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Classification of IVD medical devices
Version 2.0 December 2015
Classes of IVDs
Paragraph 3.3 (2)(b)
IVDs are classified into four risk classes on the basis of the manufacturer's intended purpose for the device:
|IVD classification||Level of risk|
|Class 1||No public health risk or low personal risk|
|Class 2||Low public health risk or moderate personal risk|
|Class 3||Moderate public health risk or high personal risk|
|Class 4||High public health risk|
Devices to be used in combination with other devices
Subregulation 3.3 (3)
If an IVD is designed to be used in combination with other IVDs, non-IVD medical devices, or accessories to medical devices, each device must be classified separately.
Accessories to medical devices are classified separately
Subregulation 3.3 (4)
Accessories are classified separately from the IVD that they are intended to be used with.
An accessory to an IVD is an item that its manufacturer specifically intends to be used together with an IVD to enable that IVD to be used as intended.
Subregulation 3.3 (5)
If a medical device is driven, or influenced, by an item of software, the software has the same classification as the medical device.
IVD software that is not intended to drive or influence an IVD instrument (or medical device that is not an IVD) is classified according to its intended purpose.
For more information, please go to Software as in vitro diagnostic medical devices (IVDs).
The highest classification determines the class of IVD
Subregulation 3.3 (7)
You must consider all of the classification rules to determine the correct class of an IVD.
If more than once classification rule applies to your IVD, apply the highest risk classification.
For example, identical devices may be classified differently if they have a different diagnostic purpose. This is why the manufacturer's intended purpose of the device is critical to determining the appropriate class.
There are exceptions, such as:
- Rule 1.5 specifies that IVDs that are non assay-specific quality control material are Class 2 IVDs
- Rule 1.6 specifies that instruments, specimen receptacles (other than a specimen receptacle for self-testing) and microbiological culture media are Class 1 IVDs
- Rule 1.8 specifies that export only IVDs are classified as Class 1 IVDs.
System or procedure pack
Subregulation 3.3 (7)
If one (or more) IVDs are supplied as part of a system or a procedure pack, the classification for the entire pack is the highest class of any individual IVD in the pack.
For example, if a procedure pack contains a selection of Class 1, 2 and 3 IVDs, then the entire pack is classified as a Class 3 IVD.
Packs containing IVDs and medical devices
IVD and medical devices with different classifications
A system or procedure pack, that contains both IVDs and non-IVD medical devices which have different levels of classification, is classified according to the highest class of device in the pack. This will also determine if a system or procedure pack is to be included in the ARTG as an IVD medical device or a non-IVD medical device.
For example, a procedure pack contains:
- a portable prothrombin time meter (Class 1 IVD)
- test strips or cartridges for prothrombin time self-testing (Class 3 IVD)
- and a lancet for obtaining a blood specimen (Class IIa medical device).
The procedure pack would take on the highest classification of any individual component in the pack (in this case, Class 3 IVD), and is therefore required to be included in the ARTG as an IVD medical device.
IVD and a medical device with comparable classifications
When a system or procedure pack contains both an IVD and a non-IVD medical device which have a comparable risk classification, the pack is classified according to its primary intended purpose. This will also determine whether the pack is included on the ARTG as an IVD or a non-IVD medical device.
Related information and guidance
Section 16 Systems and Procedure packs; Australian Regulatory Guidelines for Medical Devices