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