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SummaryEvaluationReportontheAssessmentofaMedicalDevicebytheNotifiedBodyforConformitywithCouncilDirective93/42/EECandCommissionDirective2003/32/EC.TemplateDocument-entertextdirectlytoexpandablebox.ReporterReferenceOurDesignatingCompetentAuthorityhasconfirmedthescopeofouractivitiesmeetstheprovisionsofArticle16ofCouncilDirective93/42/EECandArticle4ofCommissionDirective2003/32/EC.MedicalDeviceDataProductdescriptionandcomposition:Informationonintendeduse:Natureofthestartingtissuesanimalspeciessandgeographicalsources:Adescriptionofthekeyelementsadoptedtominimisetheriskofinfection:AnestimateoftheTSEriskarisingfromtheuseoftheproducttakingintoaccountthelikelihoodofcontaminationoftheproductthenatureanddurationofpatientexposure:AjustificationfortheuseofanimaltissuesorderivativesinthemedicaldeviceincludingarationalefortheacceptabilityoftheoverallTSEriskestimatetheevaluationofalternativematerialsandtheexpectedclinicalbenefit:Theapproachtotheauditingofsourceestablishmentsand/orthirdpartysuppliersfortheanimalmaterialusedbythedevicemanufacturer:NotifiedBodyStatementConclusionofthisassessment:BasedontheevaluationofdataandtheassessmentprocessitisourpreliminarydecisionthisapplicationmeetstherequirementsofconformitywithCouncilDirective93/42/EECandCommissionDirective2003/32/EC.DistributionRecordThisreportwassentontotheCoordinatingCompetentAuthorityoftoseekanopinionfromtheCompetentAuthoritiesoftheotherMemberStates.
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