Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:2a:p1
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 2A (pt 1/3)
Character Range: 336973–339753

Schedule 2A—Classification rules for IVD medical devices
Note: Regulation 3.2 provides for the making of classification rules. Regulation 3.3 sets out the principles for applying those rules.

1.1  Detection of transmissible agents posing high public health risk
  An IVD medical device intended to be used for any of the following purposes is classified as a Class 4 IVD medical device or a Class 4 in‑house IVD medical device:
 (a) to detect the presence of, or exposure to, transmissible agents in blood, blood components, blood products, cells, tissues or organs or any derivatives of these products of human or animal origin, in order to assess their suitability for transfusion or transplantation;
 (b) to detect the presence of, or exposure to, a transmissible agent that causes a serious disease with a high risk of propagation in Australia.

1.2  Detection of red blood cell antigens and antibodies and non‑red cell typing
 (1) An IVD medical device is classified as a Class 3 IVD medical device or a Class 3 in‑house IVD medical device if:
 (a) the device is intended to be used for detection of biological markers in order to assess the immunological compatibility of blood, blood components, blood products, cells, tissues or organs that are intended for transfusion or transplantation; and
 (b) the device is not a device mentioned in subclause (2).
 (2) An IVD medical device intended to detect any of the following markers mentioned for the following blood group systems is classified as a Class 4 IVD medical device or a Class 4 in‑house IVD medical device:
 (a) ABO system—ABO1 (A), ABO2 (B), ABO3 (AB);
 (b) Rhesus system—RH1 (D), RH2 (C), RH3 (E), RH4 (c), RH5 (e);
 (c) Kell system—KEL1 (K);
 (d) Kidd system—JK1 (Jka), JK2 (Jkb);
 (e) Duffy system—FY1 (Fya), FY2 (Fyb).

1.3  Detection of transmissible agents or biological characteristics posing moderate public health risk or high personal risk
  An IVD medical device is classified as a Class 3 IVD medical device or a Class 3 in‑house IVD medical device if it is intended for any of the following uses:
 (a) detecting the presence of, or exposure to, a sexually transmitted agent;
 (b) detecting the presence in cerebrospinal fluid or blood of an infectious agent with a risk of limited propagation;
 (c) detecting the presence of an infectious agent, if there is a significant risk that an erroneous result would cause death or severe disability to the individual or foetus being tested;
 (d) pre‑natal screening of women in order to determine their immune status towards transmissible agents;
 (e) determining infective disease status or immune status, if there is a risk that an erroneous result will lead to a patient management decision resulting in an imminent life‑threatening situation for the