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[ { "page_number": 1, "text": "02017R0745 — EN — 10.01.2025 — 005.001 — 188 \nANNEX VIII \nCLASSIFICATION RULES \nCHAPTER I \nDEFINITIONS SPECIFIC TO CLASSIFICATION RULES \n1. \nDURATION OF USE \n1.1. \n‘Transient’ means normally intended for continuous use for less than 60 \nminutes. \n1.2. \n‘Short term’ means normally intended for continuous use for between 60 \nminutes and 30 days. \n1.3. \n‘Long term’ means normally intended for continuous use for more than 30 \ndays. \n2. \nINVASIVE AND ACTIVE DEVICES \n2.1. \n‘Body orifice’ means any natural opening in the body, as well as the \nexternal surface of the eyeball, or any permanent artificial opening, such \nas a stoma. \n2.2. \n‘Surgically invasive device’ means: \n(a) an invasive device which penetrates inside the body through the \nsurface of the body, including through mucous membranes of body \norifices with the aid or in the context of a surgical operation; and \n(b) a device which produces penetration other than through a body orifice. \n2.3. \n‘Reusable surgical instrument’ means an instrument intended for surgical \nuse in cutting, drilling, sawing, scratching, scraping, clamping, retracting, \nclipping or similar procedures, without a connection to an active device \nand which is intended by the manufacturer to be reused after appropriate \nprocedures such as cleaning, disinfection and sterilisation have been \ncarried out. \n2.4. \n‘Active therapeutic device’ means any active device used, whether alone \nor in combination with other devices, to support, modify, replace or \nrestore biological functions or structures with a view to treatment or \nalleviation of an illness, injury or disability. \n2.5. \n‘Active device intended for diagnosis and monitoring’ means any active \ndevice used, whether alone or in combination with other devices, to \nsupply information for detecting, diagnosing, monitoring or treating \nphysiological conditions, states of health, illnesses or congenital \ndeformities. \n2.6. \n‘Central circulatory system’ means the following blood vessels: arteriae \npulmonales, aorta ascendens, arcus aortae, aorta descendens to the \nbifurcatio aortae, arteriae coronariae, arteria carotis communis, arteria \ncarotis externa, arteria carotis interna, arteriae cerebrales, truncus \nbrachiocephalicus, venae cordis, venae pulmonales, vena cava superior \nand vena cava inferior. \n2.7. \n‘Central nervous system’ means the brain, meninges and spinal cord. \n2.8. \n‘Injured skin or mucous membrane’ means an area of skin or a mucous \nmembrane presenting a pathological change or change following disease \nor a wound. \n▼B" }, { "page_number": 2, "text": "02017R0745 — EN — 10.01.2025 — 005.001 — 189 \nCHAPTER II \nIMPLEMENTING RULES \n3.1. \nApplication of the classification rules shall be governed by the intended \npurpose of the devices. \n3.2. \nIf the device in question is intended to be used in combination with \nanother device, the classification rules shall apply separately to each of \nthe devices. ►C1 Accessories for a medical device shall be classified in \ntheir own right ◄ separately from the device with which they are used. \n3.3. \nSoftware, which drives a device or influences the use of a device, shall fall \nwithin the same class as the device. \nIf the software is independent of any other device, it shall be classified in \nits own right. \n3.4. \nIf the device is not intended to be used solely or principally in a specific \npart of the body, it shall be considered and classified on the basis of the \nmost critical specified use. \n3.5. \nIf several rules, or if, within the same rule, several sub-rules, apply to the \nsame device based on the device's intended purpose, the strictest rule and \nsub-rule resulting in the higher classification shall apply. \n3.6. \nIn calculating the duration referred to in Section 1, continuous use shall \nmean: \n(a) the entire duration of use of the same device without regard to \ntemporary interruption of use during a procedure or temporary \nremoval for purposes such as cleaning or disinfection of the device. \nWhether the interruption of use or the removal is temporary shall be \nestablished in relation to the duration of the use prior to and after the \nperiod when the use is interrupted or the device removed; and \n(b) the accumulated use of a device that is intended by the manufacturer \nto be replaced immediately with another of the same type. \n3.7. \nA device is considered to allow direct diagnosis when it provides the \ndiagnosis of the disease or condition in question by itself or when it \nprovides