{"id":2438,"date":"2026-09-01T12:45:15","date_gmt":"2026-09-01T09:45:15","guid":{"rendered":"https:\/\/grandlocus.com\/?post_type=resources&p=2438"},"modified":"2026-09-01T12:45:55","modified_gmt":"2026-09-01T09:45:55","slug":"council-of-the-eurasian-economic-commission-resolution-no-27-of-february-12-2016","status":"publish","type":"resources","link":"https:\/\/grandlocus.com\/en\/resources\/council-of-the-eurasian-economic-commission-resolution-no-27-of-february-12-2016\/","title":{"rendered":"COUNCIL OF THE EURASIAN ECONOMIC COMMISSION RESOLUTION No. 27 of February 12, 2016"},"content":{"rendered":"

COUNCIL OF THE EURASIAN ECONOMIC COMMISSION<\/strong><\/h4>\n

\u00a0<\/strong><\/p>\n

RESOLUTION <\/strong><\/h4>\n

No.\u00a027 of February\u00a012, 2016<\/strong><\/h4>\n

\u00a0<\/strong><\/p>\n

ON APPROVING THE GENERAL REQUIREMENTS FOR THE SAFETY AND EFFICACY OF MEDICAL DEVICES, REQUIREMENTS FOR THEIR LABELLING AND OPERATIONAL DOCUMENTATION<\/strong><\/h4>\n

 <\/p>\n

 <\/p>\n

In accordance with paragraph\u00a02 of Article\u00a031 of the Treaty on the Eurasian Economic Union dated May\u00a029, 2014, paragraph\u00a02 of Article\u00a03, paragraph\u00a04 of Article\u00a04 and paragraph\u00a04 of Article\u00a07 of the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices (Medical Products and Medical Equipment) within the Framework of the Eurasian Economic Union of December\u00a023, 2014, paragraphs\u00a0104, 108 and 109 of Annex No.\u00a01 to the Rules of Procedure of the Eurasian Economic Commission, approved by Resolution No.\u00a098 of the Supreme Eurasian Economic Council dated December\u00a023, 2014, and Resolution No.\u00a0109 of the Supreme Eurasian Economic Council dated December\u00a023, 2014 \u201cOn the Implementation of the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices (Medical Products and Medical Equipment) within the Framework of the Eurasian Economic Union\u201d, the Council of the Eurasian Economic Commission RESOLVES:<\/p>\n

    \n
  1. To approve the attached General Requirements for the Safety and Efficacy of Medical Devices, Requirements for Their Labelling and Operational Documentation.<\/li>\n
  2. This Resolution shall enter into force upon the expiry of 10\u00a0calendar days from the date of entry into force of the Protocol, signed on December\u00a02, 2015, on the Accession of the Republic of Armenia to the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices (Medical Products and Medical Equipment) within the Framework of the Eurasian Economic Union of December\u00a023, 2014, but not earlier than upon the expiry of 10\u00a0calendar days from the date of the official publication of this Resolution..<\/li>\n<\/ol>\n

     <\/p>\n

    Members of the Council of the Eurasian Economic Commission:<\/p>\n

     <\/p>\n\n\n\n\n
    For the Republic of Armenia<\/td>\nFor the Republic of Belarus<\/td>\nFor the Republic of Kazakhstan<\/td>\nFor the Kyrgyz Republic<\/td>\nFor the Russian Federation<\/td>\n<\/tr>\n
    V.\u00a0Gabrielyan<\/td>\nV.\u00a0Matyushevsky<\/td>\nB.\u00a0Sagintaev<\/td>\nO.\u00a0Pankratov<\/td>\nI.\u00a0Shuvalov<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

     <\/p>\n

    APPROVED<\/em><\/p>\n

    by the Resolution of the Council<\/em><\/p>\n

    of the Eurasian Economic Commission<\/em><\/p>\n

    No.\u00a027 of February\u00a012, 2016<\/em><\/p>\n

     <\/p>\n

    GENERAL REQUIREMENTS FOR THE SAFETY AND EFFICACY OF MEDICAL DEVICES, REQUIREMENTS FOR THEIR LABELLING AND OPERATIONAL DOCUMENTATION<\/strong><\/p>\n

     <\/p>\n

      \n
    1. General Provisions<\/strong><\/li>\n
    2. These General Requirements have been developed in accordance with paragraph\u00a02 of Article\u00a031 of the Treaty on the Eurasian Economic Union dated May\u00a029, 2014, paragraph\u00a02 of Article\u00a03, paragraph\u00a04 of Article\u00a04 and paragraph\u00a04 of Article\u00a07 of the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices (Medical Products and Medical Equipment) within the Framework of the Eurasian Economic Union of December\u00a023, 2014. They establish general requirements for the safety and efficacy of medical devices, as well as requirements for the labelling and operational documentation for medical devices placed on the market within the framework of the Eurasian Economic Union (hereinafter \u2014 the Union).<\/li>\n
    3. For the purposes of these General Requirements, the following terms shall mean:<\/li>\n<\/ol>\n

      \u201cactive medical devices\u201d\u00a0\u2014\u00a0medical devices used separately or in combination with other medical devices, the operation of which requires the use of energy other than that produced by a human or gravity. Medical devices intended to transfer energy or substances from an active medical device to the user without substantially changing them are not considered active medical devices. Standalone software is considered an active medical device;<\/p>\n

      \u201csafety of a medical device\u201d\u00a0\u2014\u00a0the absence of an unacceptable risk associated with causing harm to human life, health and the environment;<\/p>\n

      \u201cinstructions for use\u201d\u00a0\u2014\u00a0operational documentation containing information provided by the manufacturer to the user regarding the intended purpose and proper and safe use of the medical device, which may include, inter alia, an operation manual, a methodology for medical application, a passport, a form, instructions for installation, adjustment, maintenance, repair, transportation, storage and disposal of the medical device;<\/p>\n

      \u201cin vitro diagnostic medical devices\u201d\u00a0\u2014\u00a0any instruments, apparatuses, 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 intended use of these products (including special software), and intended by the manufacturer for use in in vitro studies of human biological samples 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, prediction of responses to therapeutic interventions, selection of therapeutic agents and\/or monitoring of treatment;<\/p>\n

      \u201cadverse event (incident)\u201d\u00a0\u2014\u00a0any malfunction and\/or deterioration of characteristics or failure of the medical device to function properly, or insufficiency or inaccuracy of the accompanying information (documentation) for the medical device, or an adverse effect not specified in the instructions for use, which directly or indirectly led or could have led to death or serious deterioration of the health of users or third parties (where \u201cserious deterioration of health\u201d means a life\u2011threatening condition, permanent impairment of body function or irreversible damage to body structure, a condition requiring medical or surgical intervention to prevent a life\u2011threatening condition or permanent impairment of body function or irreversible damage to body structure, a condition requiring hospitalization or a significant extension of the hospital stay for an already hospitalized patient, functional impairment of a fetus, its death, congenital anomaly or birth injury);<\/p>\n

      \u201cunwanted event\u201d\u00a0\u2014\u00a0any undesirable medical event, unforeseen disease or injury, or undesirable clinical signs (including abnormal laboratory values) in users or third parties associated with the use of a medical device;<\/p>\n

      \u201cuser\u201d\u00a0\u2014\u00a0a patient, medical professional or any other individual using the medical device for the purpose defined by the manufacturer;<\/p>\n

      \u201cefficacy of a medical device\u201d\u00a0\u2014\u00a0the ability of a medical device to fulfil the purpose defined by the manufacturer.<\/p>\n

