ghtfsg1n063summarytechnicaldocumentationivdsafetyconformity110317文档格式.docx
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Date:
March17th,2011
TableofContents
1.0Introduction5
2.0Rationale,PurposeandScope5
2.1Rationale5
2.2Purpose6
2.3Scope6
3.0References6
4.0Definitions7
5.0PreparationandUseoftheSTED8
5.1Preparation8
5.2TheUseoftheSTEDinthePremarketPhase9
5.3TheUseoftheSTEDinthePost-marketPhase11
5.4TheUseoftheSTEDtoNotifyChangestotheRA/CAB11
6.0DeviceDescriptionincludingVariants(Configurations)andAccessories12
6.1DeviceDescription12
6.2ReferencetotheManufacturer’sPreviousDeviceGeneration(s)and/orSimilarDevicesorDeviceHistory13
6.2.1ForanIVDmedicaldevicenotyetavailableonanymarket13
6.2.2ForanIVDmedicaldevicealreadyavailableonthemarketinanyjurisdiction13
7.0EssentialPrinciples(EP)Checklist13
8.0RiskAnalysisandControlSummary14
9.0DesignandManufacturingInformation14
9.1DeviceDesign14
9.2ManufacturingProcesses15
9.3ManufacturingSites15
10.0ProductVerificationandValidation15
10.1AnalyticalPerformance17
10.1.1Specimentype17
10.1.2Analyticalperformancecharacteristics18
10.1.2.1Accuracyofmeasurement18
10.1.2.1.1.Truenessofmeasurement18
10.1.2.1.2.Precisionofmeasurement18
10.1.2.2Analyticalsensitivity19
10.1.2.3Analyticalspecificity19
10.1.2.4Metrologicaltraceabilityofcalibratorandcontrolmaterialvalues20
10.1.2.5Measuringrangeoftheassay21
10.1.2.6Definitionofassaycut-off21
10.2ClinicalPerformance21
10.3Stability(excludingspecimenstability)21
10.3.1Claimedshelflife22
10.3.2Inusestability22
10.3.3Shippingstability22
10.4SoftwareVerificationandValidation23
11.0Labelling23
12.0FormatoftheSTED23
13.0DeclarationofConformity24
AppendixA25
Preface
ThedocumenthereinwasproducedbytheGlobalHarmonizationTaskForce,avoluntarygroupofrepresentativesfrommedicaldeviceregulatoryauthoritiesandtheregulatedindustry.Thedocumentisintendedtoprovidenon-bindingguidanceforuseintheregulationofmedicaldevices,andhasbeensubjecttoconsultationthroughoutitsdevelopment.
Therearenorestrictionsonthereproduction,distribution,translationoruseofthisdocument.However,incorporationofthisdocument,inpartorinwhole,intoanyotherdocumentdoesnotconveyorrepresentanendorsementofanykindbytheGlobalHarmonizationTaskForce.
1.0
Introduction
TheprimarywayinwhichtheGHTFachievesitsgoalsisthroughtheproductionofaseriesofguidancedocumentsthattogetherdescribeaglobalregulatorymodelformedicaldevices,includingInVitroDiagnostic(IVD)medicaldevices.Thepurposeofsuchguidanceistoharmonizethedocumentationandproceduresthatareusedtoassesswhetheramedicaldevice,includingIVDmedicaldeviceconformstotheregulationsthatapplyineachjurisdiction.Eliminatingdifferencesbetweenjurisdictionsdecreasesthecostofgainingregulatorycomplianceandallowspatientsearlieraccesstonewtechnologiesandtreatments.
Thisdocumenthasbeendevelopedtoencourageandsupportglobalconvergenceofregulatorysystems.ItisintendedforusebyRegulatoryAuthorities(RAs),ConformityAssessmentBodies(CABs)andindustry,andwillprovidebenefitsinestablishing,inaconsistentway,aneconomicandeffectiveapproachtothecontrolofmedicaldevicesintheinterestofpublichealth.ItseekstostrikeabalancebetweentheresponsibilitiesofRegulatoryAuthoritiestosafeguardthehealthoftheircitizensandtheirobligationstoavoidplacingunnecessaryburdensupontheindustry.
TheGHTFhasidentifiedasaprioritytheneedtoharmonizethedocumentationofevidenceofconformitytotheEssentialPrinciplesofsafetyandperformance(hereafterreferredtoasEssentialPrinciples).Thisguidelineprovidesrecommendationsonthecontentofsummarytechnicaldocumentation(STED)tobeassembledandsubmittedtoaRegulatoryAuthorityorConformityAssessmentBody.ItshouldenableamanufacturertoprepareaSTEDandprovidedifferentRegulatoryAuthoritiesorConformityAssessmentBodieswiththesamebodyofdocumentaryevidencethatitsIVDmedicaldeviceconformstotheEssentialPrinciples.TheuseoftheSTEDshouldreducecostsforthemanufacturerandreviewer,removebarrierstotradeandfacilitatetimelyinternationalaccesstoIVDmedicaldevices.
Whereotherguidancedocumentswithintheseriesarereferencedwithinthistext,theirtitlesareitalicisedforclarity.
StudyGroup1oftheGlobalHarmonizationTaskForce(GHTF)haspreparedthisguidancedocument.CommentsorquestionsaboutitshouldbedirectedtoeithertheChairorSecretaryofGHTFStudyGroup1IVDSubgroupwhosecontactdetailsmaybefoundontheGHTFwebsite.
