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Guidance Document - Guidance on the Risk-based Classification System for Non-In Vitro Diagnostic Devices (non-IVDDs)

Description - Invasive Devices

Rule 1: all surgically invasive device, II, unless intended to diagnose, monitor, control or correct a defect of the CVS/CNS or fetus in utero, IV, unless intended to be absorbed by the body, III, unless long term (≥ 30 days) surgically invasive, III. Rule 2: All devices invasive via a body orifice or that come into contact with the surface of the eye; II, unless placed in the oral or nasal cavities as far as the pharynx or in the ear canal up to the ear drum, I, unless long term (≥ 30 days) invasive, III, unless intended to prevent transmission of infectious agents during sexual activities or reducing the risk thereof, III. Rule 3: despite rules 1 and 2, all denture materials and orthodontic appliances, and their accessories, II, all surgical or dental instruments, I, all latex condoms, II.

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Description - Non-Invasive Devices

Rule 4, Come into contact with injured skin, II, unless intended to be used as a mechanical barrier, for compression or for absorption of exudations, I. Rule 5, channel or store gases, liquids, tissues or body fluids for eventual administration into the body, II. Rule 6, modify the biological or chemical composition of body fluids or liquids for eventual administration into the body, III, unless, modification may introduce a foreign substance that is potentially hazardous, IV. Unless, modification accomplished through centrifugation, filtration or the exchange of heat or gas, II. Rule 7, all others, I, unless, connected to a Class II, III, or IV active device, II. Unless, act as calibrator, tester or quality control support, II.

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Description - Active Devices

Rule 8, Emit ionizing radiation, including any device intended to control, monitor or influence such a device, III, unless intended to be used in radiographic mode, II, unless, intended to be used for mammographies, III. Rule 9, active therapeutic device (and dedicated software) intended to administer or withdraw energy to or from the body, II, unless, administration or withdrawal is potentially hazardous, III, unless, control treatment of patientís condition through a closed loop system, IV. Rule 10, active diagnostic device (& dedicated software) intended to image or monitor physiological processes, II, unless, erroneous readings could result in immediate danger, III. Rule 11, administer or withdraw drugs, body fluids or other substances to or from the body, II, unless, administration or withdrawal is potentially hazardous, III, unless, control treatment of patientís condition through a closed loop system, IV. Rule 12, all others, I.

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Description - Special Rules

Rule 13, Intended to be used to: Disinfect or sterilize blood, tissues or organs that are intended for transfusion or transplantation, IV, unless, disinfect or sterilize a medical device, II. Rule 14, manufactured using animal or human cells or tissues or their derivatives or produced through the use of recombinant DNA technology, IV, unless, intended to only come into contact with intact skin, I. Rule 15, a material sold to a health care professional or dispenser for configuration or arrangement into a mould or shape to meet an individualís needs is the same class as the class of the finished medical device. Rule 16, despite rules 1 to 15, breast implants, IV, tissue expanders for breast reconstruction and augmentation, IV.

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