       <\/p>\n

        \n
      1. General Requirements for Safety and Efficacy Applicable to All Medical Devices<\/strong><\/li>\n
      2. Medical devices shall be designed and manufactured in such a way that, when used under conditions and for purposes corresponding to their intended use as defined by the manufacturer, and, if necessary, taking into account the technical knowledge, experience, education or special training, and the clinical and physical condition of the user, they perform according to the purpose defined 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 shall not be permitted to restrict the interchangeability of medical devices by using special technical or software tools or by other means.<\/li>\n
      3. The decisions made by the manufacturer during the design and manufacture of a medical device shall comply with safety principles, taking into account the generally recognized level of knowledge. If necessary, the manufacturer shall manage risks so that the residual risk associated with any hazard is acceptable. The manufacturer shall follow the following principles in order of priority:<\/li>\n<\/ol>\n
          \n
        • identification of known or foreseeable hazards and assessment of the risks associated with them arising from the use of the medical device as intended and from foreseeable misuse;<\/li>\n
        • elimination of risks by implementing appropriate technical and technological solutions during the design and manufacture of the medical device;<\/li>\n
        • reduction of residual risks by implementing adequate protective measures, including alarm signals;<\/li>\n
        • informing users of all residual risks.<\/li>\n<\/ul>\n
            \n
          1. Medical devices shall be designed, manufactured and packaged in such a way that their operational characteristics and efficacy are not compromised during transportation and storage in accordance with the instructions for use.<\/li>\n
          2. Medical devices shall be effective as intended by the manufacturer and shall be designed and manufactured so that, under normal operating conditions, they correspond to the intended purpose as defined by the manufacturer.<\/li>\n
          3. The operational characteristics and efficacy of a medical device shall not change to an extent that would 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 conditions that may occur under normal operating conditions and maintenance is carried out in accordance with the instructions for use.<\/li>\n
          4. All known and foreseeable risks arising from the use of a medical device, and any undesirable effects from such use, shall be minimized and shall be acceptable when weighed against the benefit to users derived from the intended action of the medical device under normal operating conditions.<\/li>\n
          5. 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\u2011professional) regarding the safety of the medical device, its functional properties and operational characteristics, shall be provided. Such information may be located on the medical device itself, on the packaging or in the instructions for use.<\/li>\n
          6. The information carrier, its format, content and location shall be appropriate to the medical device, its intended purpose and the technical knowledge, experience, education or training of the users. The information carrier shall include details of residual risks associated with the use of the medical device in the form of restrictions on use, contraindications, precautions or warnings. The term \u201ccontraindications\u201d is not applicable to in vitro diagnostic medical devices.<\/li>\n
          7. The information provided for in paragraph\u00a09 of these General Requirements shall be indicated on the labelling and in the instructions for use in the Russian language, and, where relevant requirements exist in the legislation of the member states, in the state language (state languages) of the member states. Such information may contain symbols established by interstate standards, as well as those established by international standards (provided that the safety of the medical device is not compromised due to individual users\u2019 failure to understand the meaning of such symbols).<\/li>\n<\/ol>\n

             <\/p>\n

            III. General Requirements for Safety and Efficacy Applicable to Medical Devices, Excluding In Vitro Diagnostic Medical Devices<\/strong><\/p>\n

             <\/p>\n

              \n
            1. Chemical, Physical and Biological Properties of Medical Devices<\/strong><\/li>\n
            2. During the design and manufacture of medical devices, special attention shall be paid to:<\/li>\n
            3. the choice of materials used, particularly with regard to toxicity and flammability;<\/li>\n
            4. the compatibility of the materials used and biological cells, tissues, fluids, substances and their derivatives (hereinafter\u00a0\u2014\u00a0biological materials), taking into account the intended purpose of the medical device;<\/li>\n
            5. the choice of materials used taking into account such parameters as hardness, wear resistance and fatigue strength.<\/li>\n
            6. During the design, manufacture and packaging of medical devices, the risk posed by contaminants and their residues to users and persons involved in the transportation, storage and maintenance of medical devices shall be reduced to the maximum extent possible (taking into account the intended purpose of the medical device, as well as the duration and frequency of exposure of these substances to the human body).<\/li>\n
            7. Medical devices shall be designed and manufactured so that they can be safely used with materials, substances and gases with which they come into contact under normal operating conditions or during maintenance. If medical devices are intended for the administration of medicinal products, their design and manufacture shall ensure compatibility with the medicinal products (subject to restrictions on their use) in order to ensure the efficacy of both the medicinal product and the medical device in accordance with their intended purpose.<\/li>\n
            8. During the design and manufacture of medical devices, risks shall be minimized to the greatest extent possible:<\/li>\n
            9. those caused by the possible release or leaching of hazardous and\/or harmful substances from the medical device (taking into account their sensitizing effect, carcinogenicity, mutagenicity or adverse impact on reproductive function);<\/li>\n
            10. those associated with the unintended entry of foreign substances into the medical device (taking into account the purpose defined by the manufacturer and the intended conditions for the use of the medical device).<\/li>\n
            11. Infectious and Microbial Contamination of Medical Devices<\/strong><\/li>\n
            12. During the manufacture of a medical device, the risk of infection to users and third parties shall be eliminated or reduced to an acceptable level. The design of the medical device shall ensure ease of operation and maintenance and, if necessary, minimize the risk of any microbial leakage from the medical device and\/or microbial exposure during use, as well as prevent microbial contamination of the medical device or sample by the user or a third party.<\/li>\n
            13. During the design, manufacture and packaging of medical devices that have a special microbiological status in accordance with the labelling, it shall be guaranteed that the microbiological status remains unchanged under the transportation and storage conditions specified by the manufacturer until the protective packaging is breached or opened.<\/li>\n
            14. During the design, manufacture and packaging of medical devices supplied in a sterile condition, their sterility shall be guaranteed under the transportation and storage conditions specified by the manufacturer until the protective packaging is breached or opened. Such medical devices shall be packaged in single\u2011use packaging.<\/li>\n
            15. Sterile medical devices or medical devices with a special microbiological status shall be manufactured, processed and, if necessary, sterilized using validated methods, equipment and processes.<\/li>\n
            16. Medical devices requiring sterilization shall be manufactured under controlled cleanliness conditions in production areas.<\/li>\n
            17. The packaging of non\u2011sterile medical devices shall ensure their integrity and cleanliness and, if the medical device must be sterilized before use, minimize the risk of microbial contamination to the greatest extent possible; the packaging shall be compatible with the sterilization method specified by the manufacturer.<\/li>\n<\/ol>\n

               <\/p>\n

                \n
              1. Medical Devices Containing a Substance Considered to Be a Medicinal Product<\/strong><\/li>\n
              2. If medical devices contain a substance that, when used independently, may be considered a medicinal product in accordance with paragraph\u00a01 of Article\u00a01 of the Agreement on Uniform Principles and Rules for the Circulation of Medicinal Products within the Framework of the Eurasian Economic Union of December\u00a023, 2014, and which has an additional effect on the human body alongside the effect of the medical devices, confirmation of the safety and efficacy of such medical devices shall include confirmation of the safety and efficacy of the medicinal product, taking into account its use as part of the medical devices.<\/li>\n<\/ol>\n

                 <\/p>\n

                  \n
                1. Medical Devices Containing Materials of Biological Origin<\/strong><\/li>\n
                2. If medical devices contain biological materials of animal origin, the animals used for this purpose shall be subject to veterinary control (supervision), following which they shall be recognized as healthy, taking into account the intended purpose of the biological materials used. An animal shall be considered healthy if it has no diseases that could affect the safety and efficacy of the medical device.<\/li>\n<\/ol>\n

                  The manufacturer\u2019s information on biological materials, including the selection of animals, their geographical origin, sampling, processing conditions, storage and handling of biological materials, shall be kept by the authorized body of the member state of the Union in the field of healthcare (hereinafter\u00a0\u2014\u00a0the authorized body of the member state).<\/p>\n

                  Processing, storage, testing and handling of biological materials of animal origin shall 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 shall be ensured through the use of validated methods of destruction or inactivation during the production process.<\/p>\n

                    \n
                  1. If medical devices contain biological materials of human origin, the selection of donors, as well as 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 optimal safety for users and third parties. In particular, safety with respect to viruses and other infectious agents shall be ensured through the use of validated methods of destruction or inactivation during the production process.<\/li>\n
                  2. If medical devices contain biological materials of microbial origin, processing, storage, testing and handling of biological materials of this nature shall ensure optimal safety for users and third parties. In particular, safety with respect to viruses and other infectious agents shall be ensured through the use of validated methods of destruction or inactivation during the production process.<\/li>\n<\/ol>\n

                     <\/p>\n

                      \n
                    1. Medical Devices Used Under the Influence of External Factors<\/strong><\/li>\n
                    2. Medical devices shall be designed and manufactured so that their assembly, adjustment, calibration, use and maintenance under the influence of external factors are carried out safely and ensure the expected efficacy of medical application.<\/li>\n
                    3. If medical devices are intended for use in combination with other medical devices and\/or equipment, the entire combination, including the connecting system, shall be safe and shall not impair the declared functional characteristics of the medical devices. Any known restrictions on the use of such a combination shall be indicated on the labelling and\/or in the instructions for use. During the design and manufacture of connecting systems, possible risks of incorrect connection shall be minimized to the greatest extent possible.<\/li>\n<\/ol>\n

                      It shall not be permitted to use special technical and\/or software tools within a medical device that exclude or restrict the possibility of its use in combination with other medical devices and\/or equipment intended for this purpose.<\/p>\n

                        \n
                      1. Medical devices shall be designed and manufactured to eliminate or reduce to an acceptable level:<\/li>\n
                      2. the risk of injury to the user or third parties due to the physical characteristics of the medical device;<\/li>\n
                      3. the risk of error in the use of medical devices due to design characteristics or human factors;<\/li>\n
                      4. the risk associated with objectively predictable external influences or environmental conditions such as external electromagnetic fields, electrostatic discharges, radiation, atmospheric pressure and its fluctuations, air humidity and temperature;<\/li>\n
                      5. the risk associated with the use of medical devices in contact with materials, liquids and gases to which the medical devices are exposed under normal operating conditions;<\/li>\n
                      6. the risk associated with possible negative interaction between the software of medical devices and the conditions in which it is operated;<\/li>\n
                      7. the risk of accidental entry of foreign substances into medical devices;<\/li>\n
                      8. the risk of mutual interference with other devices commonly used in the diagnostic and treatment process;<\/li>\n
                      9. the risk arising from the inability to maintain or calibrate medical devices (e.g., for implants) due to the aging of the materials used or loss of accuracy of a measuring or control device.<\/li>\n
                      10. Medical devices shall be designed and manufactured to eliminate or minimize to the greatest extent possible the risk of fire or explosion under normal operating conditions or in the event of a single failure. Special attention shall be paid to medical devices used with flammable or explosive substances.<\/li>\n
                      11. Medical devices shall be designed and manufactured to facilitate the safe disposal of waste generated after the use of medical devices.<\/li>\n<\/ol>\n

