Medical Device Trials

Medical device trials are systematic investigations with human participants to assess the safety, performance, and effectiveness of new or modified medical devices. The clinical investigations pathway for medical devices is different to the clinical trial pathway for medicines.

What is a Medical Device?

The Therapeutic Goods Administration (TGA), defines a medical device as: any instrument, apparatus, appliance, software (including AI), implant, reagent, material or other article (whether used alone or in combination, and including the software necessary for its proper application) intended, by the person under whose name it is or is to be supplied, to be used for human beings for the purpose of one or more of the following:

i. Diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease.
ii. Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability.
iii. Investigation, replacement or modification of the anatomy or of a physiological or pathological process or state.
iv. Control or support of conception.
v. In vitro examination of a specimen derived from the human body for a specific medical purpose and that does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its function by such means.

Find out if your product is a medical device by using the TGA’s online tool.

Digital Health & Artificial Intelligence

AI-related projects may be classified as a medical device if they meet the regulatory criteria or not classified as a medical device if they fall outside the medical-device definition.

Learn More

What are the stages of device review?

Unlike medicines, medical devices are not classified into Phase 1, 2 or 3 trials. Device development follows a staged evidence pathway that reflects the evolving nature of medical technologies.

Devices may undergo design refinement, usability adjustments or technique optimisation during development. This means that clinical investigations are structured around feasibility, pivotal evidence generation and post-market data collection rather than fixed pharmaceutical-style phases.

The clinical investigations pathway for medical technology is represented by the following stages:

Stage 1 – Early Clinical Investigation
Stage 1 studies are early clinical investigations, typically involving a small number of patients with the target condition. These studies are generally conducted before regulatory approval (pre-market) and aim to determine whether the device can be used safely and performs as intended in humans. The focus is on:
• Initial safety
• Technical performance
• Early usability

Stage 2 – Pivotal Clinical Investigation
Stage 2 studies involve a larger patient population and are designed to generate robust evidence of safety and performance. These investigations are usually conducted pre-market and provide the primary clinical evidence required to support regulatory approval. The focus is on:
• Confirming clinical performance
• Further evaluating safety
• Supporting defined clinical endpoints

Stage 3 – Post-Market Clinical Investigation
Stage 3 studies occur after regulatory approval has been granted. These investigations strengthen the evidence base and support ongoing monitoring of the device in clinical practice. The focus is on:
• Long-term safety and performance
• Real-world effectiveness
• Health economics and broader outcomes
• Expanded indications or population data

How are medical devices classified?

In Australia, medical devices are classified by level of risk, as defined in the Therapeutic Goods Act 1989 and Therapeutic Goods (Medical Devices) Regulations 2002, overseen by the Therapeutic Goods Administration (TGA). Similar to the EU system, the higher the risk, the higher the level of regulatory control.

If you are unsure of your device classification, use the TGA’s Classification Tool

Australian Medical Devices Categories

Monitoring requirements

Monitoring of device clinical trials follows the National Statement guidelines as with clinical trials. Additional requirements include:
• For implantable devices, researchers must establish a participant tracking system for the lifetime of the device (National Statement 5.4.11(c)).
• All device-related incidents must be reported to the TGA.

Consent considerations

During the consent process, additional information for participants in the Participant Information and Consent Form (PICF) should be considered, including:
• Will an implanted device be explanted following the study?
• Will an implanted device be able to/have to remain implanted following the study?
• What happens to any data collected following the completion of the study?
• Who has oversight of the implanted device following the study should it remain implanted?
• What happens if there are issues with the device, or an adverse event following completion of the study?