the package of registration materials.

The information on the marking must fully correspond to that indicated in the registration certificate.

When labeling products, it is necessary to adhere to the requirements of the Law of Ukraine "On Protection of Consumer Rights", in Art. 15 of which refers to the consumer's right to information about products, namely:

1) on the name of the product, the name or reproduction of the mark;

2) on the name of the regulatory documents, the requirements of which must be met by domestic products;

3) about the main properties of products, conditions of use and warnings regarding their use by certain categories of consumers, as well as other information about a specific product;

5) the date of manufacture;

6) storage conditions;

7) on the manufacturer's (executor's) warranty obligations;

8) on the rules and conditions for the effective and safe use of products;

9) on the period of suitability of the goods, the necessary actions of the consumer after its end, as well as on the possible consequences in case of failure to perform these actions;

10) about the name and address of the manufacturer and the company that performs its functions regarding the acceptance of claims from the consumer, and also carries out repairs and maintenance;

11) on product certification (if it is subject to mandatory certification);

12) about products that, under certain conditions, can be dangerous to the life, health of the consumer and his property, the environment, and the possible consequences of its use (use).

In addition, during the wholesale and retail trade, it is also necessary to note data on the price (tariff), conditions and rules for the purchase of products.

Information about the impact of the product on human life and health cannot be classified as information with limited access. Full details of the risks and adverse events associated with the use of the product should be provided. In addition, cautions should be given.

Thus, the specified information (adjusted for applicability to a specific medical device) must be conveyed to the attention of the consumer on the label, in the accompanying documentation (instructions, instructions for use).

The information on the label must comply with the current legislation on language policy, which today defines the Ukrainian language as the only state language and a number of languages ​​as regional. So, according to Art. 26 of the Law of Ukraine "On the principles of state language policy" labeling of goods, instructions for their use and the like are made in the state language and regional or minority language. By the decision of the manufacturers of goods, a translation into other languages ​​may be placed next to the text in the state language.

Labeling, instructions for using a medical device (user manual) and other accompanying documents must be submitted in Ukrainian

In order to establish uniform requirements for the labeling of medical devices (both domestic and foreign), the National Standard GSTU EN 980: 2007 "Graphic symbols for labeling medical devices" was created, which is an identical translation of EN 980: 2007 "Graphical symbol for use in the labeling of medical devices ", and is recommended for use by manufacturers. The standard defines the graphical symbols that are most often used by the manufacturer to provide information regarding medical devices and are intended to reduce the need for multiple translations of words into different languages.

During the state registration of a medical device at the stage of technical expertise, general requirements for labeling are agreed upon by approving a sample of packaging. With the introduction of GSTU EN 980: 2007, an examination of the provided labeling sample is carried out regarding its compliance with the specified standard, after which the labeling sample is certified as an integral part of the technical examination protocol. This, in essence, is equivalent to the declaration of the use of approved symbols on the labeling of the corresponding products when they are circulated on the Ukrainian market, and the use of such symbols becomes mandatory (Table 1).

Graphic symbol	Its meaning and explanation
	Reuse PROHIBITED
	USE BEFORE - This symbol is followed by a date, which consists of four digits for the year, two digits for the month, and, if necessary, two digits for the day. The date must appear next to or below the symbol or to the right of it
	LOT CODE - this symbol is followed by the manufacturer's lot code
	REGISTRATION NUMBER - this symbol is accompanied by the serial number of the product, which must be affixed after or below the symbol
	DATE OF MANUFACTURE - for active implantable medical devices, the symbol will be aligned with the date marked with four digits of the year and two digits of the month. For active items, the symbol must be accompanied by a year. The date must be marked after or below the symbol
	STERILITY - only for medical devices that are completely sterilized. Can be used to clarify sterilization methods
	CATALOG NUMBER - the manufacturer's catalog number must be located after or below the symbol adjacent to it
	WARNING! SEE THE ACCOMPANYING DOCUMENTS - can also be synonymous with the symbol "Attention, see instructions for use"
	MANUFACTURER - this symbol must be accompanied by the name and address of the manufacturer who is responsible for the product and which must be marked after or below the symbol
	AUTHORIZED REPRESENTATIVE IN THE EUROPEAN UNION - This symbol must be accompanied by the name and address of the authorized representative in the European Union
	CONTAINS ENOUGH FOR (n-) RESEARCH
	ONLY FOR EVALUATING THE PERFORMANCE OF A MEDICAL DEVICE FOR LABORATORY DIAGNOSTICS IN VITRO
	MEDICAL DEVICE FOR DIAGNOSTICS IN VITRO
	TEMPERATURE LIMIT Can only be used with an upper or lower indication of the temperature limit
	ABOUT THE INSTRUCTIONS FOR USE
	BIOLOGICAL RISKS

It is important to pay attention to the fact that national legislation provides for the inclusion in this standard of a mandatory supplement HA, which provides examples of using the symbol "Number of the certificate of state registration of a medical device in Ukraine" (Fig. 2).

