Basic rules for labeling pharmaceutical and medical products. Labeling of medical devices: supporting information Requirements for the labeling of medical devices GOST

In the conditions of market relations, the role of information about goods increases, since it is difficult for the consumer to understand the variety of existing and new goods and make the right choice. On the other hand, information is also necessary for the manufacturer of the product. He must monitor the manufacture of new products, their competitiveness in order to make decisions on the termination of production of individual products and the development of new ones.

There are different types and forms of information. Commodity information is divided into fundamental, commercial and consumer information. Product information media include labeling, technical documentation, reference literature, mass media, advertising, etc.

Attention to the means of product labeling is due to the fact that a saturated market poses a difficult task for consumers and manufacturers: to have reliable information about new and existing products.

Marking (from German markieren - mark, put a sign) - the application of conventional signs, letters, numbers, inscriptions on an object to distinguish it from other objects or to inform about its special properties. The marking rules are set by special GOSTs, for example, GOST 19433-88, GOST 14192-96.

Marking - a certain text, symbols or drawing applied to a product or its packaging, designed to identify the product or its individual properties, to communicate to the consumer information about the manufacturers, as well as the quantitative and qualitative characteristics of the product. The marking reflects information about the manufacturers, the standards that the product complies with, certifications, manufacturer's warranties, the service life of the product and the main consumer properties. Marking is a means of ensuring their quality control, used by regulatory organizations for identification and examination. Identification of goods - establishing the conformity of the name of the goods indicated on the label and in the accompanying documents with the requirements for it. The identifying function of marking allows to provide traceability of commodity stocks at all stages of goods distribution.

Product labeling is necessary for the following reasons:

• - for identification;
• - for the responsibility of the subject;
• - ensuring a guarantee of the quality level of the goods;
• - the commercial risk of the consumer is reduced;
• - a brand is an advertisement for a product;
• - the use of trademarks facilitates segmentation in the market.

Marking functions:

• - information;
• - identifying;
• - motivational;
• - emotional.

The information function of marking is the main one. The largest share falls on fundamental consumer information, the smallest - on commercial. The underlying information about the goods on the label should take into account the information specified in the shipping documents. If the information does not match, then the product is counterfeit. The emotional and motivational functions of labeling are interrelated. Colorfully designed labeling evokes positive emotions in consumers, becomes a motivation for buying a product.

Depending on the nature of the applied signs and symbols, the marking is divided into:

• - verbal (word, letter, number);
• - pictorial (drawing, figure, graph);
• - volume-spatial (relief or holographic image);
• - combined.

The main requirements for product labeling are reliability, accessibility and sufficiency.

The requirements for labeling are:

• - information should be simple, modern, understandable, reliable (accurate), objective (lack of subjectivity in the presentation of information), truthful (lack of disinformation, which can be considered as falsification);
• - information must be provided to the buyer in a language that he understands using generally accepted terms that are prescribed in reference books and terminological standards, specific terminology relating to the product must be explained, this includes demand - the manufacturer must provide information about the product to the buyer;
• - sufficiency - rational information saturation, prevention of both incomplete and redundant information, the sufficiency of information is very important, since the incompleteness of information may be due to its unreliability, insufficient information may relate to goods allegedly received from abroad, in reality, this information may be falsified, on the other hand, the presence of excessive information can cause a backlash among buyers and lead them to abandon the purchase;
• - the use of terminology and language of presentation should be unambiguous, drawings, diagrams, symbols, scales and tables can be effective means of conveying information to consumers, but their presentation should be unambiguous;
• - information for consumers should be clearly distinguished from information intended for advertising products;
• - the font size of the inscriptions should be easy to read and comply with the national or international standard.

The basic information on the label duplicates the same type of information in the shipping documents. The discrepancy between the data in them may be the result of falsification. Labeling is subject to general requirements for product information and specific requirements (clearness of text and drawing, the use of indelible dyes permitted by consumer supervision authorities).

The main elements of the label:

• - text (specific gravity from 50 to 100%), it is more preferable;
• - drawing (not always present, but its specific gravity can be up to 50%);
• - information signs - identification of product characteristics, up to 30%.

Marking should be clear, concise, memorable. This is due to its size, application methods. Aesthetically, the marking should be done with taste, attract the attention of the consumer, and at the same time, it is not intended for external decoration and decoration of the product.

Distinguish between consumer, trade or production and transport labeling.

Consumer labeling includes: information about the manufacturer, information about the product, design features, instructions for the use of goods, for the care of the product, the name of the manufacturer, release date, expiration date and storage period, various warning notes. The sources of such information are manufacturers of goods that inform sellers and consumers about the goods produced. Consumer labeling affects the speed of promotion, the intensity of product sales, sales promotion and the creation of consumer preferences. Consumer labeling includes information and reference data about the product and its manufacturer, instructional and warning instructions.

Consumer marking must include the following data:

• - name of the medicinal product;
• - name and location (legal address, including country) of the manufacturer, packer, exporter and importer of the medicinal product;
• - trademark of the manufacturer (if any);
• - the value of the mass, the dose of the drug, the volume or amount of the drug;
• - the composition of the medicinal product;
• - indications that the medicinal product is genetically modified or genetically modified components are used in it;
• - recommendations for the use of the medicinal product;
• - best before date;
• - shelf life;
• - date of manufacture (packaging);
• - indication of storage conditions;
• - designation of a regulatory document that establishes requirements for the quality of goods;
• - information on the certification of the medicinal product;
• - a special sign.

The text is applied on the label or on the surface of the container in the language of the manufacturer's country, if the pharmaceutical product or medical device is intended for export - in the language of the importing country, or in several languages ​​in accordance with the relevant requirements and conditions of the contract. Labeling of consumer packaging must have artistic design and symbols. Production marking is presented in the form of texts, symbols or drawings applied by manufacturers to goods and / or packaging and other media. The paint used for marking must be waterproof, non-sticky, and indelible. Labels, inserts, labels, tags, control tapes, hallmarks, stamps, and collars can be carriers of industrial marking.

Label - any colorful or descriptive characteristic of the product and its manufacturer, printed in the form of a stencil, stamp, relief on a packaging unit, as well as on an insert sheet or label attached (attached) to each unit of goods. Labels are applied by typographical or other means to the goods or packaging, in addition, they can be an independent information carrier, glued or applied to the goods. For example, most industrially packaged medical products have a label on the packaging on which text, pictures and other information are printed. Labeling of cans is carried out by gluing a paper label or applying it by lithographic method. Adhesive-backed labels are acceptable. Sometimes a label is applied directly to a medical device (for example, marking on a phonendoscope membrane, on the back of a glucometer, etc.). Labels are characterized by significant information capacity. Labels carry the greatest information load. In addition to text, they often contain images, symbols. Of all the labeling carriers, the information on the labels is the most extensive in terms of the number of characteristics characterized. Label markings may contain explanatory texts.

Collierettes - labels of a special form, pasted on the neck of bottles. Collierettes do not carry a large informational load, but mainly serve the purpose of aesthetic design of bottles. Collierettes perform an aesthetic, emotional, motivational function. They are used together with the main label on bottles with medicinal infusions, balms and tinctures, they have no independent meaning. On the collar, for example, the name of the balm, the manufacturer, the year of manufacture or information signs can be indicated. Sometimes there is no information on the collars at all.

Inserts are a type of labels that differ in the direction of product information and are designed to provide brief information about the name of a medical product, manufacturer (organization name, shift number). Sometimes inserts may contain a brief description of the consumer properties of a medical product, primarily for its functional purpose. Then the insert acquires the additional functions of a leaflet or brochure, but unlike the latter, the advertising function is not the main one, but is implemented through the characteristics of the product. Such inserts are often found in the packaging of various medical cosmetics. Inserts are often used for labeling medicines.

Labels and tags are labeling carriers that are glued, applied or hung to the product. They are characterized by a smaller information capacity, a limited list of information, and the absence of drawings. Labels are less informative than labels. Labels, labels may contain a company and trademark. Labels can be very concise and indicate only the name or brand name, or only the manufacturer. Labels usually contain the name of the product, the manufacturer, its address, grade, price, release date, as well as a number of identifying data. So, on labels hung on medical clothing, indicate the article number, model number, size, release date. The label may contain brand and trademarks, other necessary signs and symbols.

Control tapes are carriers of brief duplicating product information located on a small tape and designed to control or restore information about a product in case of loss of a label, tag or label. They can be used in addition, less often instead of other media. A distinctive feature of control tapes is the application of digital or symbolic information, the purpose of which is to indicate the article number, model number, size, grade, service marks, etc. Control tapes are most often used for marking medical clothing, shoe covers.

Hallmarks and stamps are information carriers intended for identifying symbols on goods, packaging, labels applied with the help of special devices of the established form. There are hallmarks and stamps depending on the place of application - industrial and commercial; from the purpose - veterinary, commodity, quarantine, etc., from the shape - oval, rectangular, square, triangular, diamond-shaped. Branding and stamping is advisory. Stamps are put on metal lids of glass jars, packaging made of polymeric and combined materials for biological additives, labels on bottles and jars. Stamps and hallmarks are less common on fabrics in which the mark is applied to the chazz ends from the wrong side. In addition, stamps made by the production method are applied to individual components of complex technical goods - medical equipment. Branding and stamping of goods and packaging is carried out in the following ways: applying with a brand or stamp of indelible paint, permitted by the bodies of the State Committee for Sanitary and Epidemiological Supervision; extrusion with stamps. Applying a brand or stamp with indelible paint is the most common method. Relief marking by extrusion of letters, numbers, other symbols is found on metal parts of tools and equipment. Relief marking is also found on glass packaging (bottles, vials), sometimes on glass medical products.

The requirements for labels and stamps are as follows:

• - the clarity of stamp imprints;
• - persistence regardless of external influences (for sterilized medical instruments);
• - safety of the applied methods of branding and stamping;
• - preservation of the presentation of products and products subjected to branding and stamping;
• - Compliance with the established rules of branding and stamping.

Trademarking provides information about a medical product and is intended primarily for commercial activities. Trademarks are intended to provide information about the seller and, to a lesser extent, information about the product. The requirements for industrial marking are established mainly by the standards for marking and packaging, as well as the general technical conditions of product standards.

Trade or production marking must include the following data:

• - name and location (legal address, including country) of the manufacturer, packer, exporter and importer of the product;
• - trademark of the manufacturer;
• - the value of the net weight, volume or quantity of products;
• - composition of the product;
• - the nutritional value of the product;
• - recommendations for the preparation and use of the product;
• - storage conditions;
• - expiration date, shelf life, date of manufacture;
• - designation of a normative document.

Trademark carriers are price tags, sales and cash receipts, invoices, stamps, packaging. They are not applied to the product, but to the specified media or operational documents. Implementation methods: application with indelible paint, burning, extrusion with stamps, indentation of numbers, letters. Trademarking refers to a barcode that contains information about the product and its manufacturer.

Other types of markings that characterize quality, for example, information signs, may be applied to medical products. Information signs are symbols designed to identify individual or group characteristics. Symbols allow you to distinguish a product from the mass of similar ones. In particular, due to identifying information, individual carriers of information marks can serve as the basis for filing claims against the seller in the event of defects in the goods.

Information signs are characterized by:

• - brevity;
• - expressiveness;
• - visibility;
• - recognition.

Recently, special labeling of goods, developed within the framework of the European Community (EU), other European and international organizations, has become widespread, which includes:

• - trademarks;
• - signs of compliance with established quality and safety requirements;
• - component signs (food additives);
• - handling signs - for information about the methods of handling goods, cargo;
• - warning signs - to ensure the safety of the consumer of medical products and the preservation of the environment during the transportation, storage, use of goods;
• - environmental signs - to inform consumers about environmentally friendly methods of their application, operation or sale;
• - dimensional signs - specific physical quantities (mass, volume);
• - operational - to inform the consumer about the rules of operation, installation, commissioning.

The list of signs is approved at the international level.

Component signs - signs intended for information about accepted food additives or other components characteristic (or unusual) of the product. The European Council has developed a digital codification system with the letter "E" for food additives.

Dimensional signs - signs designed to designate specific physical quantities that determine the quantitative characteristics of the goods (according to the SI system).

Operational signs - signs designed to inform the consumer about the rules of operation, methods of care, installation and adjustment of medical equipment.

Manipulation signs - signs intended for information about the methods of handling goods. Their symbolism, name, purpose is regulated by GOST 14192-96 "marking of goods".

Warning signs - signs designed to ensure the safety of the consumer and the environment during the operation of potentially dangerous goods by warning about the danger or indicating actions to prevent the danger (X-ray equipment, computed tomography)

Currently, in the countries of the European Community, the CE mark has been adopted as a single symbol for certification and labeling of products that comply with European norms and standards. This marking must be used if the product is sold on the European market. This marking is not a guarantee of the quality of the product, but shows that the product was produced in accordance with the requirements of the directives. It also means that the manufacturer has followed all the conformity assessment procedures described. The conformity assessment procedure can be carried out both by the product manufacturer and by organizations authorized by the EU. In the latter case, the CE mark is supplemented by the emblem of the assessing organization.

An important means of information about a product is a trademark, or trademark, designed to identify products and used by manufacturers and sellers to distinguish their products from those of other manufacturers. Trademarks (service marks) - a special designation by which you can distinguish the goods and services of one company from another. The development, approval and use of a trademark is regulated by national laws - "On Trademarks (Service Marks)". A trademark or a trademark is registered in the prescribed manner in accordance with the laws, which specifies the whole range of issues related to the registration of a trademark, its use, transfer to another legal entity or individual under a license agreement or a trademark assignment agreement.

