COLLEGE OF THE MINISTRY OF HEALTH OF THE REPUBLIC OF AZERBAIJAN
Q A R A R
No. 8
Baku city May 21, 2024
On approval of the classification of medical devices depending on the degree of risk Amending the Law of the Republic of Azerbaijan “On Medicines”. on” on the application of the Law of the Republic of Azerbaijan No. 979-VIQD dated July 14, 2023 and on the application of the Law of the Republic of Azerbaijan “On Medicinal Products” on amending Decree No. 528 of the President of the Republic of Azerbaijan dated February 6, 2007″ of the President of the Republic of Azerbaijan The year 2023 Subparagraph 3.1.3 of Decree No. 2298 dated August 15, Republic of Azerbaijan Approved by Decree No. 413 of the President of Azerbaijan dated May 25, 2006 “Subparagraph 14.5 and 17-1” of the Regulation on the Ministry of Health of the Republic of Azerbaijan The Collegium of the Ministry of Health of the Republic of Azerbaijan, guided by paragraph
DECIDES:
1. “Classification of medical devices depending on the degree of risk” should be approved (attached). 2. The legal department (E. Kadyrov) should be instructed to submit this Decision to the Ministry of Justice of the Republic of Azerbaijan for inclusion in the State Register of Legal Acts of the Republic of Azerbaijan within 3 days. 3. The supervision of the implementation of the decision should be entrusted to Deputy Minister R. Ismayilov.
Chairman of the College, Minister Teymur Musayev
Republic of Azerbaijan Ministry of Health May 21, 2024 of the Board Decision No. 8 dated approved by
Classification of medical devices depending on the degree of risk
- General provisions
- 1.1. This Classification is based on Article 6.8 of the Law of the Republic of Azerbaijan “On Medicines”. prepared according to the second sentence of the article and medicine in the Republic of Azerbaijan determines the classification of means depending on the degree of risk.
- Basic concepts
2.1. The terms used in this Classification have the following meanings:
2.1.1. analyte – substance to be studied;
2.1.2. risk levels of medical devices – classification of medical devices as a result of a comprehensive assessment of the area of use of medical devices, the possibility of damage to the patient’s health during application and the severity of that damage;
2.1.3. invasive medical devices – medical devices that are fully or partially inserted into the human body from the outer surface of the human body (skin, mucous membranes) or through holes on the body surface;
2.1.4. non-invasive medical means – medical means that are applied from the outer surface of the human body (skin, mucous membranes) without entering;
2.1.5. “in vitro” – obtaining information by examining samples taken from the human body in a test tube;
2.1.6. “in vitro” diagnostic medical device – examination of samples by the manufacturer of the medical device, including donor blood and tissues obtained from the human body, whether used separately or in combination Relating to a physiological or pathological process or condition, including a reagent, reagent product, calibrator, test material, kit, instrument, apparatus, equipment or software system intended for, congenital physical or mental pathology, medical condition or disease predisposition identification, matching with potential recipients and a medical device used to determine safety, predict response to treatment, identify or monitor therapeutic interventions;
2.1.7. containers for samples – products for general laboratory use, whether vacuum-type or not, unless specifically designed for in vitro diagnostic testing by the manufacturers of those products, for the purpose of in vitro diagnostic medical testing by the manufacturer for the initial collection, storage and preservation of samples obtained from the organism prescribed medicine;
2.1.8. active medicine – any medicine whose activity depends on the energy produced by the human body or on an energy source other than the energy produced under the influence of gravity and which has an effect due to changing the density of that energy or converting energy (without significant changes in the amount of energy, substances or other elements a device intended for transfer between an active device and a patient is not considered an active medical device);
2.1.9. active therapeutic medical device – an active medical device used alone or in combination with other devices to support, change, replace or restore biological functions for the purpose of treating or alleviating disease, injury or disability;
2.1.10. accessories of medical devices – in the absence of a medical device, the use or appointment of a medical device according to its purpose by the manufacturer a product intended for use with one or more medical devices in order to directly support the functionality of the medical device;
2.1.11. implantable medical device – a medical device for long-term use, including partially or completely absorbable medical devices, intended to be inserted completely into the human body by clinical intervention or to replace the epithelial surface or ocular surface and to remain in place after this procedure tool.