                         <\/p>\n

                          \n
                        1. Medical Devices Classified as Measuring Instruments<\/strong><\/li>\n
                        2. Medical devices included in the list of medical devices classified as measuring instruments, for which tests are conducted for the purpose of type approval of measuring instruments, shall be designed and manufactured to ensure sufficient accuracy, precision and stability, taking into account the intended purpose of the medical device.<\/li>\n
                        3. Measuring, control or indicator scales shall be designed in accordance with ergonomic principles, taking into account the intended purpose of the medical device. Numerical values shall be expressed in generally accepted units of measurement and shall be understandable to users.<\/li>\n
                        4. The results of measurements performed using a medical device classified as a measuring instrument shall be expressed in units of the International System of Units (SI) or in non\u2011SI units in accordance with the list of non\u2011SI units used in the development of the Union\u2019s technical regulations (including their relationships with the International System of Units (SI)), approved by the Eurasian Economic Commission (hereinafter\u00a0\u2014\u00a0the Commission).<\/li>\n<\/ol>\n

                           <\/p>\n

                            \n
                          1. Protection Against Radiation<\/strong><\/li>\n
                          2. Medical devices shall be designed, manufactured and packaged so as to minimize exposure of users and third parties to radiation, without reducing the established radiation levels necessary to achieve diagnostic and therapeutic objectives.<\/li>\n
                          3. In medical devices intended to generate hazardous or potentially hazardous radiation necessary to achieve specific medical objectives, where the benefit of using such high\u2011intensity radiation is considered to outweigh the hazard posed by the radiation, the possibility for the user to control such radiation shall be provided. During the design and manufacture of such medical devices, reproducibility of the variable parameters of the generated radiation within acceptable limits shall be ensured.<\/li>\n<\/ol>\n

                            Medical devices intended to generate hazardous visible and\/or invisible radiation shall be equipped with visual and\/or audible warning means to indicate the presence (activity) of such radiation.<\/p>\n

                              \n
                            1. During the design and manufacture of medical devices, exposure to unintentionally generated secondary or scattered radiation shall be reduced to the maximum extent possible.<\/li>\n
                            2. During the design and manufacture of medical devices intended to generate ionizing radiation, regulation of the quantitative and geometric parameters of the generated radiation shall be ensured, taking into account the intended purpose defined by the manufacturer.<\/li>\n<\/ol>\n

                              Medical devices generating ionizing radiation and intended for radiological diagnostics shall be designed and manufactured so that, with minimal radiation exposure to the user, the image quality and\/or research results obtained are sufficient for diagnostic purposes.<\/p>\n

                              Medical devices generating ionizing radiation and intended for radiological therapy shall be designed and manufactured so as to ensure control and management of the radiation dose, type, energy and, where necessary, the energy distribution of the directed radiation.<\/p>\n

                               <\/p>\n

                                \n
                              1. Medical Devices Incorporating Software and Standalone Software That Is a Medical Device<\/strong><\/li>\n
                              2. Medical devices incorporating software and standalone software that is a medical device shall be designed and manufactured to ensure stable, reliable and effective operation of these medical devices in accordance with the intended purpose defined by the manufacturer.<\/li>\n<\/ol>\n

                                 <\/p>\n

                                  \n
                                1. Active Medical Devices Connected to or Equipped with an Energy Source<\/strong><\/li>\n
                                2. For active medical devices, appropriate measures shall be taken in the event of a single failure to eliminate or reduce the subsequent risks.<\/li>\n
                                3. Active medical devices whose user safety depends on an internal power source shall be equipped with a means to determine the state of the power source.<\/li>\n
                                4. Active medical devices whose user safety depends on an external power source shall include an alarm system to notify of a power interruption.<\/li>\n
                                5. Active medical devices intended for monitoring one or more clinical parameters of the user shall be equipped with appropriate alarm systems to warn the user of a situation that may lead to death or serious impairment of their health.<\/li>\n
                                6. Active medical devices shall be designed and manufactured to minimize the risk of generating electromagnetic fields (electromagnetic interference) that could adversely affect the operation of other medical devices, equipment and communication means in accordance with their intended purpose.<\/li>\n
                                7. Active medical devices shall be designed and manufactured to provide a level of immunity to electromagnetic interference (interference immunity) ensuring their operation in accordance with the intended purpose defined by the manufacturer.<\/li>\n
                                8. Active medical devices shall be designed and manufactured 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 in the event of a single failure, provided that the medical device is installed and maintained in accordance with the manufacturer\u2019s instructions.<\/li>\n
                                9. Protection Against Mechanical and Thermal Risks<\/strong><\/li>\n
                                10. 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.<\/li>\n
                                11. Medical devices shall be designed and manufactured to minimize the risk associated with vibration generated by these medical devices by applying means to limit vibration, unless vibration is part of the intended purpose of the medical devices.<\/li>\n
                                12. Medical devices shall be designed and manufactured to minimize the risk associated with noise generated by them by applying means used to reduce noise, unless the generated noise is part of the intended purpose of the medical devices.<\/li>\n
                                13. Terminals, connectors, couplers and other devices for connecting medical devices to sources of electrical, hydraulic or pneumatic energy shall be designed and manufactured to minimize any possible risks.<\/li>\n
                                14. Medical devices shall be designed and manufactured to minimize the risk of errors arising from incorrect connection or switching during the operation of the equipment or components within such medical devices.<\/li>\n
                                15. Exposed parts of medical devices (except for parts intended to deliver heat or achieve specified temperature values) shall not reach potentially hazardous temperature levels under normal operating conditions..<\/li>\n<\/ol>\n

                                   <\/p>\n

                                    \n
                                  1. Protection Against Risks Arising from Delivered Energy or Substances<\/strong><\/li>\n
                                  2. 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 with accuracy sufficient to ensure the user\u2019s safety.<\/li>\n
                                  3. Medical devices shall be equipped with means to prevent and\/or indicate any discrepancies in the delivered amount of energy or substance that could pose a hazard.<\/li>\n
                                  4. Information on the functions of controls and indicators shall be clearly indicated on the medical device. If there is an instructions for use, operation manual or visual means of indicating the operational or adjustment parameters of the medical device, such information shall be understandable to the user.<\/li>\n<\/ol>\n

                                     <\/p>\n

                                      \n
                                    1. Protection Against Risks Associated with the Use of Medical Devices Intended by the Manufacturer for Use by Users Without Special Medical Education<\/strong><\/li>\n
                                    2. edical devices intended by the manufacturer for use by users without special medical education shall be designed and manufactured taking into account the skills and resources available to such persons, so that the medical devices operate in accordance with their intended purpose under objectively expected actions by these persons.<\/li>\n
                                    3. Medical devices intended for use by users without special medical education shall be designed and manufactured to minimize the risk of error during use of the medical devices, as well as during interpretation of test results.<\/li>\n
                                    4. Medical devices intended for use by users without special medical education shall, where objectively feasible, have a function to confirm that, when used, these medical devices will operate in accordance with the intended purpose defined by the manufacturer.<\/li>\n<\/ol>\n

                                       <\/p>\n

                                        \n
                                      1. Requirements for the Labelling of Medical Devices<\/strong><\/li>\n
                                      2. The labelling of a medical device shall contain the following information:<\/li>\n<\/ol>\n
                                          \n
                                        1. the name and\/or trade name of the medical device;<\/li>\n
                                        2. information necessary to identify the medical device, as well as information on its intended purpose (if necessary);<\/li>\n
                                        3. details of the manufacturer, including the full and abbreviated (if available) name of the legal entity, location (surname, name, patronymic (if available) and residence address of an individual registered as an individual entrepreneur), postal address of the manufacturer, country of origin of the medical device. The manufacturer\u2019s postal address may be omitted from the labelling if it is included in the instructions for use accompanying the medical device.<\/li>\n<\/ol>\n

                                          Additional labelling may be applied to medical devices manufactured in a state that is not a member of the Union, containing details of the authorized representative of the foreign manufacturer, including the full and abbreviated (if available) name of the legal entity, location (surname, name, patronymic (if available) and residence address of an individual registered as an individual entrepreneur), postal address of the authorized representative of the manufacturer. The additional labelling shall not obscure the labelling containing details of the medical device manufacturer;<\/p>\n

