The Australian Regulatory Guidelines for Medical Devices (ARGMD) released updated guidance "Clinical Evidence" on 23 November 2023, which provides information on Medical device clinical evidence requirements, including IVDs.
These guidelines provide details and guidance on the clinical evidence requirements for medical devices, including in vitro diagnostic medical devices (IVDs), under Australian legislation.
These guidelines serve as a reference point for both industry and regulators — assisting sponsors and manufacturers to gather, compile, and present clinical evidence in a way that meets regulatory requirements while reflecting our approach to assessing clinical evidence.
These guidelines provide information on:
The Essential Principles
Clinical evidence requirements
Sources of clinical data
Clinical evaluation and the Clinical Evaluation Report (CER)
Comparable devices including substantially equivalent devices
Requirements for specific device types
Clinical investigation data includes:
Documentation in relation to the design, approval, conduct and results of each investigation carried out by the manufacturer in relation to the use of the device in or on a human body
A record of qualitative or quantitative information obtained through observation, measurement, tests, or any other means used to assess the operation of the device; and
A written report by an expert in the relevant field, being a report that contains a critical evaluation of all the clinical investigation data held in relation to the device.
The manufacturer must ensure that:
The clinical data (whether it is clinical investigation data or a literature review) is evaluated by competent clinical experts and
Clinical evidence demonstrating that the device complies with the applicable provisions of the EPs is documented in writing.
A medical device must comply with the Essential Principles (EPs) in the MD Regulations, which set out requirements relating to device safety and performance. Click this LINK to know more about the requirements for specific device types.