Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:5:p15
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 5 (pt 15/26)
Character Range: 682861–685719

full designation conformity assessment body determination; and
 (b) covers:
 (i) the conformity assessment procedures set out in clause 1.6 or Part 2 of Schedule 3 (whether or not the determination also covers other procedures); or
 (ii) a Class III medical device (whether or not the determination also covers other medical devices).
patient implant card has the meaning given by clause 13A.2 of Schedule 1.
patient information leaflet has the meaning given by clause 13A.3 of Schedule 1.
patient‑matched medical device means a medical device that:
 (a) is manufactured by the manufacturer, within a specified design envelope, to match:
 (i) either or both of the anatomical and physiological features of a particular individual; or
 (ii) a pathological condition of a particular individual; and
 (b) is designed by the manufacturer (even if the design is developed in consultation with a health professional); and
 (c) is manufactured using production processes that are capable of being:
 (i) either or both validated and verified; and
 (ii) reproduced.
point of care testing, for an IVD medical device, means testing performed outside the laboratory environment, near to or at the side of the patient, that is not done under the supervision of a trained laboratory professional.
post‑production phase, in relation to a medical device, means the period during which the device is stored, transported, supplied for use and used (whether in Australia or not).
principal investigator, in relation to a clinical trial of a kind of medical device, means the person who is in charge of the conduct of the trial.
procedures for medical devices used for a special purpose means the conformity assessment procedures set out in Part 7 of Schedule 3.
production quality assurance procedures means the conformity assessment procedures set out in Part 4 of Schedule 3.
product quality assurance procedures means the conformity assessment procedures set out in Part 5 of Schedule 3.
refurbishment, of a medical device—see regulation 1.5.
residual risk for a medical device has the meaning given by subclause 2(3) of Schedule 1.
reusable surgical instrument means a medical device that is intended by the manufacturer:
 (a) to be used surgically, without being connected to an active medical device, for cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or any other similar procedure; and
 (b) to be reused after the appropriate procedures (such as cleaning, disinfection and sterilisation) specified by the manufacturer in the instructions for use have been carried out.
sample, for an IVD medical device for self‑testing, means 1 or more specimens, taken from the human body, that:
 (a) are intended to provide information on the human body; and
 (b) may serve as a basis for a decision on the human body or its processes.
serious, for a