Material List for CE Technology File

Material List for CE Technology File1. Manufacturer Information (Name, Address, Telephone)生产者信息（名称、地址、电话等）2. MDD Agreement生产者与欧洲授权代表签定的合约备注：是否需要推荐欧盟代表？3. EC Declaration of Conformity符合声明4. Certificate of ISO 9001/2, ISO 13485, 93/42/EEC MDD approvelISO 9001/2，ISO 13485，MDD 93/42/EEC 批准证书5. Product Description (including Product group/ planned variations)产品描述（如果是系列产品，请提供型号差异说明）备注：请提供产品说明书，必须包含“预期用途”6. Classification (according 93/42/EEC MDD Annex 9)分类（按照MDD 93/42/EEC 附录九）备注：是否需要指导产品分类？7. Product Specification产品规格，参数备注：请提供产品说明书，或者更详细的产品规格参数8. Technical Documents (drawings, production plans, component lists, labeling, Users manual / Instruction for Use, Sterile condition and method used, packaging material evaluation, production environmental control program, biocompatibility evaluation)相关技术文件 （产品外形结构图和三维爆炸图、元器件清单（BOM表）、说明书、标签（包括外包装彩盒）9. Certificate of Conformity (product /material)产品/材料的符合性证明10. Test Reports (testing laboratories, reports)测试报告（测试实验室，报告）备注：(1) 安规测试报告: IEC 60601-1, IEC 60601-2-x(2) EMC测试报告: IEC 60601-1-2(3) 软件测试报告: IEC 60601-1-4(4) 生物兼容性测试报告: ISO 10993 series(5) 性能测试报告(6) 其它: IEC 60601-1-6, IEC 60601-1-11, 环境测试, 老化测试11. Essential Requirements (93/42/EEC MDD Annex 1)基本要求（MDD 93/42/EEC 附录一）12. Risk Analysis风险分析备注：根据ISO14971做的风险分析报告13. The results of the design calculations and of the inspections carried out设计计算的结果和检查执行的结果14. Applicable standards (harmonized standards, international standards, partly applicable standards)所适用的标准（协调化标准，国际标准，部分适用标准）15. Literary study (Journal, Books, Internet, Magazines)文献研究（期刊、书刊、网络、杂志）备注：提供同类设备（已经上市的竞争对手设备）或者技术的文献资料（期刊、书刊、网络、杂志、或者视频新闻）16. Clinical Investigation (93/42/EEC MDD Annex 10)临床调查（MDD 93/42/EEC 附录十）17. Vigilance System警戒系统 Content of Technical Files under the Medical Devices DirectiveDevice descriptionA comprehensive description of the device and how it operatesContents listA list of contents of the technical file to allow easy navigationInstructions for use (Including service manuals etc and a declaration that these will be translated into all national languages)This should contain the finished user manual and any service or installation manuals and should also identify the translation procedure and languagesDescription of the Device and any variants and AccessoriesIncludes intended useThis should clearly depict the intended use and identify accessories and variant models with a description of the differences, important for deciding generic families for technical file selection for assessmentAuthorized Representative name and address(if applicable)The AR details should be here including the agreement with the ARLabels(EN 980, CE Mark, Notified Body no., Annex I 8.7, symbols)All product and packaging labeling should be stored in this sectionCompany information(Including manufacturing sites and key sub contractors)Detailed description of the company including key subcontractors, manufacturing sites and offsite activitiesDevice Classification(Including intended use, Rule No. and rationale for decision)A record of the device classification chart in accordance with MEDDEV 2.4/1 Parts 1 & 2A declaration if one of the following is incorporated into the deviceMedicinal substanceHuman blood or tissue derivativeAnimal blood or tissue derivative (refer to SEAC guidance and EN 12442These are important declarations as they may affect the assessmentConstructional dataDesign calculationsDrawings and design information to support the final deviceDeclaration of conformity (e.g. title, device & catalogue number, name and address of manufacturer and authorized representative if applicable, date when valid, declaration of conformity with the essential requirements or legislation transposing Directive, Name, position and signature of the authorized person approving)Declaration of ConformityEssential requirements checklist (Compliance for each applicable requirements and Rationale for any ERs deemed inapplicable)Comprehensive ER checklist. For items that are N/A a description as to why is requiredAnnex III DataIf applicableSelf explanatoryRisk Assessment data In compliance with ISO 14971Ensure the data in the technical file follows the requirements of ISO 14971 and is not just the risk analysisBiocompatibilityJustification of materials that come into contact with the patient ISO 10993It is important to address biocompatibility against the requirements of ISO 10993 and to justify the use of materials. This is applicable for any material that contacts with the patientClinical Investigation DataAny clinical investigation protocol or reviewReview of clinical literatureAnnex X investigationClinical investigation material in conjunction with MEDDEVs 2.71 & 2.72Defined lifetime for the deviceResults of stability studiesThe defined lifetime for the product devised from the design calculations, including justificationMeasuring function accuracy & repeatabilityFor Class I devices with a measuring functionFor Class I measuring devices the manufacturer must declare the accuracy of the function taking into consideration state of the artConformity with relevant harmonized standardsA comprehensive list of all harmonized standards used in the design and testing of the product Test data for the followingEMCElectrical safetySoftwareRelevant performance standardsTest reports for any harmonised standards employed, must be from a recognised test house if wishing to apply presumption of compliance to the relevant Essential RequirementProduct Performance dataEvaluations etc to support product claimsAll evaluation material that supports any performance claims for the deviceTransport and StorageInformation relating to Transport and storage parameters and results of trials to prove claimsSterilityValidation methods and assurance etcAll information relating to the validation and setting of the sterility parametersSales literatureTo determine that technical file supports the sales claimsAll published sales literature as this shows the performance claims for the device and will be matched to the performance dataQuality manualIndex of proceduresReference to the quality manual location and a list of the procedures contained in QMVigilance/ post market surveillanceCan form part of the auditCopy of the procedure or reference to locationMechanism for informing the notified body of significant changeCan form part of the auditCopy of the procedure or reference to location5