Evaluation report template and tips
The tips and template will help you overcome obstacles in the way of your product getting to market.
You must communicate effectively with applicable regulatory authorities. You might find these documents helpful for clinical evaluation reports (CERs), performance evaluation reports (PERs), biological evaluation reports (BERs) and other types of evaluation report.
Tables of content
Clinical Evaluation Report (CER) tips
- Introduction
- Writing tips
- Directives, guidelines and standards
- Databases for clinical trials, surveillance and literature reviews
Clinical Evaluation Report (CER) and/or Performance Evaluation Report (PER)
- Document title
- Document history
- Summary
- Scope
- Document distribution list
- Review and approval
- Acronyms and definitions list
- Tables list
- Figures list
- Admistrative particulars
- Table of contents
- Summary (of the evaluation report)
- Scope of the evaluation
- Sources of literature
- Clinical background, current knowledge, state-of-the-art
- Device under evaluation
- 5.1 Type of evaluation
- 5.2 Demonstration of equivalence (only if claimed)
- 5.3 Clinical data generated and held by the manufacturer
- 5.4 Clinical data from literature
- 5.5 Summary and appraisal of clinical data
- 5.6 Analysis of clinical data
- 5.6.1 Requirement on safety
- 5.6.2 Requirement on acceptable benefit/risk profile
- 5.6.3 Requirement on performance
- 5.6.4 Requirement on acceptability of side-effects
- Conclusions
- Date of the next clinical evaluation
- Dates and signatures
- Qualification of the responsible evaluators
- References
- State-of-the-art literature
- Systematic review literature
- Appendix X: Author curriculum vitaes
- Appendix X: Checklists
- Checklist: General safety and performance requirements