Demonstrating evidence to comply with the Essential Principles

You must generate and hold suitable and robust scientific, clinical, and engineering evidence that shows your device:

• Performs as intended
• Is designed and constructed safety
• Reflect current state-of-the-art (including latest scientific, technical and engineering advances). See Principle 2 at Complying with the Essential Principles on the safety and performance of medical devices.

The type of evidence required will vary depending on the device and its intended use.

Types of evidence

Evidence can be generated using a range of scientifically valid methods, including:

Traditional methods

• Bench testing
• Pre‑clinical investigations
• Clinical studies (including real‑world evidence)

Modern methods

• Computational modelling and simulation (CM&S), also known as in silico methods.

Using computational modelling and simulation (CM&S)

If you use CM&S, you must ensure the approach is appropriate and reliable for its intended purpose. CM&S may support the evidence package, including as primary supporting evidence for specific scientific or engineering questions, but should not be presented as clinical evidence in itself or used to replace clinical data where such data are needed.

When using CM&S, you should:

• apply verification, validation, and uncertainty analysis at a level proportionate to how the model is used
• link model outputs to clinically or scientifically meaningful outcomes
• explain how CM&S supports the overall evidence package, including how it complements any required clinical evidence
• support the approach with relevant standards and international guidance, where available

Factors that influence evidence requirements

The type and level of evidence you need to hold will depend on factors such as:

• Where the device is used (in, on, or away from the body)
• The setting of use (clinical or home use)
• The technologies involved in design and manufacture
• Materials used (for example, implantable devices must demonstrate sterility and biocompatibility)
• The intended user (health professional or lay person)
• Whether supplied sterile or requires sterilisation before use
• The complexity of the device
• Whether the technology is new or well established
• The intended use, clinical indications, and contraindications.

Manufacturing and design considerations

You must also demonstrate suitable production processes for specific technologies, devices, and features, including:

• Sterilisation of medical devices
• Design and development of software and programmed systems
• Use of animal-origin materials.
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The following questions might help you assess and evaluate the quality and sufficiency of your evidence.

• What is my device's intended purpose?
• Who will be using my device, in what situations, and in what environment?
• In what location of the body will my device be used?
• How does my device work? What are the risks involved with how it operates as intended, or if it is not used correctly?
• How do I know the safety and performance of my device is acceptable according to its intended purpose?
• On what basis do I conclude that my device will be able to achieve its intended purpose? What are my reasons?
• How sure am I that I have based my conclusion on data that is of sufficient quality? Is the data comprehensive, true, accurate, robust, and verifiable?
• What assumptions have I (and/or other authors) made? Are the assumptions valid?
• How am I identifying and managing biases in my data? How do biases in the data affect the validity of my evidence?
• Is there competing data? If yes, which scientific/engineering theory of the way the world works do I consider to be true and why? Are there limitations in the theories I'm following?
• What therapeutic alternatives are there to my device (including other devices and other types of therapy)? How does my device compare to the alternatives?

You must maintain and update your evidence during the lifetime of your device. You must also ensure that your evidence can be made available to the TGA on request at any time, including during the application process and while your device is being supplied.

For devices no longer included in the ARTG, you may also need to maintain:

• manufacturing and other records
• details of complaints
• details of adverse events
• records of supply
• records of recalls.

If you have implemented a quality management system, you should generate, hold, and maintain evidence according to your quality system's procedures.

Over time, you may need, or choose, to amend your intended purpose; this could involve increasing or decreasing its scope. The evidence you collect over the lifetime of the device will be from learning how your device performs in the field and the data you gather from adverse-event reports, registries, clinical trials, and customer feedback (complaints, suggestions, queries), etc. You may find that some of the supporting evidence you used initially has been updated, changed, or re-interpreted since first generated. For instance, meta studies, literature reviews and changes to technical standards.

When you no longer hold sufficient evidence

When you don't hold or are unable to maintain sufficient evidence of safety and performance (for example, new evidence becomes available about previously unforeseen hazards), you must amend your intended purpose to narrow the scope, amend your instructions for use, etc.

You must halt supply, undertake a recall, or remove your device from the ARTG if you find significant and unacceptable safety issues with your device. For more information, refer to About Australian recall actions.

There are a range of data you can use as objective evidence to show that your device complies with the Principles. The list below provides examples only and is not exhaustive.

Device design and construction

• General description including:
  • the medical device
  • Intended purpose
  • Intended user(s)
  • Validated lifetime
• Technical specifications (including software architecture)
• Details of design and development methods and technologies

Manufacturing and lifecycle processes

• Specifications and procedures for:
  • Manufacturing
  • Packaging
  • Storage, handling, and distribution
• Processes for monitoring safety, performance, and quality
• Installation and servicing procedures (if applicable)
• Sterilisation processes (if applicable)

Risk management

Risk management reports, including:

• Risk analysis and evaluation
• Identification of residual risks
• Controls of known and foreseeable risks.

Standards and best practice

Demonstrate compliance with relevant generally acknowledged state-of-the-art and best-practice:

• Technical standards, guidelines, or other validated methods
• Codes of practice
• Monographs
• Pharmacopoeias.

The Australian medical devices legislation creates a system of optional medical device standards orders (MDSO) to demonstrate compliance with the Essential Principles. Standards orders and medical devices explains how the MDSO operate.

Testing and validation

• Characterisation studies
• Verification and validation activities, including:
  • Protocols
  • Testing and analysis.
• Records of qualitative or quantitative information obtained through:
  • Observations
  • Measurements
  • Testing, or
  • Any other means used to assess how the device operates.

Clinical and literature evidence

Literature reviews including:

• a compilation, prepared using a documented methodology, of published and unpublished scientific literature, both favourable and unfavourable, of your device, including:
  • expert opinion
  • information about the hazards and associated risks from the use and potential misuse of the device
  • information about the performance of the devices you are manufacturing, including a description of the techniques used to examine whether devices of that kind achieve their intended purpose.

Post-market data

• Complaints
• Adverse-event and vigilance reports
• Registry data
• Recalls, field corrections and advisory notices.

Labelling and supporting information

• Copies of labels and packaging
• Patient information materials,
• Instructions for Use (IFU).

Expert evaluation

• Written critical evaluation of the evidence by a qualified expert
• Evidence that the expert has relevant qualifications, training, knowledge, and experience

The Essential Principles checklist can help you:

• Identify which Principles apply to your device
• Explain why certain Principles may not be relevant
• Summarise the evidence you hold in support of each of the relevant Principles

Using the checklist can support:

• Inclusion of your device in the Australian Register of Therapeutic Goods (ARTG)
• Compliance during post-market review or investigation
• Applications for an Australian Conformity Assessment certificate