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Quality, safety, and performance requirements for medical devices (the Essential Principles)

Medical devices must comply with the Essential Principles, which set out fundamental safety and performance requirements.

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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: 

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:

More information

The following Guidance and resources give more details on selected topics:

Related links

Essential Principles checklist
Quality management and medical devices
Product types