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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 /

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 toge...

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Bibliographic Details
Main Author: Frestedt, Joy L. (Author)
Corporate Author: ScienceDirect (Online service)
Format: eBook
Language:English
Published: London : Academic Press, [2025]
Subjects:
Medical instruments and apparatus.
Equipment and Supplies
Médecine > Appareils et instruments.
Electronic books.
Online Access:Connect to the full text of this electronic book
Table of Contents:
  • Front Cover
  • Planning, Writing and Reviewing Medical Device Clinical and Performance Evaluation Reports (CERs/PERs)
  • Copyright Page
  • Contents
  • 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
  • References
  • 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
  • 1.7.1 Notified Bodies, Medical Devices/2.7/Rec1 (June 1998) clinical investigations for clinical evaluation (CE) marking
  • 1.7.2 MEDDEV 2.10/2, Rev. 1 (April 2001) Notified Bodies designation and monitoring
  • 1.7.3 MEDDEV 2.7.1 (April 2003) evaluation of clinical data
  • 1.7.4 Global Harmonization Task Force Study Group 5 clinical evidence history (January 2005)
  • 1.7.5 Global Harmonization Task Force Study Group 5/N2R8:2007 clinical evaluation (May 2007)
  • 1.7.6 MEDDEV 2.7.1, Rev. 3 (December 2009) clinical evaluation
  • 1.7.7 Notified Bodies Operations Group guidance documents before and after 2009
  • 1.7.8 Poly Implant Prothèse breast implant scandal (2010)
  • 1.7.9 International Standards Organization 14155:2003, 2011, and 2020 medical device clinical trials
  • 1.7.10 Global Harmonization Task Force Study Group 5/N6, N7, N8 clinical evidence for in vitro diagnostic medical devices (.
  • 1.7.11 MEDDEV 2.7/1, Rev. 4 clinical evaluation guideline (July 2016)
  • 1.7.12 International Medical Device Regulators Forum/Good Regulatory Review Practices Group WG/N47 essential principles gui...
  • 1.7.13 International Medical Device Regulators Forum Medical Device Clinical Evaluation Working Group (MDCE WG)/N56FINAL 20...
  • 1.7.14 Medical Device Coordinating Group 2020-1 clinical evaluation/performance evaluation for medical device software
  • 1.7.15 Medical Device Coordinating Group 2020-6 clinical evidence for legacy devices
  • 1.7.16 Medical Device Coordinating Group 2022-10 clinical trials and in vitro diagnostics
  • 1.7.17 Medical Device Coordinating Group 2022-2 clinical evidence for in vitro diagnostics
  • 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 managem...
  • 1.10 Quality management system control of clinical or performance evaluation
  • 1.10.1 Use harmonized international standards
  • 1.10.2 Require data integrity and ALCOA+ compliance
  • 1.10.3 Use integrated standard operating procedure workflows
  • 1.10.4 Include detailed STEPS in work instructions
  • 1.11 Clinical data
  • 1.12 How clinical data sources change over time
  • 1.13 Clinical evaluation report/performance evaluation report TYPES
  • 1.13.1 Viability clinical evaluation report/performance evaluation report
  • 1.13.2 Equivalence clinical evaluation report/performance evaluation report
  • 1.13.3 First in human clinical evaluation report/performance evaluation report
  • 1.13.4 Traditional clinical evaluation report /performance evaluation report (trCER/trPER)
  • 1.13.5 Obsolete clinical evaluation report /performance evaluation report (oCER/oPER).
  • 1.13.6 Changing clinical evaluation report /performance evaluation report TYPES over time
  • 1.13.7 The clinical evaluation/performance evaluation document cycle
  • 1.14 Writing clinical evaluation/performance evaluation documents
  • 1.15 Conclusions
  • 1.16 Review questions
  • References
  • 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
  • 2.5.1 Strategies for success in clinical evaluation/performance evaluation work
  • 2.5.2 Improve quality thorugh clinical evaluation/performance evaluation monitoring and auditing
  • 2.5.3 Identify clinical evaluation/performance evaluation problems early
  • 2.5.4 Controlling clinical evaluation/performance evaluation problems to ensure success
  • 2.5.5 Controlling integration of clinical evaluation/performance evaluation, clinical trial, postmarket surveillance, and r...
