Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:5:p14
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 5 (pt 14/26)
Character Range: 680165–683118

ancillary medical device.
kind, in relation to a medical device—see section 41BE of the Act.
knee joint means the joint consisting of:
 (a) the articulations between each of the 2 condyles of the femur and the corresponding surface of the tibia; and
 (b) the articulation between the patella and the trochlear groove of the femur.
laboratory network means a network of laboratory organisations that satisfies the following:
 (a) the network operates with a single quality management system;
 (b) either:
 (i) the activities of the network span more than one field of testing or program; or
 (ii) the network operates at multiple sites within a field, or involves a combination of multiple sites and fields or programs.
lay person, for the use of an IVD medical device for self‑testing, means an individual who does not have formal training in a medical field or discipline to which the self‑testing relates.
manufacturing licence—see subsection 38(1B) of the Act.
mass‑produced medical device means a medical device that:
 (a) is manufactured according to standardised dimensions or designs; and
 (b) is not designed for a particular individual; and
 (c) is manufactured in a continuous production process or in a homogenous batch.
measuring function, in relation to a medical device—see regulation 1.4.
medical device production system means a system that consists of raw materials and main production equipment (whether or not the system also consists of software), where the system is intended by the manufacturer to be used (whether or not with ancillary inputs or equipment) by a health professional, or suitably qualified person within a healthcare facility, to produce a particular medical device for use in relation to a patient of the health professional or healthcare facility.
medical devices (priority applicant) determination has the meaning given by subsection 41FKA(2) of the Act.
medical device used for a special purpose means a medical device to which regulation 3.10 applies.
nanomaterial has the meaning given by Article 2(18) of Regulation 2017/745 (as in force from time to time) of the European Parliament and the Council of the European Union.
NATA means the National Association of Testing Authorities.
partial designation conformity assessment body determination (full QMS) means a conformity assessment body determination that is not:
 (a) a full designation conformity assessment body determination; or
 (b) a partial designation conformity assessment body determination (partial QMS or partial devices).
partial designation conformity assessment body determination (partial QMS or partial devices) means a conformity assessment body determination that:
 (a) is not a 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