decisive information for the diagnosis. \nCHAPTER III \nCLASSIFICATION RULES \n4. \nNON-INVASIVE DEVICES \n4.1. \nRule 1 \nAll non-invasive devices are classified as class I, unless one of the rules \nset out hereinafter applies. \n4.2. \nRule 2 \nAll non-invasive devices intended for channelling or storing blood, body \nliquids, cells or tissues, liquids or gases for the purpose of eventual \ninfusion, administration or introduction into the body are classified as \nclass IIa: \n— if they may be connected to a class IIa, class IIb or class III active \ndevice; or \n▼B" }, { "page_number": 3, "text": "02017R0745 — EN — 10.01.2025 — 005.001 — 190 \n— if they are intended for use for channelling or storing blood or other \nbody liquids or for storing organs, parts of organs or body cells and \ntissues, except for blood bags; blood bags are classified as class IIb. \nIn all other cases, such devices are classified as class I. \n4.3. \nRule 3 \nAll non-invasive devices intended for modifying the biological or \nchemical composition of human tissues or cells, blood, other body \nliquids or other liquids intended for implantation or administration into \nthe body are classified as class IIb, unless the treatment for which the \ndevice is used consists of filtration, centrifugation or exchanges of gas, \nheat, in which case they are classified as class IIa. \nAll non-invasive devices consisting of a substance or a mixture of \nsubstances intended to be used in vitro in direct contact with human \ncells, tissues or organs taken from the human body or used in vitro \nwith human embryos before their implantation or administration into the \nbody are classified as class III. \n4.4. \nRule 4 \nAll non-invasive devices which come into contact with injured skin or \nmucous membrane are classified as: \n— class I if they are intended to be used as a mechanical barrier, for \ncompression or for absorption of exudates; \n— class IIb if they are intended to be used principally for injuries to skin \nwhich have breached the dermis or mucous membrane and can only \nheal by secondary intent; \n— class \nIIa if \nthey \nare \nprincipally \nintended \nto \nmanage \nthe \nmicro-environment of injured skin or mucous membrane; and \n— class IIa in all other cases. \nThis rule applies also to the invasive devices that come into contact with \ninjured mucous membrane. \n5. \nINVASIVE DEVICES \n5.1. \nRule 5 \nAll invasive devices with respect to body orifices, other than surgically \ninvasive devices, which are not intended for connection to an active \ndevice or which are intended for connection to a class I active device \nare classified as: \n— class I if they are intended for transient use; \n— class IIa if they are intended for short-term use, except if they are used \nin the oral cavity as far as the pharynx, in an ear canal up to the ear \ndrum or in the nasal cavity, in which case they are classified as class I; \nand \n— class IIb if they are intended for long-term use, except if they are used \nin the oral cavity as far as the pharynx, in an ear canal up to the ear \ndrum or in the nasal cavity and are not liable to be absorbed by the \nmucous membrane, in which case they are classified as class IIa. \n▼B" }, { "page_number": 4, "text": "02017R0745 — EN — 10.01.2025 — 005.001 — 191 \nAll invasive devices with respect to body orifices, other than surgically \ninvasive devices, intended for connection to a class IIa, class IIb or \nclass III active device, are classified as class IIa. \n5.2. \nRule 6 \nAll surgically invasive devices intended for transient use are classified as \nclass IIa unless they: \n— are intended specifically to control, diagnose, monitor or correct a \ndefect of the heart or of the central circulatory system through direct \ncontact with those parts of the body, in which case they are classified \nas class III; \n— are reusable surgical instruments, in which case they are classified as \nclass I; \n— are intended specifically for use in direct contact with the heart or \ncentral circulatory system or the central nervous system, in which \ncase they are classified as class III; \n— are intended to supply energy in the form of ionising radiation in \nwhich case they are classified as class IIb; \n— have a biological effect or are wholly or mainly absorbed in which \ncase they are classified as class IIb; or \n— are intended to administer medicinal products by means of a delivery \nsystem, if such administration of a medicinal product is done in a \nmanner that is potentially hazardous taking account of the mode of \napplication, in which case they are classified as