This guidance is currently under construction. More information and links to further guidance will be added when available.
About the Principles
The Essential Principles are safety and performance requirements for medical devices, including in vitro diagnostic (IVD) devices. The Principles are in Schedule 1 of the Therapeutic Goods (Medical Devices) Regulations 2002 .
Manufacturers must demonstrate that their devices meet all relevant Principles, and sponsors must either hold or be able to get this evidence from their manufacturer on request.
Three key pillars
The Principles have three key pillars that the manufacturer must put in place:
- design and construct according to safety principles and risk mitigation,
- develop solutions that are state-of-the-art and best practice
- ensure that the benefits of the device outweighs its risks.
The Essential Principles
- Principle 1 - Use of medical devices not to compromise health and safety.
Applies to all medical devices - Principle 2 - Design and construction of medical devices to conform with safety principles.
Applies to all medical devices - Principle 3 - Medical devices to be suitable for intended purpose.
Applies to all medical devices - Principle 4 - Long-term safety. Applies to all medical devices for the intended lifetime of the devices, however long or short that may be.
- Principle 5 - Medical devices are not adversely affected by transport or storage.
Applies to all medical devices - Principle 6 - Benefits of medical devices to outweigh any undesirable effects.
Applies to all medical devices - Principle 7 - Chemical, physical and biological properties.
Applies to physical-form medical devices. Does not apply to devices that are just software, data, virtual anatomical models, or a service - Principle 8 - Infection and microbial contamination.
Applies to physical-form medical devices. Applies to physical-form medical devices. Does not apply to devices that are just software, data, virtual anatomical models, or a service - Principle 9 - Construction and environmental properties.
Applies to all medical devices - Principle 10 - Medical devices with a measuring function.
Applies to medical devices (including software devices) that have a measuring function as defined in Regulation 1.4. This Principle does not apply to IVD medical devices. - Principle 11 - Protection against radiation Applies to medical devices that generate radiation as part of their intended purpose
- Principle 12 - Medical devices connected to or equipped with an energy source. This includes all active medical devices (including software).
- Principle 13 - Information to be provided with medical devices.
Applies to all medical devices - Principle 14 - Clinical evidence.
Applies to all medical devices - Principle 15 - Principles applying to IVD medical devices.
Applies to all IVD medical devices
More information
The following guides give more details on selected topics.
- Demonstrating compliance with the Essential Principles
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Quality management and medical devices
This web page provides information for manufacturers about using quality management systems for management of safety, performance, and quality of their medical devices. - Active medical devices
Active medical devices are a subset of devices that use energy to operate. Software-based medical devices are a form of active medical device. This content details the requirements that apply to these devices. - Medical device cybersecurity guidance for industry
This guidance is for manufacturers and sponsors of medical devices that include software, electronic, and other programmed or programmable components. - 3-D printing (additive manufacturing) of medical devices
This web page provides information for manufacturers to address risks and meet the Australian regulatory requirements for 3D-printed medical devices. - Clinical evidence guidelines: Medical devices
This guidance gives manufacturers of medical devices (including IVDs) information on:- what clinical evidence is
- how to generate and evaluate clinical data to produce clinical evidence.
- Clinical evidence guidelines supplement: In vitro diagnostic (IVD) medical devices
This supplements guidance in Clinical evidence guidelines: Medical devices and Application audit (technical file review) of IVD medical device applications. We recommend that you review these documents together.