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

20a

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.

Yes

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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?

20b

A 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.

Yes

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