The legal basis for information support in Russia, for example, is the following laws:

• - "On Trademarks, Service Marks and Appellations of Origin";
• - "On consumer protection";
• - “On information, informatization and information protection”;
• - "About advertising";
• - "On packaging, labeling of consumer goods sold in the field of trade and services."

The license agreement must necessarily indicate that the quality of the medicinal product of the licensee will not be lower than that of the product of the licensor, and the latter will monitor compliance with these requirements. The laws reflect international experience and take into account the most important legal framework related to trademarks, industrial and intellectual property.

Trademarks are needed to ensure the following goals:

• 1) brands inspire confidence in consumers - they get used to the same product if it satisfies them in quality;
• 2) the use of a trademark facilitates advertising;
• 3) the brand helps to avoid competition: consumers who rely on the quality of products with a certain brand (mark) are often willing to pay more than for the same thing, but without a brand or mark.

To select a brand name, drug manufacturers proceed from the following considerations:

• - choose a name that is easy to pronounce;
• - choose a name that is identified with the merits of the product;
• - choose a name that can be protected legally;
• - choose a name that can be used for the entire assortment group;
• - choose a name that is associated with the high quality of the medical product.

So, a trademark is a special symbol of commodity liability, denoting who owns the right to dispose of this product, make a profit and the obligation to incur losses for the supply of low-quality goods. For the first time, trademarks as industrial property received international recognition, most fully recorded in the Paris Convention for the Protection of Industrial Property in 1883 (Russia has ratified all editions, including the Stockholm one).

There are the following types of trademarks: manufacturer's marks (nationwide marks) and private marks. A manufacturer's brand is a brand created by the manufacturer, or rented. A private label is a brand created by a trading company. It contains the manufacturer's name. Depending on the objects, trademarks are classified into branded and assortment (nominal), and the latter into specific and branded. Trademarks are intended to identify goods or services.

There are three main types of trademark designation:

• - company name - a word, letter, group of words or letters that can be pronounced;
• - brand name - a symbol, drawing, distinctive color or designation;
• - trademark - a trade name, trade mark, trade image (trade image - a personalized trade mark), or a combination of them, officially registered in the International Register, legally protected, i.e. the above types of brand designations do not provide legal protection against use by competitors unless they are registered as trademarks. Therefore, the trademark is the most important element of labeling. A trademark is presented in the form of a company name, trademark, trademark, or a combination of them, officially registered in the relevant institutions of Russia or other countries and in the International Register and legally protected, as indicated by the ® sign located next to the trademark. If the trademark is the property of the company, then the © icon is added to it. The trademark is valid for 10 years, but can be extended at the request of the owner for another 10 years. A trademark, depending on the status of the owner, can be individual or collective. By purpose and prestige, ordinary and prestigious brand names can be distinguished. Ordinary trademarks are developed by the owners or, on their behalf, by specialist designers, and are registered in the prescribed manner. Prestigious brand names are assigned to firms for special services to the state (in the form of images of medals, prizes). The peculiarity of the assignment of prestigious marks is that they are not subject to registration with patent authorities, and when exporting products, they raise national prestige.

Assortment trademarks are designed to identify assortment accessories. They are of two types: specific (the brand is presented in verbal or pictorial form) and branded (a specific name or sign inherent in a particular type of product). A brand mark can be presented in the form of various symbols.

Trademarks according to the form of providing information are divided into: verbal, alphabetic, digital, pictorial, three-dimensional, combined.

The verbal form of product information is presented in the language of the country of manufacture and a number of other countries, which makes it possible to acquaint a wide range of consumers with it. The disadvantages of such information include the inconvenience of placing it on the product, since it requires a significant amount of space on the packaging or the product itself.

The digital form of information about the product supplements the verbal form with some quantitative information about the product, about the volume, weight (net, gross), length, date and timing of release. This information is distinguished by image clarity, uniformity and conciseness. In some cases, it is available only to professionals in establishing product assortment numbers, deciphering company numbers using product classifiers. However, it can be incomprehensible to consumers of products, because they do not have enough knowledge of these recognition methods.

The main meaning of pictorial labeling is to create consumer preferences by satisfying the aesthetic needs of buyers. This form of providing information provides visual and emotional perception of information about goods using various artistic and graphic images directly on the product. An important advantage of visual information is that it is visual and accessible for perception. Such information should complement the verbal and digital information, providing additional versatile information about the product. At the same time, the possibilities of visual information are quite limited.

Symbolic marking conveys information about the product using various symbols, signs that characterize the distinctive properties of the product or product. For example, a product may have a label with the image of the “Afraid of moisture” symbol, etc. Symbols should be unambiguous and concise. Sometimes perception requires professional knowledge.

Signs of the appellation of origin of goods - the name of the country, locality, area, historical name of the object. The signs of the country are divided into international and national. In foreign trade activities, international signs are used, which include one or more letters and a numeric code. Signs of the country of origin can be found in the mark of conformity or in shipping documents (certificates and other documents). Along with or instead of these marks, the national marks of the country of origin of the goods, such as "Made in the USA", "Made in the Russian Federation", or the national mark may have symbols. The signs of the places of origin of goods do not have a generally accepted symbolism, but they can also serve as a brand mark.

Marks of conformity confirm the compliance of the medical products marked with them with the established requirements of the standard and other regulatory documents. Depending on the scope of application, national and transnational marks of conformity are distinguished. National marks of conformity confirm compliance with the requirements established by national standards or other regulatory documents. They are developed, approved and registered by the national standardization and certification body. Marks of conformity may only be used to mark certified products. Each country develops and approves its conformity marks. Transnational (regional) conformity marks confirm compliance with the requirements established by regional standards. They are applied in the countries of a certain region on the basis of harmonized

standards and mutual recognition of certification results. Along with conformity marks, quality marks are used in a number of countries. They can be assigned not only by certification bodies, but also by other organizations that are not part of the national certification system, such as health authorities.

A warning label is a special designation indicating that a trademark has been registered. As signs of warning labeling in world practice, the “®” icon, the letter combinations “TM” (short for trademark), “SM” (short for service mark), as well as the words “Trademark”, “Registered Trademark”, “registered sign”, “Marque deposee”, “Marca registrada”. Marking "" (Registered) according to world practice can only be used by owners of officially registered trademarks. The symbol is placed directly to the top right of the trademark image. The application of such a mark is a right, not an obligation, of the owner of the mark, which is reinforced by Article 5D of the Paris Convention. The designation "Trade mark ™," TM "or" ™ ", which is not regulated by the legislation in Russia, in foreign countries usually means that an application for a trademark has already been filed and when using this name after registering a trademark, you can get a claim from the copyright holder. Marking "TM" according to the legislation of the Russian Federation does not have legal protection, such marking performs only an informative function.

Eco-labeling is indicated by a special eco-label, which serves as an indication to the consumer about the environmental friendliness of the product, as well as the safety of its packaging for the environment. The decision to assign eco-labels is made by the competent authority of the EU member states. All eco-signs can be divided into three subgroups of signs informing:

• - on the ecological cleanliness of medical products or their safety for the environment;
• - on environmentally friendly methods of disposal of goods or packaging;
• - about the danger of pharmaceutical products for the environment.

Bar information has become widespread. Bar coding is a way of outputting information to a computer, which allows you to quickly recognize a product and transfer information on each item, manufacturer of goods and its quantity. On the other hand, it creates great convenience in trade as well. The presence of bar coding allows the pharmacy to reduce the cost of selling medical products while maintaining the required assortment, replenish stocks of goods in a timely manner and order new batches. At the same time, it is possible to monitor demand, the dynamics of changes in the structure and the availability of goods on the pharmaceutical market. Each entrepreneur has the opportunity to purchase an individual code, which practically means that his product can be identified and can enter the global information system. According to the Directive of the Ministry of Health of the Russian Federation No. 388-U dated 06/26/97, the packaging of drugs manufactured in the Russian Federation must have a bar code of the international EAN numbering system. The bar code of the international numbering system EAN (if available) is applied to the packaging of medicines in consumer packaging. The barcode is printed on the label or directly on consumer packaging (pack, bag, tube, etc.). It is allowed to apply a bar code on a separate label, additionally pasted on consumer packaging.

Transport marking informs about the sender and recipient of the goods, about the methods of handling the packaged products during their transportation, loading and unloading, storage. It is applied to the container, it can be made in the form of verbal information (the name of the sender and recipient of the goods, the serial number of the place, the name of the point of departure and destination), specific conventional signs indicating the special properties of the goods and methods of handling them. Transport marking is used when using barrels, boxes, containers, etc. On the label of the shipping container or directly on the surface of the shipping container indicate:

• - name and address of the manufacturer, his subordination,
• - trademark of the manufacturing organization, if any;
• - trade name of the drug;
• - series number;
• - net and gross weight;
• - the number of packaging units in the shipping container;
• - net weight of a packaging unit;
• - production date, shift number, batch number;
• - designation of product standards;
• - expiration date (storage conditions).

Transport marking information may include manipulation signs: "Afraid of dampness", "Do not throw", "Store in a dry place", "Store in a cool, dark place", "Fragile cargo", "Explosion hazard", etc. On boxes , flasks are glued with paper labels with typographic text, wooden barrels are marked with black indelible paint. When labeling bags, a label is sewn or pasted, made either from bag fabric and grade A wrapping paper, or from cardboard, etc. Transport marking must comply with the requirements of GOST 14192-96 or NTD for products for export. Transport marking of aerosol packages must comply with the requirements of GOST 19433-88. The transport labeling of drugs must comply with the requirements of GOST 14192-96 with the application of manipulation inscriptions and danger signs in accordance with GOST 19433-88, which indicate in the document a specific type of drug. Combination of transport marking and marking with data on packaged products on one side of the shipping container is not allowed.

Technological (intermediate) marking is used to ensure technological processes within a healthcare organization (structural unit) or within a pharmaceutical enterprise. Technological marking should provide unambiguous visual identification of each unit of production. Processing labels are usually black and white, but color processing labels can be used. If technological marking is carried out using labels pasted on polymer containers, then it is applied over the label of the manufacturer of polymer containers, while information about the manufacturer, batch number and expiration date of the container should not be sealed. In the process of production, processing and storage, it is allowed to apply handwritten notes or stamps on the technological label, reflecting the features of the technological process. The use of barcode labels is preferred. The size of the technological label should be no more than 80*70 mm. It is not allowed to use units of production in case of loss of technological marking by them. Procedures and requirements for technological labeling of a product unit must be established in the NTD of a healthcare organization (structural unit), a pharmaceutical enterprise engaged in the production, processing and storage of medicines.

For example, in the production of blood components, the following types of technological marking are used. Blood donation stamps - a block of labels containing a unique donation number, individual technological stickers containing personal information about the donor and donation, individual donor identification bracelets - disposable plastic bracelets designed to identify the donor during the medical examination and donation. The requirements for the format, design and information provided on the labels used to label containers with canned blood and its components are regulated by the relevant standards. The labeling of finished products applies to donated blood and its components that have passed all stages of processing and research that meet all the requirements for donor blood and its components.

The presence of labeling of finished products is a confirmation of the suitability for the use of a particular unit of products in medical practice. Preliminary (before the end of all stages of processing and research) marking of finished products, as well as applying preliminary (not confirmed by regulated laboratory tests) information on it, is not allowed. A label is intended for marking a unit of finished products. The label must be retained throughout the entire shelf life and under all modes of storage and use of the finished product unit, and the information given on the label must remain easily readable. It is preferable to provide machine-readable information on the label intended for automatic identification of containers with canned blood or its components. The information given on the label of the finished product is divided into:

• - mandatory for all blood components;
• - mandatory for individual blood components;
• - optional extra.

The label placed on the finished product must contain information that ensures the traceability of blood and its component. Information on the label must be printed in black on a white background. Information to which special attention should be paid should be applied by inversion. The most important characteristics of the blood component (date of expiration of the shelf life, Rh-affiliation) should be printed in a larger font than the rest of the inscriptions. The AB0 blood group should be printed in the largest font. The label is stuck on the container with blood or its components so that the text can be easily read on the container suspended on the rack during the transfusion, i.e. The top of the label should be at the bottom edge of the container. Labels are applied to one side of the container only. The other side is left free to visually evaluate the contents of the container. Making any additional inscriptions and corrections of data on the label of the finished product is not allowed. When making corrections, the finished product label must be replaced with a new one. Immediately before donating blood by a donor, a healthcare organization (structural unit) that collects, processes, stores and ensures the safety of donor blood and its components assigns a unique donation number of six Arabic numerals. For organizations that have banks for long-term storage of blood components, the donation number should not be repeated within 5 years, for other organizations - within 2 years. The application of an identification bar code on the label is a preferred requirement for all healthcare organizations (structural divisions) that procure, process, store and ensure the safety of donated blood and its components, but must be applied without fail when using automatic identification tools. An identification bar code is applied to the label in the form of Code 128 bar code symbols according to GOST 30743-2001, supplemented by check, start and stop digits regulated by the Code 128 bar code symbols. The bar code structure provides unambiguous identification of any container with canned blood or its components manufactured in a specific country.

