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Quality, safety, and performance requirements for medical devices
Medical devices must comply with the Essential Principles, which set out fundamental safety and performance requirements.
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. See Schedule 1 of the Therapeutic Goods (Medical Devices) Regulations 2002 .
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.
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.
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.
The following guides give more details on selected topics.
- Demonstrating compliance with the Essential Principles
- Essential Principles checklist
- Quality management and medical devices
- Active medical devices
- Medical device cybersecurity guidance for industry
- 3-D printing (additive manufacturing) of medical devices
- Clinical evidence guidelines: Medical device
- Clinical evidence guidelines supplement: In vitro diagnostic (IVD) medical devices