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

Answer

Requirements for marking (label) and instructions (accompanying documentation) are specified in the Unified Sanitary and Epidemiological and hygiene requirements to goods subject to sanitary and epidemiological supervision (control).

The rationale for this position is given below in the materials of the “Lawyer System” .

Decision of the Customs Union Commission dated

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

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

The marking is applied directly to the product and/or packaging. For a product put into circulation in sterile form, the marking must also be applied to the sterile packaging. Marking is not applied to the product if it is too small in size, or if its specific properties do not allow this.

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

It is prohibited to display symbols or inscriptions that may mislead third parties as to the meaning or graphic image marking with a mark of circulation on the market. Any other marking may be applied to the product, its packaging or product instructions, provided that this does not adversely affect the visibility and legibility of the marking.

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

The marking applied to the packaging of the product must contain: the name of the country of origin, the name, legal address and trademark of the manufacturer, the name of the product, the regulatory document whose requirements the product meets, dimensions, weight (if necessary), methods of caring for the product, year of manufacture (for BMI), expiration date or expiration date (for medical device), circulation mark, other information in accordance with the manufacturer’s documentation.

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

Labeling must be in Russian. Additional use of other languages ​​is permitted.

Packages with products must be marked with pictograms (signs and/or text) prescribing the conditions for storage and/or transportation of products established by the manufacturer in accordance with regulatory (operational) documentation.
The labeling indicates all the necessary information to ensure safe operation of the product: its main specifications, warning labels, danger signs (magnetic, laser or other for medical devices; information about the materials from which medical devices are made, etc.), requirements for the need to use personal protective equipment, safe distances or permissible duration of operation, etc. for BMI.

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

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

The manufacturer must provide information so that appropriate precautions can be taken and all hazards can be adequately controlled using a full range of protective measures.

The user of a BMI characterized by a high potential health hazard (UV devices, laser products, etc.) must be warned about the existing risk. The dangers of the products are indicated accordingly. The use of medical equipment products intended for the population at home must be carried out as prescribed by a doctor, in accordance with medical recommendations.

UV products are marked with the warning message: "WARNING: UV radiation can cause damage to eyes and skin. Please read the instructions carefully. Wear the safety glasses provided." For UV devices intended for use in beauty salons and similar places, warning notices may be provided on a poster permanently affixed in the vicinity of the UV device.

UV devices whose brightness exceeds 100,000 cd/m are marked with a warning: “Powerful light. Do not look at the emitter.”

UV irradiation installations intended for operation in the absence of people are marked with an appropriate warning label.
Laser products of different classes are marked with warning signs - “Do not look into the beam”, “Laser radiation”, “Avoid exposure of eyes and skin to direct and scattered radiation”, “Laser aperture”, etc. indicating the class of the laser product. Laser products that generate radiation in the invisible part of the spectrum are marked with an appropriate warning label - “Invisible laser radiation”, etc.

The “Safety Requirements” sections of the operational documentation include the basic requirements for ensuring the safe operation of products, as well as for their production in accordance with the main documents of sanitary legislation with links to these documents, including: the production equipment used and the levels of harmful factors in the workplace , means of collective and individual protection, labor regimes, carrying out PMO of workers and production control (if necessary). This section must indicate that the products must be safe during production and use and must have a formalized sanitary and epidemiological certificate.”

Professional reference system for lawyers, in which you will find the answer to any, even the most complex question.

In accordance with paragraph 2 of Article 31 of the Treaty on the Eurasian Economic Union of 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 products (medical products 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 Regulations of the Eurasian Economic Commission, approved by the Decision of the Supreme Eurasian economic council dated December 23, 2014 No. 98, and the Decision of the Supreme Eurasian Economic Council dated December 23, 2014 No. 109 “On the implementation of the Agreement on common principles and rules for the circulation of medical products (medical products and medical equipment) within the framework of the Eurasian Economic Union” Council The Eurasian Economic Commission decided:

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

2. This Decision comes 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 common principles and rules for the circulation of medical devices (medical devices and medical equipment) within the framework of the Eurasian economic union of December 23, 2014, but not earlier than 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 effectiveness of medical devices, requirements for their labeling and operational documentation for them
(approved by 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 of May 29, 2014, paragraph 2 of Article 3, paragraph 4 of Article 4 and paragraph 4 of Article 7 of the Agreement on common principles and rules for the circulation of medical devices (medical products purposes and medical equipment) within the framework of the Eurasian Economic Union of December 23, 2014 and establish general requirements for the safety and effectiveness of medical products, as well as requirements for labeling and operational documentation for medical products put into circulation within the framework of the Eurasian Economic Union (hereinafter referred to as 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 the user without significantly changing them are not active medical devices. Stand-alone software is considered an active medical device;

“safety of a medical device” - the absence of unacceptable risk associated with causing harm to human life, 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 medical device, which may include, among other things, an instruction manual, a methodology medical use, passport, form, instructions for installation, setup, maintenance, repair, transportation, storage, disposal of a medical device;

