Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:5:p12
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 5 (pt 12/26)
Character Range: 675199–677864

procedure.
in‑house IVD medical device means an IVD medical device that is:
 (a) within the confines or scope of an Australian laboratory or Australian laboratory network:
 (i) developed from first principles; or
 (ii) developed or modified from a published source; or
 (iii) developed or modified from any other source; or
 (iv) used for a purpose, other than the intended purpose assigned by the manufacturer; and
 (b) not supplied for use outside that laboratory or laboratory network.
injured skin or mucous membrane means an area of skin or mucous membrane that has evidence of:
 (a) a pathological change; or
 (b) a change following:
 (i) disease; or
 (ii) a wound.
instructions for use, in relation to a medical device, includes information provided by the manufacturer of the device to inform a user of the device of the intended purpose of the device, of the proper use of the device and of any precautions to be taken in relation to the use of the device.
Note: These Regulations contain requirements relating to instructions for use of a medical device. For example, clauses 13.1 to 13.4 of Schedule 1 (about essential principles) deal with information that must be included in instructions for the use of a medical device.
intended purpose, of a medical device, means the purpose for which the manufacturer of the device intends it to be used, as stated in:
 (a) the information provided with the device; or
 (b) the instructions for use of the device; or
 (c) any advertising material applying to the device; or
 (d) any technical documentation describing the mechanism of action of the device.
invasive medical device means a medical device that is intended by the manufacturer to be used, in whole or in part, to penetrate the body of a human being through a body orifice or through the surface of the body.
IVD companion diagnostic means an IVD medical device:
 (a) that is intended by the manufacturer to be used for the examination of a specimen from the body of an individual:
 (i) to identify whether the individual would be likely to benefit from the use of a particular medicine or biological; or
 (ii) to identify whether the individual is likely to be at particular risk of a serious adverse reaction to the use of a particular medicine or biological; or
 (iii) to monitor the individual's response to the use of a particular medicine or biological; and
 (b) that is mentioned in product information for the medicine or biological as being essential for the safe and effective use of the medicine or biological; and
 (c) if the medicine or biological comprises blood, a blood component, cells, tissue or an organ, from a donor other than the