class IIb. \n5.3. \nRule 7 \nAll surgically invasive devices intended for short-term use are classified as \nclass IIa unless they: \n— are intended specifically to control, diagnose, monitor or correct a \ndefect of the heart or of the central circulatory system through direct \ncontact with those parts of the body, in which case they are classified \nas class III; \n— are intended specifically for use in direct contact with the heart or \ncentral circulatory system or the central nervous system, in which \ncase they are classified as class III; \n— are intended to supply energy in the form of ionizing radiation in \nwhich case they are classified as class IIb; \n— have a biological effect or are wholly or mainly absorbed in which \ncase they are classified as class III; \n— are intended to undergo chemical change in the body in which case \nthey are classified as class IIb, except if the devices are placed in the \nteeth; or \n— are intended to administer medicines, in which case they are classified \nas class IIb. \n5.4. \nRule 8 \nAll implantable devices and long-term surgically invasive devices are \nclassified as class IIb unless they: \n▼B" }, { "page_number": 5, "text": "02017R0745 — EN — 10.01.2025 — 005.001 — 192 \n— are intended to be placed in the teeth, in which case they are classified \nas class IIa; \n— are intended to be used in direct contact with the heart, the central \ncirculatory system or the central nervous system, in which case they \nare classified as class III; \n— have a biological effect or are wholly or mainly absorbed, in which \ncase they are classified as class III; \n— are intended to undergo chemical change in the body in which case \nthey are classified as class III, except if the devices are placed in the \nteeth; \n— are intended to administer medicinal products, in which case they are \nclassified as class III; \n— are active implantable devices or their accessories, in which cases they \nare classified as class III; \n— are breast implants or surgical meshes, in which cases they are clas\nsified as class III; \n— are total or partial joint replacements, in which case they are classified \nas class III, with the exception of ancillary components such as screws, \nwedges, plates and instruments; or \n— are spinal disc replacement implants or are implantable devices that \ncome into contact with the spinal column, in which case they are \nclassified as class III with the exception of components such as \nscrews, wedges, plates and instruments. \n6. \nACTIVE DEVICES \n6.1. \nRule 9 \nAll active therapeutic devices intended to administer or exchange energy \nare classified as class IIa unless their characteristics are such that they may \nadminister energy to or exchange energy with the human body in a \npotentially hazardous way, taking account of the nature, the density and \nsite of application of the energy, in which case they are classified as \nclass IIb. \nAll active devices intended to control or monitor the performance of active \ntherapeutic class IIb devices, or intended directly to influence the \nperformance of such devices are classified as class IIb. \nAll active devices intended to emit ionizing radiation for therapeutic \npurposes, including devices which control or monitor such devices, or \nwhich directly influence their performance, are classified as class IIb. \nAll active devices that are intended for controlling, monitoring or directly \ninfluencing the performance of active implantable devices are classified as \nclass III. \n6.2. \nRule 10 \nActive devices intended for diagnosis and monitoring are classified as \nclass IIa: \n— if they are intended to supply energy which will be absorbed by the \nhuman body, except for devices intended to illuminate the patient's \nbody, in the visible spectrum, in which case they are classified as \nclass I; \n▼B" }, { "page_number": 6, "text": "02017R0745 — EN — 10.01.2025 — 005.001 — 193 \n— if they are intended to image in vivo distribution of radiophar\nmaceuticals; or \n— if they are intended to allow direct diagnosis or monitoring of vital \nphysiological processes, unless they are specifically intended for moni\ntoring of vital physiological parameters and the nature of variations of \nthose parameters is such that it could result in immediate danger to the \npatient, for instance variations in cardiac performance, respiration, \nactivity of the central nervous system, or they are intended for \ndiagnosis in clinical situations where the patient is in immediate \ndanger, in which cases they are classified as class IIb. \nActive devices intended to emit ionizing radiation and