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

Complying with the Essential Principles

• Complying with the Essential Principles on the safety and performance of medical devices

  25 September 2024

  Guidance

  Guidance on how medical devices must comply with the Essential Principles, which set out fundamental safety and performance requirements.

• Demonstrating evidence to comply with the Essential Principles

  19 November 2024

  Guidance

  Manufacturers are responsible for maintaining scientific and engineering evidence that shows that their devices comply with the Essential Principles (the Principles).

More information

• Essential Principles checklist

  22 August 2024

  Checklists

  A checklist to help medical device manufacturers prove compliance with the Essential Principles

• Quality management and medical devices

  Page

  Learn about quality management systems and medical devices.

• Meeting rules for active medical devices that use energy to operate

  24 September 2024

  Guidance

  Guidance on the requirements that specifically apply to active medical devices.

• Complying with medical device cyber security requirements

  5 November 2024

  Guidance

  Guidance for manufacturers and sponsors on cyber security of medical devices that include software or electronic components.

• Meeting 3-D printing (additive manufacturing) rules for medical devices

  23 September 2024

  Guidance

  Guidance for manufacturers to assist them with managing 3-D printing risks and meeting the Australian regulatory requirements for medical devices.

• Clinical evidence guidelines documents for medical devices

  Page

  Clinical evidence guidelines: Medical devices have been finalised and are now available

• Clinical evidence guidelines for medical devices

  31 October 2024

  Guidance

  Guidance on the clinical evidence requirements for medical devices, including in-vitro diagnostic medical devices (IVDs), under Australian legislation.