Medical device studies

What is a medical device trial?

A medical device trial is a systematic investigation with human participants to assess the safety, performance and effectiveness of a new or modified medical device.

Unlike Clinical Drug Studies, the medical device pathway is staged around the evolving nature of device development rather than fixed pharmaceutical-style phases.

Medical device trials are expected to be conducted in accordance with ISO 14155:2026 Clinical investigation of medical devices for human subjects – Good clinical practice.

What is classed as a ‘medical device’ in Australia

A medical device can be any product or software (including Artificial Intelligence) that works to achieve a therapeutic purpose in or on human beings. Importantly, a medical device does not achieve its principle intended action by pharmacological, immunological or metabolic means. 

The Therapeutic Goods Administration (TGA) specifically defines a medical device as any instrument, apparatus, appliance, software (including AI), implant, reagent, material or other article intended for us in humans for one or more of the following reasons:

• Diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease.
• Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability.
• Investigation, replacement or modification of anatomy or physiological or pathological process or state.
• Control or support of conception.
• In vitro examination of a specimen derived from the human body for a specific medical purpose, where the principal intended action is not achieved by pharmacological, immunological or metabolic means (but may be assisted in its function by such means).

Not sure if your product qualifies as a medical device? Use the TGA’s online classification tool to find out.

Stages of medical device review

Unlike medicines, medical devices are not classified into Phase I, II, III or IV trials. Device development follows a staged evidence pathway that reflects the evolving nature of medical technologies — with room for design refinement, usability adjustments and technique optimisation along the way.

This means clinical investigations are structured around feasibility, pivotal evidence generation and post-market data collection rather than fixed pharmaceutical-style phases.

Medical device trials are typically conducted in three stages each with a different focus and participant population.

How medical devices are 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 TGA. The higher the risk, the higher the level of regulatory control.

Classification	Level of Risk
Class I	Low
Class Is (supplied sterile)	Low-medium
Class Im (with measuring function)	Low-medium
Class IIa	Low-medium
Class IIb	Medium-high
Class III	High
Active implantable medical devices (AIMD)	High

If you are unsure of your device classification, use the TGA’s online classification tool.

Medical device monitoring requirements

Monitoring of medical device clinical trials follows the National Statement on Ethical Conduct in Human Research 2025 guidelines, with two additional requirements:

• For implantable devices, researchers must establish a participant tracking system for the lifetime of the device, in line with National Statement 5.4.11(c).
• All device-related incidents must be reported to the TGA.

The NHMRC sets out the requirements for monitoring and reporting of safety events and serious breaches for clinical trials conducted in Australia.

• Safety events — see NHMRC Safety Monitoring and Reporting in Clinical Trials (2016) and Bellberry’s Safety Reporting guidance.
• Serious breaches — see Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods and Bellberry’s Serious Breaches guidance.

What Bellberry’s ethics committees can review

Bellberry’s HRECs review medical device clinical investigations across all stages — from early feasibility studies through to post-market investigations — conducted under Australian regulatory requirements.

Our committees bring together scientific, medical, legal and community expertise, tailored to the type and stage of your device study. With weekly meetings and a typical turnaround of around 21 working days, Bellberry offers rigorous and efficient independent review.

Bellberry ethics approval is widely accepted across the private sector. In the public sector, acceptance of Bellberry ethics approval is determined at the discretion of the relevant health service or jurisdiction and may vary by study phase. If you are considering a submission for a public health site, please see Public Health Site submissions.

For more on our committee structure, expertise and accreditation, see Human Research Ethics Committees.

How to submit your medical device trial for review

Medical device trial applications are submitted through Bellberry’s eProtocol online system.

See How to Apply for step-by-step guidance on registration, documentation requirements and the submission process.

Participant consent considerations

When preparing your Participant Information and Consent Form (PICF), we recommend including additional information for participants to ensure they are fully aware of all study implications, including:

• Whether an implanted device will be explanted following the study
• Whether an implanted device will remain implanted after the study, and under what circumstances
• What happens to any data collected, once the study is complete
• Who has oversight of the implanted device after the study, if it remains implanted
• What happens if there are issues with the device, or an adverse event after the study is complete

Further guidance

• ISO 14155:2026 Clinical investigation of medical devices for human subjects — Good clinical practice
• Australian Clinical Trial Handbook
• National Statement on Ethical Conduct in Human Research (2025)
• NHMRC Safety Monitoring and Reporting in Clinical Trials (2016)
• Data Safety Monitoring Boards (2018)
• Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods
• ICH GCP Guidelines
• Therapeutic Goods Act 1989
• Therapeutic Goods Regulations 1990