体外诊断试剂IVD欧盟EN13612性能评估部分中英文.docx
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体外诊断试剂IVD欧盟EN13612性能评估部分中英文
3Generalrequirementsfortheperformanceevaluation
3.1Responsibilitiesandresources
Themanufacturertakestheresponsibilityfortheinitiationand/ortheconductofaperformanceevaluationstudy.Heshalldefinetheresponsibilityandtheinterrelationofallpersonnelwhomanage
andconducttheperformanceevaluationofIVDMDs,particularlyforpersonnelwhoneedthe
organisationalfreedomandauthorityto
a）assessthevalidityoftestresultsanddataalreadyavailable;
b）specifyperformanceclaimswhichshallbefurtherexaminedorconfirmed;
c）specifyanddocumenttheevaluationplanandthetestprocedures;
d）preparetheevaluationreport.
Themanufacturershallappointaco-ordinatorwithoverallresponsibilityoftheperformanceevaluation
study.Theco-ordinatorshallhimselfassurethatadequateresourcesareavailable.Theinvestigator
shallensurethattheevaluationplanisfollowedathislocationandthatthestudyisappropriately
reviewedfromanethicalpointofview.
3.2Documentation
Thedocumentationoftheperformanceevaluationstudyshallcontainthefilesrelatingtoclauses3to
7ofthisstandardandshallbepartofthetechnicaldocumentationoftheIVDMD.
3.3Finalassessmentandreview
Theco-ordinatorshallassessanddocumentwhichperformanceclaimsaremet,statewhetherclaims
arenotmetandgiverecommendationsforcorrectiveactions,wherenecessary.
Theresponsiblemanagementofthemanufacturershallmakesurethattheresultsoftheperformance
evaluationstudyandtherecommendationsforcorrectiveactionsarecarefullyconsideredandproperly
documentedbeforeissuingadeclarationofconformity.
4Organisationofaperformanceevaluationstudy
4.1Preconditions
Beforestartingaperformanceevaluationstudyitshallbeensuredbytheco-ordinatorthat
a）theperformanceclaimsoftheIVDMDwhicharethesubjectofthestudyarespecified;
b）theIVDMDhasbeenmanufacturedundercontrolledproductionprocessesandconditions;
c）theIVDMDtobeevaluatedmeetsthequalitycontrolreleasespecifications;
d）asufficientnumberofsamplesoftheIVDMDcanbeprovidedduringtheentireperiodofthe
performanceevaluationstudy;
e）alllegalrequirementsforperformanceevaluationstudiesaremet;
f）theinvestigator（s）is（are）adequatelyskilledandtrainedtoconductthestudyandthenecessary
resourcesareavailable.
4.2Evaluationplan
Theevaluationplanshallstatethepurposeonscientific,technicalormedicalgrounds,thescopeof
theevaluation,thestructureandorganizationofthestudyandthenumberofdevicesconcerned.
Definingtheobjectiveofthestudy,theco-ordinatorshallhaveassessedwhichperformanceclaims
arealreadyverifiedbydataorscientificliterature.
Theevaluationplanshallbedesignedtominimisetherequirementsforinvasivesampling.Inthecase
ofIVDMDsforself-testingitshallbeensuredthattheevaluationplanisappropriateandacceptableto
usersandtheinformationprovidedshallbeclearandeasilyunderstood.
Theevaluationplanshallspecify
a）thattheinvestigator（s）is（are）adequatelyskilledandtrainedtousetheIVDMD;
b）thelistoflaboratoriesorotherinstitutionstakingpartintheperformanceevaluationstudy;forselftesting,
thelocationandnumberoflaypersonsinvolved;
c）thetime-table;
d）thenecessaryminimumnumberofprobandsfromwhomspecimensarecollectedbyinvasive
proceduresinordertoadequatelyassesstheperformanceoftheIVDMD;
e）instructionsforuseincludingadescriptionoftheconditionsofuse;
f）theperformanceclaims（e.g.analyticalsensitivity,diagnosticsensitivity,analyticalspecificity,
diagnosticspecificity,accuracy,repeatability,reproducibility）tobevalidated;
g）theformatofperformancestudyrecords.
4.3Sitesandresources
Ingeneral,theperformancestudyprocedure（s）shallbecarriedoutunderconditionsreflectingthe
relevantintendedconditionsofuse.
Theco-ordinatorshalltaketheresponsibilityfortheproperconductoftheperformanceevaluation
studyatallsites.Allinvestigatorsshallbenamed.
Theco-ordinatorshallensureadequatecompetenceandskillatallsitesinvolvedandthatthe
necessaryresourcesareavailable.
WherelaypersonsareinvolvedinaperformanceevaluationstudyofanIVDMDforself-testing,the
locationofthestudyandthenumberofpersonsshallbegiven.Theco-ordinatorshallspecifythe
criteriafortheselectionofarepresentativepanel.