Marking is used in the commodity analysis of medical and pharmaceutical products for the analysis of consumer properties and technical indicators of medical products, for a comprehensive study of the quality of goods and the assessment of their safety. Starting from the first stage of commodity analysis, labeling plays an important role, as it provides information about the purpose of goods, consumer properties, manufacturing method, and appearance features. Based on the information contained on the label, at the first stage of commodity analysis, a classification group and a subgroup of medical products are determined. At the second stage of merchandise analysis, when studying the codes printed on containers and packaging, barcode marking is used to determine and decipher the digital code of the product. At the third stage of commodity analysis, the information contained on the label is used to determine the trade name of the medical product, to determine the type of product. At the fourth stage of commodity analysis, when determining the technological characteristics of the material from which the medical instrument is made, they are primarily guided by marking. Following the marking, you can find out: what material the medical instrument is made of (type of steel, type of polymer, type of glass). Manufacturing marking provides data, according to the general technical conditions of product standards, about the active substance, and other components of the medicinal product. At the fifth stage of the commodity analysis, the correspondence of the quantity of medicines in the primary package is established, focusing on the labeling data applied to the inner and outer packages, about the dose and the number of doses in the package. At the sixth stage of commodity analysis, when evaluating the consumer and aesthetic properties of packages, they study the brevity, expressiveness, visibility, and recognition of consumer labeling used in the design of the package. Of particular importance is the study of the properties of the labeling of medical products at the seventh stage of commodity analysis. At this stage, when analyzing the labeling of goods and packaging, it is deciphered, and its compliance with the requirements of regulatory and technical documentation is revealed. Use the information contained on the label to determine the expiration date of the product, sterility. At the eighth stage of commodity analysis, when checking the organization of storage and transportation of goods, they are guided by the storage rules set forth in the relevant orders. Instructions on the storage conditions of each individual medicinal product are contained in the information on the label. Transport marking informs about the ways of handling the packaged products during their transportation, loading and unloading, storage. At the ninth stage of commodity analysis, when choosing a method for disinfection and sterilization of medical products, the instructions displayed on consumer labels about the modes and methods of disinfection and sterilization of a particular medical instrument recommended by the manufacturer are taken into account. At the tenth stage of commodity analysis, when checking the accompanying documentation for the correctness of its execution, the information contained in the accompanying documentation and indicated on the label is compared. If this information does not match during the verification process, the question arises about the falsification of a medical product.

The laws of each particular country on the labeling of medicines follow uniform international rules and requirements and express a common understanding of the features of drug labeling, especially if these drugs are exported to international markets. For example, in the federal Russian law FZ No. 86-FZ of June 22, 1998 “On Medicines” (as amended by Federal Law No. 5 - FZ of January 2, 2000), article 16 “Labeling and registration of medicines” states:

• 1. labeling and design of medicines must comply with the requirements of this Federal Law;
• 2. Medicinal products enter circulation if the following are indicated on the inner and outer packages in a well-readable font in Russian:
  • a) the name of the medicinal product and the international non-proprietary name;
  • b) the name of the enterprise - the manufacturer of medicines;
  • c) serial number and date of manufacture;
  • d) method of application;
  • e) dose and number of doses in the package;
  • e) expiration date;
  • g) vacation conditions;
  • h) storage conditions;
  • i) Precautions when using medicines.

Based on the experience of international commercial transactions, trade agreements, a more or less unified idea of ​​the labeling and design of medicines has been developed. Labeling of drugs must comply with the following requirements. On the inner and outer packaging, on each unit of consumer packaging with a medicinal product (jar, vial, tube, pack, box, pack with ampoules, etc.), a clear and easily readable following marking must be applied to the label or directly to the surface of the container by any means in national language:

• - the trade name of the medicinal product and (if available and does not coincide with the name of the medicinal product) and the international non-proprietary name of the medicinal product, the name of the drug in Latin and Russian or in the national language, the Latin name must have a smaller font than the name in the national language;
• - the composition of the drug (the concentration or content in weight, volume or relative values ​​of the active ingredients is indicated) and all excipients are listed;
• - dosage form;
• - name of the manufacturer, its trademark, legal address, country of origin, developer of the medicinal product (if it does not match the manufacturer);
• - trademark of the manufacturing organization (if any);
• - serial number and date of manufacture, consisting of digits, where the last four indicate the month and year of manufacture of this product, and the previous ones indicate the production number;
• - expiration date, in information about expiration dates, the month is indicated in Roman numerals, the year in Arabic;
• - registration certificate number - numbers indicating the year of approval of the medicinal product by order of the Ministry of Health of the country and the number of this order or item to which this medicinal product relates, and other information on conformity assessment;
• - barcode;
• - method of application, purpose of the drug (for injection, external, etc.);
• - the amount of the medicinal product in the packaging unit (in weight, volume or quantitative units), dose and number of doses in the package, activity, [(for biological products, antibiotics (in units of action)]);
• - vacation conditions, price;
• - storage conditions;
• - Precautions when using drugs, protecting labels (“Sterile”, “Use as prescribed by a doctor”, etc.).

If drugs are controlled annually, there must be a corresponding inscription.

The design of all packaging elements of one drug must have a single font, composition and color scheme. All texts placed on the label must be clear, contrasting and easy to read. If there is free space on the consumer packaging, it is possible to apply a summary of the method of application.

For injectable medicinal products, where it is impossible to place all the information on ampoules, they should contain minimal information about the name of the drug in Latin and Russian or the national language, about the composition of the drug, activity, quantity of the drug, and the batch number of this product. It is allowed on ampoules, as well as dropper tubes, vials with a capacity of not more than 5 ml, indicate only:

• - name of the manufacturer;
• - trade name of the medicinal product, its concentration or activity;
• - the volume or mass of the medicinal product;
• - best before date;
• - series number.

For sterile drugs, the word "Sterile" is indicated. For injectable drugs, the route of administration in Russian must be indicated: 1) intravenously; 2) intramuscularly; 3) subcutaneously. If an injectable drug is administered by all means, then "For injection" is indicated.

The labeling of the antibiotic kit with a solvent on the pack, box should indicate the antibiotic series number and solvent series number, as well as the expiration date of the drug included in the kit with the shortest shelf life.

In the labeling of multi-dose sterile medicinal products, the expiration date of the medicinal product after the first opening of the package is additionally indicated. If it is stipulated in the document for a specific type of medicinal product, the labeling of the medicinal product must contain warning labels (“Drip”, “Shake before use”, etc.).

For poisonous and potent drugs (List A and B), “Use as prescribed by a doctor” should be indicated.

When manufacturing medicines to order, the name, address and trademark of the organization on whose order the medicine was produced are additionally indicated.

If the manufacturing organization manufactures a medicinal product intended for subsequent packaging or the manufacture of dosage forms, the labeling of consumer packaging additionally indicates:

• - name, address and trademark (if any) of the manufacturer of the medicinal product;
• - the inscription "Packed";
• - the batch number of the medicinal product packed in consumer containers is assigned by the manufacturing organization that carried out the packaging in consumer containers;
• - if the manufacturing organization carries out only packaging of medicinal products, the name and address of the manufacturing organization that carried out the packaging are additionally indicated on the packaging.

Medicinal products intended for clinical trials are labeled "For clinical trials". The labeling of medicines for clinical trials is generally more complex due to the greater risk of errors (which are harder to detect) than the labeling of registered drugs, due to the use of blind labels. Labels of medicinal products for clinical trials must contain the following information:

• - name of the sponsor;
• - dosage form, route of administration, number of doses, as well as the name / code of the drug and activity / dosage in the case of an open study;
• - serial number and / or code to identify the contents and the packaging operation;
• - identification (randomization) number of the test person;
• - instructions for use;
• - the inscription "Only for clinical trials";
• - surname and initials of the researcher (if they are not included in the research code);
• - code of the clinical study, which allows to identify the research center and the researcher;
• - storage conditions;
• - expiration date in months/years (expiry date, expiry date or recheck date if necessary);
• - the inscription "Keep out of the reach of children", except when the product is intended only for use in a hospital.

The outer packaging may contain symbols or pictograms with the requirement "Return the empty container and unused medicinal product." Copies of each type of label must be kept in the batch protocol. When extending the shelf life of a medicinal product for clinical trials, an additional label must be attached to it, on which the new expiration date must be indicated and the lot number repeated.

For the labeling of medicinal plant materials, the following rules apply. Shipping containers for plant materials are marked in accordance with GOST 14192-96 indicating:

• - the name of the Ministry of Health;
• - name of the manufacturer;
• - names of raw materials;
• - net weight, gross weight;
• - year and month of procurement;
• - batch number;
• - designation of NTD for specific raw materials.

A packing list must be included with each package. The packing list must include:

• - name of the company-sender;
• - name of raw materials;
• - batch number;
• - name or number of the packer.

Drugs enter circulation only with instructions for the use of drugs containing the following data in Russian or another national language:

• 1) the name and legal address of the manufacturer;
• 2) drug name and INN;
• 3) information about the components that make up the drug;
• 4) scope;
• 5) contraindications for use;
• 6) side effects;
• 7) interaction with other drugs;
• 8) dosage and method of application;
• 9) expiration date;
• 10) an indication that the drug should not be used after the expiration date;
• 11) an indication that drugs should be stored in places not accessible to children;
• 12) vacation conditions.

Instructions for the use of drugs are divided into the following categories:

• - instructions for the use of drugs for specialists;
• - instructions for the use of drugs for consumers (leaflet).

Instructions for the use of drugs for specialists is an official document containing information about the drug, necessary for its effective and safe medical use. Instructions for use of drugs for consumers (leaflet) is an official document intended for the patient and containing information necessary for the correct independent use of the drug.

The content of the labeling and the design of the inscriptions of consumer and group containers must be indicated in the NTD for specific types of medicines, or correspond to the samples approved in the prescribed manner. Each unit of consumer packaging (jar, bottle, tube, pack, box, pack of ampoules, etc.) must be provided with a label, leaflet or instructions for use, the content of which must be indicated in the NTD. If the dimensions of the pack allow, then the contents of the leaflet or instructions for use are applied to the pack. For medicinal products supplied for export, signatures on the label must be made in the language specified in the supplier's agreement with a foreign trade organization or in the NTD for medicinal products. Labels are made from label paper grade A or B in accordance with GOST 7625-86 or coated paper grade O in accordance with GOST 21444-75, or offset paper No. 1 and No. 2 of grade A, B, C in accordance with GOST 9094-89, or other quality paper not lower than specified. Labeling and packaging design should be the same for each batch of packaged medicinal products.

All medicines that have an external (secondary) package must be labeled in Braille - inscriptions in raised dotted font. On the outer packaging of medicinal products, the name of the medicinal product, the dosage of the active substance and the dosage form are also indicated in Braille. The Ministry of Health of a particular country determines medicines, the packaging of which is not labeled in Braille, or only the name of the medicine is indicated in Braille. The EU Braille labeling obligation was approved on 30.04.2004 and the end of the preparatory period was set as 30 October 2005. The duration of the transition period is 5 years, and absolutely all medicines in the EU must comply with the requirements for Braille labeling by 30.10.2010. At the same time, it is logical to assume that it makes no sense to label injection and infusion forms in Braille, because a person with limited vision will not be able to inject themselves without assistance. Although insulins and a number of other drugs that are used by the patient on their own are subject to Braille labeling. This logic also applies to all hospital medicines (including clinical trials) that are used only under medical supervision. Comments on the obligation exclude medicines that are used only by doctors: injectable and infusion forms, vaccines, radiopharmaceuticals, anesthetics. If the package is presented in several languages, the European Union legislation solves this issue as follows - Braille must repeat each of the languages ​​present on the package. If the product name is displayed the same for several languages, then in this case there is no need to repeat each language. Braille indication of dosage form, which often occupies the largest amount of information, is not required in the European Union.

Labeling of medicines in the EU that do not have secondary packaging, some of the “essential” medicines such as iodine, hydrogen peroxide, alcohol is carried out by applying Braille on an adhesive label, which, for example, is attached around the bottle.

The printed Braille should not interfere with the perception of other information on the package.

The Braille Labeling Guidelines pay particular attention to the issue of labeling small packages: for labeling such packages, alternative methods of representing information in Braille are allowed: the use of "abbreviated" Braille or certain common abbreviations, or the addition of a special label that will indicate necessary information in Braille. The abbreviated system (contracted system, also known as Grade II system) means that instead of the usual system of interpretation, in which one six-dot cell means one letter or symbol, approved abbreviations are used - that is, one cell can mean several characters, or a word , and two or four cells can mean a word or even a phrase.

In the practice of foreign countries, to inform the consumer about the quality of the goods, signs of conformity to the standard are used. For example, rubber and rubber products are sold in the EU countries and in Russia marked with conformity marks of the GOST Certification System. Control over the sale of goods subject to mandatory marking with conformity marks in Russia is carried out by the Ministry of Internal Affairs of the Russian Federation, the Ministry of Trade of the Russian Federation, the Ministry of the Russian Federation for Taxes and Duties. Mark of conformity - a mark registered in the prescribed manner, which confirms the conformity of the products marked with it to the established requirements. The sale of goods made of rubber and rubber without counterfeit-proof conformity marks is prohibited. The same requirements apply to medical products and instruments made of polymeric materials and electrical medical instruments. Marking is applied to the surface of rubber products with waterproof paint or pressure, the product is marked with the following data:

• - trademark and name of the manufacturer;
• - product designation;
• - batch number;
• - technical control stamp;
• - year of issue;
• - cipher of the composition (if necessary);
• - the letter "T" for products exported to countries with a tropical climate.

