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
• conforms with safety principles in its design and construction
• meets the generally acknowledged state-of-the-art (including current technical advances, latest scientific and engineering evidence, etc.). See Principle 2 at Complying with the Essential Principles on the safety and performance of medical devices for further information.

The evidence you need to hold will vary according to several factors including:

• the device's location (in, on, or away from the body)
• the setting where the device will be used
• technologies that may be a part of the development, design, and manufacture of the device
• materials used to make the device. For example, manufacturers of implantable devices must generate evidence that the materials used are safe to be implanted (sterile or can be safely sterilised, biocompatible, etc.)
• who will use the device (healthcare professional, lay person)
• whether the device is supplied sterile, or is to be sterilised by the user
• the complexity of the device
• how novel or well-established the device's underlying technology, or therapeutic methods employed, are
• clinical indications and contraindications for the device.

You must also demonstrate suitable production processes for specific technologies, devices, and features. These include:

• the sterilisation of medical devices
• the design and development of programmed systems (including software)
• the inclusion of animal-origin materials.

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 includes some suggestions. Please note that this list is not exhaustive.

Details of design and construction such as:

• a general description of:
  • the medical device
  • its intended purpose
  • the intended user(s)
  • the validated lifetime of the device
• specifications for the device (and architectures for software devices)
• specifications, protocols, procedures, and details of design and development methods, and technologies used for:
  • manufacturing
  • packaging
  • storage
  • handling
  • distribution
• procedures for measuring and monitoring the safety, performance, and quality of your device
• requirements for installation (as appropriate)
• procedures for servicing (as appropriate)
• procedures for assuring your medical device is sterile (as appropriate).

Risk management report(s) that include:

• risk analysis
• risk evaluation
• identification of residual risks
• controls of known and foreseeable risks.

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.

Characterisation studies.

Verification and validation activities, including:

• protocols
• testing
• analysis.

Records of qualitative or quantitative information obtained through:

• observation
• measurement
• tests, or
• any other means used to assess how the device operates.

Clinical 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.

Collation and analysis of post-market data including:

• complaints
• adverse-event reports
• vigilance reports
• registry data
• recalls/field corrections/advisory notices.

Copies of labels, packaging, patient information, and Instructions for Use (IFU).

Critical evaluation (that is, a written report), by an expert in the relevant field, of data (including outcomes from literature reviews) you hold about your device.

(Note: When making use of expert advice, you must hold evidence that the expert holds relevant qualifications, training, knowledge, and experience.)

The Essential Principles checklist is a template that may help you:

• identify the Principles that apply to your device
• give a rationale for each of the Principles that aren't relevant
• summarise the evidence you hold in support of each of the relevant Principles

Completing the checklist could help you:

• include a medical device in the Australian Register of Therapeutic Goods (ARTG)
• comply with regulations as part of a post-market review or investigation
• apply for an Australian conformity assessment certificate

The following guides provide more details on selected topics.

• Meeting rules for active medical devices that use energy to operate
  Active medical devices are a subset of devices that use energy to operate. Software-based medical devices are a form of active medical device. This document includes guidance on the requirements that apply to these devices.
• Complying with medical device cyber security requirements
  This guidance is for manufacturers and sponsors of medical devices that include software, electronic, and other programmed/programmable components.
• Meeting 3-D printing (additive manufacturing) rules for medical devices
  This web page provides information for manufacturers to assist them with addressing these risks and meeting the Australian regulatory requirements for 3D-printed medical devices.
• Clinical evidence guidelines for medical devices
  This guidance gives manufacturers of medical devices (including IVD medical devices) information on:
  • what is clinical evidence
  • how to generate and evaluate clinical data to produce clinical evidence.
• Meeting clinical evidence requirements for in-vitro diagnostic (IVD) medical devices
  This document supplements existing guidance found in the Clinical evidence guidelines for medical devices and Preparing for technical file review (application audit) for in-vitro diagnostic (IVD) medical devices. We recommend that you review these documents together.