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Applying the classification rules
Ensure the classification is consistent with the intended purpose you assign to your IVD as indicated by the packaging and information supplied with the device (e.g., instructions for use or advertising material).
We have provided some classification examples to help you, if required.
In this section: Rule 1.1 - Detection of transmissible agents posing a high public health risk | Rule 1.2 - Detection of red blood cell antigens and antibodies and non-red cell typing | Rule 1.3 - Detection of transmissible agents or biological characteristics | Rule 1.4 - IVDs for self-testing | Rule 1.5 - Non-assay specific quality control material | Rule 1.6 - Reagents, instruments | Rule 1.7 - Other IVDs are Class 2 IVD medical devices | Rule 1.8 - IVDs for export only
Rule 1.1 - Detection of transmissible agents posing a high public health risk
IVDs captured by this rule pose a high public health risk due to the significant impact incorrect results would have for public health, and are therefore Class 4 IVD medical devices or Class 4 in-house IVDs.
Rule 1.1 is presented in two parts:
- 1.1 (a) applies to IVDs that are intended to be used to establish the safety of blood and blood components for transfusion, or cells, tissues and organs for transplantation.
- 1.1 (b) applies to IVDs that are intended to be used to diagnose clinical infections that cause serious diseases with a high risk of transmission within the Australian population.
Classification Rule 1.1 (a)
This rule applies to all assays intended to be used to determine suitability for transfusion or transplantation as part of the laboratory's infectious diseases donor screening algorithm, which includes:
- front-line or screening assays
- confirmatory assays
- supplemental assays
- IVDs that detect structural components or surrogate markers of transmissible agents that cause serious disease.
In most cases, a positive result is a major determinant as to whether the donation or product will be used.
Classification Rule 1.1 (b)
This rule applies to IVDs that are intended to detect infectious agents capable of causing serious disease which:
- could result in death or long-term disability
- are often incurable or require major therapeutic interventions
- and where accurate diagnosis is vital to mitigate the public health impact of the disease.
Some IVDs are only intended to be used in a diagnostic setting, but are identical to those intended to be used for screening blood and tissue donations.
If rule 1.1 (b) does not apply
If rule 1.1 (b) does not also apply to these devices, they may be classified according to other rules, provided the IVD is marketed in accordance with the alternate classification.
For example, a syphilis assay is classified as a Class 4 IVD if it is intended to screen blood and tissue donations, but is a Class 3 IVD as per rule 1.3 (1) (a) if it is intended for diagnostic purposes only.
Recommendation from expert advisory panel
To avoid uncertainty about the classification of IVDs as Class 4 under rule 1.1 (b), TGA consulted with an expert advisory panel on which transmissible agents could be considered to cause serious disease with a high risk of propagation in Australia.
Tests for other transmissible agents would only be considered Class 4 IVDs on the basis of further expert advice.
Rule 1.2 - Detection of red blood cell antigens and antibodies and non-red cell typing
IVDs captured by this rule pose a high public health risk, or a high personal risk due to the significant impact incorrect results would have on public health and patient outcomes.
Classification rule 1.2 divides blood grouping IVDs into two subsets depending on:
- the nature of the blood group marker the IVD is designed to detect
- its importance in a transfusion or transplantation setting.
Which class applies?
Class 3 IVDs
All IVDs which:
- test for antigens, antibodies or genetic markers specific to any of the red blood cell markers not identified in rule 1.2 (2)
- are intended to be used in tissue typing to test for human leukocyte antigens and antibodies or platelet markers.
Class 4 IVDs
All IVDs which test for antigens, antibodies or genetic markers specific to any of the high risk blood groups identified in rule 1.2(2). Red blood cell markers captured by this rule are critical to ensuring safe transfusion of blood and blood components, or transplantation of cells, tissues and organs.
Rule 1.3 - Detection of transmissible agents or biological characteristics
(Posing a moderate public health risk or a high personal risk)
IVDs captured by this rule pose a moderate public health risk, or high personal risk, and often provide the critical or sole basis for correct diagnosis, and are therefore Class 3 IVDs. This rule applies to IVDs that are intended to be used for the detection of transmissible agents or biological characteristics:
- which cause diseases that, although often treatable, may result in death or long term disability if not treated in a timely manner
- where an incorrect result could lead to a patient management decision which has a significant impact on patient outcomes (e.g. result in death or severe disability)
- where an accurate diagnosis offers an opportunity to mitigate the public health impact of the condition
- Where they provide information that is critical for patient treatment
IVDs used to detect transmissible agents included in the Australian National Notifiable Diseases Surveillance System (NNDSS) were previously classified as Class 3 under now repealed classification rule 1.3(2).
The majority of IVDs to detect organisms included in the NNDSS continue to be Class 3 IVDs under classification rule 1.3(1) however there are some that are now considered to be Class 2 IVDs.
Rule 1.4 -IVDs for self-testing
Self-testing IVDs are intended to be used by individuals with no scientific or technical expertise, or formal training in a medical field or discipline that the test relates to.
In general, Rule 1.4 classifies IVDs for self-testing as Class 3 IVDs if the condition, ailment or defect to which the test relates is considered to be:
- inappropriate to be diagnosed or treated without consulting a health professional
- beyond the ability of the average person to evaluate accurately, or treat safely without adequate supervision.
Self-testing IVDs for some serious diseases, including Human Immunodeficiency Virus (HIV) and hepatitis B and C, are classified as Class 4 IVDs as classification rule 1.1b applies.
Regulation 1.3 defines an IVD medical device for self-testing as one intended to be used:
- in the home or similar environment by a lay person; or
- in the collection of a sample by a lay person and, if the sample is tested by another person (e.g. a laboratory) the results are returned directly to the person from whom the sample was taken without the direct supervision of a health professional who has formal training in a medical field or discipline to which the test relates.
