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ID:37141750
大小:268.00 KB
页数:34页
时间:2019-05-18
《无源医疗器械技术文档和设计档案材料指南》由会员上传分享,免费在线阅读,更多相关内容在行业资料-天天文库。
1、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TechnicalFilesareretainedinthepremisesofthemanufacturerortheAuthorizedRepresentativefo
2、rpotentialreviewofCompetentAuthoritiesandNotifiedBody.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(useformApplicationforCEConfo
3、rmityAssessment(Product)MED_F_03.03).Wewillassignaprojectmanagerwhowillentrustoneormorefurtherexpertswiththereviewofparticularmodules.Allexpertsareatyourdisposaldirectlyorindirectlythroughtheprojectmanager.Aftersuccessfulreview,theNotifiedBodyissuesadesignexaminationcertificateacco
4、rdingtoAnnexII.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。Article5oftheCouncilDirective
5、describesconsiderationoftheEuropeanharmonizedstandardsbythemanufacturerinordertodemonstratecompliancewiththeEssentialRequirements.ThisaspectisevenmoreimportantasInternationalStandardOrganizationshaveadoptedEuropeanNorms(andviceversa)anddemonstratingcompliancewiththesestandardscould
6、beveryhelpfulininternationalmutualrecognitionoftheCE-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.
7、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,therequirementsoftheDirectiv
8、eareappropriatelyaddressed
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