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

1. Preface 2. Introduction 2.1. What is a Clinical Evaluation Report (CER)? 2.2. What is the history of medical device regulations in Europe? 2.3. How are CERs evolving in Europe? 2.4. How does a CER fit into the medical device life cycle? 2.5. What are CER Types? 2.6. Why is a CER so difficult to write? 2.7. Who should write the CER 2.8. What advice may be helpful to CER writing group managers? 2.9. How long does the CER writing process take? 2.10. What is a “successful” CER 2.11. Conclusions 2.12. Review Questions 2.13. References 3. Planning Clinical Evaluations of Medical Devices 3.1. Clinical Evaluation Strategy 3.2. What guidance documents are available? 3.3. Safety and performance acceptance criteria 3.4. Technical file inputs 3.5. Clinical data inputs 3.6. Clinical Evaluation Plan (CEP) development and version control 3.7. Conclusions 3.8. Review Questions 3.9. References 4. Writing Clinical Evaluation Reports of Medical Devices 4.1. Writing individual CERs 4.2. Statistical considerations for clinical data 4.3. What are some tips for writing excellent and efficient CERs? 4.4. Benefits outweigh risks and product should stay on market 4.5. What if benefits do not outweigh risks? 4.6. Conclusions 4.7. Review Questions 4.8. References 5. Identifying clinical data 5.1. Clinical data selection process 5.2. Clinical data identification quality control 5.3. Clinical data differences between CER Types 5.4. Alternatives to identifying clinical data 5.5. Identifying clinical trial data 5.6. Identifying clinical literature data 5.7. Identifying clinical experience data 5.8. Conclusions 5.9. Review Questions 5.10. References 6. Appraising clinical data 6.1. Introduction to clinical data appraisal 6.2. Appraising clinical trial data 6.3. Appraising clinical literature data 6.4. Appraising clinical experience data 6.5. Who should be appraising clinical data? 6.6. What to do if the prior appraisal missed clinical data? 6.7. Conclusions 6.8. Review Questions 6.9. References 7. Analyzing clinical data 7.1. Introduction to clinical data analysis 7.2. Clinical trial analysis 7.3. Clinical literature analysis 7.4. Clinical experience analysis 7.5. Who should be analyzing clinical data? 7.6. What to do if the prior analysis miss interpreted clinical data? 7.7. Conclusions 7.8. Review Questions 7.9. References 8. Integrating post market surveillance systems 8.1. What is a corporate PMS System? 8.2. How does PMS fit within other required systems? 8.3. What’s the difference between a PMSR and PSUR? 8.4. How are the CER and PMS PMCF related to each other? 8.5. How are the PMSR and PSUR clinical data used in the CER? 8.6. What is the benefit-risk analysis and how is this done? 8.7. Conclusions 8.8. Review Questions 8.9. References 9. Integrating risk management systems 9.1. What is a corporate risk management system 9.2. How does RM fit within other required systems? 9.3. What’s the difference between the CE, RM and PMS Systems? 9.4. Conclusions 9.5. Review Questions 9.6. References 10. Evaluating Risk:Benefit Profiles 10.1. Introduction 10.2. Conclusions 10.3. Review Questions 10.4. References 11. Incorporating post market clinical follow up studies 11.1. What is post market clinical follow up? 11.2. Why PMCF is required 11.3. Where PMDF fits within the PMS System 11.4. What is sufficient clinical evidence? 11.5. Determination of PMCF requirements 11.6. Range of PMCF requirements 11.7. How to determine the PMCF needs for a medical device 11.8. Factors influencing clinical study designs 11.9. PMCF documentation: what, when, where located? 11.10. Guidance and standards 11.10.1. MED DEV 2.7.1 Evaluation of clinical data (Dec 2008) 11.10.2. MED DEV 2.7/4 Guidelines on clinical investigation (Dec 2010) 11.10.3. EN ISO 14155-1:2009 11.10.4. MED DEV 2.7/4 (Dec 2010) 11.10.5. MED DEV 2.12/2 Rev 2 Post market clinical follow up studies (Jan 2012) 11.10.6. MED DEV 2.7/1, Rev 4 (Jan 2016)11.10.7. MDR (2017) 11.11. Conclusions11. 12. Review Questions 11.13. References 12. Writing Summaries of safety and clinical performance 12.1. SSCP anatomy 12.2. Strategies for writing SSCPs 12.3. SSCP Storage in EudaMed 12.4. SSCP Updates 12.5. Conclusions 12.6. Review Questions 12.7. References 12.8. Appendix: SSCP Template 13. Reviewing medical device clinical evaluation reports 13.1. Introduction to reviewer roles and responsibilities 13.2. Who are appropriate reviewers and approvers 13.3. What are the roles and responsibilities for internal reviewers 13.3.1. Clinical engineering department reviews1 3.3.2. Clinical department reviews 13.3.3. Regulatory department reviews 13.3.4. Quality department reviews 13.3.5. Medical practitioner review 13.4. What is the role and responsibility for external reviewers? 13.4.1. External medical practitioner review 13.4.2. Regulatory authority and NB review 13.4.2.1. What is typically cited in a deficiency letter? 13.4.2.2. What is a CEAR? 13.4.3. When is an exert panel review going to happen? 13.5. Medical Device Coordinating Group (MDCG) guidance documents 13.6. What happens after CER review? 13.7. Conclusions 13.8. Review Questions 13.9. References 14. Understanding CER Regulations outside of Europe 14.1. TGA 14.1.1. Specific data is required in Australia 14.2. China 14.2.1. Choosing CER “equivalent” device for China 14.3. US14.4. Other Countries 14.5. Conclusions 14.6. Review Questions 14.7. References 15. Forecasting CER future directions 15.1. Introduction 15.2. Internal Reactions and Global Changes 15.3. Changes anticipated in the future 15.4. Conclusions 15.5. Review Questions 15.6. References 16. Appendixes 16.1. Appendix A: Global Medical Device Regulatory Timeline 16.2. Appendix B: Clinical Data Requirements Matrix 16.3. Appendix C: CER SOP Example 1 16.4. Appendix D: CER SOP Example 2 16.5. Appendix E: CEP Template Example 16.6. Appendix F: CER Template Example 16.7. Appendix G: PMCFP Template Example 16.8. Appendix H: PMCFER Template Example 16.9. Appendix I: SSCP Template Example 16.10. Appendix J: MDCG Endorsed Guidance Documents 16.11. Appendix K: NB Deficiency Examples 16.12. Appendix L: Reference List of Regulatory Jurisdictions 17. Index and Definition of Terms