(1) A medical device complies, for the purposes of this Chapter (including Part 4-11), with the essential principles if and only if it does not contravene any of the essential principles.
(2) However, a medical device is also taken, for the purposes of this Chapter (other than Part 4-11), to comply with the essential principles if:
(a) the medical device complies with one or more medical device standards that apply to it; and
(b) the medical device contravenes the essential principles only in respect of a part or parts of the essential principles to which that medical device standard, or one or more of those medical device standards, relate.
(3) For the purposes of this section, a medical device standard relates to a part or parts of the essential principles only if the standard specifies that part or parts.