CE技术文档清单.docxVIP

CE 技术文档须知 Contents of Technical File Contents Part A Notes 1 Name, Postal Address of Manufacturer /EU Representive 2 A listing of all manufacturing sites covered by the quality system 3 Product description 3.1 Product name, classification of the device and accessories 3.2 List of accessories (if applicable) 3.3 Specification, model and article numbers 3.4 Chosen conformity assessment path 3.5 Intended use 3.6 Integral parts of the sales unit 3.7 A brief product history (including existing regulatory approvals) 4 List of harmonized standards Satisfy the Annex I 5 Essential Requirements checklist the solutions adopted to satisfy the Essential Requirements (template, English version) 6 Overall manufacturing and inspection plan of the product 7 Risk analysis EN ISO 14971:2007 (template, English version) 8 Clinical report Detailed see in Part B 9 Labelling, inl. Product labels and package labels (English version) 10 Instruction for use, patient information, advertising material (English version) 11 Part B Declaration of conformity (template, English version) 12 Information concerning the quality system specific to the product 13 Detailed descriptions of the product 13.1 Design drawings and product specifications 13.2 Packaging and specification (English version) 13.3 Description of the manufacturing processes Drawings, qualification, Labeling control, Traceability,Product and environmental bioburden particles, Pyrogene testing, Preventive monitoring of processes (i.e. SPC), Viral- Prion Desactivation steps etc. 13.4 Raw materials and suppliers 14 Test, verification and evaluation report 14.1 Sterile method and validation IQ/OQ/PQ 14.2 Packaging verification (if applicable) Incl. package expired date 14.3 Chemical, physical and biology test, verification and evaluation report 15 Clinical datas The critical report must be in Part A of the Technical File. The publications quoted in the report must be available in Part B of the Technical File as original documents, reprints