Planning, Writing and Reviewing Medical Device Clinical and Performance Evaluation Reports (CERs/PERs)

A Practical Guide for the European Union and Other Countries

1st Edition - September 19, 2024
Imprint: Academic Press
Author: Joy Frestedt
Language: English
Paperback ISBN:
9 7 8 - 0 - 4 4 3 - 2 2 0 6 3 - 0
eBook ISBN:
9 7 8 - 0 - 4 4 3 - 2 2 0 6 4 - 7

A Practical Guide to Planning, Writing, and Reviewing Medical Device Clinical Evaluation Reports guides readers through clinical data evaluation of medical devices that is in com… Read more

Planning, Writing and Reviewing Medical Device Clinical and Performance Evaluation Reports (CERs/PERs)

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A Practical Guide to Planning, Writing, and Reviewing Medical Device Clinical Evaluation Reports guides readers through clinical data evaluation of medical devices that is in compliance with the EU MDR requirements and other similar regulatory requirements throughout the world. This book brings together knowledge learned as the author constructed hundreds of CERs and taught thousands of learners on how to conduct clinical data evaluations. This book will support training for clinical engineers, clinical evaluation scientists, and experts reviewing medical device CERs, and will help individual writers, teams and companies to develop stronger, more robust CERs.

Cover image
Title page
Table of Contents
Copyright
List of figures
List of tables
List of boxes
Preface
1 Historical context
2 Intended audience
3 Purpose, objectives, and goals
4 Main references and starting points
Please send feedback
Acknowledgments
Chapter 1. Introduction
1.1 The start of clinical or performance evaluations
1.2 European Union clinical and performance evaluation regulatory requirements
1.3 Relevant general safety and performance requirements
1.4 Defining a clinical evaluation report/performance evaluation report
1.5 Comparing clinical evaluation reports and performance evaluation reports
1.6 The clinical evaluation report/performance evaluation report value proposition
1.7 Clinical evaluation/performance evaluation guidance documents
1.8 Designation of Notified Bodies under medical device regulation and in vitro diagnostic regulation
1.9 Linking clinical or performance evaluation, postmarket surveillance, and risk management systems in the quality management system
1.10 Quality management system control of clinical or performance evaluation
1.11 Clinical data
1.12 How clinical data sources change over time
1.13 Clinical evaluation report/performance evaluation report TYPES
1.14 Writing clinical evaluation/performance evaluation documents
1.15 Conclusions
1.16 Review questions
References
Chapter 2. Planning clinical/performance evaluations
2.1 Product must be a medical device
2.2 Follow the regulatory requirements
2.3 Use international regulatory standards
2.4 Specify how to document the plan in the quality management system
2.5 Clinical evaluation/performance evaluation strategies and process controls
2.6 TEN stage gates
2.7 Stage Gate 1: Kick-off meeting defines clinical evaluation/performance evaluation scope
2.8 Stage Gate 2: Clinical evaluation plan/performance evaluation plan development and version control
2.9 Clinical evaluation/performance evaluation planning by clinical evaluation/performance evaluation type
2.10 Check, sign, and date clinical evaluation plan/performance evaluation plan before clinical evaluation/performance evaluation begins
2.11 Conclusions
2.12 Review questions
References
Chapter 3. Identifying clinical/performance data
3.1 Clinical data definition
3.2 Clinical data identification process
3.3 Using appropriate software to store identified clinical data
3.4 Clinical trial data identification
3.5 Clinical literature data identification
3.6 Clinical experience data identification
3.7 Clinical data identification by clinical evaluation/performance evaluation type
3.8 Conclusions
3.9 Review questions
References
Chapter 4. Appraising clinical/performance data
4.1 Good appraisal processes are iterative
4.3 Clinical trial data appraisal
4.4 Clinical literature data appraisal
4.5 Clinical experience data
4.6 Clinical data appraisal by clinical eevaluation/perfomance evaluation type
4.7 Who should appraise clinical data?
4.8 What if the prior appraisal missed or duplicated clinical data?
4.9 Conclusions
4.10 Review questions
References
Chapter 5. Analyzing clinical/performance data
5.1 Quality management system must define clinical/performance data analysis process
5.2 In vitro diagnostic and other devices have different data analysis needs
5.3 Clinical/performance trial analysis
5.4 Clinical/performance literature analysis
5.5 Clinical experience analysis
5.6 Identifying benefit-risk ratio and PMCF needs
5.7 Clinical data analysis by Clinical Evaluation/Perfromance Evaluation type
5.8 Evaluator expertise is required
5.9 Conclusions
5.10 Review questions
References
Chapter 6. Establishing clinical benefit-risk ratios
6.1 Benefit-risk ratio requirements
6.2 Benefit-risk ratio evaluation methods
6.3 Benefit-risk ratio documentation
6.4 Define the benefit-risk ratio process steps
6.5 Conclusions
6.6 Review questions
References
Chapter 7. Writing clinical/performance evaluation documents
7.1 Stay organized and focused on clinical data
7.2 Understand why clinical evaluation/performance evaluation documents are difficult to write
