Decision of the Board of the Eurasian Economic Commission dated February 12, 2016 No. 27
«On the Approval of General Requirements for the Safety and Effectiveness of Medical Devices, as well as Requirements for Their Labeling and Operating Documentation»

COUNCIL OF THE EURASIAN ECONOMIC COMMISSION

DECISION

dated February 12, 2016. N 27

ON THE APPROVAL OF GENERAL REQUIREMENTS

SAFETY AND EFFICACY OF MEDICAL DEVICES,

REQUIREMENTS FOR THEIR LABELING AND OPERATIONAL

DOCUMENTATION ON THEM

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 paragraph 4 of Article 7 of and the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices (Medical Devices and Medical Equipment) within the Eurasian Economic Union of December 23, 2014, paragraphs 104, 108 and 109 of Annex N 1 to the Regulations of the Eurasian Economic Commission, approved by the Decision of the Supreme Eurasian Economic Council of December 23, 2014. N 98, and Decision of the Supreme Eurasian Economic Council of December 23, 2014 N 109 «On the implementation of the Agreement on common principles and rules of circulation of medical devices (medical devices and medical equipment) within the Eurasian Economic Union» the Council of the Eurasian Economic Commission decided:

1. To approve the attached General requirements for safety and effectiveness of medical devices, requirements to their labeling and operational documentation for them.

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

From the Republic of BelarusV.MATYUSHEVSKY

From the Republic of KazakhstanB. SAGINTAEV

From the Kyrgyz RepublicO. PANKRATOV

From the Russian FederationI. SHUVALOV

Approved

by decision of the Board

of the Eurasian Economic Commission

dated February 12, 2016 No. 27

GENERAL REQUIREMENTS

THE SAFETY AND EFFICACY OF MEDICAL DEVICES,

REQUIREMENTS TO THEIR LABELING AND OPERATIONAL

DOCUMENTATION ON THEM

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 Uniform Principles and Rules for the Circulation of Medical Devices (Medical Devices and Medical Equipment) within the Eurasian Economic Union of December 23, 2014 and establish general requirements for the safety and effectiveness of medical devices, as well as requirements for labeling and operational documentation for medical devices,

2. For the purposes of these General Requirements, the terms used shall mean the following:

«active medical devices» means medical devices used alone or in combination with other medical devices that require the use of non-human energy or gravity for their action.

Medical devices designed to transfer energy or substances from an active medical device to the user without substantially altering them are not active medical devices. Stand-alone software is considered an active medical device;

«medical device safety» — the absence of unacceptable risk associated with 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 of a medical device, which may include, but is not limited to, an instruction manual, methodology for medical use, passport, form, instructions for installation, adjustment, maintenance, repair, transportation, storage, disposal of the medical device;

«medical devices for in vitro diagnostics» means any instruments, apparatus, devices, equipment, materials, reagents, calibrators, control materials and other products used for medical purposes separately or in combination with each other, as well as together with accessories necessary for the use of these products for their intended purpose (including special software), and intended by the manufacturer for use in in vitro testing of samples of human biological materials to obtain information on the physiological condition of the human body.

«adverse event (incident)» — any malfunction and (or) deterioration of characteristics or malfunction of a medical device, or insufficiency or incorrectness of accompanying information (documentation) for a medical device, or side effect not specified in the instructions for use, which directly or indirectly resulted or could have resulted in death or serious deterioration of health status of users or third parties (whereby serious deterioration of health status means a life-threatening illness, permanent loss of body function or

«adverse event» means any undesirable medical event, unpredictable illness or injury, or undesirable clinical signs (including abnormal laboratory values) in users or third parties related to the use of a medical device;

«user» means a patient, medical professional, or any other individual who uses a medical device for the intended purpose specified by the manufacturer;

«medical device efficacy» means the ability of a medical device to fulfill its intended purpose as defined by the manufacturer.

II. General safety and effectiveness requirements,

applicable to all medical devices

(3) Medical devices shall be designed and manufactured so that, when used under conditions and for purposes consistent with their intended use as defined by the manufacturer, and where necessary taking into account the technical knowledge, experience, education or specialized training, clinical and physical condition of the user, they perform as intended by the manufacturer and are safe for the user and third parties, provided that the risk associated with their use is acceptable when weighed against the benefit to the user.

It is not allowed to limit the interchangeability of medical devices through the use of special technical or software tools or by other means.

