Commonwealth Consolidated Regulations Commonwealth Consolidated RegulationsNote: 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).
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 patient;
(f) the selection of patients:
(i) for selective therapy and management; or
(ii) for disease staging; or
(iii) in the diagnosis of cancer;
(fa) use as an IVD companion diagnostic;
(g) human genetic testing;
(h) to monitor levels of medicines, substances or biological components, when there is a risk that an erroneous result will lead to a patient management decision resulting in an immediate life - threatening situation for the patient;
(i) the management of patients suffering from a life - threatening infectious disease;
(j) screening for congenital disorders in a foetus.
Note for paragraph (f): An IVD medical device (except an IVD companion diagnostic) would fall into Class 2 under clause 1.7 if:
(a) a therapy decision would usually be made only after further investigation; or
(b) the device is used for monitoring.
1.4 IVD medical devices for self - testing
An IVD medical device for self - testing is classified as a Class 3 IVD medical device unless:
(a) the result of the examination is not determining a serious condition, ailment or defect; or
(b) the examination is preliminary and follow - up additional testing is required.
1.5 Non assay - specific quality control material
Despite clauses 1.1 to 1.4, an IVD medical device that is intended to be used as non assay - specific quality control material is classified as a Class 2 IVD medical device or a Class 2 in - house IVD medical device.
(1) A reagent or other article that possesses specific characteristics, intended by the manufacturer, to make it suitable for in vitro diagnostic procedures related to a specific examination is classified as a Class 1 IVD medical device or a Class 1 in - house IVD medical device.
(2) Despite clauses 1.1 to 1.5, the following IVD medical devices are classified as Class 1 IVD medical devices or Class 1 in - house IVD medical devices:
(a) an instrument, intended by the manufacturer, to be specifically used for in vitro diagnostic procedures;
(b) a specimen receptacle, other than a specimen receptacle that is intended for use in self - testing;
(c) a microbiological culture medium.
(3) In this clause:
"examination" means a set of operations having the object of determining the value or characteristics of a property.
Note: In some disciplines (for example, microbiology) an examination is the combination of a number of tests, observations or measurements.
"specimen receptacle" means a device, whether vacuum - type or not, specifically intended by its manufacturer for the primary containment and preservation of a specimen derived from the human body for the purpose of in vitro diagnostic examination.
Note 1: A specimen receptacle is considered to be an IVD medical device.
Note 2: A product for general laboratory use is not an IVD medical device unless the product is specifically intended by its manufacturer to be used for in vitro diagnostic examination.
1.7 Other IVD medical devices are Class 2 IVD medical devices
An IVD medical device not mentioned in this Schedule is classified as a Class 2 IVD medical device or a Class 2 in - house IVD medical device.
1.8 IVD medical devices intended for export only
Despite clauses 1.1 to 1.7, an IVD medical device is classified as a Class 1 IVD medical device if it is intended by the manufacturer for export only.