7.3 Specify roles and responsibilities
7.4 Plan enough time to write the required documents
7.5 Follow the natural flow when writing
7.6 Evaluate statistical quality
7.7 Writing tips
7.8 Manager tips
7.9 Conclusions
7.10 Review questions
References
Chapter 8. Writing safety and performance summary documents
8.1 Writing objectives for summary documents
8.2 The quality management system must define the summary document writing process
8.3 Guidance for summary document writing
8.4 Summary document anatomy
8.5 Strategies for writing safety and performance summaries
8.6 Summary of safety and clinical performance/summary of safety and performance translations
8.7 Summary of safety and clinical performance/summary of safety and performance updates
8.8 Conclusions
8.9 Review questions
References
Chapter 9. Reviewing clinical/performance evaluation documents
9.1 Define document review process steps
9.2 Assign appropriate document reviewers and approvers
9.3 Assign reviewer roles and responsibilities
9.4 Deficiency letter examples
9.5 Examples of expert panel opinions and guidance
9.6 Conclusions
9.7 Review questions
References
Chapter 10. Integrating clinical evaluation, postmarket surveillance and risk management systems
10.1 Postmarket follow up is required
10.2 Postmarket follow up activities are varied
10.3 Integrate risk management, clinical evaluation and postmarket surveillance processes
10.4 Different departments need specific literature searches
10.5 “Signal detection” is required
10.6 Postmarket follow up guidance documents are available
10.7 Sufficient postmarket follow up clinical evidence
10.8 Integrating clinical/performance evaluation, postmarket surveillance and postmarket clinical follow up systems
10.9 Postmarket surveillance and periodic safety update report differences
10.10 Postmarket surveillance systems must be proactive and integrated
10.11 Conclusions
10.12 Review questions
References
Chapter 11. Understanding clinical evaluation regulations outside of Europe
11.1 Rest of world clinical evaluations
11.2 Australia
11.3 China
11.4 Association of Southeast Asian Nations
11.5 Examples of countries without specific clinical evaluation report/performance evaluation report requirements
11.6 Conclusions
11.7 Review questions
References
Chapter 12. Forecasting clinical evaluation future directions
12.1 Introduction
12.2 Better, more integrated clinical evaluation systems
12.3 Unifying clinical evaluation regulations for medical devices and in vitro diagnostic devices
12.4 Driving international relations and global change
12.5 Conclusions
12.6 Review questions without answers
References
Appendix A. Example regulatory evolution timeline
Further reading
Appendix B. MEDDEV guidance list
Appendix C. Medical Device Coordinating Group endorsed guidance documents
Appendix D. Appraisal question examples
Appendix E. Notified Body clinical evaluation checklist
E.1 General details
E.2 Device description and intended application
E.3 Intended therapeutic and/or diagnostic indications and claims
E.4 Context of evaluation and choice of clinical data types
E.5 Summary of clinical data and appraisal
E.6 Data analysis
E.7 Conclusions
Appendix F. Clinical evaluation plan/performance evaluation plan requirements checklist
Appendix G. Clinical evaluation standard operating procedure example 1 (short)
G.1 Policy
G.2 Purpose
G.3 Responsibility
G.4 Procedures
G.5 References
G.6 Appendices
Appendix H. Clinical evaluation standard operating procedure example 2 (long)
1 Purpose and background
2 Scope
3 References and associated documents
4 Responsibilities
5 Procedure
Appendix I. Clinical evaluation work instruction example
Appendix J. Kick off meeting agenda/minutes/slides
Appendix K. Clinical Evaluation Plan Template
Table of Contents
1 Objective and Scope
2 Specifications and Acceptance Criteria
3 Device Description
4 Background and State of the Art (SOTA)
5 Clinical Evaluation Process
6 Postmarket Clinical Follow-up Planning
7 Clinical evolution report Conclusions
8 References
Appendix L. Clinical evaluation report template
Table of Contents
Table of Abbreviations and Definitions of Terms
1 Executive summary
2 Purpose, specifications, and acceptance criteria (safety and performance criteria)
3 Device description
4 Clinical investigation review
5 Clinical literature review
6 Clinical experience review
7 Benefit/risk discussion (GSPR 1, 6, and 8 alignment)
8 Conclusions
9 References
10 Appendices
Appendix M. Clinical data requirements checklists
Appendix N. Declaration of Interest template
Declaration of Interest form
Appendix O. Summary of safety and clinical performance/summary of safety and performance template
Appendix P. Benefit-risk ratio checklist
Appendix Q. Clinical evaluation/performance evaluation strategy checklist
Appendix R. Clinical data requirements matrix
Appendix S. Reference list of regulatory jurisdictions
Appendix T. Answers to review questions
Index

Life Sciences

Physical Sciences & Engineering

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Planning, Writing and Reviewing Medical Device Clinical and Performance Evaluation Reports (CERs/PERs)

A Practical Guide for the European Union and Other Countries

Purchase options

World Book Day Celebration!

Institutional subscription on ScienceDirect

Joy Frestedt

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