4. Decisions made by the manufacturer in the design and manufacture of a medical device shall be consistent with safety principles, taking into account the generally recognized state of knowledge. Where necessary, the manufacturer shall manage risks in such a way that the residual risk associated with any hazard is acceptable. The manufacturer shall be 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 and foreseeable misuse of the medical device;

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

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

informing users of all residual risks.

5. Medical devices are designed, manufactured and packaged so that their performance and effectiveness are not compromised during transportation and storage in accordance with the instructions for use.

6. Medical devices shall be effective in the manner intended by the manufacturer and shall be designed and constructed so that under normal conditions of use they are fit for the intended use as defined by the manufacturer.

7 The performance 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 lifetime defined by the manufacturer, provided that the medical device is exposed to the effects that may occur under normal conditions of use and maintenance is carried out in accordance with the instructions for use.

8. All known and anticipated risks arising from the use of the medical device and any undesirable effects of such use shall be minimized and shall be acceptable when weighed against the benefit to users derived from the manufacturer’s intended action of the medical device under normal conditions of use.

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

10. The medium, format, content and arrangement of the information shall be appropriate to the medical device, its intended use and the technical knowledge, experience, education or training of the users.

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

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

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

III. General safety and effectiveness requirements, applicable to medical devices, with the exception of medical devices for in vitro diagnostics

1. chemical, physical and biological properties medical devices

12. In the design and manufacture of medical devices, special attention shall be paid to:

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

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

3) selection of materials to be used, taking into account such parameters as hardness, wear resistance and fatigue resistance.

13. The design, manufacture and packaging of medical devices shall minimize the risk posed by contaminants and their residues to users and persons involved in the transportation, storage and maintenance of medical devices (taking into account the purpose of the medical device and the duration and frequency of human exposure to these substances).

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

15. In the design and manufacture of medical devices, risks must be minimized as much as possible :

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

2) related to unintentional introduction of foreign substances into the medical device (taking into account the purpose defined by the manufacturer and the expected conditions of use of the medical device).

2. infectious and microbial contamination of medical devices

16. The manufacture of the medical device shall eliminate or reduce to an acceptable level the risk of infection of users and third parties. The design of the medical device shall ensure ease of use and maintenance and, if necessary, minimize the risk of any microbial leakage from the medical device and/or microbial exposure during use, and 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 according to the labeling, it must be guaranteed that the microbiological status remains unchanged under the transportation and storage conditions specified by the manufacturer as long as the protective packaging is not disturbed or opened.

18. In the design, manufacture and packaging of medical devices supplied in sterile condition, their sterility shall be guaranteed under the transportation and storage conditions specified by the manufacturer until the protective packaging is broken or opened. Such medical devices shall be packed in disposable packaging.

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

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

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

3. medical devices containing the substance, medicinal product

22. Where medical devices contain a substance which, when used independently, may be considered a medicinal product in accordance with Article 1, paragraph 1 of the Agreement on Uniform Principles and Rules for the Circulation of Medicines within the Eurasian Economic Union of December 23, 2014, and which has an additional effect on the human body along with the effect of medical devices, confirmation of the safety and effectiveness of such medical devices shall include confirmation of the safety and ee

4. Medical devices containing materials biological

23. If medical devices contain biological materials of animals, the animals used for these purposes shall be subject to veterinary control (supervision), according to the results of which they shall be recognized as healthy, taking into account the purpose of the biological materials used. An animal shall be recognized as healthy in the absence of diseases that may affect the safety and efficacy of a medical device.

Information of 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 shall be kept in the authorized body of a Member State of the Union in the field of health care (hereinafter referred to as the authorized body of a Member State).

The processing, storage, testing and handling of biological materials of animal origin should ensure the safety of users and third parties. In particular, safety with respect to viruses, other infectious agents and other pathogens common to humans and animals should be ensured through the application of validated methods of destruction or inactivation during the production process.

24. Where medical devices contain biological materials of human origin, the selection of donors and the processing, storage, testing and handling of biological materials of human origin shall be carried out in accordance with the legislation of the Member States of the Union and shall ensure optimum safety for users and third parties. In particular, safety with regard to viruses and other infectious agents shall be ensured through the application of validated methods of destruction or inactivation during the production process.

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

5. Medical devices used in exposure environments external factors

26. Medical devices shall be designed and manufactured so that their assembly, adjustment, calibration, use and maintenance under conditions of exposure to external factors are carried out safely and ensure the expected effectiveness of the medical application.