“medical products for in vitro diagnostics” - any instruments, devices, instruments, 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 certain clinical condition or disease, tissue compatibility with a potential recipient, predicting responses to therapeutic effects, choosing therapeutic agents and (or) monitoring treatment;

“adverse event (incident)” - any malfunction and (or) deterioration of characteristics, or disruption of the functioning of a medical device, or insufficiency or incorrectness of accompanying information (documentation) for a medical device, or a side effect not specified in the instructions for use, which are directly or indirectly resulted or could result in death or serious impairment of health of users or third parties (where serious impairment is defined as a life-threatening disease, permanent impairment of a bodily function or permanent damage to a body structure, a condition requiring medical or surgical intervention to prevent life-threatening disease, or permanent impairment of body function, or irreversible damage to the structure of the body, a condition requiring hospitalization or a significant increase in the length of hospital stay of an already hospitalized patient, functional impairment in the fetus, its death, congenital anomaly or birth injury);

“adverse event” - any undesirable medical event, unpredictable disease or damage or undesirable clinical signs (including laboratory values ​​different from the norm) in users or third parties associated with the use of a medical device;

“user” - a patient, medical specialist or any other individual using a medical product for the intended purpose determined by the manufacturer;

“efficiency of a medical device” is the ability of a medical device to meet the intended purpose specified by the manufacturer.

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

3. Medical devices are designed and manufactured in such a way that, when used under conditions and for purposes consistent with their intended purpose as determined by the manufacturer and, where appropriate, taking into account technical knowledge, experience, education or special training, and the clinical and physical condition of the user, they perform as intended. , as 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 products through the use of special hardware or software or other means.

4. The decisions made by the manufacturer in the design and manufacture of a medical device must be consistent with safety principles taking into account the generally accepted state of the art. Where necessary, the manufacturer controls 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 known or foreseeable hazards and assessment of associated risks arising from the intended use of the medical device and from foreseeable misuse;

eliminating risks by making appropriate technical and technological decisions when designing and manufacturing a medical device;

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

informing users of any residual risks.

5. Medical products 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 are suitable for the intended use as determined by the manufacturer.

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

8. All known and suspected 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 benefit to users obtained from the manufacturer's intended performance of the medical device under normal operating conditions.

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

10. The information medium, its format, content and location must be consistent with the medical device, its purpose and the technical knowledge, experience, education or training of the users.

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

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

Such information may contain symbols established by interstate standards, as well as established international standards(provided that the safety of the medical device is not compromised by failure by individual users to understand the meaning of such symbols).

III. General requirements for safety and effectiveness 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 device;

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

13. When designing, manufacturing and packaging medical devices, the risk posed by contaminants and their residues to users and persons involved in the transportation, storage and servicing 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 devices 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 to be administered medicines, they are designed and manufactured in such a way that they are compatible with medicinal products (subject to the restrictions on their use) in order to ensure the effectiveness of both the medicinal product and the medical device as intended.

15. When designing and manufacturing medical devices, the risks should be minimized as much as possible:

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

2) associated with the unintentional entry of foreign substances into a medical device (taking into account the purpose determined by the manufacturer and the intended conditions of use of the medical device).

2. Infectious and microbial contamination of medical devices

16. When manufacturing a medical device, 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, where appropriate, 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 third party.

17. When designing, manufacturing and packaging medical devices that have a special microbiological status in accordance with the labeling, it must be ensured that the microbiological status remains unchanged under the conditions of transportation and storage specified by the manufacturer, as long as the protective packaging is not broken or opened.

18. When designing, manufacturing and packaging medical devices supplied in a sterile condition, their sterility must be guaranteed under the conditions of transportation and storage specified by the manufacturer, as long as the protective packaging is not broken or opened. Such medical products are packaged 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, and processes.

20. Medical products requiring sterilization must be manufactured in controlled cleanliness of production areas.

21. Packaging of non-sterile medical devices must ensure their integrity and cleanliness and, if the medical device must be sterilized before use, reduce the risk as much as possible microbial contamination, and 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 products 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 common principles and rules for the circulation of medicinal products within the Eurasian Economic Union of 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 effectiveness of such medical devices includes confirmation of the safety and effectiveness of the medicinal product, taking into account its use in the composition of medical devices.

4. Medical products containing materials of biological origin

23. If medical products 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 effectiveness of the medical device.

Information from the manufacturer of a medical device on biological materials, including the selection of animals, their geographical origin, sampling, conditions of processing, storage and handling of biological materials, must be stored in the authorized body of the Union member state 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 must be ensured through the use of validated methods of destruction or inactivation during the manufacturing process.

24. If medical products 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 are carried out in accordance with the legislation of the Member States of the Union and must ensure optimal safety of users and third parties. In particular, safety against viruses and other infectious agents must be ensured through the use of validated destruction or inactivation methods during the manufacturing process.

