Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:3:p36
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 3 (pt 36/43)
Character Range: 432549–435407

(iii) any use in accordance with, or contrary to, the use intended by the manufacturer of the kind of device.

6B.6  Declaration of conformity
 (1) The manufacturer of a Class 4 in‑house IVD medical device to which these conformity assessment procedures have been applied must make a declaration of conformity in relation to the kind of device.
 (2) The declaration must:
 (a) state that the declaration is a declaration of conformity made under clause 6B.6 of Part 6B of Schedule 3 to the Therapeutic Goods (Medical Devices) Regulations 2002; and
 (b) state the name and business address of the manufacturer of the device; and
 (c) state the following information for the kind of device in relation to which the quality management system mentioned in subclause 6B.3(1) of this Part has been applied:
 (i) the unique product identifier;
 (ii) the medical device classification;
 (iii) the device nomenclature system code; and
 (d) state that the kind of device in relation to which the quality management system has been applied complies with the applicable provisions of the essential principles, the classification rules, and these conformity assessment procedures; and
 (e) if the kind of device is used in relation to the manufacture of blood, blood components and plasma derivatives, human cell and tissue based therapeutic goods—either:
 (i) state that the manufacturer satisfies the requirements in the Australian Code of Good Manufacturing Practice for Blood and Blood Components, Human Tissues and Human Cellular Therapy Products, as mentioned in subparagraph 6B.3(2)(a)(i), and state the number of the manufacturing licence held by the manufacturer, as mentioned in subparagraph 6B.3(2)(a)(ii); or
 (ii) state that the laboratory in which the kind of device is manufactured meets the requirements mentioned in subparagraphs 6B.3(2)(b)(i) and (ii), and state the NATA accreditation number issued to the laboratory; and
 (f) if the kind of device is not used in relation to the manufacture of blood, blood components and plasma derivatives, human cell and tissue based therapeutic goods—state that the laboratory in which the kind of device is manufactured meets the requirements mentioned in paragraphs 6B.3(3)(a) and (b), and state the NATA accreditation number issued to the laboratory; and
 (g) be signed by a person authorised by the manufacturer; and
 (h) set out the name and position of the person signing the declaration; and
 (i) state the date when the declaration is signed.

6B.7  Records
 (1) The manufacturer of a Class 4 in‑house IVD medical device to which these conformity assessment procedures have been applied must keep the following records in relation to the procedures and the kind of device:
 (a) the technical documentation mentioned in clause 6B.4 of this Part;
 (b) details of any changes made to the kind of device and to