The regulatory rationale for this is as follows: “In Ukraine, the packaging of a medical device is marked with the symbol“ Number of the certificate of state registration of a medical device in Ukraine ”. This symbol must be accompanied by the registration number of the certificate of state registration and the date of its issue. The registration number of the certificate must be located after the symbol, and the date - below the symbol. "

Thus, a special symbol with the number and date of issue of the registration certificate in Ukraine must be applied to the individual packaging of each product.

In addition, if, in the process of passing the technical examination, a sample of marking was approved using the symbols approved by the State Standards of Ukraine EN 980: 2007, then their use also becomes mandatory.

The Law of Ukraine "On the Protection of Rights to Indication of the Origin of Goods" establishes a mandatory indication of the geographical place of origin of goods. Thus, the name of the country of origin of the product, if it differs from that marked on the manufacturer's label, must certainly be indicated on the label, packaging (Fig. 3)

Please note that the terms "manufacturer" and "country of origin" are not the same. According to European directives, a manufacturer is a company (person) that assumes responsibility for the development, production, packaging and labeling of a product prior to placing on the market (EU), regardless of whether these operations are performed independently or by a third party. And the country of origin can be determined according to the principle of significant processing or national share in the value of the goods. Therefore, a company from Germany, for example, and the country of origin may be China, can place a product on the EU market and indicate itself as a manufacturer.

Quite often, the country of origin is mistakenly identified with the country of the manufacturer, and the registration certificate in Ukraine contains only specific names, addresses and countries of the manufacturers.

The indication of the country of origin of the medical device is mandatory

The indication of the country of origin of the medical device is mandatory. And during registration, it is important to make sure that the list of manufacturers contains not only enterprises that have provided the relevant documents and appear on the label (with names and addresses), but also those that are indicated in the marked countries of origin on the same product label.

Other aspects of medical device labeling

The marking of products with a registered trademark is regulated and provides for the application of this trademark to any product for which the mark is registered, packaging containing such a product, a sign associated with it, a label, patch, tag or other item attached to the product, as well as that the storage of such goods should be carried out with the indicated applied sign. Also, the above-mentioned law determines: "The owner of the certificate has the right to affix a warning mark next to the sign, which indicates that this mark is registered in Ukraine."

At the same time, registration of a trademark is voluntary and helps to protect the rights to a trade name or image. If the name of the product is registered without the warning symbols ™ or ®, then it is recommended to enter them into the labeling only after making the appropriate changes in the registration certificate.

If, during the technical examination, a sample of marking with the use of symbols according to GSTU EN 980: 2007 was approved, their use becomes mandatory

Requirements for the font size of the text labeling of a medical device are also not regulated. Basically, this aspect depends on the area for applying such information, as well as the decision of the manufacturer, his representative or distributor. One of the main requirements regarding the application of information in the accompanying documentation and / or on the label, as well as on the marking is its display in an accessible visual form. Consequently, the font (size and type), the form of information presentation should be easily understandable. In other words, with normal vision, information should be perceived without additional effort or the use of any devices.

The right to apply a barcode to a product has the following priority scheme: the priority right belongs to the owner of the trademark, then to the manufacturer, then to the supplier. According to clause 5 of the Regulation on bar-coding of goods, it does not contain information regarding the obligatory application of a bar-code specifically on medical devices: bar codes are provided for by the legislation of Ukraine. " So, not a single specialized regulatory act regulates the mandatory use of a barcode, therefore it can be applied at the request of the owner, in accordance with the above procedure. The barcode can be applied in a linear or two-dimensional manner.

Responsibility for providing the correct information is shared between the manufacturer and the seller. The legislation does not establish who exactly - the manufacturer or the seller - is responsible, therefore this issue requires a definition in the contract.

It should also be noted that the EN 980: 2007 standard in most European countries became invalid on 01.01.2013 and in 2012 was replaced by the EN ISO 15223-1: 2012 standard, which does not change the EN 980: 2007 symbols, but introduces some new symbols and designations (Table 2). They can be seen on imported medical devices today.

	Do not resterilize		Contains latex
	The product is not sterile		Control material
	Do not use if the package is damaged		Liquid filter with pore size
	Humidity limitation		Drops per milliliter

Thus, during the registration of a medical device, one of the essential aspects is the coordination of the main elements of its labeling. The manufacturer, his representative or distributor should pay attention to the product labeling even before the start of its state registration, determine the necessary elements and place the relevant information on the labeling and accompanying documents.

Maxim Bagreev,
company "Cratia"

Dear Alexander.

