0. PREFACE
1. INTRODUCTION
2. SCOPE
3. References
4. DEFINITIONS
5. ETHICAL CONSIDERATIONS
6. VALIDATION
7. ASSESSMENT
8. DECISION ON APPROVAL/AUTHORIZATION
9. INFORMATION TO BE EVALUATED DURING
THE CONDUCT OF A CLINICAL INVESTIGATION
AND AT THE END
APPENDICES
1a: List of the standards applied in full or in part
1b: Matrix of Essential Requirements applicable to IMD
2: Guidance notes on medical devices incorporating a
medicinal substance having ancillary action
3: Guidance on medical devices which require sterilization
4: Guidance on clinical investigations of active devices
5: Guidance on clinical investigations of software
6: Guidance on medical devices incorporating tissues
of animal origin
7: Clinical investigation application form
8: Clinical investigation validation checklist
9: Clinical investigation assessment checklist