TGA interprets direct supervision as written or verbal communication from a health professional that is able to:
- explain the significance of the test and
- answer questions that the person may have regarding the interpretation of the result.
This applies regardless of the nature of the result, e.g. positive, negative, quantitative value.
Other classification rules can apply
If the self-testing IVD does not determine a serious condition, or the result is preliminary and follow-up testing is required, other classification rules may apply. The instructions for use provided with the test should clearly advise the patient that follow-up testing with a medical practitioner is required.
Self-testing IVDs for serious diseases that can be supplied
A limited number of self-testing IVDs for serious diseases can be supplied in Australia. The Therapeutic Goods (Medical Devices - Excluded Purposes) Specification 2020 (made under 41BEA of the Act) indicates which self-testing IVDs for serious diseases are allowed to be supplied and those that are prohibited from supply in Australia.
The supply of Class 3 and Class 4 self-testing IVDs for the following serious diseases and conditions is allowed:
- chlamydia trachomatis;
- hepatitis B virus;
- hepatitis C virus;
- herpes simplex virus type 1 and 2;
- human immunodeficiency virus type 1 and type 2;
- neisseria gonorrhoea;
- seasonal influenza virus;
- treponema pallidum (syphilis)
- kidney disease; and
- cardiovascular disease
In relation to influenza virus, this is specific to seasonal strains of influenza virus only and does not include detection of specific strains that are novel or emerging (e.g. pandemic strains).
Self-testing IVDs solely intended for monitoring a previously diagnosed disease or condition can continue to be supplied.
Self-testing IVDs for serious diseases that cannot be supplied
With the exception of the above-listed serious diseases, all other Class 3 and 4 self-testing IVDs for serious diseases cannot be included in the ARTG, and therefore cannot be legally supplied in Australia, including:
- tests for certain serious pathogenic organisms or transmissible agents (i.e. ebola, pandemic strain of influenza);
- genetic tests, including direct-to-consumer genetic self-tests for a therapeutic purpose; and
- tests for serious diseases/disorders (such as cancer).
In addition, Class 2 self-testing IVDs for detecting faecal occult blood are prohibited from supply unless they are intended for supply for use in a government screening program.
The Therapeutic Goods (Medical Devices - Excluded Purposes) Specification 2020 does not apply to class 2, 3 and 4 self-testing IVDs if the IVD:
- is used as part of a government-sponsored screening program, or
- monitors a previously diagnosed disease, or
- is for export only.
Rule 1.5 - Non-assay specific quality control material
IVDs captured by this rule pose a low public health risk, or moderate personal risk.
This rule classifies non-assay specific quality control material as Class 2 IVDs, despite classification rules 1.1 to 1.4.
Non assay-specfic quality control material
Quality control material is taken to be controls, calibrators and standards. As a subset of this non assay-specific quality control materials is control material that is:
- not intended to be used with a specific IVD(s), and
- used to monitor the overall performance of a device and not intended to replace the manufacturer's controls for the target assay.
It is not control material that is intended by the manufacturer to be used on its own to validate and/or release results for a particular IVD(s). If representative values are provided as examples of typical results when used with certain assays:
- the wording in the IFU would need to reflect that it is indicative only, and
- the end user must establish expected results for their particular assay(s).
Assay-specific control material
Classification Rule 1.5 does not apply to assay-specific control material which is control material intended to be used:
- with a particular IVD(s), and
- for the validation and/or release of results.
Assay-specific control materials are classified in accordance with Classification rules 1.1 to 1.4, and can be either Class 2, 3 or 4 IVDs depending on the classification of the assay it is intended to be used with.
Rule 1.6 - Reagents, instruments
IVDs captured by this rule pose no (or minimal) public health risk, or low personal risk.
This rule classifies general laboratory products (reagents, instruments, apparatus, equipment or system) that are manufactured, sold or represented for use for in vitro diagnostic examinations as Class 1 IVDs.
In addition, despite classification rules 1.1 to 1.4, the following devices are classified as Class 1 IVDs:
- instruments specifically intended for IVD procedures
- specimen receptacles (other than those intended for use in self-testing)
- microbiological culture media.
Reagents supplied separately
A separately supplied reagent, with a clearly defined purpose relating to its use, is classified according to the class of the analyte or parameter it is intended to be used with, for example, for use:
- to determine a specific analyte or parameter
- with a particular IVD
- with a group of similar or closely related tests
Products for general laboratory use that are not IVDs
These are not IVD medical devices unless the product is specifically intended by the manufacturer to be used for in vitro diagnostic examination.
For example, pipettes, test tubes, baths, centrifuges, balances and general consumables which are not specifically intended by the manufacturer to be used to perform a particular test, are not considered IVD medical devices.
Rule 1.7 - Other IVDs are Class 2 IVD medical devices
IVDs captured by this rule pose a low public health risk, or moderate personal risk, and it is unlikely that an incorrect result will cause death or severe disability, or have a significant negative impact on patient outcomes.
The results obtained from devices captured by this rule rarely provide the sole determinant for the correct diagnosis. If it is the sole determinant, other information is available to guide the physician such as presenting signs and symptoms, or clinical information.
What devices are captured by this rule?
This rule applies to IVDs not captured by any of the other classification rules described in classification rules 1.1 to 1.6.
This classification also includes IVDs that detect infectious agents that are not easily spread in a population and/or cause 'self-limiting' disease, and are therefore considered to represent a low public health risk.
Rule 1.8 - IVDs for export only
If the manufacturer of an IVD medical device only intends it to be exported from Australia (i.e. not supply it in Australia), it is classified as a Class 1 IVD medical device.