27. If medical devices are intended for use in combination with other medical devices and (or) equipment, the entire combination, including the connection system, must be safe and must not impair the declared functional characteristics of medical devices. Any known limitations on the use of such a combination shall be indicated on the labeling and/or in the instructions for use. The design and manufacture of connection systems shall minimize possible risks of incorrect connection as much as possible.

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

28. Medical devices are designed and manufactured to eliminate or reduce to an acceptable level:

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

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

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

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

5) risk associated with possible negative interactions between medical device software and the environment in which it is operated;

6) risk of accidental ingestion of foreign substances into medical devices;

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

8) risk arising from the inability to maintain or calibrate medical devices (e.g. for implants), due to aging of the materials used or loss of accuracy of the measuring or monitoring device.

29. Medical devices shall be designed and manufactured to eliminate or minimize the risk of ignition or explosion under normal conditions of use or in the event of a single failure. Particular attention shall be paid to medical devices used with flammable or explosive substances.

30. Medical devices shall be designed and manufactured to facilitate the safe disposal of waste generated after the use of medical devices.

6. Medical devices related to measuring instruments

31. Medical devices included in the list of medical devices related to measuring instruments subject to testing for type approval of measuring instruments shall be designed and manufactured in such a way as to ensure sufficient accuracy, precision and stability taking into account the intended use of the medical device.

32. Measuring, control or indicator scales shall be designed according to ergonomic principles, taking into account the intended use of the medical device.

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

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

7. Protection against radiation

34. Medical devices shall be designed, manufactured and packaged so as to minimize the exposure of users and third parties to radiation without reducing the specified radiation levels necessary to achieve diagnostic and therapeutic purposes.

35. In medical devices intended to generate dangerous or potentially dangerous radiations necessary to achieve specific medical purposes, where the benefit from the use of these high-intensity radiations is considered to be greater in relation to the danger inherent in the radiation, it shall be possible to control these radiations on the part of the user. The design and manufacture of such medical devices shall ensure the reproducibility of the variable parameters of the generated radiation within acceptable limits.

Medical devices designed to generate dangerous visible and (or) invisible radiation shall be equipped with visual and (or) audible means of warning about the presence (activity) of such radiation.

36. The design and manufacture of medical devices should minimize as far as possible exposure to unintentionally generated incidental or scattered radiation.

37. In the design and manufacture of medical devices intended to generate ionizing radiation, the regulation of quantitative and geometric indicators of the generated radiation shall be ensured, taking into account the purpose defined by the manufacturer.

Medical devices generating ionizing radiation and intended for radiological diagnostics shall be designed and manufactured in such a way that at minimal exposure of the user to radiation the quality of images and (or) research results necessary for diagnostics is ensured.

Medical devices that generate ionizing radiation and are intended for radiological therapy shall be designed and manufactured so as to control and manage the dose, type, energy and, if necessary, the energy distribution of the directed radiation.

8. Medical devices, including software, and stand-alone software medical device software

38. Medical devices that include software and stand-alone software that is a medical device shall be designed and manufactured to ensure the stable, reliable and efficient functioning of these medical devices in accordance with the intended purpose defined by the manufacturer.

9. Active source-related medical devices of energy 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 that depend on an internal power supply for user safety shall be equipped with a means of determining the status of the power supply.

41. Active medical devices where the safety of users depends on an external power supply must include an alarm system to alert them to a power failure.

42. Active medical devices designed to monitor one or more of the user’s clinical parameters shall be equipped with appropriate alarm systems to alert the user to the occurrence of a situation that could lead to death or serious impairment of the user’s 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 may adversely affect the operation of other medical devices, equipment and means of communication in accordance with their intended use.

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

45. Active medical devices are designed and manufactured to minimize the risk of accidental electric shock to the user or a third party, both under normal conditions of use of the medical device and under conditions of a single fault, 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 shall be 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 as part of such medical devices.

47. Medical devices shall be designed and manufactured so as to minimize the risk associated with vibration generated by those medical devices by using means to limit vibration, unless vibration is part of the intended use of the medical device.

48. Medical devices shall be designed and manufactured in such a way as to minimize the risk associated with the noise generated by the application of means used to reduce noise, 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 electrical, hydraulic or pneumatic power sources shall be designed and manufactured to minimize any possible risks.

