Medical devices reforms: IVD companion diagnostics

Project overview

In 2018, the TGA sought feedback from clinicians, patients, and industry on a proposal to introduce a legal definition and regulatory approach for In vitro diagnostic (IVD) companion diagnostics.

To make sure these devices are subject to an appropriate level of premarket scrutiny.

Following consultation, a new definition of the term 'IVD companion diagnostic' was introduced. It came into effect on 1 February 2020.

An IVD companion diagnostic is an IVD medical device which provides information for the use of a corresponding medicine or biological.

The product information for the medicine, or the instructions for use of the biological, must say the device is essential for the safe and effective use of that particular medicine or biological for it to be classified as an IVD companion diagnostic.

Australia's definition of IVD companion diagnostic now aligns with the

• U.S. Food & Drug Administration's definition and;
• definition in European Union Regulation (EU) 2017/746.

Consultations

More information

• IVD companion diagnostics – Guidance on regulatory requirements
• IVD guidance documents
• Clinical evidence guidelines: Medical devices
• IVD medical devices regulation basics