Decision of the Customs Union Commission dated 28.05.2010 No. 299
On the application of sanitary measures in the customs union

Section 18. Requirements for medical devices and medical equipment

5. Requirements for consumer labeling of medical devices and medical equipment and user information

Information about medical devices and medical equipment must be stated by the manufacturer in the product labeling and in the documentation for it. The information, in addition to the address of the manufacturer of the products, must contain a list of indicators related to the protective and operational properties, the legal aspects of placing the products on the market, as well as any other information that provides the intended user with an adequate choice and use of the product and may be related to his health and security.

The marking is applied directly to the product and / or packaging. For a product introduced into circulation in a sterile form, the labeling should also be applied to the sterile packaging. Marking is not applied to a product if it is too small or is not allowed by its specific properties.

The marking should be clearly visible, legible, indelible, and applied on the product itself or in the instructions for use. If possible, the mark should be applied to the sales packaging. For products put into circulation in a sterile form, the labeling should also be applied to the sterile packaging. Marking is not applied if the product is too small or is not allowed by its specific properties.

It is prohibited to use symbols or inscriptions that may mislead third parties with regard to the meaning or graphic representation of the market circulation mark. Any other marking may be applied to the product, its packaging or the product manual, provided this does not adversely affect the visibility and legibility of the marking.

The marking applied directly to the product must contain: the name of the manufacturer and / or his trademark; product name; dimensions, weight, power supply, serial number (if necessary), date (year) of manufacture (for BMI), expiration date or expiration date, regulatory document, the requirements of which the product complies with, circulation mark; other information in accordance with the manufacturer's technical documentation.

The marking applied to the packaging of the product must contain: the name of the country of manufacture, the name, legal address and trade mark of the manufacturer, the name of the product, the regulatory document, the requirements of which the product meets, dimensions, weight (if necessary), methods of care for the product, year of manufacture (for BMI), expiration date or expiration date (for medical devices), circulation sign, other information in accordance with the manufacturer's documentation.

Information on BMI should be applied in relief (embossing, engraving, casting, stamping). It is allowed to apply information in the form of pictograms, as well as hard-to-remove paint directly on the product. The information should be easily readable and stable during storage, transportation, sale and use of products for their intended purpose.

The marking must be written in Russian. Additional use of other languages ​​is allowed.

Packages with products must be marked with pictograms (signs and / or text) prescribing the conditions for storage and / or transportation of products established by the manufacturer in accordance with the regulatory (operational) documentation.

The marking indicates all the necessary information to ensure the safe operation of the product: its main technical characteristics, warning labels, hazard signs (magnetic, laser or others for BMI; information about the materials from which the medical device is made, etc.), requirements for the need use of personal protective equipment, safety distances or permissible operating times, etc. for BMI.

The operation of medical equipment is carried out in accordance with the regulatory documentation for specific products and other documents of sanitary legislation containing requirements for the relevant characteristics of BMI.

Requirements for ensuring the safety of BMI during their operation, indicated on special plates, as well as warning signs and inscriptions are placed in prominent places of the products in which they are located.

The manufacturer must provide the information so that proper precautions can be taken and that all hazards are properly controlled using the full range of protective measures.

The user of a BMI characterized by a high potential health hazard (UV devices, laser products, etc.) should be warned of the existing risk. The danger of products is indicated accordingly. The use of medical equipment intended for the population in everyday life should be carried out according to the doctor's prescription, in accordance with medical recommendations.

UV devices are marked with a warning sign: “ATTENTION! UV radiation can damage eyes and skin. Read the instructions carefully. Please wear the supplied safety goggles. " For UV appliances intended for use in beauty salons and similar locations, warning labels may be displayed on a poster permanently affixed in the vicinity of the UV appliance.

UV devices with a brightness exceeding 100,000 cd / m2 are marked with the warning label: “Powerful light. Do not look at the emitter. "

UV irradiators that are intended to be operated in the absence of people are marked with an appropriate warning label.

Laser products of different classes are marked with warning notices - “Do not look into the beam”, “Laser radiation”, “Avoid exposure of eyes and skin to direct and scattered radiation”, “Laser aperture”, etc., indicating the class of the laser product. Laser products generating radiation in the invisible part of the spectrum are marked with a corresponding warning inscription - “Invisible laser radiation”, etc.

The sections "Safety Requirements" of the operational documentation include the basic requirements for ensuring the safe operation of products, as well as for its production in accordance with the main documents of sanitary legislation with references to these documents, including: to the used production equipment and the levels of hazardous factors at workplaces , means of collective and individual protection, work regimes, carrying out PMO of workers and production control (if necessary). This section should indicate that the products must be safe during production and use and must have a formalized sanitary and epidemiological conclusion.

Tell me what must be indicated on the label for medical products, and what can be included in the instructions?