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

5. Medical products used under conditions of exposure to external factors

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

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

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

28. Medical devices 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 when using 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 entry 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 loss of accuracy of the measuring or control device.

29. Medical devices are designed and manufactured to eliminate or minimize the risk of fire or explosion under normal operating conditions or in the event of a single failure. Particular attention should be paid to medical devices using flammable or explosive substances.

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

6. Medical products related to measuring instruments

31. Medical products included in the list of medical devices related to measuring instruments, in respect of which tests are carried out for the purpose of approval of 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 device.

Numerical values ​​must 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 ah quantities in accordance with the list of non-system units of quantities used in the development of technical regulations of the Union (including their relationships with International system 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 to minimize exposure of users and third parties to radiation without reducing the specified levels of radiation necessary to achieve diagnostic and therapeutic purposes.

35. Medical devices intended to generate hazardous or potentially hazardous radiation necessary to achieve specific medical purposes, where the benefit of using these high-intensity radiations is considered to outweigh the hazards of the radiation, must be capable of controlling these radiations from the user's side. When designing and manufacturing such medical products, the reproducibility of the variable parameters of the generated radiation must be ensured within acceptable limits.

Medical products intended to generate dangerous visible and (or) invisible radiation are equipped with visual and (or) audio means of warning about the presence (activity) of such radiation.

36. The design and manufacture of medical devices should minimize exposure to unintentionally generated stray or scattered radiation.

37. When designing and manufacturing medical products intended to generate ionizing radiation, regulation of the quantitative and geometric parameters of the generated radiation must be ensured, taking into account the purpose determined 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 exposure to radiation on the user, the quality of the image and (or) the obtained research results necessary for diagnosis is ensured.

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

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

38. Medical devices that include software, and stand-alone software that is a medical device, are designed and manufactured in such a way as to ensure stable, reliable and effective functioning of these medical devices in accordance with the intended purpose determined by the manufacturer.

9. Active medical devices connected to 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 devices, in which the safety of users depends on the internal power source, are equipped with a means of determining the state of the power source.

41. Active medical devices in which the safety of users depends on an external power source must include an alarm system to notify of power failure.

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

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

44. Active medical devices are designed and manufactured to provide a level of immunity to electromagnetic interference (immunity) that ensures they function as intended by the manufacturer.

45. Active medical devices are designed and manufactured in such a way as to minimize the risk of accidental injury to the user or third party electric shock 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 manufacturer's instructions.

10. Protection against mechanical and thermal risks

46. ​​Medical devices are designed and manufactured to protect the user and third parties from the risk of mechanical injury associated with resistance to movement, instability and the presence of moving parts within such medical devices.

47. Medical devices are designed and manufactured to minimize the risk associated with vibration caused by the medical devices by using means to limit vibration, unless vibration is part of the intended purpose of the medical devices.

48. Medical devices are designed and manufactured to minimize the risk associated with noise generated by means of noise abatement, unless the noise generated is part of the intended purpose of the medical device.

49. Terminals, connectors, 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 equipment or parts included in such medical products.

51. Open parts of medical devices (except for parts intended to supply heat or achieve specified temperatures) should not reach potentially dangerous temperatures under normal operating conditions.

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

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

53. Medical devices are equipped with means of preventing and (or) indicating any discrepancies in the supplied amount of energy or substance that may pose a danger.

54. The medical device shall clearly indicate the functions of the controls and indicators. If there are instructions for use, or an operating manual, or visual means of indicating the operating or adjustment parameters of a medical device, then such information must be understandable to the user.

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

55. Medical products 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 facilities available to such persons, so that medical devices perform in accordance with their intended purpose under the conditions objectively expected of such persons.

56. Medical products 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 during the use of medical products, as well as when interpreting test results.

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

13. Requirements for labeling of medical devices

58. The 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 full and abbreviated (if available) names legal entity, location (last name, first name, patronymic (if available) and place of residence individual, registered as an individual entrepreneur), postal address of the manufacturer, country of origin of the medical device. The manufacturer's mailing address may not be indicated on the labeling if it is contained in the instructions for use attached to the medical device.

Medical products manufactured in a state that is not a member of the Union may be subject to additional markings 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 the authorized representative of the manufacturer. Additional markings should not hide the markings containing information about the manufacturer of the medical device;

4) information about the presence of medicines or biological materials, as well as nanomaterials, in a medical product, if such nanomaterials are not contained in a bound state, excluding the possibility of their entering the user’s body when using the medical product for the intended purpose determined by the manufacturer;

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

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

7) year of manufacture of the medical device, unless the period before which the medical device can be safely used is not specified. The year of manufacture of the medical device is included in the batch number or serial number, provided that the year of manufacture is readily identifiable as part of such number;

8) information about special conditions of storage and (or) circulation of a medical device (if necessary);

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

10) a warning or precaution that is 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 about the one-time use of a medical device (if the medical device is intended for disposable);

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

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

14) information about the purpose of the medical product only for clinical trials for registration purposes;

15) information about the purpose of the medical product for exhibition or demonstration purposes only. In this case, the labeling requirements specified in subparagraphs 1-14 of this paragraph are not mandatory;

16) information about 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. If medical products or their components, intended for the introduction 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 with carcinogenic, mutagenic or toxic properties for reproductive function, or contain phthalates, then such medical devices are subject to special labeling. This special marking is applied to the medical device and its packaging or, if necessary, to the outer packaging used for storing and transporting the medical device.