intended for diag\nnostic or therapeutic radiology, including interventional radiology devices \nand devices which control or monitor such devices, or which directly \ninfluence their performance, are classified as class IIb. \n6.3. \nRule 11 \nSoftware intended to provide information which is used to take decisions \nwith diagnosis or therapeutic purposes is classified as class IIa, except if \nsuch decisions have an impact that may cause: \n— death or an irreversible deterioration of a person's state of health, in \nwhich case it is in class III; or \n— a serious deterioration of a person's state of health or a surgical inter\nvention, in which case it is classified as class IIb. \nSoftware intended to monitor physiological processes is classified as \nclass IIa, except if it is intended for monitoring of vital physiological \nparameters, where the nature of variations of those parameters is such \nthat it could result in immediate danger to the patient, in which case it \nis classified as class IIb. \nAll other software is classified as class I. \n6.4. \nRule 12 \nAll active devices intended to administer and/or remove medicinal \nproducts, body liquids or other substances to or from the body are clas\nsified as class IIa, unless this is done in a manner that is potentially \nhazardous, taking account of the nature of the substances involved, of \nthe part of the body concerned and of the mode of application in which \ncase they are classified as class IIb. \n6.5. \nRule 13 \nAll other active devices are classified as class I. \n7. \nSPECIAL RULES \n7.1. \nRule 14 \nAll devices incorporating, as an integral part, a substance which, if used \nseparately, can be considered to be a medicinal product, as defined in \npoint 2 of Article 1 of Directive 2001/83/EC, including a medicinal \nproduct derived from human blood or human plasma, as defined in \npoint 10 of Article 1 of that Directive, and that has an action ancillary \nto that of the devices, are classified as class III. \n▼B" }, { "page_number": 7, "text": "02017R0745 — EN — 10.01.2025 — 005.001 — 194 \n7.2. \nRule 15 \nAll devices used for contraception or prevention of the transmission of \nsexually transmitted diseases are classified as class IIb, unless they are \nimplantable or long term invasive devices, in which case they are clas\nsified as class III. \n7.3. \nRule 16 \nAll devices intended specifically to be used for disinfecting, cleaning, \nrinsing or, where appropriate, hydrating contact lenses are classified as \nclass IIb. \nAll devices intended specifically to be used for disinfecting or sterilising \nmedical devices are classified as class IIa, unless they are disinfecting \nsolutions or washer-disinfectors intended specifically to be used for disin\nfecting invasive devices, as the end point of processing, in which case \nthey are classified as class IIb. \nThis rule does not apply to devices that are intended to clean devices other \nthan contact lenses by means of physical action only. \n7.4. \nRule 17 \nDevices specifically intended for recording of diagnostic images generated \nby X-ray radiation are classified as class IIa. \n7.5. \nRule 18 \nAll devices manufactured utilising tissues or cells of human or animal \norigin, or their derivatives, which are non-viable or rendered non-viable, \nare classified as class III, unless such devices are manufactured utilising \ntissues or cells of animal origin, or their derivatives, which are non-viable \nor rendered non-viable and are devices intended to come into contact with \nintact skin only. \n7.6. \nRule 19 \nAll devices incorporating or consisting of nanomaterial are classified as: \n— class III if they present a high or medium potential for internal \nexposure; \n— class IIb if they present a low potential for internal exposure; and \n— class IIa if they present a negligible potential for internal exposure. \n7.7. \nRule 20 \nAll invasive devices with respect to body orifices, other than surgically \ninvasive devices, which are intended to administer medicinal products by \ninhalation are classified as class IIa, unless their mode of action has an \nessential impact on the efficacy and safety of the administered medicinal \nproduct or they are intended to treat life-threatening conditions, in which \ncase they are classified as class IIb. \n7.8. \nRule 21 \nDevices that are composed of substances or of combinations of substances \nthat are intended to be introduced into the human body via a body orifice \nor applied to the skin and that are absorbed by or locally dispersed in the \nhuman body are classified as: \n▼B" } ]

