Document ID: chunk:federal_register_of_legislation:C2024C00632:section:41mb
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 41MB
Character Range: 828379–829320

41MB  Exceptions
 (1) Sections 41MA and 41MAA do not apply if:
 (a) the medical device complies with one or more medical device standards that apply to it; and
 (b) the medical device fails to comply with 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.
Note: Medical device standards are determined under Division 2 of Part 4‑2.
 (2) 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.
Note 1: In the prosecution for an offence, the defendant bears an evidential burden in relation to the matters in this section (see subsection 13.3(3) of the Criminal Code).
Note 2: In proceedings for the contravention of a civil penalty provision, the defendant must prove the matters in this section.