Australia’s Therapeutic Goods Administration has revised its guideline on how manufacturers should classify in vitro diagnostics based on risk.
IVDs will be placed in one of four risk-based categories, ranging from Class 1 for the lowest risk to Class 4 for the highest risk. If an IVD is designed to be used in combination with other IVDs, non-IVD medical devices or accessories to medical devices, then each device must be classified separately.
The guidance, which was released Dec. 7 and replaces a November 2011 version, contains updated information to reflect an amendment to the Therapeutic Goods (Medical Devices) Regulations 2002 that removed a clause in the IVD classification rules that referred to IVDs intended to detect transmissible agents included in the Australian National Notifiable Disease Surveillance System list ().
In the section on examples provided for Class 2 IVDs, a list has been provided of transmissible agents that are of public health importance but pose a moderate personal risk because they generally cause self-limiting diseases. IVDs to detect these agents were previously deemed to be Class 3 IVDs but are now classified as Class 2 IVDs, TGA spokesman Neil Branch tells IDDM.
The new guidance reiterates that if IVDs are supplied as part of a system or procedure pack, the highest class of any component in the pack applies to the pack overall. Similarly, if IVDs are included in a pack with non-IVD devices, the highest class of product in that group applies.
The guidance also contains a detailed explanation of how to apply the classification rules, including examples for detection of transmissible agents posing a high public health risk, and detection of red blood cell antigens and antibodies and non-red cell typing.