Re: Technical File for CE declaration - Template or Sample of required contents
Table Of Contents
Section 1. General Description Of Device
Section 2. Variants
Section 3. Design Drawings And Diagrams Of Components, Sub-assemblies, Etc.
Section 4. Methods Of Manufacture
Section 5. Methods Of Sterilization And Validation
Section 6. Descriptions And Explanations Of Design Drawings, Diagrams, And Operation Of Product
Section 7. Essential Requirements
Section 8. Applicable Standards
Section 9. Hazards Analysis
Section 10. Results Of Design Calculations And Inspections
Section 11. Connection To Other Devices
Section 12. Incorporation Of Medicinal Substances
Section 13. Clinical Information
Section 14. Instructions For Use
Section 15. Previous Regulatory Clearances
Section 16. Product Accessories And Instruments
Section 17. Declaration Of Conformity