This guidance is currently under construction. More information and links to further guidance will be added when available.
The Essential Principles (the Principles) are legislative requirements relating to the safety and performance characteristics of medical devices. The Principles are in Schedule 1 of the Therapeutic Goods (Medical Devices) Regulations 2002.
Manufacturers of medical devices must hold scientific and other evidence that demonstrates that their devices meet the Principles before their devices can be supplied in Australia. Sponsors must either also hold, or be able to get, this evidence from their manufacturer(s) on request and within a reasonable time frame.
Importing, supplying, or exporting a medical device that does not meet the Principles is an offence under the Therapeutic Goods Act 1989 (Part 4-11).
This page includes guidance on Principle 9.
More information
More information on the Principles is available at: Meet safety, performance and quality requirements for medical device manufacturers..
General information on how to comply with the Principles is available at: Demonstrating compliance with the Essential Principles.
Principle 9 deals with the construction and environmental properties of a medical device and is broken down into two sub-principles:
- 9.1 Medical devices intended to be used in combination with other devices or equipment
- 9.2 Minimisation of risks associated with use of medical devices.
This Principle applies to all medical devices, including devices that are software.
Principle 9.1 - Medical devices intended to be used in combination with other devices or equipment
The legislated requirements
Principle 9.1 requires manufacturers of devices intended to be used in combination with other devices or equipment to ensure that both their device and the other devices or equipment operate safely and not have their intended performance be impaired.
The legislation says:
Principal 9.1 - Medical devices intended to be used in combination with other devices or equipment
A medical device that is intended by the manufacturer to be used in combination with another medical device or other equipment (including a connection system) must be designed and produced in a way that ensures that:
- the medical device, and any other device or equipment with which it is used, operate in a safe way; and
- the intended performance of the device, and any other device or equipment with which it is used, is not impaired.
Meeting Principle 9.1 - Guidance for manufacturers
To demonstrate that your medical device meets the requirements of Principle 9.1, you will need to consider:
- if your device is intended to be used in combination with any other device or piece of equipment
- risks associated with the use of your medical device and any other device or piece of equipment it is intended to be used with
- how using your device together in combination with other equipment or devices could affect safety and intended performance of all connected devices and equipment.
The work undertaken by you could involve, but is not restricted to:
- a well-reasoned and documented risk analysis considering all the other devices meant to be used for the intended purpose of your device
- documenting how your device is designed for use with other medical devices and evidence of appropriate testing procedures demonstrating that the combination of medical devices and equipment results in all devices and equipment operating safely and without any impairment to intended performance
- addressing the use of your device in combination with another medical device / equipment as part of your clinical evidence
- providing all the information for the use of your device in combination with another medical device / equipment as a part of your Instructions for Use (Principle 13)
- for medical electrical devices and systems, compliance to IEC 60601-1 or equivalent or superior method of demonstrating safety of medical electrical equipment and systems. Further information is available in Active medical devices.
General information on how to comply with the Principles is available at: Demonstrating compliance with the Essential Principles.
Principle 9.2 - Minimisation of risks associated with the use of medical devices
The legislated requirements
Principle 9.2 requires manufacturers to design and produce their devices so as to minimise risks associated with their use.
The legislation says:
Principal 9.2 - Minimisation of risks associated with use of medical devices
A medical device must be designed and produced in a way that ensures that, as far as practicable, the following risks are removed or minimised:
- the risk of injury arising from the physical features of the device;
- any risks associated with reasonably foreseeable environmental conditions;
- the risk of reciprocal interference involving other devices that are normally used in an investigation or treatment of the kind for which the device is intended to be used;
- any risks arising if maintenance or calibration of the device is not possible;
- any risks associated with the ageing of materials used in the device;
- any risks associated with loss of accuracy of any measuring or control mechanism of the device;
- the risk of fire or explosion occurring during normal use of the device, and in the event of a single fault condition, especially if the device is intended to be exposed to flammable substances or substances that can cause combustion;
- the risks associated with disposal of any waste substances.
Meeting Principle 9.2 - Guidance for manufacturers
To demonstrate that your medical device meets the requirements of Principle 9.2, you will need to consider risks associated with:
- injury from the physical features of your device
- reasonably foreseeable environmental conditions
- reciprocal interference involving other devices that are normally used in conjunction with your device
- potential lack of maintenance or calibration of your device
- the ageing of materials used in your device
- loss of accuracy of any measuring or control mechanism of your device
- a fire or explosion occurring during normal use or storage of your device
- disposal of any waste substances.
The work undertaken by you could involve, but is not restricted to:
- a well-reasoned and documented risk analysis
- documented compliance or consideration of relevant product safety and performance standards.
General information on how to comply with the Principles is available at: Demonstrating compliance with the Essential Principles.