                                            \n
                                          1. information on the presence of medicinal products or biological materials in the medical device, as well as nanomaterials, if such nanomaterials are not in a bound state that excludes the possibility of their entering the user\u2019s body when the medical device is used for the intended purpose defined by the manufacturer;<\/li>\n
                                          2. the batch code (number) or serial number of the medical device;<\/li>\n
                                          3. the period (indicating year and month) until which the medical device can be safely used;<\/li>\n
                                          4. the year of manufacture of the medical device, if the period until which the medical device can be safely used is not indicated. The year of manufacture of the medical device may be included in the batch number or serial number, provided that the year of manufacture is easily identifiable within such number;<\/li>\n
                                          5. information on special storage and\/or handling conditions for the medical device (if necessary);<\/li>\n
                                          6. information on the sterility of the medical device (if the medical device is supplied in a sterile condition), indicating the sterilization method;<\/li>\n
                                          7. warnings or precautions, indicated in a manner that draws the attention of the user or a third party. This information may be minimized if more detailed information is provided in the instructions for use;<\/li>\n
                                          8. information on the single\u2011use nature of the medical device (if the medical device is intended for single\u2011use);<\/li>\n
                                          9. information on the reprocessing of the medical device, indicating the number of reprocessing cycles performed and any limitations on the number of reprocessing cycles (if a single\u2011use medical device has been reprocessed);<\/li>\n
                                          10. information on the manufacture of the medical device to individual user specifications exclusively for personal use in accordance with a written prescription issued by a medical specialist;<\/li>\n
                                          11. information indicating that the medical device is intended solely for clinical trials for registration purposes;<\/li>\n
                                          12. information indicating that the medical device is intended solely for exhibition or demonstration purposes. In this case, the labelling requirements specified in subparagraphs\u00a01\u201314 of this paragraph are not mandatory;<\/li>\n
                                          13. information on the inactivation of possible viruses and other infectious agents in the medical device, applied as the statement \u201cantibodies to HIV\u20111, HIV\u20112 and hepatitis\u00a0C and HBsAg viruses are absent\u201d (if the medical device contains human blood serum (plasma) or human tissue elements).<\/li>\n<\/ol>\n
                                              \n
                                            1. If medical devices or their components intended for introducing into and removing from the human body medicinal products, body fluids or other substances, or for transporting and storing such products, fluids or substances, contain harmful substances that, depending on their concentration, exhibit carcinogenic, mutagenic or reproductive toxic properties, or contain phthalates, such medical devices shall be subject to special labelling. This special labelling 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.<\/li>\n
                                            2. The labelling of sterile and non\u2011sterile medical devices shall allow differentiation between identical or similar types of medical devices placed on the market in sterile and non\u2011sterile conditions, and shall differ in such a way that the user can distinguish a sterile medical device from a non\u2011sterile one using the labelling.<\/li>\n
                                            3. The labelling shall be applied to the medical device. If this is impossible or impractical, the labelling (in part or in full) may be applied to the packaging for each unit of the medical device, and\/or to the group packaging, and\/or to the instructions for use.<\/li>\n
                                            4. The labelling may be supplemented with information about the medical device in machine\u2011readable format, including using radio\u2011frequency identification or barcodes.<\/li>\n
                                            5. Medical devices that have passed the registration and conformity assessment procedures established within the Union with respect to the general requirements for the safety and efficacy of medical devices and the requirements for implementing and maintaining a quality management system for medical devices, prior to being placed on the market within the Union, shall be subject to mandatory labelling with a special mark of circulation of the medical device on the Union market (hereinafter\u00a0\u2014\u00a0the special mark of circulation).<\/li>\n<\/ol>\n

                                              The labelling with the special mark of circulation applied to the medical device shall be carried out by any technological method ensuring a clear and legible image throughout the entire service life (shelf life) of the medical device.<\/p>\n

                                              The special mark of circulation shall not be applied to the medical device if this is technologically impossible or would pose a threat to the life and health of the user.<\/p>\n

                                               <\/p>\n

                                                \n
                                              1. Requirements for the Information Contained in the Instructions for Use of a Medical Device<\/strong><\/li>\n
                                              2. The instructions for use may be provided to the user in paper form or in electronic form, either together with the medical device or separately from it, including by displaying the information on a screen that is part of the medical device. The chosen method of providing the instructions for use shall 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 consumer is informed about the ways to:<\/li>\n<\/ol>\n
                                                  \n
                                                1. view the instructions for use;<\/li>\n
                                                2. obtain the current version of the instructions for use;<\/li>\n
                                                3. obtain a paper version of the instructions for use.<\/li>\n<\/ol>\n
                                                    \n
                                                  1. The instructions for use shall contain the following information:<\/li>\n
                                                  2. the name and\/or trade name of the medical device;<\/li>\n
                                                  3. details of the manufacturer of the medical device and\/or its authorized representative, including the full and abbreviated (if available) name of the legal entity, location (surname, name, patronymic (if available) and residence address of an individual registered as an individual entrepreneur), postal address, telephone numbers, fax number, e\u2011mail address (if available);<\/li>\n
                                                  4. the intended purpose of the medical device, indicating the user (e.g., patient, medical specialist, individual using the medical device for the purpose defined by the manufacturer);<\/li>\n
                                                  5. the functional characteristics of the medical device;<\/li>\n
                                                  6. summarized results of the clinical trials conducted for the registration of the medical device, or a reference to the source where such information is available to the user;<\/li>\n
                                                  7. residual risks, contraindications, expected and foreseeable side effects associated with the use of the medical device for the purpose defined by the manufacturer;<\/li>\n
                                                  8. technical characteristics necessary for the user to use the medical device for the purpose defined by the manufacturer;<\/li>\n
                                                  9. information on the presence of a medicinal product, biological material and\/or nanomaterial;<\/li>\n
                                                  10. information on the installation and commissioning procedure (if necessary), as well as on the need for preliminary preparation prior to using the medical device;<\/li>\n
                                                  11. special requirements regarding premises, special training or specific qualifications of the user and\/or third parties;<\/li>\n
                                                  12. information necessary to verify the correct installation of the medical device and its readiness for safe operation for the purpose defined by the manufacturer, including the following details:\n
                                                      \n
                                                    • the content and frequency of maintenance, including cleaning and disinfection of the medical device;<\/li>\n
                                                    • the presence of consumable components of the medical device and the procedure for their replacement;<\/li>\n
                                                    • the need for calibration to ensure proper and safe operation of the medical device throughout its service life;<\/li>\n
                                                    • methods for reducing risks associated with the installation, calibration or maintenance of the medical device;<\/li>\n<\/ul>\n<\/li>\n
                                                    • information on special storage and\/or maintenance conditions for the medical device;<\/li>\n
                                                    • information on the procedure to be followed if the sterile packaging of the medical device is compromised before its use (if the medical device is supplied sterile);<\/li>\n
                                                    • information on the sterilization method for the medical device (if the medical device is supplied non\u2011sterile and sterilization prior to use is required);<\/li>\n
                                                    • information on the proper processing of the medical device for its reuse, including cleaning, disinfection, packaging and, if necessary, the method of re\u2011sterilization (if the medical device is intended for multiple use), as well as criteria for determining the unsuitability of the medical device for use;<\/li>\n
                                                    • information necessary for the identification of medical devices to obtain a safe combination, and information on known restrictions on the combined use of medical devices (for medical devices intended for use together with other medical devices and\/or general\u2011purpose items);<\/li>\n
                                                    • information on the nature, type, and (if necessary) intensity and distribution of radiation emitted by the medical device, and methods for protecting users or third parties from unintended radiation during the use of the medical device (if the medical device generates a hazardous or potentially hazardous level of radiation for medical purposes);<\/li>\n
                                                    • information for users (warnings, precautions, necessary measures and restrictions when using the medical device), including:\n
                                                        \n
                                                      • warning, precautions and\/or measures to be taken in the event of a malfunction of the medical device or deviations in its functioning that may affect the safety of the medical device;<\/li>\n
                                                      • warning, precautions and\/or measures to be taken if the operation of the medical device is affected by external factors related to 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 fluctuations, air humidity and temperature;<\/li>\n
                                                      • warning, precautions and\/or measures to be taken in the event of a foreseeable risk of electromagnetic interference generated by the medical device during the conduct and evaluation of the results of specific diagnostic studies, therapeutic treatment or during its use (e.g., electromagnetic radiation from the medical device affecting other equipment);<\/li>\n
                                                      • information on restrictions or incompatibilities with certain medicinal products or biological materials (if the medical device is intended for the administration of medicinal products or biological materials);<\/li>\n
                                                      • warning, precautions and\/or restrictions related to medicinal substances or biological materials that are part of the medical device;<\/li>\n
                                                      • warning related to carcinogenic, mutagenic or toxic materials included in the medical device, the possible release or leaching of which may lead to sensitization, an allergic reaction or adversely affect reproductive function;<\/li>\n
                                                      • 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:\n
                                                          \n
                                                        • infectious or microbial hazard of the medical device;<\/li>\n
                                                        • environmental hazard of the medical device;<\/li>\n
                                                        • physical hazard of the medical device;<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n
                                                            \n
                                                          1. information on circumstances under which the user should consult a medical specialist (for medical devices intended for use by persons without medical education);<\/li>\n
                                                          2. data on the issue or last revision of the instructions for use;<\/li>\n
                                                          3. information on the need to report to the manufacturer or its authorized representative any adverse events that have signs of an adverse event (incident).<\/li>\n
                                                          4. The instructions for use shall be drafted using terms that are understandable to the user, and, if necessary, shall be accompanied by drawings and diagrams.<\/li>\n<\/ol>\n

