1. Introduction
2. Scope
3. References
4. Definitions
5. Abbreviations
6. General principles of clinical evaluation
7. Definition of the scope of the clinical
evaluation (Stage 0)
8. Identification of pertinent data (Stage 1)
9. Appraisal of pertinent data (Stage 2)
10. Analysis of the clinical data (Stage 3)
11. The clinical evaluation report (CER, Stage 4)
12. The role of the notified body in the assessment
of clinical evaluation reports
Appendices
A1. Demonstration of equivalence
A2. When should additional clinical investigations
be carried out?
A3. Device description - typical contents
A4. Sources of literature
A5. Literature search and literature review protocol,
key elements
A6. Appraisal of clinical data - examples of studies
that lack scientific validity for demonstration of
adequate clinical performance and/or clinical
safety
A7. Analysis of the clinical data - compliance to
specific Essential Requirements
A8. Devices for unmet medical needs - aspects to
consider
A9. Clinical evaluation report - proposed table of
contents, examples of contents
A10. Proposed checklist for the release of the
clinical evaluation report
A11. Information on declarations of interests
A12. Activities of notified bodies