50. Medical devices are designed and manufactured to minimize the risk of errors resulting from improper connection or switching during operation of hardware or parts within such medical devices.

51. The exposed parts of medical devices (except for parts intended to supply heat or to reach setpoint temperatures) must not reach potentially hazardous temperatures under normal conditions of use.

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

52. Medical devices intended to deliver energy or substances to the user shall be designed and manufactured so that the amount of energy or substance delivered can be set and maintained accurately enough to ensure the safety of the user.

53. Medical devices shall be equipped with means of preventing and/or indicating any discrepancy in the delivered amount of energy or substance that may pose a hazard.

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

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

55. Medical devices intended by the manufacturer for use by users without specialized medical training shall be designed and manufactured taking into account the skills and facilities available to such persons, so that the medical devices function in accordance with their intended use under conditions of objectively expected actions on the part of such persons.

56. Medical devices intended for use by users without specialized medical training are designed and manufactured in such a way as to minimize the risk of error in the process of use of medical devices, as well as in the interpretation of test results.

57. Medical devices intended for use by users without specialized medical training should have, if objectively possible, the function of confirming that, when used, these medical devices will function in accordance with the purpose defined by the manufacturer.

13. Requirements for labeling of medical devices

58. The medical device labeling shall contain the following information:

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

2) information necessary for identification of the medical device, as well as information on its purpose (if necessary);

3) information on the manufacturer, including full and abbreviated (if any) name of the legal entity, location (surname, name, patronymic (if any) and place of residence of a natural person registered as an individual entrepreneur), postal address of the manufacturer, country of origin of the medical device. The manufacturer’s postal address may not be indicated in the labeling, if it is contained in the instructions for use attached to the medical device.

Medical devices manufactured in a state that is not a member of the Union may bear additional marking containing information on the authorized representative of the foreign manufacturer, including full and abbreviated (if any) name of the legal entity, location (surname, name, patronymic (if any) and place of residence of an individual registered as an individual entrepreneur), postal address of the manufacturer’s authorized representative. Additional marking shall not conceal the marking containing information on the manufacturer of the medical device;

4) information on the presence of drugs or biological materials or nanomaterials in the medical device, unless such nanomaterials are contained in a bound state that excludes the possibility of their entry into the user’s body when the medical device is used for the purpose specified by the manufacturer;

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

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

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

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

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

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

11) information on single use of the medical device (if the medical device is intended for single use);

12) information on the reconditioning of the medical device, indicating the number of reconditioning cycles performed and any limitations on the number of reconditioning cycles (if the single-use medical device is reconditioned);

13) information on the manufacturing of a medical device customized by the user exclusively for personal use in accordance with the prescription of a medical specialist issued in writing;

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

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

16) information on inactivation of possible viruses and other infectious agents in the medical device, applied in the form of inscription «no antibodies to HIV 1, 2 and hepatitis C and HBsAg viruses» (if the medical device has human blood serum (plasma) or human tissue elements in its composition).

59. If medical devices or their components intended for the administration into and excretion from the human body of medicines, body fluids or other substances, or for the transportation and storage of such medicines, fluids or substances, contain harmful substances with carcinogenic, mutagenic or reproductive toxicity properties depending on their concentration, or contain phthalates, such medical devices shall be subject to special marking. This special marking shall be applied to the medical device and its packaging or, if necessary, to the outer packaging used for storage and transportation of the medical device.

60. Labeling of sterile and non-sterile medical devices shall ensure the possibility of distinguishing identical or similar types of medical devices released into circulation in sterile and non-sterile form, and shall be distinguished in such a way that the user can distinguish a sterile medical device from a non-sterile one by means of labeling.

61. Labeling must be applied to the medical device. If it is impossible or impractical, the labeling (partially or completely) may be applied on the package for each unit of the medical device, and (or) on the group package, and (or) on the instructions for use.

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

63. Medical devices that have passed the procedures of registration and confirmation of compliance with the general requirements for safety and effectiveness of medical devices, requirements for implementation and maintenance of the quality management system for medical devices established within the Union shall be subject to mandatory marking with a special mark of medical device circulation on the market of the Union (hereinafter — special mark of circulation) before release into circulation within the Union.

Labeling with a special circulation mark applied to a medical device shall be performed by any technological method ensuring its clear and distinct image during the entire service life (shelf life) of the medical device.