3. Criteria, classes and groups for risk degrees of medical devices
3.1. The classification of medical devices depending on the degree of risk is carried out according to the following criteria, taking into account the functional purpose and conditions of application based on their division into classes:
3.1.1. duration of use of the medical device;
3.1.2. the possibility of damage to the patient’s health and the degree of severity of that damage;
3.1.3. whether the medical device is invasive;
3.1.4. whether the medical device is sterile;
3.1.5. whether or not the medicine has contact or interaction with tissues and organs of the human body;
3.1.6. method of administration of the medicine to the human body/injection route (anatomical holes, skin or mucous membranes, or surgical intervention);
3.1.7. whether the medicinal product is applied in connection with the activity of vital organs (including the heart, blood circulation, central nervous system);
3.1.8. whether energy sources are used or not.
3.2. Each medicine is assigned only one risk level.
3.3. Depending on the level of potential risk associated with their application, medical devices (except for “in vitro” diagnostic medical devices) are classified into 4 risk levels: 3.3.1. low-risk medical devices (class 1);
3.3.2. medical devices of medium risk (class 2a);
3.3.3. high-risk medical devices (class 2b);
3.3.4. medical devices belonging to a higher degree of risk (class 3).
3.4. Article 1.0.8 of the Law of the Republic of Azerbaijan “On Medicines”. Medicines with a higher, high and (or) medium risk level state registration of the vehicle.
3.5. Medicines are divided into 3 groups according to the duration of use:
3.5.1. medical devices for temporary use – medical devices intended for continuous use for less than 60 minutes;
3.5.2. medical devices for short-term use – medical devices intended for continuous use from 60 minutes to 30 days;
3.5.3. medical means for long-term use – medical means intended for continuous use for more than 30 days.
3.6. The term “continuous use” provided for in subsections 3.5.1-3.5.3 of this Classification means the following:
3.6.1. the total duration of use of the same medical device, without taking into account the temporary suspension of the application of the medical device during the procedure for purposes such as cleaning or disinfection;
3.6.2. the total (total) period of use of the medical device, which can be immediately replaced by the same type of medical device when provided by the manufacturer.
3.7. Whether the suspension of use or removal of the medicinal product from the human body is temporary, the suspension of that use or it is determined taking into account the duration of use before and after the removal of that medicine.
3.8. The risk level of medical equipment supplies is determined separately from the medical equipment to which they belong.
4. Determining the risk level of invasive medical devices
4.1. Excluding surgical invasive medical devices, invasive medical devices that are not intended to be connected to an active medical device or are intended to be connected to an active medical device of a low risk level, the use of which is related to body openings the following risk level is defined for:
4.1.1. if intended for temporary use – low risk level;
4.1.2. intended for short-term use, when used in the oral cavity (up to the pharynx), ear canal (up to the eardrum) or nasal cavity – low risk level;
4.1.3. in other cases, if intended for short-term use – medium risk level;
4.1.4. intended for long-term use, used in the oral cavity (up to the pharynx), ear canal (up to the eardrum) or nasal cavity and could not be absorbed by the mucous membrane – medium risk level;
4.1.5. in other cases, if it is intended for long-term use – a high degree of risk.
4.2. With the exception of surgical invasive medical devices, invasive medical devices that are intended to be connected to an active medical device of medium, high or higher risk and whose use is related to body holes are considered to be medical devices of medium risk. 4.3. Surgical invasive medical devices intended for temporary use are considered medium risk medical devices, except for the following:
4.3.1. if it is intended for the examination, diagnosis, monitoring or correction of the existing pathology of the said parts through direct contact with the heart or central circulatory system – they are considered medical devices belonging to a higher level of risk;
4.3.2. in the case of reusable surgical instruments – they are considered low-risk medical devices;
4.3.3. if it is intended for use by direct contact with the heart or central circulatory system, or the central nervous system – it is considered a higher risk medical device;
4.3.4. if it is intended to provide energy in the form of ionizing radiation – it is considered a high-risk medical device;
4.3.5. if they have a biological effect, or if they are intended to be completely or significantly absorbed – they are considered high-risk medical devices;
4.3.6. if it is intended for the injection of a medicine and if it poses a potential danger taking into account the method of injection and administration of the medicine – it is considered a high-risk medicine.