When hitting a hole for rivets, letters or numbers are allowed to be omitted, except for the batch number and date of manufacture. By agreement between the manufacturer and the consumer, products with a width of not more than 40 mm are allowed not to be marked or marked with incomplete content. For each packaging unit of rubber medical products (package, pack of more than 20 products), a label is attached or enclosed or stamped indicating:

• - trademark and name of the manufacturer or trademark;
• - product names and designations;
• - batch number;
• - technical control stamp;
• - number or signature of the packer (picker);
• - date of issue (month, year);
• - designation of the NTD, according to which the product is manufactured.

Basic, additional, informational inscriptions and the sign "Afraid of dampness" are applied to paper, cardboard, plywood and other labels or containers. Additional requirements for labeling products are established in the NTD for products of specific types. Labeling of medical instruments, medical rubber products and spare parts for them intended for the prevention, diagnosis and treatment of diseases, rehabilitation and patient care should contain:

• - Name of product;
• - company name and location (legal address) of the manufacturer of the goods, location of the organization authorized by the manufacturer (seller) to accept claims from the buyer and carry out repairs and maintenance of the goods;
• - designation of standards, the requirements of which the product must comply with;
• - information about the main consumer properties of the goods;
• - warranty period, if it is established for a specific product;
• - service life or shelf life, if they are established for a particular product;
• - the price and conditions for the purchase of goods.

Also, information should be provided on the number and date of the registration certificate for the use of such products for medical purposes, issued by the Ministry of Health in the prescribed manner, as well as, taking into account the characteristics of a particular product, information about its purpose, method and conditions of use, action and effect, restrictions (contraindications) for use. Medical instruments must be clearly marked with the following information:

• - tool number or designation;
• - trademark of the manufacturer;
• - year of issue;
• - symbol "H" for tools made of corrosion-resistant steel or "Ti" (for tools made of titanium alloys).

The marking of metal tools must contain the symbol “H” (stainless steel) for tools intended for export, the designation of the exporter must be indicated, the inscription: “Made in ... the country of manufacture”, for example, “Made in Russia”, the trademark of the exporter, the name tools, the following inscriptions must additionally be applied: "Stainless Steel" or "Stainless" (on tools made of stainless steel), on tools made of titanium alloys, the inscription "Titanium" is allowed.

Steel used for the production of medical metal instruments is marked as follows. For the manufacture of surgical tweezers, retractors, probes, grade A steel is used, this is indicated on the instrument. For the manufacture of bone cutters, bone curettes, chisels, scissors, clamps, dental forceps for removing teeth, grade B steel is used, this is indicated on the tool. For the manufacture of scaling instruments, dental curettes, laboratory forceps. For dental tweezers, steel grade C, R is used, this is indicated on the tool. For the manufacture of conchotomes. Scalpels, knives, root elevators, canalizers, scaling tools use grade D steel, this is indicated on the tool. From steel grades E, F, G, scalpels, large scissors are made, tools are marked accordingly. Steel grades H, I are used for the manufacture of scissors, bone curettes, wire cutters - the instruments are marked accordingly. For the manufacture of chisels and bone curettes, probes, steel grades K, N are used - the instruments are marked accordingly. For the manufacture of handles, pins, steel grades L, M are used - tools are marked accordingly. For the manufacture of bits, probes, nuts, rivets, steel grades N, O, P are used - tools are marked accordingly. Marking of metal tools should contain a reference to the international standard ISO 7153/1 - 88.

Marking is applied to the non-working part of the tool by mechanical, electrocorrosive, thermal printing, tracing, laser, dot-impact or other method that ensures image clarity. The marking must be preserved (and legible) during use, sterilization and transportation of instruments. Marking is allowed not on each tool, but on consumer containers or labels or on group containers in the absence of individual containers.

Dental tips are labeled with a symbol indicating the possibility of autoclaving (if necessary).

For disposable handpiece parts, if sold as a sterile product, the label “Use by…” is affixed to the package with a specific date.

Medical metal instruments are indelibly marked with the designation of a standard that defines the typical requirements for a particular type of medical product.

The obligation of the seller supplying the equipment includes the condition to submit a set of technical documentation upon shipment of the goods. This kit includes a label. For durable goods such as instruments, devices and medical devices, the manufacturer is required to establish a service life. The manufacturer is responsible for the quality of these products during the entire service life or shelf life.

From 01.02.2008 mandatory labeling of medical devices with the help of graphic symbols is introduced on the territory of Ukraine. Mandatory marking is regulated by the order of the State Committee of Ukraine on technical regulation and consumer policy No. 294 dated 01.11.2007. Labeling of medical products should be carried out in accordance with the national standard DSTU EN 980:2007 "Graphic symbols for labeling medical devices (EN 980:2003, IDT)" ("Graphic symbols for labeling medical products (EN 980:2003, IDT)") . This standard has been developed in order to harmonize regulatory requirements and in accordance with the EU standard EN 980:2003. Mandatory labeling applies to both domestic and imported medical devices.

The consumer and outer packaging of sterile medical devices must contain the inscription "Sterile", the words "For single use" or their substitutes. In addition, the outer packaging must contain an indication of checking the integrity of each package, the batch marking and the date (month, year) of sterilization must be applied.

labeling medical medicinal pharmaceutical

In accordance with paragraph 2 of Article 31 of the Treaty on the Eurasian Economic Union dated May 29, 2014, paragraph 2 of Article 3, paragraph 4 of Article 4 and paragraph 4 of Article 7 of the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices (Medical Devices and Medical Equipment) in within the framework of the Eurasian Economic Union of December 23, 2014, paragraphs 104, 108 and 109 of Appendix No. 1 to the Rules of Procedure of the Eurasian Economic Commission, approved by the Decision of the Supreme Eurasian Economic Council of December 23, 2014 No. 98, and the Decision of the Supreme Eurasian Economic Council of December 23 2014 No. 109 "On the implementation of the Agreement on uniform principles and rules for the circulation of medical devices (medical devices and medical equipment) within the framework of the Eurasian Economic Union" The Council of the Eurasian Economic Commission decided:

1. Approve the attached General Requirements for the Safety and Efficiency of Medical Devices, the requirements for their labeling and operational documentation for them.

2. This Decision shall enter into force after 10 calendar days from the date of entry into force of the Protocol, signed on December 2, 2015, on the accession of the Republic of Armenia to the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices (Medical Devices and Medical Equipment) within the Eurasian Economic Union of December 23, 2014, but not earlier than after 10 calendar days from the date of official publication of this Decision.

Members of the Council of the Eurasian Economic Commission:

From the Republic of Armenia
V. Gabrielyan

From the Republic of Belarus
V. Matyushevsky

From the Republic of Kazakhstan
B. Sagintaev

From the Kyrgyz Republic
O. Pankratov

From the Russian Federation
I. Shuvalov

General requirements
safety and efficacy of medical devices, requirements for their labeling and operational documentation for them
(approved by the decision of the Council of the Eurasian Economic Commission dated February 12, 2016 No. 27)

I. General provisions

1. These General Requirements have been developed in accordance with paragraph 2 of Article 31 of the Treaty on the Eurasian Economic Union dated May 29, 2014, paragraph 2 of Article 3, paragraph 4 of Article 4 and paragraph 4 of Article 7 of the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices (Medical Products) purpose and medical equipment) within the framework of the Eurasian Economic Union dated December 23, 2014 and establish general requirements for the safety and effectiveness of medical devices, as well as requirements for labeling and operational documentation for medical devices put into circulation within the Eurasian Economic Union (hereinafter - the Union) .

2. For the purposes of these General Requirements, concepts are used that mean the following:

"active medical devices" - medical devices used alone or in combination with other medical devices, the operation of which requires the use of energy other than that produced by humans, or gravity.

Medical devices designed to transfer energy or substances from an active medical device to a user without significant change are not active medical devices. Standalone software is treated as an active medical device;

"safety of a medical device" - the absence of an unacceptable risk associated with harm to life, human health, and the environment;

"instructions for use" - operational documentation containing information provided by the manufacturer to the user regarding the purpose, proper and safe use of the medical device, which may include, but is not limited to, the instruction manual, the method of medical use, passport, form, instructions for installation, commissioning , maintenance, repair, transportation, storage, disposal of a medical device;

"medical products for in vitro diagnostics" - any instruments, devices, devices, equipment, materials, reagents, calibrators, control materials and other products used for medical purposes separately or in combination with each other, as well as together with accessories necessary for use specified products for their intended purpose (including special software), and intended by the manufacturer for use in in vitro studies of samples of human biological materials to obtain information regarding the physiological or pathological condition, congenital pathology, predisposition to a particular clinical condition or disease, tissue compatibility with a potential recipient, predicting responses to therapeutic interventions, selecting therapeutic agents and/or monitoring treatment;

"adverse event (incident)" - any malfunction and (or) deterioration in performance, or malfunction of a medical device, or insufficiency or incorrectness of the accompanying information (documentation) for a medical device, or a side effect not specified in the instructions for use, which directly or indirectly led or could lead to the death or serious deterioration of the health of users or third parties (whereby a serious deterioration in health means a life-threatening disease, permanent impairment of bodily function or irreversible damage to the structure of the body, a condition requiring medical or surgical intervention in order to prevent a life-threatening disease, or a permanent impairment of a bodily function, or an irreversible damage to the structure of the body, a condition requiring hospitalization or a significant increase in the length of stay in the hospital of an already hospitalized patient, a functional disorder in the fetus, his death, congenital anomaly or birth trauma);

"adverse event" - any undesirable medical event, unpredictable disease or damage or undesirable clinical signs (including abnormal laboratory values) in users or third parties associated with the use of a medical device;

"user" - a patient, a medical specialist or any other natural person who uses a medical device for its intended purpose, determined by the manufacturer;

"efficacy of a medical device" - the ability of a medical device to meet the intended use as defined by the manufacturer.

II. General requirements for safety and efficacy applicable to all medical devices

3. Medical devices are designed and manufactured in such a way that, when used under conditions and for purposes corresponding to their intended purpose, as determined by the manufacturer, and, if necessary, taking into account the technical knowledge, experience, education or special training, clinical and physical condition of the user, they act as intended. determined by the manufacturer and are safe for the user and third parties, provided that the risk associated with their use is acceptable when compared with the benefit to the user.

It is not allowed to limit the interchangeability of medical devices by using special hardware or software or by other means.

4. Decisions made by the manufacturer in the design and manufacture of a medical device must comply with the principles of safety, taking into account the generally recognized level of development of knowledge. Where appropriate, the manufacturer manages the risks so that the residual risk associated with any hazard is acceptable. The manufacturer is guided by the following principles in order of priority:

identification of a known or foreseeable hazard and assessment of the risks associated with it arising from the use of a medical device for its intended purpose and from predictable misuse;

elimination of risks by making appropriate technical and technological solutions in the design and manufacture of a medical device;

reducing residual risks by taking adequate protective measures, including alarms;

informing users of any residual risks.

5. Medical devices are designed, manufactured and packaged in such a way that their performance characteristics and effectiveness are not impaired during transportation and storage in accordance with the instructions for use.

6. Medical devices must be effective as intended by the manufacturer, and must be designed and manufactured in such a way that, under normal operating conditions, they correspond to the intended use for the intended purpose specified by the manufacturer.

7. The performance characteristics and effectiveness of the medical device should not change to such an extent as to endanger the life and health of users and third parties during the period of operation specified by the manufacturer, provided that the medical device is exposed to effects that may occur under normal operating conditions , and maintenance is carried out in accordance with the instructions for use.

8. All known and anticipated risks arising from the use of a medical device, and any undesirable effects from such use, are minimized and must be acceptable when compared with the benefits for users derived from the action of the medical device intended by the manufacturer under normal operating conditions.

9. For each medical device, information is provided that is necessary to identify this medical device and its manufacturer, country of origin, as well as information for the user (professional or non-professional) regarding the safety of the medical device, its functional properties and operational characteristics. Such information may be on the medical device itself, on the packaging or in the instructions for use.

10. The media, its format, content and location must correspond to the medical product, its purpose and technical knowledge, experience, education or training of users.

The information carrier, as restrictions on use, contraindications, precautions or warnings, must contain information about the residual risks associated with the use of a medical device. The concept of "contraindications" is not applicable to medical devices for in vitro diagnostics.

11. The information provided for by paragraph 9 of these General Requirements is indicated on the label and in the instructions for use in Russian, as well as, if there are relevant requirements in the legislation of the Member States, in the state language (state languages) of the Member States.

Such information may contain symbols established by interstate standards, as well as those established by international standards (provided that the safety of the medical product is not violated due to a lack of understanding by individual users of the meaning of such symbols).

III. General safety and efficacy requirements applicable to medical devices, with the exception of in vitro diagnostic medical devices

1. Chemical, physical and biological properties of medical devices

12. When designing and manufacturing medical devices, special attention should be paid to:

1) the choice of materials used, especially with regard to toxicity and flammability;

2) compatibility of the materials used and biological cells, tissues, liquids, substances and their derivatives (hereinafter referred to as biological materials), taking into account the purpose of the medical product;

3) the choice of materials used, taking into account such indicators as hardness, wear resistance and fatigue strength.

13. When designing, manufacturing and packaging medical devices, the risk posed by contaminants and their residues for users and persons involved in the transportation, storage and maintenance of medical devices should be minimized (taking into account the purpose of the medical device, as well as the duration and frequency of exposure these substances on the human body).