                                                            The instructions for use may contain separate information for professional and non\u2011professional users.<\/p>\n

                                                              \n
                                                            1. The instructions for use may be presented in an abbreviated form or on the labelling (for medical devices of potential risk classes\u00a01 and\u00a02a) if the medical device can be used safely and for the purpose defined by the manufacturer without the instructions for use.<\/li>\n
                                                            2. One copy of the instructions for use may be sufficient if several medical devices are supplied to one user at one address. Upon the consumer\u2019s request, the manufacturer shall provide additional copies of the instructions for use.<\/li>\n<\/ol>\n

                                                               <\/p>\n

                                                                \n
                                                              1. General Requirements for Safety and Efficacy Applicable to In\u00a0Vitro Diagnostic Medical Devices<\/strong><\/li>\n<\/ol>\n

                                                                 <\/p>\n

                                                                  \n
                                                                1. Chemical, Physical and Biological Properties of In\u00a0Vitro Diagnostic Medical Devices<\/strong><\/li>\n
                                                                2. During the design and manufacture of in\u00a0vitro diagnostic medical devices, special attention shall be paid to the possible deterioration of analytical performance due to incompatibility of the materials used, samples and\/or analytes.<\/li>\n
                                                                3. During the design, manufacture and packaging of in\u00a0vitro diagnostic medical devices, the risk posed by contaminants and their residues to users and persons involved in the transportation, storage, maintenance and use of in\u00a0vitro diagnostic medical devices shall be reduced to the maximum extent possible (taking into account the intended purpose of the in\u00a0vitro diagnostic medical device, as well as the duration and frequency of exposure of these substances to the human body).<\/li>\n
                                                                4. During the design and manufacture of in\u00a0vitro diagnostic medical devices, the following risks shall be reduced:<\/li>\n<\/ol>\n

                                                                  risks associated with hazardous and\/or harmful substances that may leach or leak from the in\u00a0vitro diagnostic medical device (taking into account their sensitizing effect, carcinogenicity, mutagenicity or adverse impact on reproductive function);<\/p>\n

                                                                  risks associated with the unintended entry of foreign substances into the in\u00a0vitro diagnostic medical device (taking into account the purpose defined by the manufacturer and the intended conditions for the use of the in\u00a0vitro diagnostic medical device).<\/p>\n

                                                                   <\/p>\n

                                                                    \n
                                                                  1. Infectious and Microbial Contamination of In\u00a0Vitro Diagnostic Medical Devices<\/strong><\/li>\n
                                                                  2. During the design and manufacture of in\u00a0vitro diagnostic medical devices, the risk of infection to users and third parties shall be eliminated or reduced to an acceptable level.<\/li>\n<\/ol>\n

                                                                    The design of the in\u00a0vitro diagnostic medical device shall ensure ease of operation and maintenance and, if necessary, minimize the risk of microbial leakage from the in\u00a0vitro diagnostic medical device and\/or microbial exposure during use, as well as prevent microbial contamination of the in\u00a0vitro diagnostic medical device or sample by the user or a third party.<\/p>\n

                                                                      \n
                                                                    1. During the design, manufacture and packaging of in\u00a0vitro diagnostic medical devices that have a special microbiological status in accordance with the labelling, it shall be guaranteed that the microbiological status remains unchanged under the transportation and storage conditions specified by the manufacturer until the protective packaging is breached or opened.<\/li>\n
                                                                    2. Sterile in\u00a0vitro diagnostic medical devices or in\u00a0vitro diagnostic medical devices with a special microbiological status shall be manufactured, processed and, if necessary, sterilized using validated methods, equipment and processes.<\/li>\n
                                                                    3. In\u00a0vitro diagnostic medical devices requiring sterilization shall be manufactured under controlled production conditions.<\/li>\n
                                                                    4. The packaging of non\u2011sterile in\u00a0vitro diagnostic medical devices shall ensure their integrity and cleanliness and, if the in\u00a0vitro diagnostic medical device must be sterilized before use, minimize the risk of microbial contamination to the greatest extent possible; the packaging shall be compatible with the sterilization method specified by the manufacturer<\/li>\n<\/ol>\n

                                                                      .<\/p>\n

                                                                       <\/p>\n

                                                                        \n
                                                                      1. In\u00a0Vitro Diagnostic Medical Devices Containing Materials of Biological Origin<\/strong><\/li>\n
                                                                      2. If in\u00a0vitro diagnostic medical devices contain biological materials of animal origin, the processing, storage, testing and handling of biological materials of animal origin shall be carried out in such a way as to ensure the safety of users and third parties.<\/li>\n<\/ol>\n

                                                                        Safety with respect to viruses, other infectious agents and other pathogens common to humans and animals shall be ensured through the use of validated methods of destruction or inactivation during the production process. The said validated methods shall not be applied to in\u00a0vitro diagnostic medical devices if the activity of viruses and other infectious agents is due to the intended purpose of the in\u00a0vitro diagnostic medical devices or if the destruction or inactivation process may reduce the effectiveness of the in\u00a0vitro diagnostic medical device.<\/p>\n

                                                                          \n
                                                                        1. If in\u00a0vitro 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.<\/li>\n<\/ol>\n

                                                                          Safety with respect to viruses and other infectious agents shall be ensured through the use of validated methods of destruction or inactivation during the production process. The said validated methods shall not be applied to in\u00a0vitro diagnostic medical devices if the activity of viruses and other infectious agents is due to the intended purpose of the in\u00a0vitro diagnostic medical devices or if the destruction or inactivation process may reduce the effectiveness of the in\u00a0vitro diagnostic medical devices.<\/p>\n

                                                                            \n
                                                                          1. If in\u00a0vitro diagnostic medical devices contain biological materials of microbial origin, the processing, storage, testing and handling of biological materials of this nature shall be carried out in such a way as to ensure the safety of users and third parties.<\/li>\n<\/ol>\n

                                                                            Safety with respect to viruses and other infectious agents shall be ensured through the use of validated methods of destruction or inactivation during the production process. The said validated methods shall not be applied to in\u00a0vitro diagnostic medical devices if the activity of viruses and other infectious agents is due to the intended purpose of the in\u00a0vitro diagnostic medical devices or if the destruction or inactivation process may reduce the effectiveness of the in\u00a0vitro diagnostic medical device.<\/p>\n

                                                                             <\/p>\n

                                                                              \n
                                                                            1. In\u00a0Vitro Diagnostic Medical Devices Used Under the Influence of External Factors<\/strong><\/li>\n
                                                                            2. In\u00a0vitro diagnostic medical devices shall be designed and manufactured so that their assembly, adjustment, calibration, use and maintenance under the influence of external factors are carried out safely.<\/li>\n
                                                                            3. If in\u00a0vitro diagnostic medical devices are intended for use in combination with other medical devices and\/or equipment, the entire combination, including the connecting system, shall be safe and shall not impair the declared functional characteristics of the in\u00a0vitro diagnostic medical devices. Any known restrictions on the use of such a combination shall be indicated on the labelling and\/or in the instructions for use. During the design and manufacture of connecting systems, possible risks of incorrect connection shall be minimized to the greatest extent possible.<\/li>\n<\/ol>\n

                                                                              It shall not be permitted to use special technical and\/or software tools within an in\u00a0vitro diagnostic medical device that exclude or restrict the possibility of its use in combination with other in\u00a0vitro diagnostic medical devices and\/or equipment intended for this purpose.<\/p>\n

