Four risk classes: I, IIa, IIb and III, plus separate IVD lists
Medical devices are classified by the degree of risk to the user into Class I (low risk), Class IIa (higher risk), Class IIb (high risk) and Class III (highest risk). Devices are additionally classified by their nature, energy coupling and other properties as non-invasive, invasive and active. In vitro diagnostic medical devices are classified separately into List A and List B (for use by professionals only), devices for self-diagnosis, and all other in vitro diagnostic devices.
Original (bs): as quoted. Translation: '(1) Medical devices are classified, according to the degree of risk to the user, into: a) Class I — medical devices with a low degree of risk; b) Class IIa — medical devices with a higher degree of risk; c) Class IIb — medical devices with a high degree of risk; d) Class III — medical devices with the highest degree of risk.' Source bytes are the official gazette text as published in the legacy YUSCII-derived encoding used by „Službeni glasnik BiH“; the excerpt is normalised to standard Latin orthography (č/ć/š/ž/đ) without changing any wording.
