če so namenjeni neposrednemu diagnosticiranju ali nadziranju vitalnih fizioloških procesov, razen če so izrecno namenjeni spremljanju vitalnih fizioloških parametrov, pri katerih je narava spreminjanja taka, da bi lahko to pomenilo neposredno nevarnost za bolnika, na primer spreminjanje delovanja srca, dihanja, delovanje osrednjega živčnega sistema; v tem primeru spadajo v razred IIb.
if they are intended to allow direct diagnosis or monitoring of vital physiological processes, unless they are specifically intended for monitoring of vital physiological parameters, where the nature of variations is such that it could result in immediate danger to the patient, for instance variations in cardiac performance, respiration, activity of CNS in which case they are in Class IIb.