60. Labeling of sterile and non-sterile medical devices must provide the ability to distinguish between identical or similar types of medical products put into circulation in sterile and non-sterile form, and be differentiated in such a way that the user can use the marking to distinguish a sterile medical product from a non-sterile one.

61. Marking must be applied to the medical device. If this is impossible or impractical, marking (partially or completely) may be applied to the packaging for each unit of the medical product, 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 barcodes.

63. Medical products that have passed the procedures established within the Union for registration and confirmation of compliance with the general requirements for the safety and effectiveness of medical products, 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 medical device circulation mark. market of the Union (hereinafter referred to as the special circulation mark).

Marking with a special circulation sign applied to a medical product is carried out using any technological method that ensures a clear and clear image of it throughout the entire service life (shelf life) of the medical product.

A special circulation mark is not applied to a medical product if this is technologically impossible or would pose a threat to the life and health of the user.

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

64. Instructions for use can be provided to the user on paper or in in electronic format both together with the medical device and separately from it, including by placing information on the screen that is part of the medical device. The chosen method of 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 how to:

1) viewing the instructions for use;

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

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

65. Instructions for use must contain the following information:

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

2) information about the manufacturer of the medical device 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 an individual registered as an individual entrepreneur ), postal address, telephone, fax numbers, email address (if available);

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

4) functional characteristics of the medical device;

5) summarized results of clinical trials conducted for the purpose of registration of 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 related to the use of a medical device for its intended purpose as determined by the manufacturer;

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

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

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

10) special requirements regarding 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 determined by the manufacturer, indicating the following information:

availability of consumable components of a medical device and the procedure for replacing them;

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

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

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

13) information on the procedure in case of violation of the sterile packaging of a 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 sterilization before use);

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

17) information on the nature, type, and (if necessary) intensity and distribution of radiation emitted by a medical device and methods of protecting users or third parties from unintentional radiation during the use of a 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 taken if necessary and restrictions when using a medical device), including:

warnings, precautions and (or) measures taken in the event of a malfunction of a medical device or deviations in its functioning that may affect the safety of the medical device;

warning, precautionary measures and (or) measures taken in the event of exposure to 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 factors such as external electromagnetic fields, electrostatic discharges, radiation, Atmosphere pressure and its changes, humidity and air temperature;

warnings, precautions and/or measures taken in the event of a foreseeable risk of electromagnetic interference created by a medical device during the conduct and evaluation of the results of specific diagnostic tests, therapeutic treatments or during its use (for example, electromagnetic radiation from a medical device affecting other equipment) ;

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

warnings, 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 contained in 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 device;

physical danger of a medical device;

19) information about the circumstances under which the user must consult a medical specialist (for medical devices intended for use by persons without medical education);

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

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

66. Instructions for use must be drawn up using terms understandable to the user and, if necessary, accompanied by pictures 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 product can be used safely and for the intended purpose determined by the manufacturer, without instructions for use.

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

IV. General requirements for safety and effectiveness 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 incompatibility of the materials, samples and (or) analytes used.

70. When designing, manufacturing and packaging in vitro diagnostic medical devices, the risk posed by contaminants and their residues for users and persons involved in the transportation, storage, maintenance and use of in vitro diagnostic medical devices (taking into account the intended purpose) should be minimized. 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 devices for in vitro diagnostics, the risks should be reduced:

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

2) associated with the unintentional entry of foreign substances into a medical device for in vitro diagnostics (taking into account the purpose determined by the manufacturer and the intended 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 in vitro diagnostic medical devices, the risk of infection to users and third parties must be eliminated or reduced to an acceptable level.

The design of the IVD medical device should ensure ease of handling and maintenance and, where necessary, minimize the risk of microbial leakage from the IVD medical device and/or microbial exposure during use, as well as prevent microbial contamination of the IVD medical device or sampling by a user or third party.

73. When designing, manufacturing and packaging medical devices for in vitro diagnostics having a special microbiological status in accordance with the labeling, it must be ensured that the microbiological status remains unchanged, subject to the conditions of transportation and storage defined by the manufacturer, until the protective the packaging will not be tampered with or opened.

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

75. In vitro diagnostic medical devices that require sterilization must be manufactured under controlled manufacturing 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 their handling 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 intended use of IVD medical devices or the destruction or inactivation process may reduce the effectiveness of the IVD medical device.