14. Medical products are designed and manufactured in such a way that they can be safely used with materials, substances and gases with which they come into contact under normal operating conditions or during maintenance. If medical devices are intended for the administration of medicinal products, they are designed and manufactured in such a way that they are compatible with medicinal products (subject to restrictions on their use) in order to ensure the effectiveness of both the medicinal product and the medical device in accordance with the intended use.

15. When designing and manufacturing medical devices, the risks of:

1) caused by the possible release or leaching of hazardous and (or) harmful substances from the medical device (taking into account their sensitizing effect, carcinogenicity, mutagenicity or negative effect on reproductive function);

2) associated with the unintentional ingress of foreign substances into the medical device (taking into account the purpose determined by the manufacturer and the expected conditions for the use of the medical device).

2. Infectious and microbial contamination of medical devices

16. When manufacturing a medical product, the risk of infection of users and third parties must be eliminated or reduced to an acceptable level. The design of the medical device should ensure ease of operation and maintenance and, if necessary, minimize the risk of any microbial leakage from the medical device and (or) microbial exposure during use, as well as prevent microbial contamination of the medical device or sample by the user or a third party.

17. When designing, manufacturing and packaging medical devices that have a special microbiological status in accordance with the labeling, it must be guaranteed that the microbiological status remains unchanged under the conditions of transportation and storage determined by the manufacturer until the protective packaging is broken or opened.

18. When designing, manufacturing and packaging medical devices supplied in a sterile state, their sterility must be guaranteed under the conditions of transportation and storage determined by the manufacturer until the protective packaging is broken or opened. Such medical products are packed in disposable packaging.

19. Sterile medical devices or medical devices with a special microbiological status are manufactured, processed and, if necessary, sterilized using validated methods, equipment, processes.

20. Medical devices requiring sterilization must be manufactured under conditions of controlled cleanliness of production areas.

21. The packaging of non-sterile medical devices must ensure their integrity and cleanliness and, if the medical device must be sterilized before use, minimize the risk of microbial contamination, while the packaging must be compatible with the sterilization method specified by the manufacturer.

3. Medical devices containing a substance considered as a medicinal product

22. If medical devices contain a substance that, when used independently, can be considered a medicinal product in accordance with paragraph 1 of Article 1 of the Agreement on uniform principles and rules for the circulation of medicines within the Eurasian Economic Union dated December 23, 2014 and which has an additional effect on the human body, along with the impact of medical devices, confirmation of the safety and efficacy of such medical devices includes confirmation of the safety and efficacy of the medicinal product, taking into account its use as part of medical devices.

4. Medical devices containing materials of biological origin

23. If medical devices contain biological materials of animals, then the animals used for these purposes must be subject to veterinary control (supervision), according to the results of which they must be recognized as healthy, taking into account the purpose of the biological materials used. An animal is considered healthy if there are no diseases that may affect the safety and efficacy of the medical device.

Information of the manufacturer of a medical device on biological materials, including the choice of animals, their geographical origin, sampling, conditions for processing, storage and handling of biological materials, must be stored in the authorized body of the Member State of the Union in the field of healthcare (hereinafter referred to as the authorized body of the state -member).

Processing, storage, testing and handling of biological materials of animal origin must ensure the safety of users and third parties. In particular, safety against viruses, other infectious agents and other pathogens common to humans and animals should be ensured through the use of validated methods of destruction or inactivation during the manufacturing process.

24. If medical devices contain biological materials of human origin, then the selection of donors, as well as the processing, storage, testing and handling of biological materials of human origin, shall be carried out in accordance with the legislation of the Member States of the Union and must ensure optimal safety for users and third parties. In particular, safety against viruses and other infectious agents must be ensured through the use of validated methods of destruction or inactivation during the manufacturing process.

25. If medical devices contain biological materials of microbial origin, then the processing, storage, testing and handling of biological materials of this nature should ensure optimal safety for users and third parties. In particular, safety against viruses and other infectious agents must be ensured through the use of validated methods of destruction or inactivation during the manufacturing process.

5. Medical devices used under the influence of external factors

26. Medical devices are designed and manufactured in such a way that their assembly, adjustment, calibration, use and maintenance under the influence of external factors are carried out safely and ensure the expected effectiveness of medical use.

27. If medical devices are intended for use in combination with other medical devices and (or) equipment, the entire combination, including the connecting system, must be safe and must not impair the declared functional characteristics of medical devices. Any known restrictions on the use of such a combination are indicated on the label and / or in the instructions for use. When designing and manufacturing connection systems, the possible risks of incorrect connection should be minimized as much as possible.

It is not allowed to use special technical and (or) software tools as part of a medical device that exclude or limit the possibility of its use in combination with other medical devices and (or) equipment intended for this purpose.

28. Medical products are designed and manufactured in such a way as to eliminate or reduce to an acceptable level:

1) the risk of injury to the user or third parties due to the physical characteristics of the medical device;

2) the risk of error in the use of medical devices due to design characteristics or human factors;

4) the risk associated with the use of medical devices in contact with materials, liquids and gases to which medical devices are exposed under normal operating conditions;

5) the risk associated with possible negative interaction between the software of medical devices and the conditions in which it is operated;

6) the risk of accidental ingress of foreign substances into medical devices;

7) the risk of mutual interference associated with other devices commonly used in the diagnostic and treatment process;

8) the risk arising from the impossibility of maintenance or calibration of medical devices (for example, for implants), due to the aging of the materials used or the loss of accuracy of the measuring or control device.

29. Medical products are designed and manufactured in such a way as to eliminate or minimize the risk of ignition or explosion under normal operating conditions or in the event of a single failure. Particular attention should be paid to medical devices used with flammable or explosive substances.

30. Medical devices are designed and manufactured in such a way as to facilitate the safe disposal of waste generated after the use of medical devices.

6. Medical products related to measuring instruments

31. Medical devices included in the list of medical devices related to measuring instruments, in respect of which tests are carried out in order to approve the type of measuring instruments, are designed and manufactured in such a way as to ensure sufficient accuracy, precision and stability, taking into account the purpose of the medical device.

32. Measuring, control or indicator scales are designed in accordance with ergonomic principles, taking into account the purpose of the medical product.

Numerical values ​​should be expressed in generally accepted units of measurement and understandable to users.

33. The results of measurements performed using a medical device related to measuring instruments are expressed in units of the International System of Units (SI) or in non-system units of quantities in accordance with the list of non-system units of quantities used in the development of technical regulations of the Union (including their ratios with International System of Units (SI)), approved by the Eurasian Economic Commission (hereinafter referred to as the Commission).

7. Radiation protection

34. Medical devices are designed, manufactured and packaged in such a way as to minimize the exposure of users and third parties to radiation, without reducing the established radiation levels necessary to achieve diagnostic and therapeutic goals.

35. In medical products designed to generate hazardous or potentially hazardous radiation necessary to achieve specific medical purposes, if the benefits of using these high-intensity radiations are considered more significant in relation to the danger posed by radiation, the possibility of managing these radiations should be provided. by the user. When designing and manufacturing such medical devices, the reproducibility of the variable parameters of the generated radiation must be ensured within acceptable limits.

Medical products designed to generate hazardous visible and (or) invisible radiation are equipped with visual and (or) audible warnings about the presence (activity) of such radiation.

36. When designing and manufacturing medical devices, the impact of unintentionally generated spurious or scattered radiation should be minimized as much as possible.

37. When designing and manufacturing medical products intended to generate ionizing radiation, regulation of the quantitative and geometric parameters of the generated radiation should be ensured, taking into account the purpose specified by the manufacturer.

Medical products that generate ionizing radiation and are intended for radiological diagnostics are designed and manufactured in such a way that, with minimal radiation exposure to the user, the quality of the image and (or) obtained research results necessary for diagnosis is provided.

Medical products that generate ionizing radiation and are intended for radiological therapy are designed and manufactured in such a way as to ensure control and management of the radiation dose, type, energy and, if necessary, the distribution of energy of directed radiation.

8. Medical devices that include software and stand-alone software that is a medical device

38. Medical devices, including software, and stand-alone software, which is a medical device, are designed and manufactured in such a way as to ensure the stable, reliable and efficient operation of these medical devices in accordance with the purpose specified by the manufacturer.

9. Active medical devices associated with or equipped with an energy source

39. For active medical devices, in the event of a single malfunction, appropriate measures are taken to eliminate or reduce subsequent risks.

40. Active medical products, when using which the safety of users depends on an internal power source, are equipped with a means of determining the state of the power source.

41. Active medical devices, when using which the safety of users depends on an external power source, should include an alarm system to alert you to a power failure.

42. Active medical devices designed to monitor one or more clinical parameters of the user are equipped with appropriate alarm systems to warn the user of a situation that could lead to death or serious impairment of his health.

43. Active medical products are designed and manufactured in such a way as to minimize the risk of creating electromagnetic fields (electromagnetic interference) that may adversely affect the operation of other medical products, equipment and communication facilities in accordance with their purpose.

44. Active medical products are designed and manufactured in such a way as to provide a level of resistance to electromagnetic interference (noise immunity) that ensures their operation in accordance with the intended purpose specified by the manufacturer.

45. Active medical devices are designed and manufactured in such a way as to minimize the risk of accidental electric shock to the user or a third person both under normal operating conditions of the medical device and under conditions of a single malfunction, provided that the medical device is installed and maintained in accordance with the instructions. manufacturer.

10. Protection against mechanical and thermal risks

46. ​​Medical devices are designed and manufactured in such a way as to protect the user and third parties from the risk of mechanical damage associated with resistance to movement, instability and the presence of moving parts in the composition of such medical devices.

47. Medical products are designed and manufactured in such a way as to minimize the risk associated with the vibration created by these medical products by using means to limit vibration, unless vibration is part of the purpose of the medical products.

48. Medical products are designed and manufactured in such a way as to minimize the risk associated with the generated noise by using means used to reduce noise, unless the generated noise is part of the purpose of the medical products.

49. Terminals, sockets, connectors and other devices for connecting medical devices to sources of electrical, hydraulic or pneumatic energy are designed and manufactured in such a way as to minimize any possible risks.

50. Medical products are designed and manufactured in such a way as to minimize the risk of errors arising from incorrect connection or switching during operation of the equipment or parts in the composition of such medical products.

51. Exposed parts of medical products (with the exception of parts intended for supplying heat or achieving specified temperatures) should not reach potentially dangerous temperatures under normal operating conditions.

11. Protection against risks arising to the user from the supplied energy or substances

52. Medical products intended to supply the user with energy or substances are designed and manufactured in such a way that the amount of energy or substance supplied can be set and maintained with an accuracy sufficient to ensure the safety of the user.

53. Medical products are equipped with means to prevent and (or) indicate any inconsistencies in the supplied amount of energy or a substance that may be dangerous.

54. Information about the functions of controls and indicators is clearly indicated on the medical product. If there is an instruction for use, or operating manual, or visual means of indicating the operating or adjustment parameters of the medical device, then such information should be understandable to the user.

12. Protection against risks arising from the use of medical devices intended by the manufacturer for use by users who do not have special medical education

55. Medical devices intended by the manufacturer for use by users who do not have special medical education are designed and manufactured taking into account the skills and means available to these persons, so that the medical devices function in accordance with their intended use under the conditions of objectively expected actions on the part of these persons.

56. Medical devices intended for use by users who do not have special medical education are designed and manufactured in such a way as to minimize the risk of error in the process of using medical devices, as well as in interpreting test results.

57. Medical devices intended for use by users who do not have special medical education should have, if objectively possible, the function of confirming that, when used, these medical devices will function in accordance with the intended use specified by the manufacturer.

13. Requirements for the labeling of medical devices

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

2) information necessary to identify the medical device, as well as information about its purpose (if necessary);

3) information about the manufacturer, including the full and abbreviated (if any) name of the legal entity, location (last name, first 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 postal address may not be indicated on the label 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 additionally labeled containing information about the authorized representative of the foreign manufacturer, including the full and abbreviated (if any) name of the legal entity, location (last name, first name, patronymic (if any) and place of residence of an individual registered as an individual entrepreneur), postal address of an 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 in the medical device of drugs or biological materials, as well as nanomaterials, if such nanomaterials are not contained in a bound state, which excludes the possibility of their entry into the user's body when using the medical device for the intended purpose specified by the manufacturer;

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

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

7) the year of manufacture of the medical device, if the period until the expiration of which the medical device can be safely used is not indicated. The year of manufacture of the 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 special conditions of storage and (or) handling of the medical device (if necessary);

9) information on the sterility of the medical device (if the medical device is supplied in a sterile form) indicating the method of sterilization;

10) a 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 single use of the medical device (if the medical device is intended for single 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 remanufactured);

13) information on the manufacture of a medical product 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 purpose of the medical device only for clinical trials for the purposes of registration;

15) information about the purpose of the medical product only for exhibition or demonstration purposes. In this case, the labeling requirements specified in subparagraphs 1-14 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 "antibodies to HIV 1, 2 and hepatitis C viruses and HBsAg are absent" (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 drugs, body fluids or other substances or for the transportation and storage of such drugs, liquids or substances, contain harmful substances that, depending on their concentrations of carcinogenic, mutagenic or toxic to reproductive function properties, or contain phthalates, then such medical products 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 storage and transportation of 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 put into circulation in a sterile and non-sterile form, and be distinguished in such a way that the user can distinguish a sterile medical device from a non-sterile one using the marking.

61. Marking must be applied to a medical device. If this is impossible or impractical, the marking (partially or completely) can be applied to the packaging for each unit of the medical device, and (or) to the group packaging, and (or) to the instructions for use.

