NB-MED-2.5.1-Rec5-技术文件指南

Co-ordinationofNotifiedBodiesMedicalDevices(NB-MED)onCouncilDirectives90/385/EEC,93/42/EECand98/79/ECRecommendationNB-MED/2.5.1/Rec5Title:TechnicalDocumentationChapter:2.5.1Conformityassessmentprocedures;GeneralrulesText:.........................................Keywords:Designdossier,technicaldocumentation,technicalfileArationaleandhistorysheetisavailable;pleasecontactTechnicalSecretariat.ReferencetoDirectives:Article/Annex:Referencetostandards:AIMDAnnex:2,3,4,5MDDAnnex:II,III,IV,V,VI,VIIIVDAnnex:IIIStageproposedbyRev.-Nr.Rev.dateacceptedamendedwithdrawnPage3403.02.200029.02.20001/21VdTÜVTechnicalSecretariatNB-MEDPOBox103834D-45038EssenG.HinrichSchaub(-178)JörgHöppner(-138)Kurfürstenstraße56D-45138EssenPhone:++49/201/8987-0Fax:++49/201/8987-120eMail:[e-mail]-documentdn:...\hoeppner\mp\nb\rec_vdt2\R2_5_1-5_rev4.doc1.IntroductionTherequirementsforthetechnicaldocumentationarelaiddowninthevariousAn-nexesofthemedicaldevicesDirectives,asappropriatefortheconformityassess-mentprocedureandtheproductsconcerned.Asageneralrule,thedocumentationshouldcoverthedesign,manufactureandintendedoperationoftheproduct.Note.The‘operation’oftheproductwouldincludeinstallation,preparationforuse,pre-usechecksandmaintenance,calibrationandservicingasappropriatetotheparticularmedicaldevicesinvolved.Thedetailsincludedinthedocumentationwilldependonthenatureoftheproductandonwhatisconsideredasnecessary,fromatechnicalpointofview,fordemon-stratingtheconformityoftheproducttotheessentialrequirementsofthemedicaldevicesDirectives.Iftheharmonisedstandardshavebeenapplied,thetechnicaldocumentationshouldalsomakeclearwherethesehavebeenusedtodemonstrateconformitywiththeparticularessentialrequirementscoveredbythestandards.Note:ThisRecommendationhasbeenwrittenparticularlytomeettheneedsforguidanceontechnicaldocumentationformedicaldevicesandactiveimplantablemedicaldevices.TheRecommendationmayalsobehelpful,however,inrelationtoIVDs,butmayneedrevisioninthelightofexperienceofthepracticalimplementationoftheIVDD.2.PurposeofRecommendationCo-ordinationofNotifiedBodiesMedicalDevices(NB-MED)onCouncilDirectives90/385/EEC,93/42/EECand98/79/ECRecommendationNB-MED/2.5.1/Rec5Title:TechnicalDocumentationPage2/21vdtuev-documentdn:...\hoeppner\mp\nb\rec_vdt2\R2_5_1-5_rev4.docThepurposeofthisRecommendationistoprovideguidancetoNotifiedBodies,CompetentAuthoritiesandmanufacturersonthetechnicaldocumentationneededtomeettherequirementsofthemedicaldevicesDirectives.Note:ItisnotthepurposeofthisRecommendationtoobligethemanufacturertore-organiseexistingtechnicaldocumentationwherethisalreadyprovesappropriateandsufficient.3TechnicalInformation3.1GeneralSubjectGuidance(i)Contentoftechnicaldocu-mentationThisRecommendationisnotintendedasanex-haustivelistingofallthetechnicaldocumentationthatmayberequiredinparticularcases.Equally,whereparticularinformationindicatedbythisRecommendationisnotincluded,ajustificationshouldbeprovided.ThemanufacturerisrequiredbytheDirectivestopreparethetechnicaldocumentationandtode-termineandjustifywhatisappropriateandsuffi-cienttoassurehisparticularmedicaldevicescomplywiththerelevantDirective(s).Thiswillobviouslyvaryonacase-by-casebasis,de-pendingonthetypeofproduct,theriskassoci-atedwithitsmanufacture,installation,useandservicing,andtheperiodthatithasbeenonthemarket.Forexample,itisunlikelythatwell-establishedproducts,regardlessoftheirclassifi-cation,willhavemuchformaldesignvalidation-butthemanufacturerwillhaveconsiderablemarketexperienceofuse,togetherwithdetailsonhowhehasrespondedtoanyproblemsthathaveemerged,andthisavailabledatashouldbeusedbywayofvalidation.(ii)OtherThetechnicaldocumentationshouldincludetheinformationindicatedinsections3.2-3.5Co-ordinationofNotifiedBodiesMedicalDevices(NB-MED)onCouncilDirectives90/385/EEC,93/42/EECand98/79/ECRecommendationNB-MED/2.5.1/Rec5Title:TechnicalDocumentationPage3/21vdtuev-documentdn:...\hoeppner\mp\nb\rec_vdt2\R2_5_1-5_rev4.doc3.2ProductDescriptionSubjectGuidance(i)ageneraldescriptionofthedevice(s)Thisshouldincludetheintendedrangeofvari-ants(forexample,agroupofcathetersofapar-ticulartypedifferingonlyinlength),andade-scriptionofthepackagingwherethisisrelevanttothepreservationoftheintendedcharacteris-ticsandperformancesofthedevice(s).Allthatisneeded,however,isabriefdescriptionsufficienttoallowanunderstandingofthedesign,char-acteristics,andwhereappropriate,performancesofthedevice(s)andtodistinguishbetweenvari-ants.Inmanycases,thenameofthedevice(s)willbesufficient.Wherethe‘technicaldocu-mentation’istobeevaluatedbyaNotifiedBody,ageneralpictorialrepresentationofthedevice(s),e.g.aschematicdiagram,photographordrawingmaybeofassistance.Note:Forguidanceonwhatconstitutesa‘range’ofproductvariants,seeNB-MEDRecommenda-tionNB-MED/2.1/Rec2.(ii)adescriptionoftheintendeduseandoperationofthedevice(s)Ashortdescriptionoftheintendedpur-pose/applicationand/ormethodofuseofthedevice(s)isneeded.Thismayinclude,whereappropriate,detailsoftheintendedpatientpopulation(s)andmedicalcondition(s)forwhichthedeviceisintended.Thisshoulda