Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:3:p41
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 3 (pt 41/43)
Character Range: 445193–447999

medical device, as affected by the modification; and
 (ii) evidence that the medical device, as affected by the modification, complies with the applicable provisions of the essential principles.
 (2B) If the manufacturer of a system or procedure pack has modified the packaging of any medical device included in the system or procedure pack or modified any medical device included in the system or procedure pack:
 (a) the manufacturer of the system or procedure pack must ensure that the modification does not affect the quality, safety or performance of the medical device; and
 (b) if the modification has not been done in accordance with the instructions for use of the medical device provided by the manufacturer of the device—the manufacturer of the system or procedure pack must have:
 (i) if a conformity assessment document, a declaration of conformity under clause 6.6 or a statement under subclause 7.2(2) is required for the medical device—such a document, declaration or statement for the medical device, as affected by the modification; and
 (ii) evidence that the medical device, as affected by the modification, complies with the applicable provisions of the essential principles.
 (3) The manufacturer of a system or procedure pack must establish, and keep up‑to‑date, a post‑marketing system that complies with subclause (4) for use in relation to the system or procedure pack.
 (4) A post‑marketing system complies with this subclause in relation to a system or procedure pack if the post‑marketing system requires the manufacturer of the system or procedure pack:
 (a) to systematically review experience gained in the post‑production phase in relation to the system or procedure pack; and
 (b) to implement appropriate means to apply any necessary corrective action in relation to the production of the system or procedure pack; and
 (c) to notify the Secretary as soon as practicable after becoming aware of:
 (i) information relating to:
 (A) any malfunction or deterioration in the characteristics or performance of the system or procedure pack; or
 (B) any inadequacy in the production, labelling, instructions for use or advertising materials of the system or procedure pack; or
 (C) any use in accordance with, or contrary to, the use intended by the manufacturer of the system or procedure pack;
  that might lead, or might have led, to the death of a patient or a user of the system or procedure pack, or to a serious deterioration in his or her state of health; or
 (ii) information relating to any technical or medical reason for a malfunction or deterioration of a kind mentioned in subparagraph (i) that has led the manufacturer to take steps to recall system or procedure packs of that kind that have been distributed.
Note: See also paragraph 41FN(3)(d) and sections 41MP