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 2.
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.
The legislated requirements
Principle 2 focuses on manufacturers identifying and minimising risks from their medical devices during the design and construction stages. Manufacturers must consider current advances in technology and safety approaches to identify, eliminate, reduce, and manage risks.
All manufacturers must comply with this Principle.
The legislation says:
Principal 2 - Design and construction of medical devices to conform with safety principles
- The solutions adopted by the manufacturer for the design and construction of a medical device must conform with safety principles, having regard to the generally acknowledged state of the art.
- Without limiting subclause (1), in selecting appropriate solutions for the design and construction of a medical device so as to minimise any risks associated with the use of the device, the manufacturer must:
- first, identify hazards and associated risks arising from the use of the device for its intended purpose, and foreseeable misuse of the device; and
- second, eliminate, or reduce, these risks as far as possible by adopting a policy of inherently safe design and construction; and
- third, if appropriate, ensure that adequate protection measures are taken, including alarms if necessary, in relation to any risks that cannot be eliminated; and
- fourth, inform users of any residual risks that may arise due to any shortcomings of the protection measures adopte
- In paragraph (2)(d):
residual risk, for a medical device, means the risk remaining after the measures described in paragraphs (2)(a), (b) and (c) have been applied.
Guidance for manufacturers
To meet Principle 2, you must design and construct your device to reduce risks from use. You should:
- identify hazards and risks
- remove or reduce these risks as much as possible
- develop adequate protection measures where risks cannot be removed
- inform users of risks.
You should document an analysis of safety and design to show compliance with Principle 2.
You should regularly review and update records and designs to account for advances in technology (this is also referred to in the legislation as the generally acknowledged state-of-the-art). You should also consider new information gained from adverse-event reporting and consumer complaints.
When developing the device design and construction processes, you need to consider all possible risks from the device. This includes risks from using the device as intended and from foreseeable misuse.
Your device design and construction process should include the removal of risks where possible. Where risks cannot be removed, efforts must be made to reduce risks to the lowest possible level. For remaining risks, you must put in place appropriate measures, including alarms, to protect your users and other people. You must alert and inform users residual risks arising from any shortcomings from your protection measures and provide guidance on how they can reduce or manage them further.
Work undertaken by you could involve, but is not restricted to:
- outlining your approach to safety management. This includes the methodology applied, responsible personnel, and plans for review
- performing and recording safety analyses, taking care to avoid confirmation bias
- reviewing your experience with the device
- recording compliance with, and/or consideration of, relevant standards and best-practice guides, science, and engineering methods.
Note
Compliance with relevant Australian and international technical standards is often used by manufacturers to show compliance with Principle 2. However, standards are not mandatory, and you can use other relevant methods of design, construction, and testing in order to comply with Principle 2.
If your device does not comply with relevant standards, you should record why you made this decision. You should also explain how your methods of design, construction, and testing for safety and performance are equivalent to, or better than, using the relevant standard(s).
General information on how to comply with the Principles is available at: Demonstrating compliance with the Essential Principles.