The special handling mark shall not be applied to a medical device if it is technologically impossible or would endanger the life and health of the user.

14. Requirements to the information contained in the instruction on the use of a medical device

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

1) reviewing the instructions for use;

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

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

65. The instructions for use shall contain the following information:

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

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

3) the intended use of the medical device, specifying the user (e.g., patient, medical professional, individual using the medical device for the purpose specified by the manufacturer);

4) functional characteristics of the medical device;

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

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

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

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

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

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

11) information necessary to verify that the medical device is properly installed and ready for safe operation for the intended purpose specified by the manufacturer, specifying the following information:

content and frequency of maintenance, including cleaning and disinfection of the medical device;

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

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

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

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

13) information on the procedure to be followed in case the sterile packaging of the medical device is broken 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 with indication of the need to sterilize it before use);

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

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

17) information on the nature, type, as well as (if necessary) intensity and distribution of radiation emitted by the medical device and methods of protection of users or third parties from unintentional radiation during the use of the medical device (if the medical device generates dangerous or potentially dangerous level of radiation for medical purposes);

18) information for users (warnings, precautions, measures taken when necessary and restrictions in the use of the medical device), including:

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

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

warning, precautions and/or measures taken in case of foreseeable risk of electromagnetic interference caused by the medical device in the performance and evaluation of specific diagnostic tests, therapeutic treatments or in its use (e.g. electromagnetic radiation from the medical device affecting other equipment);

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

Warnings, precautions, and/or restrictions related to drugs or biological materials that are part of a medical device;

A warning related to carcinogenic, mutagenic or toxic materials in a medical device, the possible release or leaching of which leads to sensitization, allergic reaction or adversely affects reproduction;

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

The infectious or microbial hazard of the medical device;

the environmental hazards of the medical device;

The physical danger of a medical device;

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

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

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

66. The instructions for use must be written in terms that the user can understand and, if necessary, be accompanied by drawings and diagrams.

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

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

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

IV. General safety and effectiveness requirements, applied to in vitro diagnostic medical devices

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

69. In the design and manufacture of 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. The design, manufacture and packaging of in vitro diagnostic medical devices shall minimize the risk posed by contaminants and their residues to users and persons involved in the transportation, storage, maintenance and use of in vitro diagnostic medical devices (taking into account the intended use of the in vitro diagnostic medical device and the duration and frequency of human exposure to these substances).

71. The design and manufacture of medical devices for in vitro diagnostics shall mitigate risks:

1) associated with hazardous and (or) harmful substances that may leach or leak from an in vitro diagnostic medical device (taking into account their sensitizing effect, carcinogenicity, mutagenicity or adverse effect on reproduction);

2) related to unintentional ingestion of foreign substances into the in vitro diagnostic medical device (taking into account the purpose defined by the manufacturer and the intended conditions of use of the in vitro diagnostic medical device).

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

72. In the design and manufacture of medical devices for in vitro diagnostics, the risk of infection of users and third parties shall be eliminated or reduced to an acceptable level.

The design of the in vitro diagnostic medical device should ensure ease of handling and maintenance and, where appropriate, minimize the risk of microbial leakage from the in vitro diagnostic medical device and/or microbial exposure during use, and prevent microbial contamination of the in vitro diagnostic medical device or sample by the user or a third party.

73. In the design, manufacture and packaging of in vitro diagnostic medical devices having a special microbiological status according to the labeling, it shall be ensured that the microbiological status remains unchanged under the transport and storage conditions specified by the manufacturer as long as the protective packaging is not disturbed or opened.

74. Sterile medical devices for in vitro diagnostics or medical devices for in vitro diagnostics with special microbiological status shall be manufactured, processed and, if necessary, sterilized using validated methods, equipment, processes.

75. In vitro diagnostic medical devices requiring sterilization shall be manufactured under controlled production conditions.

76. The packaging of non-sterile in vitro diagnostic medical devices shall ensure their integrity and cleanliness and, where the in vitro diagnostic medical device is to be sterilized before use, shall minimize the risk of microbial contamination to the extent possible, and the packaging shall be compatible with the sterilization method specified by the manufacturer.