                                                                                \n
                                                                              1. In\u00a0vitro diagnostic medical devices shall be designed and manufactured to eliminate or reduce to an acceptable level:<\/li>\n
                                                                              2. the risk of injury to the user or third parties due to the physical characteristics of the in\u00a0vitro diagnostic medical device;<\/li>\n
                                                                              3. the risk of error in the use of in\u00a0vitro diagnostic medical devices due to design characteristics or human factors;<\/li>\n
                                                                              4. the risk associated with objectively predictable external influences or environmental conditions such as external electromagnetic fields, electrostatic discharges, radiation, atmospheric pressure and its fluctuations, air humidity and temperature;<\/li>\n
                                                                              5. the risk associated with the use of in\u00a0vitro diagnostic medical devices in contact with materials, liquids and gases to which the in\u00a0vitro diagnostic medical devices are exposed under normal operating conditions;<\/li>\n
                                                                              6. the risk associated with possible negative interaction between the software of in\u00a0vitro diagnostic medical devices and the conditions in which it is operated;<\/li>\n
                                                                              7. the risk of accidental entry of foreign substances into in\u00a0vitro diagnostic medical devices;<\/li>\n
                                                                              8. the risk of incorrect identification of samples within the framework of in\u00a0vitro diagnostics;<\/li>\n
                                                                              9. the risk of mutual interference with other devices commonly used in the diagnostic and treatment process.<\/li>\n
                                                                              10. In\u00a0vitro diagnostic medical devices shall be designed and manufactured to eliminate or minimize to the greatest extent possible the risk of fire or explosion under normal operating conditions or in the event of a single failure. Special attention shall be paid to in\u00a0vitro diagnostic medical devices used with flammable or explosive substances.<\/li>\n
                                                                              11. In\u00a0vitro diagnostic medical devices shall be designed and manufactured to facilitate the safe disposal of waste generated after the use of in\u00a0vitro diagnostic medical devices.<\/li>\n<\/ol>\n

                                                                                 <\/p>\n

                                                                                  \n
                                                                                1. Functional Characteristics of In\u00a0Vitro Diagnostic Medical Devices<\/strong><\/li>\n
                                                                                2. \u041c\u0435\u0434\u0438\u0446\u0438\u043d\u0441\u043a\u0438\u0435 \u0438\u0437\u0434\u0435\u043b\u0438\u044f \u0434\u043b\u044f \u0434\u0438\u0430\u0433\u043d\u043e\u0441\u0442\u0438\u043a\u0438 in vitro \u043f\u0440\u043e\u0435\u043a\u0442\u0438\u0440\u0443\u044e\u0442\u0441\u044f \u0438 \u0438\u0437\u0433\u043e\u0442\u0430\u0432\u043b\u0438\u0432\u0430\u044e\u0442\u0441\u044f \u0442\u0430\u043a\u0438\u043c In\u00a0vitro diagnostic medical devices shall be designed and manufactured so that their functional characteristics are based on an appropriate scientific and technical foundation. In\u00a0vitro diagnostic medical devices shall function throughout their service life in accordance with the intended purpose defined by the manufacturer in terms of:<\/li>\n
                                                                                3. analytical performance characteristics: accuracy (trueness and precision), systematic error, analytical sensitivity, analytical specificity, limit of detection, analytical range, linearity, cut\u2011off point, repeatability, reproducibility (including the conditions for determining it), identification of possible interferents of endogenous and exogenous nature and cross\u2011reactivity;
                                                                                  \nb) clinical performance characteristics: diagnostic sensitivity, diagnostic specificity, positive and negative predictive value, likelihood ratio, expected values in a normal or selected population.<\/li>\n
                                                                                4. If the performance of in\u00a0vitro diagnostic medical devices depends on calibrators and\/or control materials, the metrological traceability of their values shall be ensured by reference methods and\/or available reference materials of a higher order.<\/li>\n
                                                                                5. Numerical values of the results of studies of human biological samples obtained within the framework of in\u00a0vitro diagnostics shall be expressed in commonly accepted and standardized units.<\/li>\n<\/ol>\n

                                                                                   <\/p>\n

                                                                                    \n
                                                                                  1. Protection Against Radiation<\/strong><\/li>\n
                                                                                  2. In\u00a0vitro diagnostic medical devices shall be designed, manufactured and packaged so as to minimize exposure of users and third parties to potentially hazardous radiation.<\/li>\n
                                                                                  3. In\u00a0vitro diagnostic medical devices intended to generate potentially hazardous radiation shall be designed and manufactured so as to guarantee control and\/or adjustment of the characteristics and amount of emitted radiation, and shall be equipped with visual and\/or audible warning means to indicate the presence (activity) of such radiation.<\/li>\n<\/ol>\n

                                                                                     <\/p>\n

                                                                                      \n
                                                                                    1. In\u00a0Vitro Diagnostic Medical Devices Incorporating Software and Standalone Software That Is an In\u00a0Vitro Diagnostic Medical Device<\/strong><\/li>\n
                                                                                    2. In\u00a0vitro diagnostic medical devices incorporating software and standalone software that is an in\u00a0vitro diagnostic medical device shall be designed and manufactured to ensure stable, reliable and effective operation of these medical devices in accordance with the intended purpose defined by the manufacturer.<\/li>\n<\/ol>\n

                                                                                       <\/p>\n

                                                                                        \n
                                                                                      1. Active In\u00a0Vitro Diagnostic Medical Devices Connected to or Equipped with an Energy Source<\/strong><\/li>\n
                                                                                      2. Active in\u00a0vitro diagnostic medical devices whose user safety depends on an internal power source shall be equipped with a means to determine the state of the power source.<\/li>\n
                                                                                      3. Active in\u00a0vitro diagnostic medical devices shall be designed and manufactured to minimize the risk of generating electromagnetic fields (electromagnetic interference) that could adversely affect the operation of other medical devices, equipment and communication means in accordance with their intended purpose.<\/li>\n
                                                                                      4. Active in\u00a0vitro diagnostic medical devices shall be designed and manufactured to provide a level of immunity to electromagnetic interference (interference immunity) ensuring their operation in accordance with the intended purpose defined by the manufacturer.<\/li>\n
                                                                                      5. Active in\u00a0vitro diagnostic medical devices shall be designed and manufactured 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 in the event of a single failure, provided that the medical device is installed and maintained in accordance with the manufacturer\u2019s instructions..<\/li>\n<\/ol>\n

                                                                                         <\/p>\n

                                                                                          \n
                                                                                        1. Protection Against Mechanical and Thermal Risks<\/strong><\/li>\n
                                                                                        2. In\u00a0vitro 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.<\/li>\n
                                                                                        3. If in\u00a0vitro diagnostic medical devices include moving parts, means shall be provided to protect the user from the risk associated with the possible failure of moving parts or their detachment.<\/li>\n
                                                                                        4. In\u00a0vitro diagnostic medical devices shall be designed and manufactured to minimize the risk associated with vibration generated by these medical devices by applying means to limit vibration, unless vibration is part of the intended purpose of such medical devices.<\/li>\n
                                                                                        5. In\u00a0vitro diagnostic medical devices shall be designed and manufactured to minimize risks associated with noise generated by them by applying (if necessary) means used to reduce noise.<\/li>\n
                                                                                        6. Terminals, connectors, couplers and other devices for connecting in\u00a0vitro diagnostic medical devices to sources of electrical, hydraulic or pneumatic energy shall be designed and manufactured to minimize any possible risks.<\/li>\n<\/ol>\n

                                                                                          100.In\u00a0vitro diagnostic medical devices shall be designed and manufactured to minimize the risk of errors arising from incorrect connection or switching during the operation of the equipment or components within such medical devices.<\/p>\n

                                                                                            \n
                                                                                          1. Exposed parts of in\u00a0vitro diagnostic medical devices (except for parts intended to supply heat or achieve specified temperature values) shall not reach potentially hazardous temperature levels under normal operating conditions.<\/li>\n<\/ol>\n

                                                                                             <\/p>\n

                                                                                              \n
                                                                                            1. Protection Against Risks Posed by In\u00a0Vitro Diagnostic Medical Devices Intended for Self\u2011Testing by the User or Testing Near the User<\/strong><\/li>\n
                                                                                            2. In\u00a0vitro diagnostic medical devices intended for self\u2011testing by the user or testing near the user shall be designed and manufactured so that they function in accordance with the intended purpose defined by the manufacturer, taking into account the user\u2019s skills and the operating conditions of the medical device.<\/li>\n
                                                                                            3. In\u00a0vitro diagnostic medical devices intended for self\u2011testing by the user or testing near the user shall be designed and manufactured to minimize to the greatest extent possible the risk of error by a user who does not have special medical education when using such medical devices, as well as when collecting samples or interpreting test results.<\/li>\n
                                                                                            4. In\u00a0vitro diagnostic medical devices intended for self\u2011testing by the user or for testing near the user shall, if objectively feasible, have a function to confirm that, when used, these medical devices will function in accordance with the intended purpose defined by the manufacturer.<\/li>\n<\/ol>\n

                                                                                               <\/p>\n

                                                                                                \n
                                                                                              1. Additional Requirements for the Labelling of In\u00a0Vitro Diagnostic Medical Devices<\/strong><\/li>\n
                                                                                              2. In addition to the labelling requirements specified in subsection\u00a013 of Section\u00a0III of these General Requirements, the following additional requirements apply to in\u00a0vitro diagnostic medical devices: the labelling of in\u00a0vitro diagnostic medical devices shall contain the following information:<\/li>\n<\/ol>\n
                                                                                                  \n
                                                                                                1. information on the intended purpose of the in\u00a0vitro diagnostic medical device;<\/li>\n
                                                                                                2. details on the net weight (or volume) of the contents (in units of weight or volume), the number of units, or any combination of indicators that accurately reflect the package contents (if applicable);<\/li>\n
                                                                                                3. details on the main ingredients contained in the package of the in\u00a0vitro diagnostic medical device;<\/li>\n
                                                                                                4. a hazard warning symbol if the in\u00a0vitro diagnostic medical device contains hazardous substances;<\/li>\n
                                                                                                5. information on the special microbiological status or purity of the in\u00a0vitro diagnostic medical device (if necessary);<\/li>\n
                                                                                                6. information on the intended use of the in\u00a0vitro diagnostic medical device for self\u2011testing by the user or for testing near the user (if applicable).<\/li>\n<\/ol>\n