4.4. Surgical invasive devices intended for short-term use are considered medium-risk medical devices, except for the following:
4.4.1. if it is intended for the examination, diagnosis, monitoring or correction of the existing pathology of the said parts through direct contact with the heart or central circulatory system – it is considered a medical device belonging to a higher degree of risk;
4.4.2. if intended for use through direct contact with the heart or central circulatory system, or the central nervous system – are considered medical devices belonging to a higher degree of risk;
4.4.3. if it is intended to provide energy in the form of ionizing radiation – it is considered a high-risk medical device;
4.4.4. if it has a biological effect, or if it is intended to be completely or significantly absorbed – medicine belonging to a higher degree of risk means are considered;
4.4.5. except for the cases of intradental placement, when it is intended to be subjected to chemical changes in the body – they are considered high-risk medical devices;
4.4.6. if it is intended for the injection of drugs – it is considered a high-risk medical device.
4.5. Implantable devices and surgically invasive medical devices intended for long-term use are considered high-risk medical devices, except for the following:
4.5.1. if it is intended for intradental placement – it is considered a medium risk medical device;
4.5.2. if intended for use through direct contact with the heart or central circulatory system, or the central nervous system – are considered medical devices belonging to a higher degree of risk;
4.5.3. if it has a biological effect, or if it is intended to be completely or significantly absorbed – medicine belonging to a higher degree of risk means are considered;
4.5.4. except when medical devices are placed intradentally, when they are intended to undergo a chemical change in the body – higher risk medical means belonging to the degree are considered;
4.5.5. if it is intended for the injection of medicinal products – it is considered to be a medical product belonging to a higher risk level;
4.5.6. in the case of active implantable medical devices or accessories of such medical devices – medical devices belonging to a higher degree of risk are considered;
4.5.7. in the case of breast implants or surgical meshes – medical devices belonging to a higher degree of risk are considered;
4.5.8. with the exception of auxiliary components such as screws, wedges, plates, in the case of full or partial joint replacements (endoprostheses) – medical devices belonging to a higher degree of risk are considered;
4.5.9. with the exception of components such as screws, wedges, plates, intervertebral disc prostheses (replacement implants) or implantable devices in contact with the spinal column – medical devices belonging to a higher degree of risk are considered is being
5. Determining the degree of risk of non-invasive medical devices
5.1. Except for blood bags, non-invasive means intended for the transfer or storage of blood, biological fluids, cells or tissues, fluids and gases intended for injection into the human body include the following In the following cases, medical devices belonging to the medium risk level are considered:
5.1.1. when those tools can be connected to an active medical tool with a higher, high or medium risk level;
5.1.2. when those means are intended for use in order to preserve organs, organ parts or cells or tissues taken from the body.
5.2. Except for the cases mentioned in clause 5.1 of this Classification, those medical devices are considered low-risk medical devices.
5.3. Blood bags are considered high-risk medical devices.
5.4. Non-invasive medical devices intended to change the biological or chemical composition of human tissues or cells (including blood), biological fluids or other fluids intended for injection or implantation into the body, the treatment method of using these medical devices is filtration, centrifugation and or if they do not involve gas/heat exchange, they are considered high-risk medical devices, and in those cases, medium-risk medical devices.
5.5. A substance or mixture of substances intended for use in direct contact with human cells, tissues or organs “in vitro” or for use “in vitro” with human embryos prior to injection or implantation into the body non-invasive medical devices consisting of are considered higher risk medical devices.
5.6. The following risk levels are defined for non-invasive medical devices that come into contact with damaged skin or mucous membranes:
5.6.1. mechanical barrier, if intended for compression or absorption of exudates – low risk level;
5.6.2. if it is intended for use in skin injuries that violate the integrity of the dermis or mucous membrane of the skin and the treatment of which is possible only through secondary healing – high risk level;
5.6.3. if it is mainly intended to affect the microenvironment of the damaged skin or mucous membrane – it is considered a medium risk medical means;
5.6.4. in other cases medium risk.
5.7. Clause 5.6 of this Classification also applies to determining the degree of risk of invasive medical devices that come into contact with the damaged mucous membrane.
6. Determining the risk level of active medicinal products
6.1. Active therapeutic drugs intended for energy transfer or energy exchange are considered medium risk drugs.
6.2. According to the characteristics of active medical devices, taking into account the characteristics of energy, including its density, as well as the areas where this energy is applied high-risk medical devices are considered when energy is transferred to the human body or energy exchange with it is carried out in a potentially life-threatening way.
6.3. Active medical devices intended for checking, managing or monitoring the activity of a high-risk active therapeutic drug, or to directly affect the activity of that drug, are considered high-risk medical devices.
6.4. Active medical devices intended to emit ionizing radiation for therapeutic purposes, including for the inspection, management or monitoring of such medical devices or to directly affect the operation of such medical devices the intended medical devices are considered high-risk medical devices.