3. in vitro diagnostic medical devices containing biological materials

77. Where in vitro diagnostic medical devices contain animal biological materials, the processing, storage, testing and handling of animal biological materials shall 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 shall be ensured through the application of validated methods of destruction or inactivation during the manufacturing process. These validated methods shall not be applied to in vitro diagnostic medical devices if the activity of viruses and other infectious agents is due to the intended use of the in vitro diagnostic medical device or if the destruction or inactivation process may reduce the efficacy of the in vitro diagnostic medical device.

78. Where in vitro diagnostic medical devices contain biological materials of human origin, the processing, storage, testing and handling of biological materials of human origin shall be carried out in such a way as to ensure the safety of users and third parties.

Safety with respect to viruses and other infectious agents shall be ensured through the application of validated methods of destruction or inactivation during the manufacturing process. These validated methods shall not be applied to in vitro diagnostic medical devices if the activity of viruses and other infectious agents is due to the intended use of the in vitro diagnostic medical devices or the destruction or inactivation process may reduce the efficacy of the in vitro diagnostic medical devices.

79. Where in vitro diagnostic medical devices contain biological materials of microbial origin, the handling, storage, testing and processing of biological materials of this nature shall be carried out in such a way as to ensure the safety of users and third parties.

Safety with respect to viruses and other infectious agents shall be ensured through the application of validated methods of destruction or inactivation during the manufacturing process. These validated methods shall not be applied to in vitro diagnostic medical devices if the activity of viruses and other infectious agents is due to the intended use of the in vitro diagnostic medical device or if the destruction or inactivation process may reduce the efficacy of the in vitro diagnostic medical device.

4. Medical devices for in vitro diagnostics, used in environments exposed to external factors

80. In vitro diagnostic medical devices are designed and manufactured so that they can be assembled, adjusted, calibrated, used and maintained safely under conditions of exposure to external factors.

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

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

82. In vitro diagnostic medical devices are designed and manufactured to eliminate or reduce to an acceptable level:

1) 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 in the use of a medical device for in vitro diagnostics due to design characteristics or human error;

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

(5) the risk associated with possible adverse interactions between the software of an in vitro diagnostic medical device and the environment in which it is operated;

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

7) risk of misidentification of samples as part of in vitro diagnostics;

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

83. In vitro diagnostic medical devices shall be designed and manufactured to eliminate or minimize the risk of ignition or explosion under normal conditions of use or in the event of a single failure. Particular attention shall be paid to in vitro diagnostic medical devices used with flammable or explosive substances.

84. In vitro diagnostic medical devices shall be designed and manufactured to facilitate the safe disposal of waste generated after the use of in vitro diagnostic medical devices.

5. Functional characteristics of medical devices for in vitro diagnostics

85. In vitro diagnostic medical devices shall be designed and manufactured so that their functional performance is based on an appropriate scientific and technical basis. In vitro diagnostic medical devices shall function throughout their life cycle in accordance with their intended use as defined by the manufacturer, in part:

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

b) characteristics of clinical efficacy: diagnostic sensitivity, diagnostic specificity, predictive value of positive and negative results, likelihood ratio, expected values in normal or selected population.

86. Where the performance 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 examination of samples of human biological materials obtained within the framework of in vitro diagnostics shall be expressed in generally accepted and standardized units.

6. Protection against radiation

88. In vitro diagnostic medical devices shall be designed, manufactured and packaged so as to minimize the exposure of users and third parties to potentially harmful radiation.

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

7. Medical devices for in vitro diagnostics, which include software, and stand-alone Software that is a medical device for in vitro diagnostics

90. In vitro diagnostic medical devices comprising software, and stand-alone software that is an in vitro diagnostic medical device, are designed and manufactured to ensure stable, reliable, and efficient operation of these medical devices in accordance with the intended use as defined by the manufacturer.

8. Active medical devices for diagnostics in vitro, connected to an energy source or equipped with a energy source

91. Active medical devices for in vitro diagnostics, wherein the safety of users depends on an internal power supply, shall be provided with a means for detecting the status of the power supply.

92. Active medical devices for in vitro diagnostics are designed and manufactured to minimize the risk of generating electromagnetic fields (electromagnetic interference) that may adversely affect other medical devices, equipment and communications in accordance with their intended use.

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

94. Active in vitro diagnostic medical devices are designed and manufactured to minimize the risk of accidental electric shock to the user or a third party, both under normal conditions of use of the medical device and under conditions of a single fault, 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 shall be 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.

96. Where the in vitro medical device contains moving parts, means shall be provided to protect the user from the risk of the moving parts breaking or coming loose.