Especiallyforstudiesinvolvinglaypersonsitshallbeensuredthatthesepersonsdonotreceive
additionalinformationontheuseoftheIVDMDapartfromthatwhichisprovidedwiththeIVDMD
whenitisplacedonthemarketbecausethecomprehensionofthemanufacturer'sinstructionsforuse
isoneoftheimportantaspectsofthestudy.ltshallalsobeensuredthattheuntrainedperson（s）do
notreceiveanyadditionalinformationorhelp,e.g.fromatutor,otherthanthetrainingspecifiedand
providedbythemanufacturerintheinstructionsforuse.
4.4Basicdesigninformation
Theco-ordinatorshallprovidetheinvestigator（s）withsufficientinformationinordertounderstandthe
functionandapplicationoftheIVDMDand,wherenecessary,theinvestigatorshallmakehimself
familiarwiththeIVDMDanditsapplication.Theinformationprovidedshallincludeastatementthat
thedeviceinquestionconformswiththerequirementsoftheDirective98/79/ECapartfromthosetobe
evaluated.
4.5Experimentaldesign
Theexperimentalprocedurestovalidateeachperformanceclaimsubjecttotheperformance
evaluationstudyshallbedocumentedintheevaluationplan.
Specialconsiderationinperformanceevaluationstudiesofreagents/kitsshallbegiven,where
applicable,tothefollowing:
–specificationoftype（e.g.serum,plasma,urine）andproperties（e.g.concentrationrange,age
andsexoftheprobandpopulation）ofspecimensappropriatetotheintendeduse;
–probandstobeenrolled;
–suitability,stabilityandvolumeofspecimensandspecimenexclusioncriteria;
–blindprocedures,wherenecessary;
–reagentstability;
–inclusionofcommoninterferingfactors,causedbyspecimenconditionorthe
pathological/physiologicalstatusofthespecimendonorortreatment;
–conditionsforusewhichcanbereasonablyanticipated;specialattentionshallbepaidtothe
conditionsofusebylaypersons;
–selectionofanappropriatereferencemeasurementprocedureandreferencematerialof
higherorder,whereavailable;
–determinationofthestatusofspecimens（forqualitativetestswithanominalorordinalscale）;
–calibrationprocedures,includingtraceability,whereappropriate;
–appropriatemeansofcontrol;
–limitationsofthetest;
–criteriaforre-examinationanddataexclusion;
–availabilityofadditionalinformationconcerningthespecimenordonoriffollow-upof
unexpectedresultsisrequired;
–appropriatemeasurestoreduceriskofinfectiontotheuser.
Wherethestudyisintendedtovalidatetheperformanceclaimsofaninstrumentspecialconsideration
shallbegivenadditionallytothefollowing:
–maintenanceandcleaning;
–carry-overeffects;
–softwarevalidation.
NOTEFortheinvestigationofthetechnicalaspectsofinstruments,otherstandardscanberelevant.
4.6Performancestudyrecords
Theperformancestudyrecordsshall
–refertotheexperimentalproceduresintheevaluationplan;
–beunequivocallyidentifiable;
–containorrefertoallresultsandrelatedrelevantdata;
–bepartofthetechnicaldocumentationoftheIVDMD.
Theprotectionofallconfidentialdatashallbeensured.
4.7Observationsandunexpectedoutcomes
Specialattentionshallbepaidtoobservationsandunexpectedoutcomes,e.g.dropouts,outliers,
instabilityofsampleorreagentsignaletc.,non-reproducibility,non-correlationofresultstothe
referenceortothediagnosticpattern,defectsorbreakdowns,softwareerrors,orerrorsignals.
Anydeviationfromthedefinedproceduresshallberecorded.InthecaseofIVDMDsforself-testing,
theinvestigatorortutorshalldulynoteanydifficultyorquestionausermayhaveandanydeviation
fromthemodeofapplicationoftheIVDMDasdescribedbythemanufacturer.
Anysuchobservationshallbeproperlyrecorded.Theco-ordinatorshall,togetherwiththeinvestigator,
tracethecausewheneverpossible.Theresultshallberecordedandshallbepartoftheevaluation
report.
Wherethevalidityoftheexaminationsalreadyperformedmaybequestionablebecauseofan
identifiedsourceoferrorthetestsshallberepeatedafterexclusionofthatcause.
Whereamisuseormisinterpretationoftheinstructionsforusehasbeenthecauseandwherean
unexpectedriskinherenttotheproductdesignorthemodeofapplicationhasbeenidentifiedthisshall
beclearlystated.
Theproposalsoftheinvestigator（s）andtheco-ordinatorforanyimprovementoftheIVDMDand/orits
applicationshallberecorded.
4.8Evaluationreport
Theco-ordinatorshallestablishanevaluationreport.Itshallcontainadescriptionofthestudy,an
analysisoftheresultstogetherwithaconclusionontheperformanceclaimsinvestigated.
Thereportshallalsodiscussanyunexpectedoutcomeswhichhaveoccurred.Itshallidentifythe
causewheneverpossibleandgiverecommendationsforcorrectiveactionstobetaken,where
necessary.
IfseveralstudieshavebeenconductedforoneIVDMD,asinglesummarizingreportmaybe
established.
5Modificationsduringtheperformanceevaluationstudy
Wherethemanufacturingprocesshasbeenchangeditshallbecheckedwhethertheperformance
claimsoftheIVDMDstillconformtothosewhichhadbeensetinitiall
升级会员 