  • 2.5.6 Clinical evaluation/performance evaluation success
  • 2.5.7 A good process timeline for clinical evaluation report/performance evaluation report writing
  • 2.6 TEN stage gates
  • 2.7 Stage Gate 1: Kick-off meeting defines clinical evaluation/performance evaluation scope
  • 2.7.1 Clinical evaluation/performance evaluation strategy session checklist
  • 2.7.2 Clinical data amounts vary
  • 2.7.3 Other meetings beyond the kick-off meeting
  • 2.8 Stage Gate 2: Clinical evaluation plan/performance evaluation plan development and version control
  • 2.8.1 Use a quality management system clinical evaluation plan/performance evaluation plan template
  • 2.8.2 Follow the clinical evaluation plan/performance evaluation plan table of contents.
  • 2.8.3 State the clinical evaluation/performance evaluation objective and scope
  • 2.8.4 Ensure safety and performance acceptance criteria are "well-developed"
  • 2.8.5 Describe the device
  • 2.8.6 Group low-risk devices into device families
  • 2.8.7 Define "equivalence" if required
  • 2.8.8 Describe device developmental context
  • 2.8.9 Discuss background knowledge, state-of-the-art, and alternative therapies
  • 2.8.10 Document clinical evaluation/performance evaluation planning process
  • 2.8.11 Use a good clinical data identification strategy
  • 2.8.12 Use "sandbox" to select appropriate search terms
  • 2.8.13 Select the right trials
  • 2.8.14 Select the right literature
  • 2.8.15 Select the right experiences
  • 2.8.16 Define the appraisal process
  • 2.8.17 Explain plans to develop related clinical evaluation/performance evaluation documents
  • 2.8.18 Specify postmarket surveillance activities to cover clinical data gaps
  • 2.8.19 Document device changes over time
  • 2.8.20 Document risk management including newly emerged safety and performance concerns
  • 2.8.21 Specify summary of safety and clinical performance/summary of safety and performance template development, if required
  • 2.8.22 Write clinical evaluation plan/performance evaluation plan conclusions
  • 2.9 Clinical evaluation/performance evaluation planning by clinical evaluation/performance evaluation type
  • 2.9.1 Viability clinical evaluation plan/performance evaluation plan
  • 2.9.2 Key viability clinical evaluation plan/performance evaluation plan contents
  • 2.9.3 Equivalence clinical evaluation plan/performance evaluation plan
  • 2.9.4 Key equivalence clinical evaluation plan/performance evaluation plan contents
  • 2.9.5 First-in-human clinical evaluation plan/performance evaluation plan
  • 2.9.6 Key first-in-human clinical evaluation plan/performance evaluation plan contents.
  • 2.9.7 Traditional clinical evaluation plan/performance evaluation plan
  • 2.9.8 Key traditional clinical evaluation plan/performance evaluation plan contents
  • 2.9.9 Obsoleted clinical evaluation plan/performance evaluation plan
  • 2.9.10 Key obsoleted clinical evaluation plan/performance evaluation plan contents
  • 2.10 Check, sign, and date clinical evaluation plan/performance evaluation plan before clinical evaluation/performance eval...
  • 2.11 Conclusions
  • 2.12 Review questions
  • References
  • 3 Identifying clinical/performance data
  • 3.1 Clinical data definition
  • 3.2 Clinical data identification process
  • 3.2.1 Clinical data identification should be standardized
  • 3.2.2 Sound scientific processes must be used to identify clinical data
  • 3.2.3 Quality control processes should be used during clinical data identification
  • 3.2.4 Qualified evaluators should oversee all clinical data identification efforts
  • 3.2.5 Appropriate clinical data must be identified
  • 3.2.6 Clinical data must be relevant to subject device
  • 3.2.7 Clinical data must be high quality
  • 3.2.8 Clinical data must be sufficient
  • 3.2.9 Clinical trials may be exempted when clinical data are sufficient
  • 3.2.10 Justification is allowed if clinical data are not deemed appropriate
  • 3.3 Using appropriate software to store identified clinical data
  • 3.4 Clinical trial data identification
  • 3.4.1 Clinical trial database searches
  • 3.4.2 Controlling clinical trial identification and data gathering
  • 3.4.3 Challenges during clinical trial identification
  • 3.5 Clinical literature data identification
  • 3.5.1 Clinical literature database searches
  • 3.5.2 Quality control for clinical literature identification
  • 3.5.3 Challenges during clinical literature identification
  • 3.6 Clinical experience data identification
  • 3.6.1 Clinical experience database searches.