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[ { "page_number": 1, "text": "02017R0745 — EN — 10.01.2025 — 005.001 — 188 \nANNEX VIII \nCLASSIFICATION RULES \nCHAPTER I \nDEFINITIONS SPECIFIC TO CLASSIFICATION RULES \n1. \nDURATION OF USE \n1.1. \n‘Transient’ means normally intended for continuous use for less than 60 \nminutes. \n1.2. \n‘Short term’ means normally intended for continuous use for between 60 \nminutes and 30 days. \n1.3. \n‘Long term’ means normally intended for continuous use for more than 30 \ndays. \n2. \nINVASIVE AND ACTIVE DEVICES \n2.1. \n‘Body orifice’ means any natural opening in the body, as well as the \nexternal surface of the eyeball, or any permanent artificial opening, such \nas a stoma. \n2.2. \n‘Surgically invasive device’ means: \n(a) an invasive device which penetrates inside the body through the \nsurface of the body, including through mucous membranes of body \norifices with the aid or in the context of a surgical operation; and \n(b) a device which produces penetration other than through a body orifice. \n2.3. \n‘Reusable surgical instrument’ means an instrument intended for surgical \nuse in cutting, drilling, sawing, scratching, scraping, clamping, retracting, \nclipping or similar procedures, without a connection to an active device \nand which is intended by the manufacturer to be reused after appropriate \nprocedures such as cleaning, disinfection and sterilisation have been \ncarried out. \n2.4. \n‘Active therapeutic device’ means any active device used, whether alone \nor in combination with other devices, to support, modify, replace or \nrestore biological functions or structures with a view to treatment or \nalleviation of an illness, injury or disability. \n2.5. \n‘Active device intended for diagnosis and monitoring’ means any active \ndevice used, whether alone or in combination with other devices, to \nsupply information for detecting, diagnosing, monitoring or treating \nphysiological conditions, states of health, illnesses or congenital \ndeformities. \n2.6. \n‘Central circulatory system’ means the following blood vessels: arteriae \npulmonales, aorta ascendens, arcus aortae, aorta descendens to the \nbifurcatio aortae, arteriae coronariae, arteria carotis communis, arteria \ncarotis externa, arteria carotis interna, arteriae cerebrales, truncus \nbrachiocephalicus, venae cordis, venae pulmonales, vena cava superior \nand vena cava inferior. \n2.7. \n‘Central nervous system’ means the brain, meninges and spinal cord. \n2.8. \n‘Injured skin or mucous membrane’ means an area of skin or a mucous \nmembrane presenting a pathological change or change following disease \nor a wound. \n▼B" }, { "page_number": 2, "text": "02017R0745 — EN — 10.01.2025 — 005.001 — 189 \nCHAPTER II \nIMPLEMENTING RULES \n3.1. \nApplication of the classification rules shall be governed by the intended \npurpose of the devices. \n3.2. \nIf the device in question is intended to be used in combination with \nanother device, the classification rules shall apply separately to each of \nthe devices. ►C1 Accessories for a medical device shall be classified in \ntheir own right ◄ separately from the device with which they are used. \n3.3. \nSoftware, which drives a device or influences the use of a device, shall fall \nwithin the same class as the device. \nIf the software is independent of any other device, it shall be classified in \nits own right. \n3.4. \nIf the device is not intended to be used solely or principally in a specific \npart of the body, it shall be considered and classified on the basis of the \nmost critical specified use. \n3.5. \nIf several rules, or if, within the same rule, several sub-rules, apply to the \nsame device based on the device's intended purpose, the strictest rule and \nsub-rule resulting in the higher classification shall apply. \n3.6. \nIn calculating the duration referred to in Section 1, continuous use shall \nmean: \n(a) the entire duration of use of the same device without regard to \ntemporary interruption of use during a procedure or temporary \nremoval for purposes such as cleaning or disinfection of the device. \nWhether the interruption of use or the removal is temporary shall be \nestablished in relation to the duration of the use prior to and after the \nperiod when the use is interrupted or the device removed; and \n(b) the accumulated use of a device that is intended by the manufacturer \nto be replaced immediately with another of the same type. \n3.7. \nA device is considered to allow direct diagnosis when it provides the \ndiagnosis of the disease or condition in question by itself or when it \nprovides decisive information