97. Medical devices for in vitro diagnostics shall be designed and manufactured to minimize the risk associated with vibration generated by these medical devices by means that limit vibration, unless vibration is part of the intended use of such medical devices.

98. Medical devices for in vitro diagnostics are designed and manufactured to minimize the risks associated with the noise generated as much as possible by applying (where appropriate) means used to reduce noise.

99. Terminals, connectors, connectors and other devices for connecting in vitro diagnostic medical devices to electrical, hydraulic or pneumatic power sources shall be designed and manufactured to minimize any possible risks.

100. In vitro diagnostic medical devices are designed and manufactured to minimize the risk of errors resulting from improper connection or switching during operation of hardware or parts within such medical devices.

101. The exposed parts of in vitro diagnostic medical devices (except for parts intended to supply heat or to reach setpoint temperatures) must not reach potentially hazardous temperatures under normal conditions of use.

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

102. In vitro diagnostic medical devices for user self-testing or near-user testing are designed and manufactured to function as intended by the manufacturer, taking into account the skills of the user and the operating environment of the medical device.

103. In vitro diagnostic medical devices intended for user self-testing or near-user testing are designed and manufactured to minimize the risk of error by a user without specialized medical training in the use of such medical devices and in sampling or interpreting test results.

104. In vitro diagnostic medical devices intended for self-testing by the user or for testing in the vicinity of the user shall have, if objectively possible, a function to confirm that, when used, the medical devices will function as intended by the manufacturer.

11. Additional requirements for labeling of medical in vitro diagnostic products

105. With regard to medical devices for in vitro diagnostics, in addition to the labeling requirements specified in Section III, subsection 13 of these General Requirements, additional requirements shall also apply, stipulating that the labeling of medical devices for in vitro diagnostics shall contain the following information:

1) information on the intended use of the medical device for in vitro diagnostics;

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

3) information on the main ingredients contained in the packaging of the in vitro diagnostic medical device;

4) a hazard warning sign if the in vitro diagnostic medical device contains hazardous substances;

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

6) information on the purpose of the in vitro diagnostic medical device for self-testing by the user or for testing near the user (if available).

12. requirements to the information contained in the instructions on the use of a medical device for in vitro diagnostics

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

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

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

3) 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 the detection, detection or differentiation of which the in vitro diagnostic medical device is intended to detect, identify or differentiate (if applicable);

the intended use of an in vitro diagnostic medical device for qualitative, semi-quantitative or quantitative determinations;

the type of sample to be analyzed;

4) information on the intended use of the in vitro diagnostic medical device for clinical laboratory diagnostics;

5) the intended use of the medical device for in vitro diagnostics, specifying the user (e.g. patient, medical professional, individual using the medical device for the intended purpose specified by the manufacturer);

6) Principle of the test;

7) A description of reagents, calibrators, and control materials;

8) list of materials and special materials required for testing (analysis) but not contained in the delivery set of the medical device for in vitro diagnostics;

9) for in vitro diagnostic medical devices intended for use in combination with other medical devices, including in vitro diagnostic medical devices — information for identification of medical devices in order to obtain a safe combination and (or) information on known restrictions on joint use of medical devices;

10) information on special storage conditions (e.g. temperature and humidity, lighting, etc.) and/or user handling of the in vitro medical device;

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

12) information on sterile condition, sterilization method and procedure in case of sterile packaging breach (if the in vitro diagnostic medical device is supplied in sterile form);

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

warning, precautions and/or measures taken in the event of failure or abnormalities in the functioning of an in vitro diagnostic medical device as determined by external signs;

warning, precautions and/or measures taken against foreseeable external factors such as external electromagnetic fields, electrostatic discharges, radiation, atmospheric pressure and its variations, humidity and air temperature;

warning, precautions and/or measures taken in case of foreseeable risk of electromagnetic interference caused by an in vitro diagnostic medical device to other medical devices, equipment and communications;

A warning related to materials in an in vitro diagnostic medical device that are carcinogenic, mutagenic or toxic, or that result in sensitization, allergic reaction or adversely affect reproduction;

The warning, precautions and/or measures taken against potentially infectious material contained in an in vitro diagnostic medical device;

14) information on the intended use of the in vitro diagnostic medical device for single use;

