Skip to main content

What is Required

Overview​

Essential Principle 14 requires that every medical device is supported by clinical evidence, appropriate to the device's use and classification, demonstrating that the device meets the relevant Essential Principles. Clinical evidence is not optional — it applies to all device classes including Class I. The volume and rigour of evidence required scales with device class and the novelty of the device. The manufacturer is responsible for generating, collating, assessing, and maintaining clinical evidence throughout the device lifecycle.

What is Clinical Evidence?​

Clinical evidence is scientific evidence that demonstrates a medical device performs as intended and is safe and effective when used as directed. It is distinct from pre-clinical (bench) testing and is specifically related to performance in clinical use. Clinical evidence may include:

  • Clinical investigations (trials) — prospective studies involving human subjects
  • Clinical literature — published peer-reviewed literature on the device or equivalent/similar devices
  • Post-market clinical follow-up (PMCF) data — data collected after ARTG inclusion from real-world use
  • Clinical evaluation of equivalent devices — for devices that are substantially equivalent to an already approved device, clinical data from the equivalent device may be used (with justification of equivalence)
  • Post-market surveillance data — adverse event reports, complaint data, and registry data

The compilation, assessment, and reporting of clinical evidence is documented in a Clinical Evaluation Report (CER). The CER is a living document that must be updated as new data becomes available.

Clinical Evidence Requirements by Device Class​

The TGA does not prescribe a fixed minimum volume of clinical evidence for each class, but the general expectations are:

ClassClinical Evidence Expectations
Class ILiterature review typically sufficient; CER not always formally required but evidence must be held
Class Is / ImLiterature review; proportionate to sterility/measurement claims
Class IIaCER based on literature and/or clinical data; equivalence claims acceptable with justification
Class IIbRobust CER; stronger evidence of clinical performance; equivalence more difficult to justify
Class IIIComprehensive CER; clinical investigation data typically expected for novel devices; equivalence claims very difficult to justify
IVD Class 1–2Performance evaluation studies; literature review
IVD Class 3–4Comprehensive performance evaluation; clinical utility data; post-market surveillance plan

The Clinical Evaluation Report (CER)​

The CER is the document that records the clinical evaluation process and conclusions. It must:

  • Define the scope and purpose of the evaluation
  • Identify the applicable Essential Principles addressed by clinical evidence
  • Describe the clinical literature search strategy and results
  • Evaluate the relevance and quality of identified clinical data
  • Assess whether the clinical evidence demonstrates the device meets the EPs
  • Identify any gaps in clinical evidence and how they are addressed (e.g., post-market clinical follow-up)

The TGA's guidance on clinical evidence follows the IMDRF Clinical Evaluation framework and aligns closely with EU MEDDEV 2.7.1 Rev 4 guidance on clinical evaluation.

👉 Clinical evidence for medical devices — TGA

Equivalence​

For many non-novel devices, clinical evidence is based on data from an equivalent device — a device that is clinically, technically, and biologically equivalent to the device being evaluated. Demonstrating equivalence requires rigorous documentation of the similarities and differences between the subject device and the claimed equivalent. The equivalence argument must be conservative — any differences must be shown not to clinically affect safety or performance.

For Class III devices and novel devices, the bar for demonstrating equivalence is very high. In many cases, a clinical investigation in the target patient population will be required.

Ongoing Clinical Evidence — Post-Market Requirements​

Clinical evidence obligations do not end at ARTG inclusion. Manufacturers must:

  • Update the CER with new clinical data as it becomes available
  • Conduct post-market clinical follow-up (PMCF) where the pre-market evidence was insufficient to address all questions
  • Report adverse events that may affect the clinical evidence assessment

Official Sources​