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2023-09-02T09:23:45
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(e) An active diagnostic medical device shall be assigned to Class C, if it is intended for the control or mon

(e) An active diagnostic 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 any active diagnostic medical device referred to in clause (d). (f) Subject to clause (g), an active medical device shall be assigned to Class B, if it is intended for the administration, or removal of, any medicinal product, body liquid or other substance to or from a human body. (g) An active medical device referred to in clause (f) shall be assigned to Class C, if the administration or removal of the medicinal product, body liquid or other substance is done in a manner that is potentially hazardous, taking into account, — (1) the nature of the medicinal product, body liquid or substance; (2) the part of the body concerned; and (3) the mode and route of the administration or removal.

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