                                                                                                   <\/p>\n

                                                                                                    \n
                                                                                                  1. Requirements for the Information Contained in the Instructions for Use of an In\u00a0Vitro Diagnostic Medical Device<\/strong><\/li>\n
                                                                                                  2. The instructions for use of an in\u00a0vitro diagnostic medical device shall contain the following information:<\/li>\n<\/ol>\n
                                                                                                      \n
                                                                                                    1. the name and\/or trade name of the in\u00a0vitro diagnostic medical device;<\/li>\n
                                                                                                    2. details of the manufacturer of the in\u00a0vitro diagnostic medical device and\/or its authorized representative, including the full and abbreviated (if available) name of the legal entity, location (surname, name, patronymic (if available) and residence address of an individual registered as an individual entrepreneur), postal address, telephone numbers, fax number, e\u2011mail address (if available);<\/li>\n
                                                                                                    3. the intended purpose of the in\u00a0vitro diagnostic medical device, including:\n
                                                                                                        \n
                                                                                                      • functional purpose;<\/li>\n
                                                                                                      • description of what is detected and\/or measured;<\/li>\n
                                                                                                      • specific disorder, condition or risk factor for detection, determination or differentiation for which the in\u00a0vitro diagnostic medical device is intended (if necessary);<\/li>\n
                                                                                                      • intended use of the in\u00a0vitro diagnostic medical device for qualitative, semi\u2011quantitative or quantitative determinations;<\/li>\n
                                                                                                      • type of sample to be analysed;<\/li>\n<\/ul>\n<\/li>\n
                                                                                                      • information on the intended use of the in\u00a0vitro diagnostic medical device for clinical laboratory diagnostics;<\/li>\n
                                                                                                      • the intended purpose of the in\u00a0vitro diagnostic medical device indicating the user (e.g., patient, medical specialist, individual using the medical device for the purpose defined by the manufacturer);<\/li>\n
                                                                                                      • the test principle;<\/li>\n
                                                                                                      • description of reagents, calibrators and control materials;<\/li>\n
                                                                                                      • a list of materials and special materials required to perform the testing (analysis) but not included in the kit of the in\u00a0vitro diagnostic medical device;<\/li>\n
                                                                                                      • for in\u00a0vitro diagnostic medical devices intended for use in combination with other medical devices, including in\u00a0vitro diagnostic medical devices\u00a0\u2014\u00a0information for identifying medical devices to obtain a safe combination and\/or information on known restrictions on the combined use of medical devices;<\/li>\n
                                                                                                      • details on special storage conditions (e.g., temperature and air humidity, lighting, etc.) and\/or user handling of the in\u00a0vitro medical device;<\/li>\n
                                                                                                      • details on the stability characteristics of the in\u00a0vitro diagnostic medical device (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);<\/li>\n
                                                                                                      • information on the sterile condition, sterilization method and the procedure to be followed if the sterile packaging is compromised (if the in\u00a0vitro diagnostic medical device is supplied sterile);<\/li>\n
                                                                                                      • information for users (warnings, precautions, necessary measures and restrictions when using the in\u00a0vitro diagnostic medical device), including:\n
                                                                                                          \n
                                                                                                        • warning, precautions and\/or measures to be taken in the event of a malfunction or deviations in the functioning of the in\u00a0vitro diagnostic medical device as determined by external signs;<\/li>\n
                                                                                                        • warning, precautions and\/or measures to be taken with respect to such foreseeable external factors as external electromagnetic fields, electrostatic discharges, radiation, atmospheric pressure and its fluctuations, air humidity and temperature;<\/li>\n
                                                                                                        • warning, precautions and\/or measures to be taken in the event of a foreseeable risk of electromagnetic interference generated by the in\u00a0vitro diagnostic medical device to other medical devices, equipment and communication means;<\/li>\n
                                                                                                        • warning related to materials included in the in\u00a0vitro diagnostic medical device that are carcinogenic, mutagenic or toxic or that lead to sensitization, an allergic reaction or adversely affect reproductive function;<\/li>\n
                                                                                                        • warning, precautions and\/or measures to be taken with respect to potentially infectious material contained in the in\u00a0vitro diagnostic medical device;<\/li>\n<\/ul>\n<\/li>\n
                                                                                                        • information on the intended use of the in\u00a0vitro diagnostic medical device for single use;<\/li>\n
                                                                                                        • information on the proper processing of the in\u00a0vitro diagnostic medical device for its reuse, including cleaning, disinfection, packaging and, if necessary, the method of re\u2011sterilization (if the in\u00a0vitro diagnostic medical device is intended for multiple use);<\/li>\n
                                                                                                        • special requirements regarding premises, special training or specific qualifications of the user and\/or third parties (if necessary);<\/li>\n
                                                                                                        • information on the conditions necessary for sample collection, processing and preparation, data on the stability of the samples to be analysed, including storage conditions and duration, transportation conditions, restrictions on freeze\u2011thaw cycles;<\/li>\n
                                                                                                        • detailed information on preparation for use of the in\u00a0vitro diagnostic medical device;<\/li>\n
                                                                                                        • information necessary to verify the correct installation of the in\u00a0vitro diagnostic medical device and its readiness for safe operation for the purpose defined by the manufacturer, including the following details:\n
                                                                                                            \n
                                                                                                          • the content and frequency of maintenance, including cleaning and disinfection of the medical device;<\/li>\n
                                                                                                          • the need for calibration to ensure proper and safe operation of the in\u00a0vitro diagnostic medical device throughout its service life;<\/li>\n
                                                                                                          • methods for reducing risks associated with the installation, calibration or maintenance of the in\u00a0vitro diagnostic medical device;<\/li>\n<\/ul>\n<\/li>\n
                                                                                                          • recommendations regarding quality control procedures, if necessary;<\/li>\n
                                                                                                          • information on the traceability of values assigned to calibrators or control materials, which is ensured through available reference measurement procedures (methods) and\/or reference standards;<\/li>\n
                                                                                                          • the testing procedure, including calculations and interpretation of test results, and, if necessary, information on the advisability of performing confirmatory tests;<\/li>\n
                                                                                                          • analytical performance characteristics: sensitivity, specificity, trueness, repeatability, reproducibility, limit of detection and measurement range, including information on the effect of known interferents, method limitations and the use of available reference materials and analysis methods (as applicable);<\/li>\n
                                                                                                          • clinical performance characteristics: diagnostic sensitivity and diagnostic specificity (if necessary);<\/li>\n
                                                                                                          • biological reference interval, if necessary;<\/li>\n
                                                                                                          • information on interfering substances or sample\u2011related limitations that may affect the test result;<\/li>\n
                                                                                                          • warning and\/or special precautions regarding the safe disposal of the in\u00a0vitro diagnostic medical device and accessories (if any), which, if necessary, should cover the following factors:\n
                                                                                                              \n
                                                                                                            • infectious or microbial risks, including the possibility of contamination of consumables with infectious agents of human origin;<\/li>\n
                                                                                                            • environmental risks associated with potentially hazardous materials and substances;<\/li>\n
                                                                                                            • physical risks, including the possibility of explosion or fire;<\/li>\n<\/ul>\n<\/li>\n
                                                                                                            • for an in\u00a0vitro diagnostic medical device intended for self\u2011testing by the user or testing near the user, the following information shall also be provided:\n
                                                                                                                \n
                                                                                                              • detailed information on the testing procedure (reagent preparation, sample collection (preparation), execution order and interpretation of test results);<\/li>\n
                                                                                                              • recommendations regarding the user\u2019s actions in the event of a positive, negative or indeterminate test result;<\/li>\n
                                                                                                              • information on test inaccuracies and the possibility of obtaining false\u2011positive or false\u2011negative test results, as well as on factors affecting the test result;<\/li>\n
                                                                                                              • information on the inadmissibility of the user making medical decisions without prior consultation with a medical specialist;<\/li>\n<\/ul>\n<\/li>\n
                                                                                                              • data on the issue or last revision of the instructions for use;<\/li>\n
                                                                                                              • information on the need to report to the manufacturer or its authorized representative any adverse events that have signs of an adverse event (incident).<\/li>\n<\/ol>\n
                                                                                                                  \n
                                                                                                                1. The instructions for use may be presented in an abbreviated form or on the labelling (for in\u00a0vitro diagnostic medical devices of potential risk classes\u00a01 and\u00a02a) if the medical device can be used safely and for the purpose defined by the manufacturer without the instructions for use.<\/li>\n
                                                                                                                2. One copy of the instructions for use may be sufficient if several in\u00a0vitro diagnostic medical devices are supplied to one user at one address. Upon the consumer\u2019s request, the manufacturer shall provide additional copies of the instructions for use.<\/li>\n<\/ol>\n