78. If in vitro diagnostic medical devices contain biological materials of human origin, 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 destruction or inactivation methods during the manufacturing process. These validated methods are not applicable to IVD medical devices if the activity of viruses and other infectious agents is due to the intended use of IVD medical devices or the destruction or inactivation process may reduce the effectiveness of IVD medical devices.

79. If medical devices 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 destruction or inactivation methods 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 intended use 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 conditions of exposure to external factors

80. Medical devices for in vitro diagnostics are designed and manufactured in such a way that their assembly, adjustment, calibration, use and maintenance under conditions of exposure to external factors can be 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 labeling and (or) in the instructions for use. When designing and manufacturing connection systems, possible risks of incorrect connections must be reduced as much as possible.

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

82. Medical devices 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 in vitro diagnostic medical device;

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 changes, humidity and air temperature;

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

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

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

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

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

83. In vitro diagnostic medical devices are designed and manufactured to eliminate or minimize the risk of fire 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 using 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 from the use of in vitro diagnostic medical devices.

5. Functional characteristics of medical devices for in vitro diagnostics

85. Medical devices 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 devices for in vitro diagnostics must function throughout their entire service life in accordance with the intended purpose determined by the manufacturer, in terms of:

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

b) # characteristics of clinical effectiveness: 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 devices for in vitro diagnostics depends on calibrators and (or) control materials, metrological traceability of their values ​​should be ensured by reference methods and (or) available higher-order reference materials.

87. Numerical values ​​of the results of studying samples of human biological materials obtained as part of in vitro diagnostics must be expressed in generally accepted and standardized units.

6. Radiation protection

88. In vitro diagnostic medical devices are designed, manufactured and packaged in such a way as to minimize exposure of users and third parties to potentially hazardous radiation.

89. In vitro diagnostic medical devices intended to generate potentially harmful radiation are designed and manufactured in such a way as to ensure control and (or) adjustment of the characteristics and amount of emitted radiation, and are equipped with visual and (or) audible means of warning of the presence (activity ) 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 stand-alone software, which is a medical product for in vitro diagnostics, are designed and manufactured in such a way as to ensure stable, reliable and efficient functioning of these medical products in accordance with their intended purpose, by a specific manufacturer.

8. Active in vitro diagnostic medical devices associated with or equipped with an energy source

91. Active medical devices for in vitro diagnostics, during the use of which the safety of users depends on the internal power source, are equipped with a means of determining the state of the power source.

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

93. In vitro diagnostic active medical devices are designed and manufactured to provide a level of immunity to electromagnetic interference (immunity) that ensures they function as intended 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 party, 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 manufacturer's instructions.

9. Protection against mechanical and thermal risks

95. In vitro diagnostic medical devices are designed and manufactured in such a way as to protect the user and third parties from the risk of mechanical injury associated with resistance to movement, instability and the presence of moving parts within such medical devices.

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

97. In vitro diagnostic medical devices are designed and manufactured to minimize the risk associated with vibration caused by the medical devices by using means to limit vibration, unless vibration is part of the intended purpose of the medical devices.

98. In vitro diagnostic medical devices are designed and manufactured in such a way as to reduce as much as possible the risks associated with noise generated by the use, where necessary, of means used to reduce noise.

99. Terminals, connectors, connectors and other devices for connecting in vitro diagnostic medical devices 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 equipment or parts included in such medical devices.

101. Open parts of medical devices for in vitro diagnostics (except for parts intended to supply heat or achieve specified temperatures) should not reach potentially hazardous temperatures under normal operating conditions.

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

102. In vitro diagnostic medical devices 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 determined by the manufacturer, taking into account the skills of the user and the operating conditions of the medical device.

103. In vitro diagnostic medical devices 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 error by a user who does not have special medical training when using such medical devices, as well as during sampling or interpretation test results.

104. In vitro diagnostic medical devices intended for self-testing by the user or for testing near the user must, if objectively possible, be capable of confirming that, when used, the medical devices will perform as intended by the manufacturer.

11. Additional requirements for 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, stipulating that the labeling of medical devices for in vitro diagnostics must contain the following information:

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

2) information about the net weight 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 a medical device for in vitro diagnostics;

4) a danger 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 device for in vitro diagnostics for self-testing by the user or for testing near the user (if available).