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

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

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

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

19) information necessary to verify that the in vitro diagnostic medical device is correctly installed and ready for safe operation for the intended purpose specified by the manufacturer, specifying the following information:

content and frequency of maintenance, including cleaning and disinfection of the medical device;

the need for calibration to ensure proper and safe operation of the in vitro diagnostic medical device during its lifetime;

Methods for reducing risks associated with the installation, calibration, or maintenance of an in vitro diagnostic medical device;

(20) Recommendations for quality control procedures, as appropriate;

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

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

23) analytical performance characteristics: sensitivity, specificity, correctness, repeatability, reproducibility, limit of detection and range of measurement, 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) clinical efficacy characteristics: diagnostic sensitivity and diagnostic specificity (if necessary);

25) biological reference interval if necessary;

(26) Information on interfering substances or limitations associated with the sample that may affect the outcome of the study;

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

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

environmental risks associated with potentially hazardous materials and substances;

physical risks, including the possibility of explosion or fire;

28) for an in vitro diagnostic medical device for user self-testing or near-user testing, also the following information:

detailed information on the testing procedure (reagent preparation, sample collection (preparation), procedure and interpretation of test results);

recommendations regarding the user’s actions in case of positive, negative or uncertain test results;

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

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

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

30) information on the necessity to send a message to the manufacturer or his authorized representative about undesirable events, which have signs of an adverse event (incident).

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

108. One copy of the instructions for use may be sufficient if several in vitro diagnostic medical devices are supplied to one user at one address. The manufacturer shall provide additional copies of the instructions for use at the request of the user.

V. Evidence of compliance with medical of products to the general safety and efficiency requirements for the purposes of registration

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

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

The order of formation of the list shall be adopted by recommendation of the Commission.

For inclusion of standards in the list, the authorized bodies of Member States shall submit to the Commission information in the form according to Annex N 1.

111. For the purposes of registration, compliance of a medical device with these General Requirements shall be 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 according to Annex No. 2. The said form shall be completed in accordance with the established procedure.

112. Evidence of compliance of a medical device with the provisions set out in paragraphs 3, 6 and 8 of these General Requirements shall include clinical justification based on clinical evidence for the medical device.

Annex N 1

to the General Safety Requirements

and effectiveness of medical

products, requirements for their

labeling and operational

documentation on them

FORM

Submissions for inclusion of standards

to the list of standards, as a result of the application of which

on a voluntary basis, in whole or in part

Ensures compliance with the medical

product safety and efficiency requirements

medical devices

Standard designation	Name of the standard	Effective date	Applicable sections of the standard <*>	General Requirements Clause <**>
1	2	3	4	5

———————————

<*> The applicable sections of the standard are specified, if not all sections of the standard provide a presumption of conformity of the medical device to the General requirements for the safety and effectiveness of medical devices, 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. N 27.

<**> The relevant paragraph of the General requirements for the safety and effectiveness of medical devices, 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. N 27, which is fulfilled when applying the section of the standard specified in column 4 of this form.

Annex N 2

to the General Safety Requirements

and effectiveness of medical

products, requirements for their

labeling and operational

documentation on them

REPORTING FORM

THE COMPLIANCE OF THE MEDICAL DEVICE WITH THE REQUIREMENTS

SAFETY AND EFFICACY OF MEDICAL DEVICES

AND HOW TO FILL IT OUT

I. Form of submission of information the compliance of the medical device with the requirements safety and efficacy of medical devices

Name of medical device:

General requirements paragraph	Applicability to medical device	Method used to prove compliance	Details of the normative document for the method used	Details of the document confirming compliance	Evaluation result
1	2	3	4	5	6

II. Procedure for completing the form

submitting information on the compliance of medical

product safety and efficiency requirements

medical devices

1. Column 1 indicates the relevant paragraph of the General requirements for the safety and effectiveness of medical devices, 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. N 27 (hereinafter — the General Requirements).

2. Column 2 shall indicate whether the requirement specified in the General Requirements paragraph indicated in column 1 is applicable to the medical device («yes» or «no»). If this requirement is not applicable to the medical device, an explanation shall be given in the column.

3. Column 3 shall indicate the method used to demonstrate compliance of the medical device with the requirement specified in column 1 of the General Requirements (e.g., application of a standard, in-house testing using a standardized method, testing using an in-house test method, testing by a third party, or other method).

4. Column 4 shall specify details of the normative document for the method used to prove compliance of the medical device with the requirement specified in column 1 of the General Requirements.

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

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