Guidance about the Essential Principles 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. See Schedule 1 of the Therapeutic Goods (Medical Devices) Regulations 2002 .
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, and
- ensure that the benefits of the device outweigh its risks.
Complying with the Essential Principles
To understand requirements under the Essential Principles see this Guidance:
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GuidanceGuidance on how medical devices must comply with the Essential Principles, which set out fundamental safety and performance requirements.
Manufacturers must demonstrate that their devices meet all relevant Principles. Sponsors must either hold or be able to get this evidence from their manufacturer on request. See this Guidance:
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GuidanceManufacturers are responsible for maintaining scientific and engineering evidence that shows that their devices comply with the Essential Principles (the Principles).
More information
The following Guidance and resources give more details on selected topics:
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ChecklistsA checklist to help medical device manufacturers prove compliance with the Essential Principles
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PageLearn about quality management systems and medical devices.
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GuidanceGuidance on the requirements that specifically apply to active medical devices.
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GuidanceGuidance for manufacturers and sponsors on cyber security of medical devices that include software or electronic components.
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GuidanceGuidance for manufacturers to assist them with managing 3-D printing risks and meeting the Australian regulatory requirements for medical devices.
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PageClinical evidence guidelines: Medical devices have been finalised and are now available
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GuidanceGuidance on the clinical evidence requirements for medical devices, including in-vitro diagnostic medical devices (IVDs), under Australian legislation.