Document ID: chunk:federal_register_of_legislation:C2007C00652:clause:1_41bh
Version: federal_register_of_legislation:C2007C00652
Segment Type: clause
Provision Reference: sch 1 cl 41BH
Character Range: 28410–29294

41BH  Meaning of compliance with essential principles

 (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.