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Presentation: Draft clinical evidence guidelines - medical devices

TGA presentations: ARCS Scientific Congress Canberra, 10-11 August 2016

15 August 2016


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  • Presented by: Dr Cheryl McRae
  • Presented at: ARCS Scientific Congress Canberra
  • Presentation date: 10-11 August 2016
  • Presentation summary: This presentation will outline the draft guidelines and also the feedback received through recent consultations.


Draft clinical evidence guidelines - medical devices

Dr Cheryl McRae
Assistant Secretary
Medical Devices Branch
Medical Devices and Product Quality Division, TGA

ARCS Scientific Congress Canberra 2016, 10-11 August 2016

Slide 1 - What are the clinical evidence guidelines?

  • Outline current TGA expectations for:
    • clinical evaluation reports
    • underlying evidence to be held by medical device manufacturers
  • Written for manufacturers and sponsors (recognising other stakeholders)
  • Aim is to clarify requirements
    • lots of errors in clinical evidence reports received by TGA
    • multiple rounds of review delays decisions and wastes time and resources

Slide 2 - Common errors in the clinical evaluation reports

  • Gaps and omissions
    • Absence of report components
    • Lack of information about the overseas regulatory history of the device
    • Information on predicate devices not included

Slide 3 - Common errors in the clinical evaluation reports

  • Inadequate evidence and/or analysis
    • Intended purpose, indications and claims not supported by data
    • Substantial equivalence not demonstrated
    • Insufficient information and/or poor quality search protocol
    • Provision of a multitude of publications with little or no explanation as to why they are of relevance

Slide 4 - Common errors in the clinical evaluation reports

  • Inconsistency and/or inappropriateness
    • Inconsistent intended purpose, indications and claims
    • Inappropriate selection of clinical experts

A full list of common errors in clinical evaluation reports is on page 30 of the draft guidelines

Slide 5 - Structure

Six sections:

  1. Introduction
  2. Legislative basis
  3. Clinical evidence
  4. Clinical evaluation report and supporting documents
  5. Demonstrating substantial equivalence
  6. Requirements for specific high risk devices

Plus a number of appendices

Slide 6 - Structure

Section 6 - Requirements for specific high risk devices

  • Total and partial joint prostheses
  • Cardiovascular devices to promote patency or functional flow
  • Electrical impulse generators
  • Heart valve replacements using a prosthetic valve
  • Supportive Devices - Meshes, Patches and Tissue Adhesives
  • Demonstrating the safety of implantable medical devices (AIMDs) in the magnetic resonance environment.

Feedback appreciated on priorities for other high risk device groups for future development

Slide 7 - What is clinical evidence?

  • Clinical investigation data
    • investigation carried out by the manufacturer of the device in relation to the use of the device in or on a human body
    • qualitative or quantitative information obtained through observation, measurement, tests or any other means used to assess the operation of the device in or on a human body
  • Literature review
    • Compilation of published and unpublished scientific literature, both favourable and unfavourable, relating to medical devices of that kind, including:
      • expert opinion
      • information about the hazards and associated risks and foreseeable misuse of the device
      • performance of devices of that kind
  • Clinical experience (usually post-market data)

Slide 8 - Clinical evaluation report - components

  1. Device description, lineage and version if applicable
  2. Intended purpose/indications and claims
  3. Regulatory status in other countries
  4. Summary of any relevant pre-clinical data
  5. Demonstration of substantial equivalence (if applicable)
  6. Overview of clinical data...

Slide 9 - Clinical evaluation report - components

  1. Critical evaluation of clinical data
  2. Critical evaluation of post-market data (clinical experience)
  3. Risk analysis and risk management
  4. Instructions for use, labelling and other documents supplied with the device
  5. Risk-benefit analysis
  6. Conclusions
  7. The name, signature and curriculum vitae of the clinical expert and date of report

Slide 10 - Current status of guidelines

  • Draft document for consultation
  • Consultation period - 15 March 2016 to 10 June 2016
  • Received 24 submissions from variety of stakeholders
  • Currently reviewing submissions and revising document

Email any comments to

Slide 11 - Any questions?

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