无源医疗器械技术文件和设计文档指南Whereastheterm“TechnicalFile“isusedforMedicalDevicesofclassI,classIIaandclassIIb,theterm“DesignDossier“isusedfortheclassIIIproducts.标题中的“技术文件”适用于I类，IIa类,IIb类医疗器械，“设计文档”适用于III类医疗器械。TechnicalFilesareretainedinthepremisesofthemanufacturerortheAuthorizedRepresentativeforpotentialreviewofCompetentAuthoritiesandNotifiedBody.PartBoftheTechnicalFilemaybeavailableatthemanufactureronly.技术文件是保留在制造商或授权代表单位的主管部门和认证机构。部分技术文件B部分只保留在制造商处。WhereasDesignDossiershavetobesubmittedtotheNotifiedBodyforreviewpriortoCE-Markingoftheproduct(useformApplicationforCEConformityAssessment(Product)MED_F_03.03).Wewillassignaprojectmanagerwhowillentrustoneormorefurtherexpertswiththereviewofparticularmodules.Allexpertsareatyourdisposaldirectlyorindirectlythroughtheprojectmanager.Aftersuccessfulreview,theNotifiedBodyissuesadesignexaminationcertificateaccordingtoAnnexII.4oftheCouncilDirectivecertifyingcompliancewiththerelevantprovisionsofAnnexIoftheMDD.设计档案材料已被提交到公告机构用于需要CE认证前的产品审查（用CE合格评定（产品）MED_F_03.03规定的格式）。我们将委派一个项目经理，他将委托一个或多个资深专家审查特定的模块。所有专家会直接或通过项目经理间接与你接触，在成功的审查后，公告机构会按照MDD法规附件I和附件II.4相关规定签发检验证书。Article5oftheCouncilDirectivedescribesconsiderationoftheEuropeanharmonizedstandardsbythemanufacturerinordertodemonstratecompliancewiththeEssentialRequirements.ThisaspectisevenmoreimportantasInternationalStandardOrganizationshaveadoptedEuropeanNorms(andviceversa)anddemonstratingcompliancewiththesestandardscouldbeveryhelpfulininternationalmutualrecognitionoftheCE-Markingprocess.理事会指令5描述了制造商要遵守的欧洲统一标准，以证明附合基本要求，这方面更重要的是为国际标准组织已经通过了欧洲规范（反之亦然），并且遵守这些标准可能非常有助于国际的相互承认在CE认证过程中。ItisnotnecessarytoincludealldocumentsintheDesignDossierwhichhavealreadybeensubjecttoanISO/EN/MDDAuditbytheNotifiedBody.ExamplesofdocumentsnotnecessarytobeincludedareQualityManualsandrelatedlowerleveldocuments.设计档案材料不必一定包括那些已经提交给ISO/EN/MDD审查公告机构的所有的文档，例如文档不必包括质量手册和一些相关更下层文档。IfthemanufacturerofaclassIIIdeviceprovidesdetailedinformationaccordingtothechecklistdescribedbelow,therequirementsoftheDirectiveareappropriatelyaddressed.如果一个类III器件制造商提供详细的资料按下述清单，该指令的要求得到适当处理ThisisevenmoreimportantincaseaCompetentAuthorityoranotherNotifiedBodywishestoreviewthedocumentation.这样很重要如果主管部门或其他认证机构要审查文件Generally,theinformationshouldbeprovidedasconclusions,summaries,reports,tablesorflowcharts(withreferencetothefulldocumentationintheEssentialRequirementchecklist).一般的，提供的信息应包括结论，摘要，报告，表或流程图（参照完整文档在基本要求检查表中）SpecialcareshouldbetakentoensurethatanyinformationisconsistentthroughouttheDesignDossier(e.g.descriptionandvariantsofthedeviceindifferentdocuments;adverseeventsasstatedintheIFUandhazardsinnormalconditionaswellasinfaultconditionintheRiskManagement).特别应注意确保任何信息在整个卷中是一致的（例如：在不同的文档中器械的规格描述；说明书中不良事件的声明和在正常情况下的危害，以及在故障情况下的风险管理）AcompletepaginationoftheDesignDossieroranothertypeofcontrolmechanismisnecessary,e...