Answer

Requirements for marking (labeling) and instructions (accompanying documentation) are specified in the Unified Sanitary and Epidemiological and Hygienic Requirements for Goods Subject to Sanitary and Epidemiological Supervision (Control).

The rationale for this position is given below in the materials of Sistema Yurist .

Decision of the Customs Union Commission from

"5. Requirements for consumer labeling of medical devices and medical equipment and user information

Information about medical devices and medical equipment must be stated by the manufacturer in the product labeling and in the documentation for it *. The information, in addition to the address of the manufacturer of the products, must contain a list of indicators related to the protective and operational properties, the legal aspects of placing the products on the market, as well as any other information that provides the intended user with an adequate choice and use of the product and may be related to his health and security.

The marking is applied directly to the product and / or packaging. For a product introduced into circulation in a sterile form, the labeling should also be applied to the sterile packaging. Marking is not applied to a product if it is too small or is not allowed by its specific properties.

The marking should be clearly visible, legible, indelible, and applied on the product itself or in the instructions for use. If possible, the mark should be applied to the sales packaging. For products put into circulation in a sterile form, the labeling should also be applied to the sterile packaging. Marking is not applied if the product is too small or is not allowed by its specific properties.

It is prohibited to use symbols or inscriptions that may mislead third parties with regard to the meaning or graphic representation of the market circulation mark. Any other marking may be applied to the product, its packaging or the product manual, provided this does not adversely affect the visibility and legibility of the marking.

The marking applied directly to the product must contain: the name of the manufacturer and / or his trademark; product name; dimensions, weight, power supply, serial number (if necessary), date (year) of manufacture (for BMI), expiration date or expiration date, regulatory document, the requirements of which the product complies with, circulation mark; other information in accordance with the manufacturer's technical documentation.

The marking applied to the packaging of the product must contain: the name of the country of manufacture, the name, legal address and trade mark of the manufacturer, the name of the product, the regulatory document, the requirements of which the product meets, dimensions, weight (if necessary), methods of care for the product, year of manufacture (for BMI), expiration date or expiration date (for medical devices), circulation sign, other information in accordance with the manufacturer's documentation.

Information on BMI should be applied in relief (embossing, engraving, casting, stamping). It is allowed to apply information in the form of pictograms, as well as hard-to-remove paint directly on the product. The information should be easily readable and stable during storage, transportation, sale and use of products for their intended purpose.

The marking must be written in Russian. Additional use of other languages ​​is allowed.

Packages with products must be marked with pictograms (signs and / or text) prescribing the conditions for storage and / or transportation of products established by the manufacturer in accordance with the regulatory (operational) documentation.
The marking indicates all the necessary information to ensure the safe operation of the product: its main technical characteristics, warning labels, hazard signs (magnetic, laser or others for BMI; information about the materials from which the medical device is made, etc.), requirements for the need use of personal protective equipment, safety distances or permissible operating times, etc. for BMI.

The operation of medical equipment is carried out in accordance with the regulatory documentation for specific products and other documents of sanitary legislation containing requirements for the relevant characteristics of BMI.

Requirements for ensuring the safety of BMI during their operation, indicated on special plates, as well as warning signs and inscriptions are placed in prominent places of the products in which they are located.

The manufacturer must provide the information so that proper precautions can be taken and that all hazards are properly controlled using the full range of protective measures.

The user of a BMI characterized by a high potential health hazard (UV devices, laser products, etc.) should be warned of the existing risk. The danger of products is indicated accordingly. The use of medical equipment intended for the population in everyday life should be carried out according to the doctor's prescription, in accordance with medical recommendations.

UV appliances are marked with a warning notice: "WARNING! UV radiation can cause damage to eyes and skin. Read instructions carefully. Please wear the supplied safety goggles." For UV appliances intended for use in beauty salons and similar locations, warning labels may be displayed on a poster permanently affixed in the vicinity of the UV appliance.

UV devices with a brightness exceeding 100,000 cd / m2 are marked with a warning sign: "Strong light. Do not look at the emitter".

UV irradiators that are intended to be operated in the absence of people are marked with an appropriate warning label.
Laser products of different classes are marked with warning notices - "Do not look into the beam", "Laser radiation", "Avoid exposure of eyes and skin to direct and scattered radiation", "Laser aperture", etc. indicating the class of the laser product. Laser products generating radiation in the invisible part of the spectrum are marked with a corresponding warning inscription - "Invisible laser radiation", etc.

The sections "Safety Requirements" of the operational documentation include the basic requirements for ensuring the safe operation of products, as well as for its production in accordance with the main documents of sanitary legislation with references to these documents, including: to the used production equipment and the levels of hazardous factors at workplaces , means of collective and individual protection, work regimes, carrying out PMO of workers and production control (if necessary). This section should indicate that the products must be safe during production and use and must have a formalized sanitary and epidemiological conclusion. "

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