for the diagnosis. \nCHAPTER III \nCLASSIFICATION RULES \n4. \nNON-INVASIVE DEVICES \n4.1. \nRule 1 \nAll non-invasive devices are classified as class I, unless one of the rules \nset out hereinafter applies. \n4.2. \nRule 2 \nAll non-invasive devices intended for channelling or storing blood, body \nliquids, cells or tissues, liquids or gases for the purpose of eventual \ninfusion, administration or introduction into the body are classified as \nclass IIa: \n— if they may be connected to a class IIa, class IIb or class III active \ndevice; or \n▼B" }, { "page_number": 3, "text": "02017R0745 — EN — 10.01.2025 — 005.001 — 190 \n— if they are intended for use for channelling or storing blood or other \nbody liquids or for storing organs, parts of organs or body cells and \ntissues, except for blood bags; blood bags are classified as class IIb. \nIn all other cases, such devices are classified as class I. \n4.3. \nRule 3 \nAll non-invasive devices intended for modifying the biological or \nchemical composition of human tissues or cells, blood, other body \nliquids or other liquids intended for implantation or administration into \nthe body are classified as class IIb, unless the treatment for which the \ndevice is used consists of filtration, centrifugation or exchanges of gas, \nheat, in which case they are classified as class IIa. \nAll non-invasive devices consisting of a substance or a mixture of \nsubstances intended to be used in vitro in direct contact with human \ncells, tissues or organs taken from the human body or used in vitro \nwith human embryos before their implantation or administration into the \nbody are classified as class III. \n4.4. \nRule 4 \nAll non-invasive devices which come into contact with injured skin or \nmucous membrane are classified as: \n— class I if they are intended to be used as a mechanical barrier, for \ncompression or for absorption of exudates; \n— class IIb if they are intended to be used principally for injuries to skin \nwhich have breached the dermis or mucous membrane and can only \nheal by secondary intent; \n— class \nIIa if \nthey \nare \nprincipally \nintended \nto \nmanage \nthe \nmicro-environment of injured skin or mucous membrane; and \n— class IIa in all other cases. \nThis rule applies also to the invasive devices that come into contact with \ninjured mucous membrane. \n5. \nINVASIVE DEVICES \n5.1. \nRule 5 \nAll invasive devices with respect to body orifices, other than surgically \ninvasive devices, which are not intended for connection to an active \ndevice or which are intended for connection to a class I active device \nare classified as: \n— class I if they are intended for transient use; \n— class IIa if they are intended for short-term use, except if they are used \nin the oral cavity as far as the pharynx, in an ear canal up to the ear \ndrum or in the nasal cavity, in which case they are classified as class I; \nand \n— class IIb if they are intended for long-term use, except if they are used \nin the oral cavity as far as the pharynx, in an ear canal up to the ear \ndrum or in the nasal cavity and are not liable to be absorbed by the \nmucous membrane, in which case they are classified as class IIa. \n▼B" }, { "page_number": 4, "text": "02017R0745 — EN — 10.01.2025 — 005.001 — 191 \nAll invasive devices with respect to body orifices, other than surgically \ninvasive devices, intended for connection to a class IIa, class IIb or \nclass III active device, are classified as class IIa. \n5.2. \nRule 6 \nAll surgically invasive devices intended for transient use are classified as \nclass IIa unless they: \n— are intended specifically to control, diagnose, monitor or correct a \ndefect of the heart or of the central circulatory system through direct \ncontact with those parts of the body, in which case they are classified \nas class III; \n— are reusable surgical instruments, in which case they are classified as \nclass I; \n— are intended specifically for use in direct contact with the heart or \ncentral circulatory system or the central nervous system, in which \ncase they are classified as class III; \n— are intended to supply energy in the form of ionising radiation in \nwhich case they are classified as class IIb; \n— have a biological effect or are wholly or mainly absorbed in which \ncase they are classified as class IIb; or \n— are intended to administer medicinal products by means of a delivery \nsystem, if such administration of a medicinal product is done in a \nmanner that is potentially hazardous taking account of the mode of \napplication, in which case they are classified as class IIb. \n5.3. \nRule 7 \nAll surgically invasive devices intended for short-term use are classified as \nclass IIa unless they: \n— are intended specifically to control, diagnose, monitor or correct a \ndefect of the heart or of the central circulatory system through direct \ncontact with those parts of the body, in which case they are classified \nas class III; \n— are intended specifically for use in direct contact with the heart or \ncentral circulatory system or the central nervous system, in which \ncase they are classified as class III; \n— are intended to supply energy in the form of ionizing radiation in \nwhich case they are classified as class IIb; \n— have a biological effect or are wholly or mainly absorbed in which \ncase they are classified as class III; \n— are intended to undergo chemical change in the body in which case \nthey are classified as class IIb, except if the devices are placed in the \nteeth; or \n— are intended to administer medicines, in which case they are classified \nas class IIb. \n5.4. \nRule 8 \nAll implantable devices and long-term surgically invasive devices are \nclassified as class IIb unless they: \n▼B" }, { "page_number": 5, "text": "02017R0745 — EN — 10.01.2025 — 005.001 — 192 \n— are intended to be placed in the teeth, in which case they are classified \nas class IIa; \n— are intended to be used in direct contact with the heart, the central \ncirculatory system or the central nervous system, in which case they \nare classified as class III; \n— have a biological effect or are wholly or mainly absorbed, in which \ncase they are classified as class III; \n— are intended to undergo chemical change in the body in which case \nthey are classified as class III, except if the devices are placed in the \nteeth; \n— are intended to administer medicinal products, in which case they are \nclassified as class III; \n— are active implantable devices or their accessories, in which cases they \nare classified as class III; \n— are breast implants or surgical meshes, in which cases they are clas\nsified as class III; \n— are total or partial joint replacements, in which case they are classified \nas class III, with the exception of ancillary components such as screws, \nwedges, plates and instruments; or \n— are spinal disc replacement implants or are implantable devices that \ncome into contact with the spinal column, in which case they are \nclassified as class III with the exception of components such as \nscrews, wedges, plates and instruments. \n6. \nACTIVE DEVICES \n6.1. \nRule 9 \nAll active therapeutic devices intended to administer or exchange energy \nare classified as class IIa unless their characteristics are such that they may \nadminister energy to or exchange energy with the human body in a \npotentially hazardous way, taking account of the nature, the density and \nsite of application of the energy, in which case they are classified as \nclass IIb. \nAll active devices intended to control or monitor the performance of active \ntherapeutic class IIb devices, or intended directly to influence the \nperformance of such devices are classified as class IIb. \nAll active devices intended to emit ionizing radiation for therapeutic \npurposes, including devices which control or monitor such devices, or \nwhich directly influence their performance, are classified as class IIb. \nAll active devices that are intended for controlling, monitoring or directly \ninfluencing the performance of active implantable devices are classified as \nclass III. \n6.2. \nRule 10 \nActive devices intended for diagnosis and monitoring are classified as \nclass IIa: \n— if they are intended to supply energy which will be absorbed by the \nhuman body, except for devices intended to illuminate the patient's \nbody, in the visible spectrum, in which case they are classified as \nclass I; \n▼B" }, { "page_number": 6, "text": "02017R0745 — EN — 10.01.2025 — 005.001 — 193 \n— if they are intended to image in vivo distribution of radiophar\nmaceuticals; or \n— if they are intended to allow direct diagnosis or monitoring of vital \nphysiological processes, unless they are specifically intended for moni\ntoring of vital physiological parameters and the nature of variations of \nthose parameters is such that it could result in immediate danger to the \npatient, for instance variations in cardiac performance, respiration, \nactivity of the central nervous system, or they are intended for \ndiagnosis in clinical situations where the patient is in immediate \ndanger, in which cases they are classified as class IIb. \nActive devices intended to emit ionizing radiation and intended for diag\nnostic