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

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

1) name and (or) trade name of the medical device for in vitro diagnostics;

2) information about the manufacturer of the medical device 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, email address (if available);

3) the purpose of the medical device for in vitro diagnostics, including:

functional purpose;

a description of what is being defined and/or measured;

a specific disorder, condition or risk factor for which the in vitro diagnostic medical device is intended to detect, define or differentiate (if necessary);

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

type of sample analyzed;

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

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

6) test principle;

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 package 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, temperature and humidity, lighting, etc.) and (or) user handling of the medical device in vitro;

11) information on 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 about the sterile state, the sterilization method and the procedure for action in case of violation of the sterile packaging (if the medical device for in vitro diagnostics is supplied in sterile form);

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

warnings, precautions and (or) measures taken in the event of failure or deviations in the functioning of a medical device for in vitro diagnostics, determined by external signs;

warnings, precautions and/or measures taken in relation to foreseeable external factors such as external electromagnetic fields, electrostatic discharges, radiation, atmospheric pressure and its changes, humidity and air temperature;

warnings, precautions and/or measures taken in the event of a foreseeable risk of electromagnetic interference created by an in vitro diagnostic medical device for other medical devices, equipment and communications;

a warning associated with materials contained in an in vitro diagnostic medical device that are carcinogenic, mutagenic or toxic, or lead to sensitization, an allergic reaction or adversely affect reproduction;

warnings, precautions and/or measures taken regarding potentially infectious material contained in an in vitro diagnostic medical device;

14) information about the purpose of the medical device for in vitro diagnostics for one-time use;

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

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

17) information on the conditions necessary for collecting, processing and preparing 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 preparation for use of a medical device for in vitro diagnostics;

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

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

methods to reduce risks associated with the installation, calibration or servicing of an in vitro diagnostic medical device;

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

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

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

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

25) biological reference interval if necessary;

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

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

infectious or microbial risks, including the potential for contamination of supplies 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 an in vitro diagnostic medical device intended for self-testing by the user or testing near the user, also the following information:

detailed information about the testing procedure (preparation of reagents, sample collection (preparation), order of execution and interpretation of test results);

information about test errors and the possibility of obtaining false positive or false negative test results, as well as regarding factors influencing the test result;

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

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

30) information about 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 product can be used safely and for the intended purpose determined 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 consumer's request, the manufacturer must provide additional copies of the instructions for use.

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

109. Compliance of a medical device with these General Requirements is ensured by fulfilling the requirements established by this document directly or by fulfilling 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 fully or partially ensured (hereinafter referred to as the list).

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

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

To include standards in the list, the authorized bodies of the Member States submit information to the Commission in the form according to 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 its 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. The specified form is filled out in accordance with the established procedure.

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

Appendix 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 a medical device with the requirements for the safety and effectiveness 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 effectiveness 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 Efficiency 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, is indicated, which is met when applying the section of the standard specified in Column 4 of this forms.

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

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 submitting 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 corresponding paragraph of the General requirements for the safety and effectiveness of medical products, requirements for their labeling and operational documentation for them, approved by the Decision of the Council of the Eurasian Economic Commission of February 12, 2016 No. 27 (hereinafter referred to as the General Requirements).

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

3. Column 3 shall indicate the method used to prove compliance of the medical device with the requirement specified in paragraph 1 of the General Requirements (for example, application of a standard, in-house testing using a standardized method, testing using an in-house test method, testing carried out by a third party, or another method).

4. Column 4 indicates the details of the regulatory document for the method used to prove the compliance of a medical device with the requirement specified in paragraph 1 of the General Requirements.

5. Column 5 indicates the details of documents confirming the compliance of the medical device with the requirement specified in paragraph 1 of the General Requirements (test reports, certificates, declarations of conformity, reports on studies, other documents).

6. Column 6 indicates the conclusion about the compliance or non-compliance of the medical device with the General Requirements.

Document overview

General requirements for the safety and effectiveness of medical products released 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 a medical device with established requirements is ensured by their implementation directly or by compliance with the requirements of standards, as a result of voluntary application of which the compliance of the medical device with general requirements is ensured. To confirm the compliance of a medical device with the established requirements, the manufacturer (its authorized representative) must submit information on compliance with general requirements to the authorized body of the EAE member state. The information submission form and instructions for filling it out are provided.

The decision comes into force no 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 effective use of the product. Proper labeling is extremely important for several reasons. Thus, failure to comply with the requirements may lead to stopping/suspension customs clearance goods, loss of VAT preferences. Since regulatory authorities primarily pay attention to the information that accompanies the product, incorrect execution of this can lead to various consequences, including suspension of the certificate of state registration of the product. And at the stage of its circulation on the market, failure to comply with labeling requirements can lead to improper use 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.

The main difficulty in this issue is 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 recommended to be displayed on the label of a medical device, and how to correctly develop labeling taking into account all laws, regulations, and relevant regulations. In addition, the stages of approval of a marking sample will be covered.

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

At the stage of registration of medical devices during 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, regulations of the Cabinet of Ministers of Ukraine and standards. Among them there are documents that are mandatory:

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

Non-binding regulatory acts:

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

Non-binding regulations contain advisory requirements that become mandatory for specific products after the manufacturer declares their compliance.