2.0Rationale,PurposeandScope
2.1Rationale
Manufacturersareexpectedtoprepare,andeitherholdorprovidetimelyaccessto,technicaldocumentationthatshowshoweachIVDmedicaldevicewasdeveloped,designedandmanufactured.Thistechnicaldocumentation,typicallycontrolledinthemanufacturer’squalitymanagementsystem(QMS),isoftenextensiveandsectionsofitmaybeheldindifferentlocations.ThedocumentationisrevisedtoreflectanychangesmadeduringthelifecycleoftheIVDmedicaldevicethroughnormalapplicationofthemanufacturer’sQMS.
ItisadvantageoustobothRAs/CABsandtheregulatedindustryifasubsetofthistechnicaldocumentationisusedforselectedpremarketandpost-marketconformityassessmentactivities.Thistechnicaldocumentationsubsetisintendedtobeinaconsistent,summarisedorabridgedform,withsufficientdetailtoallowtheRA/CABtofulfilitsobligations.Inthemain,thedocumentscontainedwithinthissubsetarederivedfromthetechnicaldocumentationheldbythemanufacturerandallowthemanufacturertodemonstratethattheIVDmedicaldevicetowhichitappliesconformstotheEssentialPrinciplesofSafetyandPerformanceofMedicalDevices.
TheavailabilityofsuchSummaryTechnicalDocumentation(STED)shouldhelpeliminatedifferencesindocumentationrequirementsbetweenjurisdictions,thusdecreasingthecostofestablishinganddocumentingregulatorycomplianceandallowingpatientsearlieraccesstonewtechnologiesandtreatments.
2.2Purpose
ThisdocumentisintendedtoprovideguidanceonthecontentoftheSTEDforIVDmedicaldevicestobeassembledandsubmitted,whereapplicable,toaRAorCABforpremarketreview,andforusepost-markettoassesscontinuingconformitytotheEssentialPrinciples.
2.3Scope
ThisdocumentappliestoallproductsthatfallwithinthedefinitionofanIVDmedicaldevicethatappearswithintheGHTFdocumentPrinciplesofInVitroDiagnosticMedicalDevicesClassification.
3.0References
GHTF/SG1/N044:
2008RoleofStandardsintheAssessmentofMedicalDevices.
GHTF/SG1/N45:
2007PrinciplesofInVitroDiagnosticMedicalDevicesClassification.
GHTF/SG1/N29:
2005InformationDocumentConcerningtheDefinitionoftheTerm
‘MedicalDevice’.
GHTF/SG1/N46:
2007PrinciplesofConformityAssessmentforInVitroDiagnosticMedicalDevices.
GHTF/SG1/N41:
2005EssentialPrinciplesofSafetyandPerformanceofMedicalDevices.
GHTF/SG1/N43:
2005LabellingforMedicalDevices.
4.0Definitions
RecognisedStandard:
StandarddeemedtoofferthepresumptionofconformitytospecificEssentialPrinciplesofsafetyandperformance.
TechnicalDocumentation:
Thedocumentedevidence,normallyanoutputofthequalitymanagementsystem,whichdemonstratesconformityofadevicetotheEssentialPrinciplesofSafetyandPerformanceofMedicalDevices.
PART1–PURPOSEOFTHESTED
5.0PreparationandUseoftheSTED
5.1Preparation
ManufacturersofallClassesofIVDmedicaldevicesareexpectedtodemonstrateconformityoftheIVDmedicaldevicetotheEssentialPrinciplesofSafetyandPerformanceofMedicalDevices5throughthepreparationandholdingoftechnicaldocumentationthatshowshoweachIVDmedicaldevicewasdeveloped,designedandmanufacturedtogetherwiththedescriptionsandexplanationsnecessarytounderstandthemanufacturer’sdeterminationwithrespecttosuchconformity.ThistechnicaldocumentationisrevisedtoreflectthecurrentstatusoftheIVDmedicaldevicethroughnormalapplicationofthemanufacturer’sQMS.
Forthepurposeofconformityassessment,themanufacturerassemblestheSTEDfromexistingtechnicaldocumentationtoprovideevidencetotheRA/CABthatthesubjectIVDmedicaldeviceisinconformitywiththeEssentialPrinciples.TheSTEDreflectsthestatusoftheIVDmedicaldeviceataparticularmomentintime(e.g.atthemomentofpremarketsubmissionorwhenrequestedbyaRAforpost-marketpurposes)andispreparedinordertomeetregulatoryrequirements.TheflowofinformationfromthetechnicaldocumentationtotheSTEDisillustratedinFigures1and2.ItcanbeseenfromthesefiguresthatthecontentoftheSTEDisthesameforbothpreandpostmarketusebutthecircumstancesfortheuseoftheSTEDaredifferent.
WheretheSTEDissubmittedtoaRA/CAB,itshouldbeinalanguageacceptabletothereviewingorganisation.
ThedepthanddetailoftheinformationcontainedintheSTEDwillprimarilydependontheclassificationofthesubjectIVDmedicaldevice.
FurtherconsiderationswhendevelopingtheindividualsectionsoftheSTEDinclude,forinstance:
a)ahighdegre