                                                                                                                   <\/p>\n

                                                                                                                    \n
                                                                                                                  1. Evidence of Conformity of Medical Devices with the General Requirements for Safety and Efficacy for Registration Purposes<\/strong><\/li>\n
                                                                                                                  2. Conformity of a medical device with these General Requirements is ensured by direct compliance with the requirements established by this document or by compliance with the requirements of standards included in the list of standards the application of which, on a voluntary basis, fully or partially ensures compliance of the medical device with these General Requirements (hereinafter\u00a0\u2014\u00a0the List).<\/li>\n
                                                                                                                  3. The List is formed on the basis of proposals from the authorized bodies of the Member States, adopted by a Commission recommendation in coordination with the Member States and shall be updated as necessary.<\/li>\n<\/ol>\n

                                                                                                                    The procedure for forming the List is adopted by a Commission recommendation.<\/p>\n

                                                                                                                    To include standards in the List, the authorized bodies of the Member States shall submit to the Commission the information in the form specified in Annex\u00a0No.\u00a01.<\/p>\n

                                                                                                                      \n
                                                                                                                    1. For registration purposes, conformity of the 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 specified in Annex\u00a0No.\u00a02. This form shall be completed in accordance with the established procedure.<\/li>\n
                                                                                                                    2. Evidence of conformity of the medical device with the provisions set out in paragraphs\u00a03, 6 and\u00a08 of these General Requirements shall include a clinical justification based on clinical data on the medical device.<\/li>\n<\/ol>\n

                                                                                                                       <\/p>\n

                                                                                                                      Annex\u00a0No.\u00a01<\/em><\/p>\n

                                                                                                                      to the General Requirements <\/em><\/p>\n

                                                                                                                      for the Safety and <\/em><\/p>\n

                                                                                                                      Efficacy of Medical Devices, <\/em><\/p>\n

                                                                                                                      Requirements for Their<\/em><\/p>\n

                                                                                                                      \u00a0Labelling and Operational <\/em><\/p>\n

                                                                                                                      Documentation<\/em><\/p>\n

                                                                                                                       <\/p>\n

                                                                                                                      Form for Submission of Information for Inclusion of Standards in the List of Standards the Application of Which, on a Voluntary Basis, Fully or Partially Ensures Compliance of the Medical Device with the Requirements for Safety and Efficacy of Medical Devices<\/strong><\/p>\n

                                                                                                                       <\/p>\n\n\n\n\n
                                                                                                                      Standard Designation<\/td>\nStandard Name<\/td>\nDate of Entry into Force<\/td>\nApplicable Sections of the Standard<*><\/td>\nParagraph of the General Requirements\u00a0<**><\/td>\n<\/tr>\n
                                                                                                                      1<\/td>\n2<\/td>\n3<\/td>\n4<\/td>\n5<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

                                                                                                                      <*> The applicable sections of the standard shall be indicated if not all sections of the standard provide a presumption of conformity of the medical device with the General Requirements for the Safety and Efficacy of Medical Devices, Requirements for Their Labelling and Operational Documentation, approved by the Decision of the Council of the Eurasian Economic Commission dated 12\u00a0February 2016, No.\u00a027.<\/p>\n

                                                                                                                       <\/p>\n

                                                                                                                      <**> The relevant paragraph of the General Requirements for the Safety and Efficacy of Medical Devices, Requirements for Their Labelling and Operational Documentation, approved by the Decision of the Council of the Eurasian Economic Commission dated 12\u00a0February 2016, No.\u00a027, which is fulfilled by applying the section of the standard indicated in column\u00a04 of this form, shall be specified.<\/p>\n

                                                                                                                      .<\/p>\n

                                                                                                                       <\/p>\n

                                                                                                                      Annex\u00a0No.\u00a02<\/em><\/p>\n

                                                                                                                      to the General Requirements<\/em><\/p>\n

                                                                                                                      \u00a0for the Safety and Efficacy <\/em><\/p>\n

                                                                                                                      of Medical Devices, <\/em><\/p>\n

                                                                                                                      Requirements for Their <\/em><\/p>\n

                                                                                                                      Labelling and <\/em><\/p>\n

                                                                                                                      Operational Documentation<\/em><\/p>\n

                                                                                                                       <\/p>\n

                                                                                                                      Form for Submission of Information on Conformity of the Medical Device with the Requirements for Safety and Efficacy of Medical Devices and the Procedure for Its Completion<\/strong><\/p>\n

                                                                                                                       <\/p>\n

                                                                                                                        \n
                                                                                                                      1. Form for Submission of Information on Conformity of the Medical Device with the Requirements for Safety and Efficacy of Medical Devices<\/strong><\/li>\n<\/ol>\n

                                                                                                                         <\/p>\n

                                                                                                                         <\/p>\n\n\n\n\n\n
                                                                                                                        Medical Device Name:<\/td>\n<\/tr>\n
                                                                                                                        Paragraph of the General Requirements<\/td>\nApplicability to the Medical Device<\/td>\nMethod Used to Demonstrate Conformity<\/td>\nReference Details of the Normative Document for the Method Used<\/td>\nReference Details of the Document Confirming Conformity<\/td>\nAssessment Result<\/td>\n<\/tr>\n
                                                                                                                        1<\/td>\n2<\/td>\n3<\/td>\n4<\/td>\n5<\/td>\n6<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

                                                                                                                         <\/p>\n

                                                                                                                         <\/p>\n

                                                                                                                          \n
                                                                                                                        1. Procedure for Completing the Form for Submission of Information on Conformity of the Medical Device with the Requirements for Safety and Efficacy of Medical Devices<\/strong><\/li>\n
                                                                                                                        2. Column\u00a01 shall indicate the relevant paragraph of the General Requirements for the Safety and Efficacy of Medical Devices, Requirements for Their Labelling and Operational Documentation, approved by the Decision of the Council of the Eurasian Economic Commission dated 12\u00a0February 2016, No.\u00a027 (hereinafter\u00a0\u2014\u00a0General Requirements).<\/li>\n
                                                                                                                        3. Column\u00a02 shall indicate whether the requirement provided for in the paragraph of the General Requirements specified in Column\u00a01 is applicable to the medical device (\u201cyes\u201d or \u201cno\u201d). If this requirement is not applicable to the medical device, an explanation shall be provided in the column.<\/li>\n
                                                                                                                        4. Column\u00a03 shall indicate the method applied to demonstrate conformity of the medical device with the requirement provided for in the paragraph of the General Requirements specified in Column\u00a01 (e.g., application of a standard, own tests using a standardized method, tests using an in\u2011house test method, tests carried out by a third party, or another method).<\/li>\n
                                                                                                                        5. Column\u00a04 shall indicate the reference details of the normative document for the method used to demonstrate conformity of the medical device with the requirement provided for in the paragraph of the General Requirements specified in Column\u00a01.<\/li>\n
                                                                                                                        6. Column\u00a05 shall indicate the reference details of documents confirming conformity of the medical device with the requirement provided for in the paragraph of the General Requirements specified in Column\u00a01 (test reports, certificates, declarations of conformity, study reports, other documents).<\/li>\n
                                                                                                                        7. Column\u00a06 shall indicate the conclusion on whether the medical device complies or does not comply with the General Requirements.<\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

                                                                                                                          COUNCIL OF THE EURASIAN ECONOMIC COMMISSION \u00a0 RESOLUTION No.\u00a027 of February\u00a012, 2016 \u00a0 ON APPROVING THE GENERAL REQUIREMENTS FOR THE SAFETY AND EFFICACY OF MEDICAL DEVICES, REQUIREMENTS FOR THEIR LABELLING AND OPERATIONAL DOCUMENTATION     In accordance with paragraph\u00a02 of Article\u00a031 of the Treaty on the Eurasian Economic Union dated May\u00a029, 2014, paragraph\u00a02 of Article\u00a03, […]<\/p>\n","protected":false},"featured_media":2424,"template":"","categories":[25],"class_list":["post-2438","resources","type-resources","status-publish","has-post-thumbnail","hentry","category-regulatory-framework-en"],"_links":{"self":[{"href":"https:\/\/grandlocus.com\/en\/wp-json\/wp\/v2\/resources\/2438","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/grandlocus.com\/en\/wp-json\/wp\/v2\/resources"}],"about":[{"href":"https:\/\/grandlocus.com\/en\/wp-json\/wp\/v2\/types\/resources"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/grandlocus.com\/en\/wp-json\/wp\/v2\/media\/2424"}],"wp:attachment":[{"href":"https:\/\/grandlocus.com\/en\/wp-json\/wp\/v2\/media?parent=2438"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/grandlocus.com\/en\/wp-json\/wp\/v2\/categories?post=2438"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}