The most important requirements

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

Thus, it is necessary to ensure that the information on the label fully corresponds to 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, as well as the catalog number, if one is indicated. It is important to pay attention to this aspect at the stage of state registration of products, when preparing an application, as well as an appendix 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 talks about the consumer’s right to information about products, namely:

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

2) on the name of regulatory documents, the requirements of which domestic products must meet;

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

5) about the date of manufacture;

6) about storage conditions;

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

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

9) about the shelf life of the product, the necessary actions of the consumer after its expiration, as well as possible consequences in case of failure to perform these actions;

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

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

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

Moreover, during wholesale and retail trade It is also necessary to note information about 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 limited access. Full details should be provided regarding the risks and adverse events associated with the use of the products. In addition, warnings must be given.

Thus, the specified information (adjusted for applicability to a specific medical device) must be brought to the attention of the consumer on the label and 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 state language policy”, labeling of goods, instructions for their use, and the like are carried out in the state language and the regional or minority language. By decision of product manufacturers, 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 presented in Ukrainian

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

During the state registration of a medical device, at the stage of technical examination, general requirements for labeling are agreed upon by approving a sample package. 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, after which the marking sample is certified as an integral part of the technical examination protocol. This, in essence, equates to declaring the use of approved symbols on the labeling of the relevant products when they are circulated on the Ukrainian market, and the use of such symbols becomes mandatory (Table 1).

Graphic symbol	Its meaning and explanation
	DO NOT reuse
	USE UNTIL - This symbol is followed by a date, which consists of a four-digit year, two-digit month, and, optionally, two-digit day. The date must appear next to or below the symbol, or to the right of it
	BATCH CODE - this symbol is accompanied by the manufacturer's batch code
	REGISTRATION NUMBER - This symbol is accompanied by the product serial number, which must appear after or below the symbol
	DATE OF MANUFACTURE - For active implantable medical devices, the symbol will be combined with the date, marked by four digits of the year and two digits of the month. For active products, the symbol must be accompanied 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 located after or below the symbol adjacent to it
	WARNING! READ ACCOMPANYING DOCUMENTS - may also be synonymous with the “Attention, see instructions for use” symbol
	MANUFACTURER - this symbol must be accompanied by the name and address of the manufacturer responsible for the product, which must be marked after or below the symbol
	AUTHORIZED REPRESENTATIVE IN THE EUROPEAN UNION - this symbol must be accompanied by the name and address of the authorized representative in the European Union
	CONTAINS ENOUGH FOR (n-)RESEARCH
	ONLY FOR EVALUATING THE PERFORMANCE OF A MEDICAL DEVICE FOR LABORATORY DIAGNOSTICS IN VITRO
	MEDICAL DEVICE FOR DIAGNOSTICS IN VITRO
	TEMPERATURE LIMIT Can only be used with upper or lower temperature limit indication
	READ THE INSTRUCTIONS FOR USE
	BIOLOGICAL RISKS

It is important to pay attention to the fact that national legislation provides for the inclusion in this standard of a mandatory addition 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 regulatory 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 product. This symbol must be accompanied by the registration number of the state registration certificate and the date of its issue. The registration number of the certificate must be located after the symbol, and the date - below the symbol."

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

In addition, if during the technical examination a marking sample was approved using 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 the goods. Thus, the name of the country of origin of the product, if it differs from the manufacturer’s marking, must certainly be indicated on the label and packaging (Fig. 3)

Please note that the terms “manufacturer” and “country of origin” are not identical. According to European directives, a manufacturer is a company (person) that accepts responsibility for the development, production, packaging and labeling of a product before placing it on the market (EU), regardless of whether these operations are carried out in-house or by a third party. And the country of origin can be determined on the basis of significant processing or the national share in the value of the product. Therefore, for example, a company from Germany can place a product on the EU market and indicate itself as a manufacturer, and the country of origin can be China.

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

Indication of the country of origin of the medical device is mandatory

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 companies that have provided the relevant documents and appear on the label (with names and addresses), but also those that are indicated in the noted countries of origin on the same product label.

Other aspects of medical device labeling

The marking of products with a registered trademark is regulated and involves 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 attached to the product, as well as that the storage of such goods must be carried out with the indicated sign. The law mentioned above also defines: “The owner of the certificate has the right to affix a warning mark next to the sign, which indicates that this mark is registered in Ukraine.”

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

If during the technical examination a marking sample using symbols in accordance with GSTU EN 980:2007 was approved, their use becomes mandatory

Requirements for the font size of 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 markings, is its display in an accessible, visual form. Therefore, the font (size and type), the form of information presentation should be easily accessible to 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 to a product has the following priority scheme: the priority right belongs to the owner of the trademark, then to the manufacturer, then to the supplier. According to clause 5 of the Regulations on bar coding of goods, it does not contain information regarding the mandatory application of a bar code specifically to medical products: “Mandatory marking with GS1 bar codes is subject to alcoholic drinks and tobacco products, copies of audiovisual works and phonograms, medicines and other goods, the marking of which with bar codes is provided for by the legislation of Ukraine.” Thus, not a single specialized regulatory act regulates the mandatory use of a barcode, therefore it can be applied at the request of the owner, according to the above procedure. The barcode can be applied in a linear or two-dimensional manner.

