The Therapeutic Goods Administration (TGA) Australia has published an updated guideline on clinical evidence requirements for medical devices, including in vitro diagnostic medical devices (IVDs) in November 2021.
The main update is the restructuring of the overall content and information in the guideline, as well as updates to the general requirements.
For clinical evidence, it comprises of clinical data and its evaluation pertaining to a medical device. TGA will need to be provided with a clear, updated, and precise explanation of the state of scientific knowledge in relation to the treatment modality to which a device relates, and in relation to the subject device specifically.
A suitable benefit-risk profile may be established from the clinical evidence and will provide the necessary assurance that the medical device can perform according to its intended use. It is also useful in identifying any unwanted effects and risks, and that they do not outweigh the benefits of the device.
The updated section also highlights the importance of clinical evidence in the establishment of the safety and performance profile of a medical device, submission of clinical evidence and the requirements, as well as the evidence required for the different type of medical devices.
More details can be found in “Clinical evidence guidelines for medical devices, November 2021”: https://www.tga.gov.au/resource/clinical-evidence-guidelines-medical-devices