top of page

Is the invasive device with respect to body orifices, other than surgically invasive devices, intended to administer medicinal products by inhalation ?


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.

An inhalator is a device providing a mixture of oxygen and carbon dioxide for breathing that is used especially in conjunction with artificial respiration.

Does the device's mode of action have an essential impact on the efficacy and safety of the administered medicinal product or is it intended to treat life- threatening conditions?


mode of action (MoA) describes a functional or anatomical change, resulting from the exposure of a living organism to a substance. Some sources consider the mode of action to be only at the cellular level. In comparison, a mechanism of action (MOA) describes such changes at the molecular level.

bottom of page