62. Labeling can be supplemented with information about the medical device in a machine-readable format, including using radio frequency identification or bar codes.

63. Medical devices that have passed the procedures established within the Union for registration and confirmation of compliance with the general requirements for the safety and efficacy of medical devices, the requirements for the implementation and maintenance of a quality management system for medical devices, before being released into circulation within the Union, are subject to mandatory marking with a special mark of circulation of a medical device on market of the Union (hereinafter referred to as the special sign of circulation).

Marking with a special sign of circulation, applied to a medical device, is carried out by any technological method that ensures its clear and distinct image throughout the entire service life (usefulness) of the medical device.

A special sign of circulation is not applied to a medical device if it is technologically impossible or if it would pose a threat to the life and health of the user.

14. Requirements for the information contained in the instructions for use of the medical device

64. Instructions for use may be provided to the user on paper or in electronic form both together with the medical device and separately from it, including by placing information on the screen, which is part of the medical device. The method chosen for providing instructions for use must be suitable and accessible to users. If instructions for use are provided on a medium other than paper, the manufacturer must ensure that the consumer is informed about the methods:

1) viewing instructions for use;

2) obtaining the current version of the instructions for use;

3) obtaining a paper version of the instructions for use.

65. Instructions for use should contain the following information:

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

2) information about the manufacturer of the medical device and (or) its authorized representative, including the full and abbreviated (if any) names of the legal entity, location (last name, first name, patronymic (if any) and place of residence of an individual registered as an individual entrepreneur ), postal address, telephone, fax numbers, e-mail address (if available);

3) the purpose of the medical device, indicating the user (for example, a patient, a medical specialist, an individual using a medical device for the intended purpose specified by the manufacturer);

4) functional characteristics of the medical device;

5) generalized results of clinical trials conducted for the purpose of registering a medical device, or a link to a source where such information is available to the user;

6) residual risks, contraindications, expected and predictable side effects associated with the use of the medical device for its intended purpose, determined by the manufacturer;

7) technical characteristics necessary for the user to use the medical device for its intended purpose, determined by the manufacturer;

8) information on the presence of a medicinal product, biological material and (or) nanomaterial;

9) information on the procedure for installation and commissioning (if necessary), as well as on the need for preliminary preparation for the use of the medical device;

10) special requirements for premises, special training or special qualifications of the user and (or) third parties;

11) information necessary to verify the correct installation of the medical device and its readiness for safe operation for the intended purpose specified by the manufacturer, indicating the following information:

availability of consumable components of the medical device and the procedure for their replacement;

the need for calibration to ensure the proper and safe operation of the medical device during its service life;

methods to reduce the risks associated with the installation, calibration or maintenance of a medical device;

12) information on special conditions for storage and (or) maintenance of a medical device;

13) information on the procedure for actions in case of violation of the sterile packaging of the medical device before its use (if the medical device is supplied sterile);

14) information on the method of sterilization of the medical device (if the medical device is supplied non-sterile, indicating the need for its sterilization before use);

15) information on the proper processing of the medical device for its reuse, including cleaning, disinfection, packaging and, if necessary, the method of re-sterilization (if the medical device is intended for multiple use), as well as the criteria for the unsuitability of the medical device;

16) information necessary to identify medical devices in order to obtain a safe combination and information about known restrictions on the joint use of medical devices (for medical devices intended for use together with other medical devices and (or) with general purpose devices);

17) information about the nature, type, as well as (if necessary) the intensity and distribution of radiation emitted by the medical product and methods for protecting users or third parties from unintentional radiation during the use of the medical product (if the medical product creates a dangerous or potentially dangerous level of radiation for medical purposes );

18) information for users (warnings, precautions, measures to be taken, if necessary, and restrictions when using a medical device), including:

warning, precautionary measures and (or) measures taken in case of a malfunction of a medical device or deviations in its functioning, which may affect the safety of a medical device;

warning, precautions and (or) measures taken in case of impact on the functioning of a medical device by external factors associated with the use of a medical device in combination with other medical devices and (or) equipment, or such factors as external electromagnetic fields, electrostatic discharges, radiation, atmospheric pressure and its fluctuations, humidity and air temperature;

warning, precautions and (or) measures taken in case of a foreseeable risk of electromagnetic interference created by a medical device during the performance and evaluation of the results of specific diagnostic tests, therapeutic treatment or its use (for example, electromagnetic radiation of a medical device that affects other equipment) ;

information on limitations or incompatibility with the medical device of certain medicinal products or biological materials (if the medical device is intended for the administration of medicinal products or biological materials);

warning, precautions and (or) restrictions associated with medicinal substances or biological materials that are part of a medical device;

a warning related to carcinogenic, mutagenic or toxic materials that are part of a medical device, the possible release or leaching of which leads to sensitization, an allergic reaction or adversely affects reproductive function;

warning or precautions to be taken by the user when disposing of the medical device, accessories and consumables used with it (if any), including the following information:

infectious or microbial hazard of a medical device;

environmental hazard of a medical product;

physical danger of a medical product;

19) information on the circumstances under which the user must consult a medical specialist (for medical devices intended for use by persons who do not have medical education);

20) data on the issue or last revision of the instructions for use;

21) information on the need to send a message to the manufacturer or his authorized representative about undesirable events that have signs of an adverse event (incident).

66. Instructions for use should be drawn up using terms understandable to the user, and, if necessary, be accompanied by drawings and diagrams.

The instructions for use may contain separate information for professional and non-professional users.

67. Instructions for use may be presented in abbreviated form or on the label (for medical devices of potential risk classes 1 and 2a), if the medical device can be used safely and for the intended purpose specified by the manufacturer, without instructions for use.

68. One copy of the instructions for use may be sufficient if several medical devices are supplied to one user at one address. At the request of the consumer, the manufacturer must provide additional copies of the instructions for use.

IV. General safety and efficacy requirements applicable to in vitro diagnostic medical devices

1. Chemical, physical and biological properties of medical devices for in vitro diagnostics

69. When designing and manufacturing medical devices for in vitro diagnostics, special attention should be paid to the possible deterioration of analytical performance due to the incompatibility of the materials, samples and (or) analytes used.

70. When designing, manufacturing and packaging medical devices for in vitro diagnostics, the risk posed by contaminants and their residues for users and persons involved in the transportation, storage, maintenance and use of medical devices for in vitro diagnostics (taking into account the purpose medical device for in vitro diagnostics, as well as the duration and frequency of exposure to these substances on the human body).

71. When designing and manufacturing medical products for in vitro diagnostics, the risks of:

1) associated with dangerous and (or) harmful substances that can be washed out or leaked from a medical product for in vitro diagnostics (taking into account their sensitizing effect, carcinogenicity, mutagenicity or negative effect on reproductive function);

2) related to the inadvertent entry of foreign substances into the medical device for in vitro diagnostics (taking into account the intended use of the medical device for in vitro diagnostics and the expected conditions of use of the medical device for in vitro diagnostics).

2. Infectious and microbial contamination of medical devices for in vitro diagnostics

72. When designing and manufacturing medical products for in vitro diagnostics, the risk of infection of users and third parties must be eliminated or reduced to an acceptable level.

The design of the in vitro diagnostic medical device should ensure ease of handling and maintenance and, if necessary, minimize the risk of microbial leakage from the in vitro diagnostic medical device and (or) microbial exposure during use, as well as prevent microbial contamination of the in vitro diagnostic medical device or samples by the user or a third party.

73. When designing, manufacturing and packaging medical devices for in vitro diagnostics with a special microbiological status in accordance with the labeling, it must be guaranteed that the microbiological status remains unchanged under the conditions of transportation and storage specified by the manufacturer, as long as the protective packaging will not be broken or opened.

74. Sterile medical products for in vitro diagnostics or medical products for in vitro diagnostics, having a special microbiological status, are manufactured, processed and, if necessary, sterilized using validated methods, equipment, processes.

75. Medical products for in vitro diagnostics requiring sterilization must be manufactured under controlled production conditions.

76. The packaging of non-sterile in vitro diagnostic medical devices must ensure their integrity and cleanliness, and if the in vitro diagnostic medical device must be sterilized before use, minimize the risk of microbial contamination, while the packaging must be compatible with the sterilization method specified manufacturer.

3. Medical products for in vitro diagnostics containing materials of biological origin

77. If medical devices for in vitro diagnostics contain biological materials of animals, then the processing, storage, testing of biological materials of animal origin, as well as handling them must be carried out in such a way as to ensure the safety of users and third parties.

Safety against viruses, other infectious agents and other pathogens common to humans and animals must be ensured through the use of validated methods of destruction or inactivation during the manufacturing process. These validated methods do not apply to IVD medical devices if the activity of viruses and other infectious agents is due to the purpose of IVD medical devices or the destruction or inactivation process may reduce the effectiveness of the IVD medical device.

78. If medical products for in vitro diagnostics contain biological materials of human origin, then the processing, storage, testing and handling of biological materials of human origin must be carried out in such a way as to ensure the safety of users and third parties.

Safety against viruses and other infectious agents must be ensured through the use of validated methods of destruction or inactivation during the manufacturing process. These validated methods do not apply to IVD medical devices if the activity of viruses and other infectious agents is due to the purpose of IVD medical devices or the destruction or inactivation process may reduce the effectiveness of IVD medical devices.

79. If medical products for in vitro diagnostics contain biological materials of microbial origin, then the processing, storage, testing and handling of biological materials of this nature must be carried out in such a way as to ensure the safety of users and third parties.

Safety against viruses and other infectious agents must be ensured through the use of validated methods of destruction or inactivation during the manufacturing process. These validated methods do not apply to IVD medical devices if the activity of viruses and other infectious agents is due to the purpose of IVD medical devices or the destruction or inactivation process may reduce the effectiveness of the IVD medical device.

4. Medical products for in vitro diagnostics used under the influence of external factors

80. Medical products for in vitro diagnostics are designed and manufactured in such a way that their assembly, adjustment, calibration, use and maintenance under the influence of external factors are carried out safely.

81. If medical devices for in vitro diagnostics are intended for use in combination with other medical devices and (or) equipment, the entire combination, including the connecting system, must be safe and must not impair the declared functional characteristics of medical devices for in vitro diagnostics. Any known restrictions on the use of such a combination are indicated on the label and / or in the instructions for use. When designing and manufacturing connection systems, the possible risks of incorrect connection should be minimized as much as possible.

It is not allowed to use as part of a medical device for in vitro diagnostics special technical and (or) software tools that exclude or limit the possibility of its use in combination with other medical devices and (or) equipment intended for this purpose.

82. Medical products for in vitro diagnostics are designed and manufactured in such a way as to eliminate or reduce to an acceptable level:

1) the risk of injury to the user or third parties due to the physical characteristics of the medical product for in vitro diagnostics;

2) the risk of error when using a medical device for in vitro diagnostics due to design characteristics or human factors;

3) risk associated with objectively predictable external influences or environmental conditions such as external electromagnetic fields, electrostatic discharges, radiation, atmospheric pressure and its fluctuations, humidity and air temperature;

4) the risk associated with the use of medical products for in vitro diagnostics in contact with materials, liquids and gases that medical products for in vitro diagnostics are exposed to under normal operating conditions;

5) the risk associated with possible negative interaction between the software of the medical product for in vitro diagnostics and the conditions in which it is operated;

6) the risk of accidental ingress of foreign substances into medical devices for in vitro diagnostics;

7) the risk of incorrect identification of samples in the framework of in vitro diagnostics;

8) the risk of mutual interference associated with other devices commonly used in the treatment and diagnostic process.

83. Medical products for in vitro diagnostics are designed and manufactured in such a way as to eliminate or minimize the risk of ignition or explosion under normal operating conditions or in the event of a single failure. Particular attention should be paid to in vitro diagnostic medical devices used with flammable or explosive substances.

84. In vitro diagnostic medical devices are designed and manufactured in such a way as to facilitate the safe disposal of waste generated after the use of in vitro diagnostic medical devices.

5. Functional characteristics of medical devices for in vitro diagnostics

85. Medical products for in vitro diagnostics are designed and manufactured in such a way that their functional characteristics are based on an appropriate scientific and technical basis. Medical products for in vitro diagnostics must function throughout the entire period of operation in accordance with the purpose specified by the manufacturer, in terms of:

1) characteristics of analytical performance: accuracy (correctness and precision), systematic error, analytical sensitivity, analytical specificity, limit of detection (detection), analytical range, linearity, cut-off point, repeatability, reproducibility, including the conditions for its determination, determination of possible interferences of endogenous and exogenous nature and cross-reactivity;

b) # of clinical performance characteristics: diagnostic sensitivity, diagnostic specificity, predictive value of positive and negative results, likelihood ratio, expected values ​​in a normal or isolated population.

86. If the effectiveness of medical products for in vitro diagnostics depends on calibrators and (or) control materials, the metrological traceability of their values ​​should be ensured by reference methods and (or) available reference materials of a higher order.

87. The numerical values ​​of the results of the study of samples of human biological materials obtained as part of in vitro diagnostics should be expressed in generally accepted and standardized units.

6. Radiation protection

88. Medical products for in vitro diagnostics are designed, manufactured and packaged in such a way as to minimize exposure of users and third parties to potentially hazardous radiation.

89. Medical devices for in vitro diagnostics intended to generate potentially hazardous radiation are designed and manufactured in such a way as to guarantee control and (or) regulation of the characteristics and amount of emitted radiation, and are equipped with visual and (or) audible means of warning about the presence (activity) of ) of such radiation.

