Template-Tech-File_Contents_for-MDD_v8-5a CE技术文件参考格式.doc

Technical File (for Medical Devices covered by directive 93/42/eec) Version No. : ___________________ Report/File No. : ___________________ Issued On : Date/Month/Year Name Position Signature Date (dd/mm/yy) Compiled By: Checked By: Approved By: Copyright ? Company Name Company Name. Address line 1 Address line 2 Country Telephone: +xxx-(xxx) xxxx-xxxx Fax: +xxx-(xxx) xxxx-xxxx Website: xxx.xxxxxxxxx.xxx CONTENTS Page Number Contents x Executive Summary x 1. Product Specification x 1.1 Product Description x 1.2 Intended Purpose/Intended Use x 1.3 Product Family x 1.4 Performance Specifications x 1.5 Product Photographs/Drawings x 1.6 List of Standards Applied in full or part x 1.7 Pre-Production Design Input and Control x 1.8 Results of Design Verification x 1.9 Clinical Evaluation Data x 1.10 Packaging and Labeling x 1.11 IFU-Instructions for Use x 2. Manufacturer and Subcontractors x 2.1 Manufacturer x 2.2 Subcontractors x 2.3 Special Processes x 3. CE Marking Compliance x 3.1 European Authorized Representative x 3.2 Classification and Attestation Route x 3.3 Conformity Assessment Procedures x 3.4 Declaration of Conformity x 3.5 Lifetime of Product x 3.6 Retention of QA Records x 3.7 Retention of CA/NB Records x 3.8 Complaints Handling x 3.9 Advisory Notices and Recalls x 3.10 Vigilance System x 3.11 Post-Market Surveillance/Feedback x 3.12 Registration with Competent Authority x 3.13 Notified Body Intervention and Certifications x 4. Essential Requirements x 4.1 General Requirements x 4.2 Requirements Regarding Design and Construction x 4.3 Requirements Regarding Information Supplied by the Manufacturer x 5. Risk Assessment x 5.1 Risk Assessment x 5.2