This presentation will outline the draft guidelines and also the feedback received through recent consultations.

1. Draft Clinical Evidence Guidelines – Medical Devices
Dr Cheryl McRae
Assistant Secretary
Medical Devices Branch
Medical Devices and Product Quality Division
ARCS Scientific Congress Canberra 2016
11 August 2016

2. 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
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3. 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
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4. 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
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5. 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
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6. 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
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Draft Clinical Evidence Guidelines – Medical Devices

7. 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
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8. 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)
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9. Clinical evaluation report - components
• Device description, lineage and version if applicable1
• Intended purpose/indications and claims2
• Regulatory status in other countries3
• Summary of any relevant pre-clinical data4
• Demonstration of substantial equivalence (if applicable)5
• Overview of clinical data…6
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10. Clinical evaluation report - components
• Critical evaluation of clinical data7
• Critical evaluation of post-market data (clinical experience)8
• Risk analysis and risk management9
• Instructions for use, labelling and other documents supplied with the device10
• Risk-benefit analysis11
• Conclusions12
• The name, signature and curriculum vitae of the clinical expert and date of
report13
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11. 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
devicereforms@tga.gov.au
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12. Any questions?
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