Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:3:p40
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 3 (pt 40/43)
Character Range: 442658–445456

or procedure pack; and
 (ha) state that the manufacturer of the system or procedure pack has manufactured the system or procedure pack in accordance with the instructions referred to in subparagraph (h)(i) and the indications referred to in subparagraph (h)(ii); and
 (i) state that the information supplied with the system or procedure pack for the use of the system or procedure pack includes instructions for use provided by the manufacturer of each item in the system or procedure pack; and
 (ia) if the manufacturer of the 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—state the matters covered by subclause (2A); and
 (j) state that the process of manufacturing the system or procedure pack, and the verification and packaging (if any) of the system or procedure pack, has been subjected to a documented method of internal control and inspection that ensures the safety, quality, performance and effectiveness of each item in the system or procedure pack; and
 (k) if the system or procedure pack is intended by the manufacturer to be supplied in a sterile state—state that the full quality assurance procedures (other than clause 1.6), or the production quality assurance procedures (other than clause 4.7), have been applied to the system or procedure pack in accordance with:
 (i) the instructions for use of each medical device included in the system or procedure pack, being the instructions for use provided by the manufacturer of the device; and
 (ii) the approved indications of each medicine, biological and other therapeutic goods (if any) included in the system or procedure pack; and
 (l) be signed by a person authorised by the manufacturer; and
 (m) set out the name and position of the person signing the declaration; and
 (n) state the date when the declaration is signed.
 (2A) For the purposes of paragraph (2)(ia), the matters are the following:
 (a) that the modification has not affected the quality, safety or performance of the medical device;
 (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—that the manufacturer of the system or procedure pack has:
 (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.
 (2B) If the manufacturer of a system or procedure pack has modified