Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:5:p10
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 5 (pt 10/26)
Character Range: 669819–672830

device classification.
classification rules, in relation to a medical device, means the rules for classifying the device set out in Schedule 2.
client of an Australian conformity assessment body means a manufacturer with whom the body has an agreement under which the body will carry on certification‑related activities, including issuing Australian conformity assessment body certificates to the manufacturer.
clinical evaluation procedures means the conformity assessment procedures set out in Part 8 of Schedule 3.
conformity assessment body determination assessment fee means a fee payable under regulation 9.1B for assessing an application for a conformity assessment body determination.
conformity assessment (priority applicant) determination has the meaning given by subsection 41ECA(2) of the Act.
custom‑made medical device means a medical device that:
 (a) is intended by the manufacturer to be for:
  (i) the sole use of a particular patient (the intended recipient); or
 (ii) the sole use of a particular health professional (the intended recipient) in the course of the health professional's practice; and
 (b) is manufactured by the manufacturer in accordance with a written request of a health professional (the requesting health professional) and with particular design characteristics specified by that health professional in the request (even if the design is developed in consultation with the manufacturer), where those design characteristics are intended to address:
 (i) either or both of the anatomical and physiological features of the intended recipient; or
 (ii) a pathological condition of the intended recipient; and
 (c) the requesting health professional has determined is necessary to address the matters covered by paragraph (b) because there is no kind of medical device included in the Register to address those matters or to address those matters to an appropriate level.
However, a custom‑made medical device does not include a patient‑matched medical device, an adaptable medical device or other mass‑produced medical device.
declaration of conformity (not requiring assessment by Secretary) procedures means the conformity assessment procedures set out in Part 6 of Schedule 3.
device lifetime, in relation to a medical device, means the period, indicated by the manufacturer, during which:
 (a) the device can be safely used; and
 (b) the characteristics and performance of the device are not affected by its age.
device nomenclature system code, for a medical device, means the device nomenclature system code mentioned for the device in regulation 1.7.
essential principles means the essential principles set out in Schedule 1.
EU IVD regulation has the meaning given by subclause 2(3) of Schedule 3AA.
EU medical devices regulation has the meaning given by subclause 2(2) of Schedule 3AA.
faecal microbiota transplant product means a thing that:
 (a) comprises, contains or is derived from human stool; and
 (b) is for introduction into a person for a therapeutic use.