6.5. Active medical devices intended to test, control, or monitor the performance of an active implantable medical device, or to directly affect the performance of that medical device, are higher risk medical devices. are considered means.
6.6. Active medical devices intended for diagnostics and monitoring are considered medium-risk medical devices, except for the following cases:
6.6.1. when intended for demonstration of imaging of distribution of radiopharmaceutical dosage forms in or on the human body;
6.6.2. if intended for direct diagnosis of vital functions or their monitoring;
6.7. Medical devices intended for the transmission of energy to be absorbed by the human body and used to illuminate the patient’s body in the visible spectrum are considered low-risk medical devices.
6.8. When the medical devices mentioned in subsection 6.6.2 of this Classification are intended for the monitoring of vital physiological parameters and the nature of the variations of those parameters can result in a direct danger to the patient (heart variations of function, breathing or activity of the central nervous system) or those tools are considered high-risk medical tools when they are intended for diagnosis in clinical situations where the patient is in immediate danger.
6.9. Active medical devices intended for use in the field of ionizing radiation and diagnostic or therapeutic radiology, including medical devices intended for use in the field of invasive radiology and the use of such medical devices medical devices intended for inspection, management or monitoring or to directly affect the operation of these medical devices are considered high-risk medical devices.
6.10. Software intended to provide information used to make patient-related decisions for diagnostic or therapeutic purposes is considered medium-risk medical devices.
6.11. If making the decisions mentioned in clause 6.10 of this Classification can lead to the death of a person or an irreversible deterioration of the state of health, medical devices whose software belongs to a higher degree of risk, the health of a person software is considered high-risk medical devices if it can cause serious deterioration or surgical intervention.
6.12. Software intended for monitoring physiological processes is considered medium-risk medical devices.
6.13. Software is considered high-risk medical devices if it is intended to monitor vital physiological parameters, and in which case it may cause immediate dangerous consequences for the patient.
6.14. In other cases, except for clauses 6.10 – 6.13 of this Classification, software is considered a low-risk medical device.
6.15. Active medical devices intended for the introduction and (or) removal of drugs, biological fluids or other substances into the human body are considered medium-risk medical devices.
6.16. Active medical devices are considered high-risk medical devices if the method of introduction or removal of the substance poses a potential threat to human health, taking into account the nature of the relevant body parts and the method of application.
6.17. Except for clauses 6.1 – 6.16 of this Classification, other active medical devices are considered low-risk medical devices.
7. Determination of risk levels of “in-vitro” diagnostic medical devices
7.1. Calibrators intended for use with “in vitro” diagnostic medical equipment are assigned the same risk level as the medical equipment used.
7.2. Control materials intended for a specific analyte or several analytes, having defined quantitative and qualitative indicators, are attributed to the same risk level as the corresponding medicine.
7.3. “In vitro” diagnostic medical devices intended to be used for the following purposes are considered medical devices with a higher degree of risk:
7.3.1. determining the presence or exposure to transmissible agents in blood, blood components, cells, tissues or organs, or their derivatives, for the purpose of assessing suitability for transfusion, transplantation or cell injection procedure;
7.3.2. determination of the presence of, or exposure to, a transmissible agent causing a life-threatening disease with a high or presumed high risk of spread;
7.3.3. determining the infection burden of life-threatening diseases in cases where disease monitoring is crucial.
7.4. Means intended for blood grouping or tissue typing for the purpose of ensuring the immunological compatibility of blood, blood components, cells, tissues or organs intended for transfusion, transplantation or cell injection procedures, intended for the determination of any of the following markers as a high risk rate except in cases, and in cases where one of the following markers is intended for determination A high-risk medical device is considered to be:
7.4.1. ABO system [A (ABO1), B (ABO2), AB (ABO3)];
7.4.2. Rhesus system [RH1 (D), RHW1, RH2 (C), RH3 (E), RH4 (c), RH5 (e)];
7.4.3. Kell system [Kel1 (K)];
7.4.4. Kidd system [JK1 (Jka), JK2 (Jkb)];
7.4.5. Duffy system [FY1 (Fya), FY2 (Fyb)].
7.5. In vitro diagnostic medical devices intended for the following purposes are considered high-risk medical devices:
7.5.1. presence of or exposure to sexually transmitted infectious agents;
7.5.2. detection of the presence of an infectious agent in the cerebrospinal fluid or blood with a high or presumed high risk of dissemination;
7.5.3. detection of the presence of an infectious agent when there is a serious risk that an incorrect diagnostic result may result in the death or severe disability of the tested person, fetus or embryo;
7.5.4. prenatal screening to determine the immune status of women in relation to transmissible agents;
7.5.5. identification of an infectious disease or immune status, when there is a risk that the wrong result may cause a life-threatening situation for the patient or his future generations; 7.5.6. use as an auxiliary diagnostic tool;
7.5.7. determination of the stage of the disease, when there is a risk that the wrong result may cause a life-threatening situation for the patient or his future generation;
7.5.8. used in cancer screening, diagnosis or staging;
7.5.9. human genetic testing;
7.5.10. laboratory monitoring of the levels of drugs, substances or biological components in the body, when there is a risk that the wrong result may cause a life-threatening situation for the patient or his future generation;
7.5.11. disease management of patients suffering from a life-threatening disease or condition;
7.5.12. screening of congenital pathologies in the embryo or fetus;
7.5.13. screening of newborns for congenital pathologies that, if undetected or untreatable, can result in life-threatening conditions or severe disabilities.
7.6. Intended for self-examination and used for determining pregnancy, fertility tests and cholesterol levels, as well as for the determination of bacteria, glucose, erythrocytes and leukocytes in the urine “vitro” diagnostic medical devices are considered medium-risk medical devices.
7.7. The following “in vitro” diagnostic medical devices are considered low-risk medical devices:
7.7.1. on the application of “in vitro” diagnostic medical devices by the manufacturer products intended for general laboratory use intended for procedures, critical supplies of uncharacterized medical devices, buffer solutions
8. Additional Provisions
8.1. An integral component of the drug, including human blood or plasma Medicines containing a substance that can be considered a medicinal product and has an auxiliary effect on the effects of the products included in its composition are considered to be higher risk medical products.
8.2. Those used for contraception or the prevention of sexually transmitted diseases are considered high-risk medical devices, and those medical devices are implantable or intended for long-term use. Invasive medical devices are considered higher risk medical devices.
8.3. Medicines used specifically for disinfecting, cleaning, rinsing or moistening contact lenses are considered high-risk medicine.
8.4. Medical devices used for the purpose of disinfection or sterilization of medical devices are considered to be medium risk medical devices, those medical devices are used for the purpose of disinfection of invasive medical devices. and high in the presence of disinfectant solutions or detergent-disinfectants are considered high-risk medical devices. 8.5. The requirements mentioned in clauses 8.3 and 8.4 of this Classification do not apply to medical devices intended for cleaning other devices only by physical action, except for contact lenses.
8.6. Means intended for recording diagnostic images generated by X-rays are considered medium risk medical means.
8.7. Medicines manufactured using non-viable or non-viable, human or animal tissue or cells or their derivatives are considered higher risk medical devices.
8.8. Medicinal products referred to in clause 8.7 of this Classification are non-viable or non-viable, produced using animal tissue or cells or their derivatives and only intact skin high-risk medical devices if they are intended for contact with
8.9. The following risk level is determined for medical devices containing nanomaterials or consisting of nanomaterials:
8.9.1. if the potential for internal exposure is high or medium – a higher degree of risk;
8.9.2. if the potential for internal exposure is low – high risk level;
8.9.3. when the potential for internal exposure is very low – medium risk.
8.10. With the exception of surgical invasive medical devices, invasive medical devices intended for the inhalation of drugs are considered medium-risk medical devices, if the mode of action of these devices has a significant impact on the effectiveness and safety of the injected drug, or if these devices are used to treat life-threatening conditions. and when it is intended for, it is considered a high-risk medical device.
8.11. The following risk levels are defined for medical devices that are intended to be introduced into the body through body openings or applied to the skin surface, and which are absorbed by the human body or consist of substances or combinations of substances that are locally dispersed:
8.11.1. when these medicinal products or the metabolic products of these medicinal products are systematically absorbed by the human body in order to achieve their intended purpose – a higher degree of risk;
8.11.2. when the intended purpose is achieved in the stomach or in the lower part of the gastrointestinal tract, and when these medicinal products or the metabolic products of these medicinal products are systematically absorbed by the human body – higher degree of risk;
8.11.3. when applied to the skin surface, or when applied to the nose or oral cavity (up to the pharynx) and obtained in the spaces indicated for the intended purpose – medium risk level;
8.11.4. in other cases – a high degree of risk.
8.12. Active therapeutic medical devices with a diagnostic function that significantly determines patient management, such as closed-loop systems or automated external defibrillators, are considered higher risk medical devices