Essential Principles checklist

Manufacturers must demonstrate their medical device complies with the Essential Principles.

Manufacturers must generate, collate, assess, and maintain scientific and clinical evidence that shows their devices comply with the Essential Principles. 

Evidence must be relevant to the device's intended purpose and must be objective, sufficient, and robust.

The checklist is a template to help you:

• identify the safety and performance requirements that apply to your device
• document a rationale for any of the safety and performance requirements that aren't relevant
• summarise the evidence you hold in support of each of the relevant safety and performance requirements

Completing the checklist can help you:

• apply for an Australian conformity assessment certificate
• determine if you have considered and addressed all the requirements with supporting evidence

Using the checklist

Your checklist should:

• be completed for each new medical device conformity assessment application
• provide an updated checklist for conformity assessment substantial change applications relating to your medical device
• be applicable to the subject medical devices or may be completed for a family or group of devices

Filling out the checklist

Next steps

• Manufacturers should keep completed Essential Principles checklists on file for use when required.
• Completed checklists can be provided to the TGA as part of conformity assessment applications.

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