ghtfsg1n063summarytechnicaldocumentationivdsafetyconformity110317文档格式.docx

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