Overview — All 15 Essential Principles
Overview
The Essential Principles (EPs) are the fundamental safety and performance requirements that all medical devices supplied in Australia must meet. They are set out in Schedule 1 of the Therapeutic Goods (Medical Devices) Regulations 2002 and have three core pillars: design and construct according to safety principles and risk mitigation; develop solutions that reflect the state of the art; and ensure that the benefits of the device outweigh its risks. Supplying a device that does not meet the Essential Principles is an offence under Part 4-11 of the Therapeutic Goods Act 1989.
The Three Pillars
Pillar 1 — Safety-based design and construction Devices must be designed and manufactured to eliminate or reduce risks to an acceptable level, using inherently safe design first, then protective measures, then warnings.
Pillar 2 — State of the art The solutions adopted must reflect the generally acknowledged state of the art — the best current knowledge and technology appropriate to the device.
Pillar 3 — Benefit-risk balance The benefits of the device must outweigh its residual risks. This is assessed in light of the intended purpose and the population it is used in.
All 15 Essential Principles
Part 1 — General Principles (apply to all devices)
| EP | Title | Applies to |
|---|---|---|
| EP 1 | Use of medical devices not to compromise health and safety | All devices |
| EP 2 | Design and construction of medical devices to conform with safety principles | All devices |
| EP 3 | Medical devices to be fit for intended purpose | All devices |
| EP 4 | Long-term safety | All devices |
| EP 5 | Medical devices not to be adversely affected by transport or storage | All devices |
| EP 6 | Medical devices not to be harmful to persons associated with their use | All devices |
Part 2 — Design and Construction Principles (apply case-by-case)
| EP | Title | Applies to |
|---|---|---|
| EP 7 | Chemical, physical and biological properties | Hardware devices |
| EP 8 | Infection and microbial contamination | Hardware devices |
| EP 9 | Construction and environmental properties | All devices |
| EP 10 | Medical devices with a measuring function | Devices with a measuring function (non-IVD) |
| EP 11 | Protection against radiation | Devices generating radiation |
| EP 12 | Medical devices connected to or equipped with an energy source | Active medical devices |
| EP 12.1 | Software — programmed or programmable devices | Software-based medical devices |
| EP 13 | Information to be provided with a medical device | All devices |
| EP 13B | Software — version numbers and build numbers | Software-based medical devices |
| EP 14 | Clinical evidence | All devices |
| EP 15 | Principles applying to IVD medical devices | IVDs only |
Not All EPs Apply to Every Device
The manufacturer is responsible for identifying which Essential Principles apply to their specific device and documenting this in an Essential Principles Checklist. The TGA publishes a standard checklist template that manufacturers can use and is expected in most technical files. For each applicable EP, the manufacturer must provide evidence of compliance — typically through testing, documented design processes, clinical evidence, and reference to applicable standards.
The TGA publishes an Essential Principles Checklist template:
👉 Essential Principles Checklist template — TGA
How to Demonstrate Compliance
There is no mandated method for demonstrating compliance with the Essential Principles. The most common approaches are:
Compliance with harmonised standards Many Australian and international standards (Australian Standards, ISO standards, IEC standards) provide a presumption of compliance with specific EPs when followed. Manufacturers should document which standards they have applied and confirm they have followed the relevant edition.
Clinical evaluation EP 14 requires clinical evidence for all devices. Clinical evidence may include clinical trial data, published literature, post-market clinical follow-up data, or data from equivalent devices.
Testing and verification Physical, chemical, biological, and performance testing appropriate to the device type and intended use.
Risk management documentation ISO 14971 (Risk Management for Medical Devices) is the accepted standard for demonstrating compliance with the risk management aspects of EPs 1, 2, and related principles.
Maintaining Compliance
Essential Principles compliance is not a one-time exercise — it must be maintained for as long as the device is supplied in Australia. If the device design, materials, manufacturing process, or intended use changes, compliance with all affected EPs must be re-evaluated. This is a post-market obligation for both the manufacturer and sponsor.
Official Sources
- Schedule 1 — Essential Principles (legislation.gov.au)
- Complying with the Essential Principles — TGA guidance
- Essential Principles overview — TGA