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

It should also be noted that the EN 980:2007 standard in most European countries has lost force since 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). They can already be seen on imported medical products today.

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

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

Maxim Bagreev,
company "Cratia"

Decision of the Council of the Eurasian Economic Commission dated 02.12.2016 N 27 "On approval of the General requirements for the safety and effectiveness of medical devices, requirements for their labeling and operational documentation for them"

13. Requirements for labeling of medical devices

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

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

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 mailing address may not be indicated on the labeling if it is contained in the instructions for use attached to the medical device.

Medical products manufactured in a state that is not a member of the Union may be subject to additional markings 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 the authorized representative of the manufacturer. Additional markings should not hide the markings containing information about the manufacturer of the medical device;

4) information about the presence of medicines or biological materials, as well as nanomaterials, in a medical product, if such nanomaterials are not contained in a bound state, excluding the possibility of their entering the user’s body when using the medical product for the intended purpose determined by the manufacturer;

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

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

7) year of manufacture of the medical device, unless the period before which the medical device can be safely used is not specified. The year of manufacture of the medical device is included in the batch number or serial number, provided that the year of manufacture is readily identifiable as part of such number;

8) information about special conditions of storage and (or) circulation of a medical device (if necessary);

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

10) a warning or precaution that is 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 about the single-use use of a medical device (if the medical device is intended for single use);

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

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

14) information about the purpose of the medical product only for clinical trials for registration purposes;

15) information about the purpose of the medical product for exhibition or demonstration purposes only. In this case, the labeling requirements specified in subparagraphs 1 of this paragraph are not mandatory;

16) information about the inactivation of possible viruses and other infectious agents in a medical product, printed in the form of the inscription “antibodies to HIV 1, 2 and hepatitis C viruses and HBsAg are absent” (if the medical product contains human blood serum (plasma) or elements human tissue).

59. If medical products or their components, intended for the introduction 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 with carcinogenic, mutagenic or toxic properties for reproductive function, or contain phthalates, then such medical devices are subject to special labeling. This special marking is applied to the medical device and its packaging or, if necessary, to the outer packaging used for storing and transporting the medical device.

60. Labeling of sterile and non-sterile medical devices must provide the ability to distinguish between identical or similar types of medical products put into circulation in sterile and non-sterile form, and be differentiated in such a way that the user can use the marking to distinguish a sterile medical product from a non-sterile one.

Dear Alexander.

Decision of the Customs Union Commission dated May 28, 2010 No. 299
On the application of sanitary measures in the customs union

Section 18. Requirements for medical products and medical equipment

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

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

The marking is applied directly to the product and/or packaging. For a product put into circulation in sterile form, the marking must also be applied to the sterile packaging. Marking is not applied to the product if it is too small in size, or if its specific properties do not allow this.

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

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

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

The marking applied to the packaging of the product must contain: the name of the country of origin, the name, legal address and trademark of the manufacturer, the name of the product, the regulatory document whose requirements the product meets, dimensions, weight (if necessary), methods of caring for the product, year of manufacture (for BMI), expiration date or expiration date (for medical device), circulation mark, other information in accordance with the manufacturer’s documentation.

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

Labeling must be in Russian. Additional use of other languages ​​is permitted.

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

The labeling indicates all the necessary information to ensure the safe operation of the product: its main technical characteristics, warning labels, danger signs (magnetic, laser or others for medical devices; information about the materials from which medical devices are made, etc.), requirements for the need use of personal protective equipment, safe distances or permissible duration of operation, etc. for BMI.

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

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

The manufacturer must provide information so that appropriate precautions can be taken and all hazards can be adequately controlled using a full range of protective measures.

The user of a BMI characterized by a high potential health hazard (UV devices, laser products, etc.) must be warned about the existing risk. The dangers of the products are indicated accordingly. The use of medical equipment products intended for the population at home must be carried out as prescribed by a doctor, in accordance with medical recommendations.

UV devices are marked with a warning inscription: “ATTENTION! UV radiation can cause damage to the eyes and skin. Please read the instructions carefully. Wear the supplied safety glasses." For UV devices intended for use in beauty salons and similar places, warning notices may be provided on a poster permanently affixed in the vicinity of the UV device.

UV devices whose brightness exceeds 100,000 cd/m2 are marked with the warning inscription: “Powerful light. Don't look at the emitter."

UV irradiation installations intended for operation in the absence of people are marked with an appropriate warning label.

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

The “Safety Requirements” sections of the operational documentation include the basic requirements for ensuring the safe operation of products, as well as for their production in accordance with the main documents of sanitary legislation with links to these documents, including: the production equipment used and the levels of harmful factors in the workplace , means of collective and individual protection, labor regimes, carrying out PMO of workers and production control (if necessary). This section must indicate that the products must be safe during production and use and must have a formalized sanitary and epidemiological certificate.