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1. DURATION OF USE 1.1. ‘Transient’ means normally intended for continuous use for less than 60 minutes.

1.2. ‘Short term’ means normally intended for continuous use for between 60 minutes and 30 days.

1.3. ‘Long term’ means normally intended for continuous use for more than 30 days.

2. INVASIVE AND ACTIVE DEVICES 2.1. ‘Body orifice’ means any natural opening in the body, as well as the external surface of the eyeball, or any permanent artificial opening, such as a stoma.

2.2. ‘Surgically invasive device’ means:

(a) an invasive device which penetrates inside the body through the surface of the body, including through mucous membranes of body orifices with the aid or in the context of a surgical operation; and (b) a device which produces penetration other than through a body orifice.

2.3. ‘Reusable surgical instrument’ means an instrument intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection to an active device and which is intended by the manufacturer to be reused after appropriate procedures such as cleaning, disinfection and sterilisation have been carried out.

2.4. ‘Active therapeutic device’ means any active device used, whether alone or in combination with other devices, to support, modify, replace or restore biological functions or structures with a view to treatment or alleviation of an illness, injury or disability.

2.5. ‘Active device intended for diagnosis and monitoring’ means any active device used, whether alone or in combination with other devices, to supply information for detecting, diagnosing, monitoring or treating physiological conditions, states of health, illnesses or congenital deformities.

2.6. ‘Central circulatory system’ means the following blood vessels: arteriae pulmonales, aorta ascendens, arcus aortae, aorta descendens to the bifurcatio aortae, arteriae coronariae, arteria carotis communis, arteria carotis externa, arteria carotis interna, arteriae cerebrales, truncus brachiocephalicus, venae cordis, venae pulmonales, vena cava superior and vena cava inferior.

2.7. ‘Central nervous system’ means the brain, meninges and spinal cord.

2.8. ‘Injured skin or mucous membrane’ means an area of skin or a mucous membrane presenting a pathological change or change following disease or a wound. CHAPTER II IMPLEMENTING RULES 3.1. Application of the classification rules shall be governed by the intended purpose of the devices.

3.2. If the device in question is intended to be used in combination with another device, the classification rules shall apply separately to each of the devices. Accessories for a medical device shall be classified in their own right ◄ separately from the device with which they are used.

3.3. Software, which drives a device or influences the use of a device, shall fall within the same class as the device. If the software is independent of any other device, it shall be classified in its own right.

3.4. If the device is not intended to be used solely or principally in a specific part of the body, it shall be considered and classified on the basis of the most critical specified use.

3.5. If several rules, or if, within the same rule, several sub-rules, apply to the same device based on the device's intended purpose, the strictest rule and sub-rule resulting in the higher classification shall apply.

3.6. In calculating the duration referred to in Section 1, continuous use shall mean:

(a) the entire duration of use of the same device without regard to temporary interruption of use during a procedure or temporary removal for purposes such as cleaning or disinfection of the device. Whether the interruption of use or the removal is temporary shall be established in relation to the duration of the use prior to and after the period when the use is interrupted or the device removed; and (b) the accumulated use of a device that is intended by the manufacturer to be replaced immediately with another of the same type.

3.7. A device is considered to allow direct diagnosis when it provides the diagnosis of the disease or condition in question by itself or when it provides decisive information for the diagnosis. CHAPTER III CLASSIFICATION RULES 4. NON-INVASIVE DEVICES 4.1. Rule 1 All non-invasive devices are classified as class I, unless one of the rules set out hereinafter applies.

4.2. Rule 2

All non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases for the purpose of eventual infusion, administration or introduction into the body are classified as class IIa:

— if they may be connected to a class IIa, class IIb or class III active device; or — if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts of organs or body cells and tissues, except for blood bags; blood bags are classified as class IIb. In all other cases, such devices are classified as class I.

4.3. Rule 3 All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class IIb, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class IIa.

All non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class III.

4.4. Rule 4 All non-invasive devices which come into contact with injured skin or mucous membrane are classified as:

— class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;

— class IIb if they are intended to be used principally for injuries to skin which have breached the dermis or mucous membrane and can only heal by secondary intent;

— class IIa if they are principally intended to manage the micro-environment of injured skin or mucous membrane; and — class IIa in all other cases. This rule applies also to the invasive devices that come into contact with injured mucous membrane.

5. INVASIVE DEVICES 5.1. Rule 5

All invasive devices with respect to body orifices, other than surgically invasive devices, which are not intended for connection to an active device or which are intended for connection to a class I active device are classified as:

— class I if they are intended for transient use;

— class IIa if they are intended for short-term use, except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in the nasal cavity, in which case they are classified as class I; and — class IIb if they are intended for long-term use, except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in the nasal cavity and are not liable to be absorbed by the mucous membrane, in which case they are classified as class IIa. All invasive devices with respect to body orifices, other than surgically invasive devices, intended for connection to a class IIa, class IIb or class III active device, are classified as class IIa.

5.2. Rule 6 All surgically invasive devices intended for transient use are classified as class IIa unless they:

— are intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with those parts of the body, in which case they are classified as class III;

— are reusable surgical instruments, in which case they are classified as class I;

— are intended specifically for use in direct contact with the heart or central circulatory system or the central nervous system, in which case they are classified as class III;

— are intended to supply energy in the form of ionising radiation in which case they are classified as class IIb;

— have a biological effect or are wholly or mainly absorbed in which case they are classified as class IIb; or — are intended to administer medicinal products by means of a delivery system, if such administration of a medicinal product is done in a manner that is potentially hazardous taking account of the mode of application, in which case they are classified as class IIb.

5.3. Rule 7 All surgically invasive devices intended for short-term use are classified as class IIa unless they:

— are intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with those parts of the body, in which case they are classified as class III;

— are intended specifically for use in direct contact with the heart or central circulatory system or the central nervous system, in which case they are classified as class III;

— are intended to supply energy in the form of ionizing radiation in which case they are classified as class IIb;

— have a biological effect or are wholly or mainly absorbed in which case they are classified as class III;

— are intended to undergo chemical change in the body in which case they are classified as class IIb, except if the devices are placed in the teeth; or — are intended to administer medicines, in which case they are classified as class IIb.

5.4. Rule 8 All implantable devices and long-term surgically invasive devices are classified as class IIb unless they:

— are intended to be placed in the teeth, in which case they are classified as class IIa;