(xii) Active therapeutic medica I devices for administering or exchanging energy (a) Subject to clause (b), an active therapeutic medical device shall be assigned to Class B, if it is intended for the administration or exchange of energy to or with a human body. (b) An active therapeutic medical device referred to in (a) shall be assigned to Class C, if the administration or exchange of energy may be done in a potentially hazardous way (such as through the emission of ionizing radiation), taking into account the nature, density and site of application of the energy and the type of technology involved. (c) An active therapeutic medical device shall be assigned to Class C., if it is intended for the control or monitoring, or to be used to directly influence the performance, of a Class C active therapeutic device.
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