CE技術(shù)文檔須知ContentsofTechnicalFileContentsNotesPartA1/EUofManufacturerName,PostalAddressRepresentive2Alistingofallmanufacturingsitescoveredbythequalitysystem3Productdescription3.1ofthedeviceandProductname,classificationaccessories3.2Listofaccessories(ifapplicable)3.3Specification,modelandarticlenumbers3.4Chosenconformityassessmentpath3.5Intendeduse3.6Integralpartsofthesalesunit3.7existingproductAbriefhistory(includingregulatoryapprovals)4ListofharmonizedstandardsSatisfytheAnnexI5EssentialRequirementschecklistthesolutionsadoptedtosatisfytheEssentialRequirements(template,Englishversion)6Overallmanufacturingandinspectionplanoftheproduct7RiskanalysisENISO14971:2007(template,Englishversion)8ClinicalreportDetailedseeinPartB9Labelling,ini.Productlabelsandpackagelabels(Englishversion)10Instructionforuse,patientinformation,advertisingmaterial(Englishversion)11Declarationofconformity(template,Englishversion)PartB12Informationconcerningthequalitysystemspecifictotheproduct13Detaileddescriptionsoftheproduct

13.1Designdrawingsandproductspecifications13.2Packagingandspecification(Englishversion)13.3DescriptionofthemanufacturingprocessesDrawings,qualification,Labelingcontrol,Traceability,Productandenvironmentalbioburdenparticles,Pyrogenetesting,Preventivemonitoringofprocesses(i.e.SPC),Viral-PrionDesactivationstepsetc.13.4Rawmaterialsandsuppliers14Test,verificationandevaluationreport14.1SterilemethodandvalidationIQ/OQ/PQ14.2Packagingverification(ifapplicable)Incl.packageexpireddate14.3physicalandbiologytest,verificationChemical,andevaluationreport15ClinicaldatasThecriticalreportmustbeinPartAoftheTechnicalFile.ThepublicationsquotedinthereportmustbeavailableinPartBoftheTechnicalFileasoriginaldocuments,reprintsorcopies.15.1PreclinicalEvaluation,ExpertOpinions15.2Clinicalplan15.3Clinicaldatas15.4ClinicalSummary,ExpertOpinions15.5Clinicalreport15.6RelevantLiterature容內(nèi)的檔文術(shù)技．內(nèi)容注備PartA1歐洲代表的名字、地址制造商和2質(zhì)量體系所涉及的全部制造場所清單

3產(chǎn)品描述3.1產(chǎn)品名字、器械及附件的分類3.2產(chǎn)品附件清單（適用時(shí)）3.3規(guī)格、型號(hào)及貨號(hào)3.4符合性評(píng)價(jià)路徑3.5預(yù)期用途描述3.6主要的銷售單元（適用時(shí)）3.7簡要的產(chǎn)品歷史（包括現(xiàn)有的管理審批）4適用的標(biāo)準(zhǔn)清單I符合醫(yī)療器械指令附錄5基本要求檢查表I的方案符合醫(yī)療器械指令附錄）有固定模板，需提交英文文件（6產(chǎn)品的總體生產(chǎn)或質(zhì)量控制方案7風(fēng)險(xiǎn)分析ENISO14971:2007有固定模板，需提交英文文件8臨床報(bào)告PartB詳細(xì)的臨床數(shù)據(jù)見9標(biāo)簽，包括產(chǎn)品標(biāo)簽、包裝標(biāo)簽）（需提交英文文件10使用說明、患者信息、廣告材料）（需提交英文文件11符合性聲明）（有固定模板，需提交英文文件PartB12與產(chǎn)品有關(guān)的質(zhì)量體系的信息13詳細(xì)的產(chǎn)品描述13.1設(shè)計(jì)圖及產(chǎn)品技術(shù)規(guī)范13.2包裝條件及規(guī)格）（需提交英文文件

13.3生產(chǎn)過程描述包括流程圖、資格確認(rèn)、標(biāo)簽控制、追溯性、產(chǎn)品及生產(chǎn)環(huán)境控制、過程的預(yù)防監(jiān)控、消毒或防護(hù)過程等13.4原材料和供方14試驗(yàn)、驗(yàn)證及評(píng)估報(bào)告14.1滅菌方法和驗(yàn)證的概述，滅菌證書（適用時(shí)）IQ/OQ/PQ14.2包裝驗(yàn)證（適用時(shí)）包括包裝有效期驗(yàn)證14.3化學(xué)、物理和生物學(xué)試驗(yàn)、驗(yàn)證或評(píng)估