7. Medical products for in vitro diagnostics, including software, and stand-alone software, which is a medical product for in vitro diagnostics

90. Medical products for in vitro diagnostics, including software, and standalone software, which is a medical product for in vitro diagnostics, are designed and manufactured in such a way as to ensure the stable, reliable and efficient operation of these medical products in accordance with their intended purpose, by a certain manufacturer.

8. Active IVD medical devices associated with or equipped with an energy source

91. Active medical products for in vitro diagnostics, when using which the safety of users depends on an internal power source, are equipped with a means of determining the state of the power source.

92. Active medical products for in vitro diagnostics are designed and manufactured in such a way as to minimize the risk of creating electromagnetic fields (electromagnetic interference) that may adversely affect the operation of other medical products, equipment and communication facilities in accordance with their purpose.

93. Active medical products for in vitro diagnostics are designed and manufactured in such a way as to provide a level of resistance to electromagnetic interference (noise immunity) that ensures their operation in accordance with the intended purpose specified by the manufacturer.

94. Active medical devices for in vitro diagnostics are designed and manufactured in such a way as to minimize the risk of accidental electric shock to the user or a third person both under normal operating conditions of the medical device and under single failure conditions, provided that the medical device is installed and maintained in accordance with the manufacturer's instructions.

9. Protection against mechanical and thermal risks

95. Medical products for in vitro diagnostics are designed and manufactured in such a way as to protect the user and third parties from the risk of mechanical damage associated with resistance to movement, instability and the presence of moving parts in the composition of such medical products.

96. If there are moving parts in the in vitro medical device, the means of protecting the user from the risk associated with the possible destruction of the moving parts or their separation are provided.

97. Medical products for in vitro diagnostics are designed and manufactured in such a way as to minimize the risk associated with the vibration generated by these medical products by using means to limit vibration, unless vibration is part of the purpose of such medical products.

98. Medical products for in vitro diagnostics are designed and manufactured in such a way as to minimize the risks associated with the generated noise, by using (if necessary) means used to reduce noise.

99. Terminals, connectors, connectors and other devices for connecting medical products for in vitro diagnostics to sources of electrical, hydraulic or pneumatic energy are designed and manufactured in such a way as to minimize any possible risks.

100. Medical devices for in vitro diagnostics are designed and manufactured in such a way as to minimize the risk of errors arising from incorrect connection or switching during operation of the equipment or parts in the composition of such medical devices.

101. Exposed parts of medical products for in vitro diagnostics (with the exception of parts intended for supplying heat or achieving specified temperatures) should not reach potentially dangerous temperatures under normal operating conditions.

10. Protection against risks posed by IVD medical devices intended for self-testing by the user or testing near the user

102. Medical devices for in vitro diagnostics, intended for self-testing by the user or testing near the user, are designed and manufactured in such a way that they function in accordance with the intended purpose specified by the manufacturer, taking into account the user's skills and operating conditions of the medical device.

103. Medical devices for in vitro diagnostics, intended for self-testing by the user or testing near the user, are designed and manufactured in such a way as to minimize the risk of user error when using such medical devices, as well as when sampling or interpreting test results.

104. Medical devices for in vitro diagnostics, intended for self-testing by the user or for testing near the user, should, if objectively possible, have the function of confirming that, when used, these medical devices will function in accordance with the intended use specified by the manufacturer.

11. Additional requirements for the labeling of medical devices for in vitro diagnostics

105. In relation to medical devices for in vitro diagnostics, in addition to the labeling requirements specified in subsection 13 of Section III of these General Requirements, additional requirements are also applied, providing that the labeling of medical devices for in vitro diagnostics must contain the following information:

1) information about the purpose of the medical product for in vitro diagnostics;

2) information about the mass (net) of the contents (in units of weight or volume), the number of units or any combination of indicators that accurately reflect the contents of the package (if any);

3) information about the main ingredients contained in the packaging of the medical product for in vitro diagnostics;

4) hazard warning sign if the medical product for in vitro diagnostics contains hazardous substances;

5) information on the special microbiological status or purity of the medical device for in vitro diagnostics (if necessary);

6) information about the purpose of the medical product for in vitro diagnostics for self-testing by the user or for testing near the user (if available).

12. Requirements for the information contained in the instructions for use of the medical device for in vitro diagnostics

106. Instructions for use of a medical device for in vitro diagnostics should contain the following information:

1) name and (or) trade name of a medical product for in vitro diagnostics;

2) information about the manufacturer of the medical product for in vitro diagnostics and (or) its authorized representative, including the full and abbreviated (if any) name of the legal entity, location (last name, first name, patronymic (if any) and place of residence of the individual registered as an individual entrepreneur), postal address, telephone, fax numbers, e-mail address (if any);

3) purpose of a medical product for in vitro diagnostics, including:

functional purpose;

a description of what is defined and/or measured;

a specific disorder, condition or risk factor for the detection, definition or differentiation of which the medical product is intended for in vitro diagnostics (if necessary);

the purpose of the medical product for in vitro diagnostics for qualitative, semi-quantitative or quantitative determinations;

type of analyzed sample;

4) information on the purpose of the medical device for in vitro diagnostics for clinical laboratory diagnostics;

5) the purpose of the medical device for in vitro diagnostics, indicating the user (for example, a patient, a medical specialist, an individual using a medical device for the intended purpose specified by the manufacturer);

6) the principle of the test;

7) description of reagents, calibrators and control materials;

8) a list of materials and special materials that are required for testing (analysis), but are not included in the delivery set of the medical device for in vitro diagnostics;

9) for medical devices for in vitro diagnostics intended for use in combination with other medical devices, including medical devices for in vitro diagnostics, information for identifying medical devices in order to obtain a safe combination and (or) information about known restrictions on joint use medical products;

10) information about special storage conditions (for example, air temperature and humidity, lighting, etc.) and (or) user handling of the medical product in vitro;

11) information about the stability characteristics of a medical device for in vitro diagnostics (for example, storage conditions, shelf life after the first opening of the primary container), as well as storage conditions and stability of working solutions (if necessary);

12) information on the sterile condition, the method of sterilization and the procedure for actions in case of violation of the sterile packaging (if the medical product for in vitro diagnostics is supplied in a sterile form);

13) information for users (warnings, precautions, measures to be taken, if necessary, and restrictions when using a medical device for in vitro diagnostics), including:

warning, precautionary measures and (or) measures taken in case of failure or deviations in the functioning of a medical product for in vitro diagnostics, determined by external signs;

warning, precautionary measures and/or measures taken in relation to such predictable external factors as external electromagnetic fields, electrostatic discharges, radiation, atmospheric pressure and its fluctuations, humidity and air temperature;

warning, precautionary measures and (or) measures taken in case of a predictable risk of electromagnetic interference created by a medical device for in vitro diagnostics for other medical devices, equipment and communication facilities;

a warning related to materials contained in a medical product for in vitro diagnostics that are carcinogenic, mutagenic or toxic, or lead to sensitization, an allergic reaction, or adversely affect reproductive function;

warning, precautions and (or) measures taken in relation to potentially infectious material contained in a medical product for in vitro diagnostics;

14) information on the purpose of the medical product for in vitro diagnostics for single use;

15) information on the proper processing of the medical device for in vitro diagnostics for its reuse, including cleaning, disinfection, packaging and, if necessary, the method of re-sterilization (if the medical device for in vitro diagnostics is intended for multiple use);

16) special requirements for premises, special training or special qualifications of the user and (or) third parties (if necessary);

17) information on the conditions necessary for the collection, processing and preparation of samples, data on the stability of the analyzed samples, including storage conditions and duration, transportation conditions, restrictions on freezing (thawing) cycles;

18) detailed information on the preparation for the use of a medical device for in vitro diagnostics;

19) information necessary to verify the correct installation of the medical product for in vitro diagnostics and its readiness for safe operation for the intended purpose specified by the manufacturer, indicating the following information:

the need for calibration to ensure the proper and safe operation of a medical device for in vitro diagnostics during its service life;

methods to reduce the risks associated with the installation, calibration or maintenance of a medical product for in vitro diagnostics;

21) information on the traceability of values ​​specified for calibrators or control materials, which is provided through available reference methods (methods) of measurement and (or) standards;

22) testing procedure, including calculations and interpretation of test results, and, if necessary, information on the feasibility of conducting confirmatory tests;

23) characteristics of analytical performance: sensitivity, specificity, correctness, repeatability, reproducibility, limit of detection (detection) and measurement range, including information about the influence of known interferences, method limitations and the use of available reference materials and methods of analysis (as applicable);

24) characteristics of clinical performance: diagnostic sensitivity and diagnostic specificity (if necessary);

25) biological reference interval, if applicable;

26) information about interfering substances or limitations associated with the sample, which may affect the result of the study;

27) warning and (or) special precautions regarding the safe disposal of a medical device for in vitro diagnostics and accessories (if any), which, if necessary, should cover the following factors:

infectious or microbial risks, including the possibility of contamination of consumables with infectious agents of human origin;

environmental risks associated with potentially hazardous materials and substances;

physical risks, including the possibility of explosion or fire;

28) in relation to a medical device for in vitro diagnostics intended for self-testing by the user or testing near the user, the following information is also provided:

detailed information on the testing procedure (preparation of reagents, sampling (preparation) of samples, procedure for performing and interpretation of test results);

information on test errors and the possibility of obtaining false positive or false negative test results, as well as on factors affecting the test result;

information about the inadmissibility of making medical decisions by the user without prior consultation with a medical specialist;

29) data on the issue or last revision of the instructions for use;

30) information on the need to send a message to the manufacturer or its authorized representative about undesirable events that have signs of an adverse event (incident).

107. Instructions for use may be presented in abbreviated form or on the label (for medical devices for in vitro diagnostics of potential risk classes 1 and 2a), if the medical device can be used safely and for the intended purpose specified by the manufacturer, without instructions for use.

108. One copy of the instructions for use may be sufficient if several medical devices for in vitro diagnostics are supplied to one user at one address. At the request of the consumer, the manufacturer must provide additional copies of the instructions for use.

V. Evidence of compliance of medical devices with general safety and efficacy requirements for registration purposes

109. Compliance of a medical device with these General Requirements is ensured by the fulfillment of the requirements established by this document directly or by the fulfillment of the requirements of the standards included in the list of standards, as a result of which, on a voluntary basis, compliance of the medical device with these General Requirements is ensured in full or in part (hereinafter referred to as the list).

110. The list is formed on the basis of proposals from the authorized bodies of the Member States, is adopted by the recommendation of the Commission in agreement with the Member States and is subject to updating as necessary.

The procedure for the formation of the list is adopted by the recommendation of the Commission.

To include standards in the list, the authorized bodies of the Member States submit to the Commission information in the form in accordance with Appendix No. 1.

111. For the purpose of registration, the compliance of a medical device with these General Requirements is confirmed by the manufacturer or his authorized representative by submitting to the authorized body of the Member State information on compliance with the established requirements in the form in accordance with Appendix No. 2. This form is filled in in accordance with the established procedure.

112. Evidence of the compliance of the medical device with the provisions established by paragraphs 3, 6 and 8 of these General Requirements must include a clinical justification based on clinical data on the medical device.

Application No. 1

and effectiveness of medical
products, requirements for their
labeling and operational
documentation for them

Form
submission of information for inclusion of standards in the list of standards, as a result of which, on a voluntary basis, compliance of the medical device with the safety and efficacy requirements of medical devices is fully or partially ensured

_____________________________

* The applicable sections of the standard are indicated if not all sections of the standard provide a presumption of compliance of the medical device with the General Requirements for the Safety and Efficacy of Medical Devices, the requirements for their labeling and operational documentation for them, approved by the Decision of the Council of the Eurasian Economic Commission dated February 12, 2016 No. 27.

** The corresponding paragraph of the General requirements for the safety and efficacy of medical devices, the requirements for their labeling and operational documentation for them, approved by the Decision of the Council of the Eurasian Economic Commission dated February 12, 2016 No. 27, is indicated, which is performed when applying the section of the standard specified in column 4 of this forms.

Application No. 2
to the General Safety Requirements
and effectiveness of medical
products, requirements for their
labeling and operational
documentation for them

The form for submitting information on the compliance of a medical device with the requirements for the safety and effectiveness of medical devices and the procedure for filling it out

I. Form for presenting information on the compliance of a medical device with the requirements for the safety and effectiveness of medical devices

II. The procedure for filling out the form for submitting information on the compliance of a medical device with the requirements for the safety and effectiveness of medical devices

1. Column 1 indicates the relevant paragraph of the General requirements for the safety and efficacy of medical devices, the requirements for their labeling and operational documentation for them, approved by the Decision of the Council of the Eurasian Economic Commission dated February 12, 2016 No. 27 (hereinafter referred to as the General Requirements).

2. Column 2 indicates whether the requirement provided for by the paragraph of the General Requirements specified in column 1 is applicable to the medical device (“yes” or “no”). If this requirement is not applicable to a medical device, an explanation is given in the column.

3. Column 3 indicates the method used to prove the compliance of the medical device with the requirement specified in paragraph 1 of the General Requirements (for example, the application of the standard, own tests using a standardized method, tests using our own test method, tests conducted by a third party, or another method).

4. Column 4 shall indicate the details of the regulatory document for the method used to prove the compliance of the medical device with the requirement provided for by the paragraph of the General Requirements specified in column 1.

5. Column 5 contains the details of the documents confirming the compliance of the medical device with the requirement provided for by the paragraph of the General Requirements specified in column 1 (test reports, certificates, declarations of conformity, research reports, other documents).