or therapeutic radiology, including interventional radiology devices \nand devices which control or monitor such devices, or which directly \ninfluence their performance, are classified as class IIb. \n6.3. \nRule 11 \nSoftware intended to provide information which is used to take decisions \nwith diagnosis or therapeutic purposes is classified as class IIa, except if \nsuch decisions have an impact that may cause: \n— death or an irreversible deterioration of a person's state of health, in \nwhich case it is in class III; or \n— a serious deterioration of a person's state of health or a surgical inter\nvention, in which case it is classified as class IIb. \nSoftware intended to monitor physiological processes is classified as \nclass IIa, except if it is intended for monitoring of vital physiological \nparameters, where the nature of variations of those parameters is such \nthat it could result in immediate danger to the patient, in which case it \nis classified as class IIb. \nAll other software is classified as class I. \n6.4. \nRule 12 \nAll active devices intended to administer and/or remove medicinal \nproducts, body liquids or other substances to or from the body are clas\nsified as class IIa, unless this is done in a manner that is potentially \nhazardous, taking account of the nature of the substances involved, of \nthe part of the body concerned and of the mode of application in which \ncase they are classified as class IIb. \n6.5. \nRule 13 \nAll other active devices are classified as class I. \n7. \nSPECIAL RULES \n7.1. \nRule 14 \nAll devices incorporating, as an integral part, a substance which, if used \nseparately, can be considered to be a medicinal product, as defined in \npoint 2 of Article 1 of Directive 2001/83/EC, including a medicinal \nproduct derived from human blood or human plasma, as defined in \npoint 10 of Article 1 of that Directive, and that has an action ancillary \nto that of the devices, are classified as class III. \n▼B" }, { "page_number": 7, "text": "02017R0745 — EN — 10.01.2025 — 005.001 — 194 \n7.2. \nRule 15 \nAll devices used for contraception or prevention of the transmission of \nsexually transmitted diseases are classified as class IIb, unless they are \nimplantable or long term invasive devices, in which case they are clas\nsified as class III. \n7.3. \nRule 16 \nAll devices intended specifically to be used for disinfecting, cleaning, \nrinsing or, where appropriate, hydrating contact lenses are classified as \nclass IIb. \nAll devices intended specifically to be used for disinfecting or sterilising \nmedical devices are classified as class IIa, unless they are disinfecting \nsolutions or washer-disinfectors intended specifically to be used for disin\nfecting invasive devices, as the end point of processing, in which case \nthey are classified as class IIb. \nThis rule does not apply to devices that are intended to clean devices other \nthan contact lenses by means of physical action only. \n7.4. \nRule 17 \nDevices specifically intended for recording of diagnostic images generated \nby X-ray radiation are classified as class IIa. \n7.5. \nRule 18 \nAll devices manufactured utilising tissues or cells of human or animal \norigin, or their derivatives, which are non-viable or rendered non-viable, \nare classified as class III, unless such devices are manufactured utilising \ntissues or cells of animal origin, or their derivatives, which are non-viable \nor rendered non-viable and are devices intended to come into contact with \nintact skin only. \n7.6. \nRule 19 \nAll devices incorporating or consisting of nanomaterial are classified as: \n— class III if they present a high or medium potential for internal \nexposure; \n— class IIb if they present a low potential for internal exposure; and \n— class IIa if they present a negligible potential for internal exposure. \n7.7. \nRule 20 \nAll invasive devices with respect to body orifices, other than surgically \ninvasive devices, which are intended to administer medicinal products by \ninhalation are classified as class IIa, unless their mode of action has an \nessential impact on the efficacy and safety of the administered medicinal \nproduct or they are intended to treat life-threatening conditions, in which \ncase they are classified as class IIb. \n7.8. \nRule 21 \nDevices that are composed of substances or of combinations of substances \nthat are intended to be introduced into the human body via a body orifice \nor applied to the skin and that are absorbed by or locally dispersed in the \nhuman body are classified as: \n▼B" } ]

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