6. Column 6 shall indicate the conclusion on the conformity or non-compliance of the medical device with the General Requirements.

Document overview

General requirements for the safety and effectiveness of medical devices put into circulation within the EAEU have been established.

The requirements for medical devices for in vitro diagnostics are separately defined.

Uniform requirements for the labeling of medical devices and operational documentation for them are being introduced.

Compliance of the medical device with the established requirements is ensured by their fulfillment directly or by the fulfillment of the requirements of the standards, as a result of the voluntary application of which the compliance of the medical device with the general requirements is ensured. To confirm the compliance of the medical device with the established requirements, the manufacturer (its authorized representative) must submit to the authorized body of the EEA member state information on compliance with the general requirements. The form for submitting information and instructions for filling it out are given.

The decision shall enter into force not earlier than 10 calendar days from the date of its official publication.

The marking carries very important information for the consumer, which, first of all, determines all the necessary data for the safe and efficient use of the product. Proper labeling is extremely important for several reasons. Thus, non-compliance with the requirements for it can lead to a stop / 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, improper execution of such information 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, failure to comply 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 matter, 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 is only recommended to be displayed 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 marking sample will be covered.

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

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

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

• Law of Ukraine dated July 3, 2012 No. 5029-VI “On the principles of the state language policy”;
• p and others.

Normative legal acts, optional for execution:

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

Normative legal acts that are not mandatory for execution contain recommendations of a recommendatory nature, which become mandatory for specific products after the manufacturer declares compliance with them.

The most important requirements

These include the identity of information on the labeling of the product and in the certificate of its state registration. Resolution of the Cabinet of Ministers of Ukraine No. 1497 determines that "the import into the customs territory, sale and use of medical devices in Ukraine is allowed only after their state registration." The certificate of state registration contains information about the name of the product, the manufacturer, as well as its address. In addition, this document may contain a product catalog number. During customs clearance and market supervision, 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 label is fully consistent with that specified in the registration certificate. This applies to the name of the product, the name and address of the manufacturer, the country of origin, and 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 annex to the package of registration materials.

The information on the label must fully correspond to that specified 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 right of the consumer to information about products, namely:

1) about the name of the goods, the name or reproduction of the mark;

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

3) on 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 particular product;

5) date of manufacture;

6) on storage conditions;

7) on warranty obligations of the manufacturer (executor);

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

9) on the shelf life 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) the name and address of the manufacturer and the company that performs its functions regarding the acceptance of claims from the consumer, as well as 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 wholesale and retail trade, it is also necessary to note data on the price (tariff), conditions and rules for purchasing products.

Information about the impact of a product on human life and health cannot be classified as information with restricted access. Full data should be provided regarding the risks and adverse events associated with the use of the product. In addition, there should be warnings.

Thus, the specified information (adjusted for applicability to a specific medical device) must be brought 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 ones. So, according to Art. 26 of the Law of Ukraine "On the Principles of the State Language Policy", labeling of goods, instructions for their use and the like are made in the state language and the regional or minority language. By decision of the manufacturers of goods, next to the text written in the state language, its translation into other languages ​​may be placed.

Labeling, instructions for use of the 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 graphic symbols that are most commonly used by manufacturers to provide information on 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, the general requirements for labeling are agreed upon by approving the packaging sample. With the introduction of GSTU EN 980:2007, an examination of the provided marking sample is carried out regarding its compliance with the specified standard, after which the marking sample is certified as an integral part of the technical examination protocol. This, in essence, is equivalent to declaring the use of approved symbols on the labeling of the relevant products when they are circulating on the Ukrainian market, and the use of such symbols becomes mandatory (Table 1).

Graphic symbol	Its meaning and explanation
	Re-use is FORBIDDEN
	USE TILL - this character is followed by a date, which consists of four digits for the year, two digits for the month, and optionally two digits for the day. The date must appear next to or below the symbol, or to the right of it.
	BATCH CODE - this symbol is followed by the manufacturer's batch code
	REGISTRATION NUMBER - this symbol is accompanied by the serial number of the product, which must be placed after or below the symbol
	DATE OF MANUFACTURE - for active implantable medical devices, the symbol will be combined with the date marked with four digits for the year and two digits for the month. For active items, the symbol must be followed by the year. The date must be marked after or below the symbol
	STERILITY - only for medical devices that are completely sterilized. Can be used with refinement of sterilization methods
	CATALOG NUMBER - the manufacturer's catalog number must be placed after or below the symbol adjacent to it
	WARNING! PLEASE READ THE ACCOMPANYING DOCUMENTS - can also be synonymous with the symbol "Attention, see instructions for use"
	MANUFACTURER - this symbol must be followed by the name and address of the manufacturer responsible for the products, which must be placed 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 EVALUATION OF THE PERFORMANCE OF A MEDICAL DEVICE FOR LABORATORY DIAGNOSIS IN VITRO
	MEDICAL DEVICE FOR DIAGNOSIS IN VITRO
	TEMPERATURE LIMIT Can only be used with upper or lower temperature limit indication
	READ THE INSTRUCTIONS FOR USE
	BIOLOGICAL RISKS

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

The normative justification for this is as follows: “In Ukraine, the symbol “Number of the certificate of state registration of a medical device in Ukraine” is marked on the packaging of a medical device. 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 placed 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 marking sample was approved using the symbols approved by GSTU EN 980:2007, then their use also becomes mandatory.

The Law of Ukraine "On the Protection of Rights to Indicate 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 the one marked on the manufacturer's label, must certainly be indicated on the label, packaging (Fig. 3)

It should be noted that the terms "manufacturer" and "country of origin" are not identical. According to European directives, a manufacturer is a company (person) that assumes responsibility for the development, production, packaging and labeling of a product before being placed on the market (EU), regardless of whether these operations are carried out independently or by a third party. And the country of origin can be determined by the principle of significant processing or national share in the value of the goods. Therefore, a company from Germany, for example, can place a product on the EU market and indicate itself as a manufacturer, while China can be the country of origin.

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.

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 listed in the marked countries of origin on the same product label.

Other aspects of medical device labeling

Marking products with a registered trademark is regulated and provides for the application of this trademark on any product for which the mark is registered, the packaging in which such product is contained, a sign associated with it, a label, patch, tag or other item affixed to the product, and also that the storage of such goods must be carried out with the indicated sign applied. Also, the law mentioned above defines: “The owner of the certificate has the right to affix a warning marking next to the sign, which indicates that this sign is registered in Ukraine.”

At the same time, trademark registration is voluntary and helps 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 add them to the marking only after making the appropriate changes to the registration certificate.

If during the technical examination a marking sample was approved using symbols according to GSTU EN 980:2007, 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 accessible for perception. 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 on a product has the following priority scheme: the priority right belongs to the trademark owner, then to the manufacturer, then to the supplier. According to paragraph 5 of the Regulations on the bar coding of goods, it does not contain information regarding the mandatory application of a bar code specifically for medical devices: “Alcoholic drinks and tobacco products, copies of audiovisual works and phonograms, medicines and other goods marked with GS1 bar codes barcodes is provided for by the legislation of Ukraine. So, not a single specialized normative 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 way.

The 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 definition in the contract.

It should also be noted that the EN 980:2007 standard in most European countries became invalid from 01/01/2013 and in 2012 was replaced by the EN ISO 15223-1:2012 standard, which does not change the symbols of EN 980:2007, but introduces some new symbols and designations (Table 2). You can already see them on imported medical devices today.

	Do not re-sterilize		Contains Latex
	The product is not sterile		Control material
	Do not use if the integrity of the package is broken		Liquid filter with pore size
	Humidity limitation		Number of drops per milliliter

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

Maxim Bagreev,
Cratia company

Deciphering labels: eco-labels

Ecological cleanliness and the absence of harmful chemical additives in the product are guaranteed by the following icons:

	Ecological emblem of the European Union. Goods with this marking comply with the declared requirements and regulations of the EU countries.
	This mark, called the "Green Dot", is placed on products whose manufacturer has paid a fee for recycling and disposal. Not valid in the CIS countries.
	Mark of conformity with organic standards of the European Union.
	The main signs of European countries for the designation of environmentally friendly products.
	A sign with a rabbit or rabbit's foot means that the product (mostly cosmetics) has not been tested on animals.
	Badge "mandatory certification for eco-requirements in Russia".
	The sign speaks for itself. Nevertheless, it should be understood that today manufacturers put it voluntarily and do not undergo any certifications and checks.
	This marking is given to products that have been tested in the "Testing and Certification Center - St. Petersburg"
	The mark of the Swedish Confederation of Professional Workers guarantees that the product meets quality and energy saving standards.

Medical device packaging labeling

During the state registration of a medical device, at the stage of technical expertise, the general requirements for labeling are agreed upon by approving the packaging sample. With the entry into force of GSTU EN 980:2007, an examination of the provided marking sample is carried out regarding its compliance with the specified standard, the result of which is a certified marking sample as an integral part of the conclusion of the technical examination. This, in essence, is equivalent to declaring the use of approved symbols on the labeling of the relevant products when they are circulating on the Ukrainian market, and the use of symbols becomes mandatory .

Graphic symbol:	Its value (according to DSTU EN 980) and explanation:
	Re-use is FORBIDDEN
	USE BEFORE - this character is followed by the date, which consists of four digits for the year, two digits for the month, and optionally two digits for the day. The date must be written next to the symbol, or below it, or to the right of it.
	PARTY CODE - this symbol is accompanied by the manufacturer's batch code, which must be combined with the symbol
	REGISTRATION NUMBER - this symbol is accompanied by the serial number of the product, which must be marked after or below the symbol
	DATE OF MANUFACTURE - for active implantable medical devices, the symbol will be combined with the date marked with four digits for the year and two digits for the month. For active products, the symbol must be followed by the year. The date must be placed after or below the symbol.
	STERILITY - only for medical devices that are completely sterilized. Can be applied with refinement of sterilization methods
	PART NUMBER - the manufacturer's catalog number must be placed after or below the symbol adjacent to it
	WARNING! READ THE ACCOMPANYING DOCUMENTS - can also be synonymous with the symbol "Attention, see instructions for use"
	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 -) TESTS
	FOR IN VITRO DIAGNOSIS MEDICAL DEVICE PERFORMANCE EVALUATION ONLY
	MEDICAL DEVICE FOR IN VITRO DIAGNOSIS
	TEMPERATURE LIMIT - Can only be used with upper or lower temperature limit indication
	READ THE INSTRUCTIONS FOR USE
	BIOLOGICAL RISKS

It is important to note that this standard is supplemented by national compulsory addendum HA, which gives examples of the use of the symbol "Number of the certificate of state registration of a medical device in Ukraine".

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 delivered, assembled for the purpose of operation and use in accordance with the intended purpose.

2. For each type or model of a medical device, the manufacturer, prior to release for circulation, must create a summary 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 authorities exercising state control (supervision) over the fulfillment of the requirements of this Federal Law. The requirements of this paragraph do 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 mandatory confirmation of compliance with the requirements of this Federal Law may be put into circulation and put into operation. Such a medical device must be marked with the mark of circulation on 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. Misrepresentation occurs if:

the medical product is attributed operational properties that it does not have;

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

Article 15. Requirement for the packaging of medical devices

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

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

3. The packaging of a medical device supplied in a sterile state must ensure its sterility when released into circulation, as well as the preservation of sterility under the storage and transportation conditions established by the manufacturer.

4. The 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 its 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 must be different.

6. The inner packaging of photosensitive 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 a material that provides maximum protection.

8. Separate outer packaging must be used to package different components of a reagent kit shipped at different temperatures.

9. The 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 its transportation, storage and operation, and comply with the requirements of the legislation of the Russian Federation on sanitary and epidemiological well-being. The packaging of a medical device must have a biohazard label.
^

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

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

4. The text of the marking applied to a medical product or its component must contain information in brief form that makes it possible to unambiguously identify the properties of this product 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 expiration date (year, month inclusive);

date of manufacture (year, month);

indication of the method of sterilization;

lot number;

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

if the device is intended for clinical research or performance testing, a statement, “for clinical research only” or “for medical testing only”

any special instructions;

any warnings and precautions that must be followed, manipulation inscriptions (if necessary);

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

net weight and gross weight on a group package, reusable container or transport container;

net weight of consumer packaging.

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

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

name and address of the manufacturer;

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 series 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 method of sterilization;

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

a statement that this product is intended for single use;

if the product is for individual use, the indication “product for individual use”;

if the device is intended for clinical research or performance testing, the statement "for clinical research only, for medical testing only";

any special instructions;

any warnings and precautions to be followed;

intended use of the device, intended user, type of patients for whom the device is intended to be used (if it is not obvious);

information necessary for the user 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 caused by this device and its components;.

mark of circulation on the market;

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

the name of the ingredients contained in the package (complete set);

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

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

warning label "for in vitro diagnostic use only";

date of manufacture (year, month);

expiration date (year, month inclusive);

an identification number;

number of definitions (if necessary);

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

Other special information that is not of an advertising nature, as well as pictograms and holograms, may be applied to the outer packaging.

6.2. For medical products 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 manufacturer;

series number;

best before date;

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 containers of medical devices.

6.3. Products containing human blood serum (plasma) or human tissue elements 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 cliche or printed method.

6.4. On the packaging of products intended for self-testing, the inscriptions are applied: “For self-testing”, “Keep out of the reach of children”, “Over-the-counter”.

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