MEDDEV271 Rev4最新附中文.docx

MEDDEV271 Rev4最新附中文.docx

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MEDDEV271Rev4最新附中文

EUROPEANCOMMISSION

DGInternalMarket,Industry,EntrepreneurshipandSMEs

Consumer,EnvironmentalandHealthTechnologies

HealthtechnologyandCosmetics

备注：

中文翻译中的临床调查=临床研究，评估=评价、设备=器械、数据=资料

MEDDEV2.7/1revision4

June2016

GUIDELINESONMEDICALDEVICES医疗器械指南

CLINICALEVALUATION:

AGUIDEFORMANUFACTURERSANDNOTIFIEDBODIESUNDERDIRECTIVES93/42/EECand90/385/EEC

Note

ThepresentGuidelinesarepartofasetofGuidelinesrelatingtoquestionsofapplicationofEC-DirectivesonmedicalDevices.Theyarelegallynotbinding.TheGuidelineshavebeencarefullydraftedthroughaprocessofintensiveconsultationofthevariousinterestedparties（competentauthorities,Commissionservices,industries,otherinterestedparties）duringwhichintermediatedraftswherecirculatedandcommentsweretakenupinthedocument.Therefore,thisdocumentreflectspositionstakenbyrepresentativesofinterestpartiesinthemedicaldevicessector.TheseguidelinesincorporatechangesintroducedbyDirective2007/47/ECamendingCouncilDirective90/385/EECandCouncilDirective

93/42/EEC.

本指南为一系列与CE—医疗器械指令应用问题相关的指南中的一部分。

并不具有法律约束力。

该指南在经过与各个利益方（主管当局、服务委员会、行业委员会、其他利益相关团体）进行深入协商之后谨慎拟定而成，期间对中期草案进行了传阅，而且部分意见还为本文件所采纳。

因此，本文件反映出了来自医疗器械行业的利益团体代表所持的立场。

本指南包含了指令2007/47/EC对90/385/EEC和93/42/EEC修正中的变更

（没规定实施时间）

MEDICALDEVICESDIRECTIVESCLINICALINVESTIGATION

CLINICALEVALUATION:

AGUIDEFORMANUFACTURERSANDNOTIFIEDBODIESUNDERDIRECTIVES93/42/EECand90/385/EEC

Index

1.Introduction.......................................................................................................................4

2.Scope...............................................................................................................................4

3.References.........................................................................................................................4

4.Definitions.........................................................................................................................5

5.Abbreviations....................................................................................................................8

6.Generalprinciplesofclinicalevaluation.............................................................................9

6.1.Whatisclinicalevaluation?

................................................................................................9

6.2.Whenisclinicalevaluationundertakenandwhyisitimportant?

......................................10

6.2.1.Clinicalevaluationundertakenforthedevelopmentofamedicaldevice.........................10

6.2.2.ClinicalevaluationforinitialCE-marking..........................................................................11

6.2.3.Updatingtheclinicalevaluation........................................................................................11

6.3.Howisaclinicalevaluationperformed?

...........................................................................13

6.4.Whoshouldperformtheclinicalevaluation?

....................................................................14

7.Definitionofthescopeoftheclinicalevaluation（Stage0）...............................................15

8.Identificationofpertinentdata（Stage1）...........................................................................17

8.1.Datageneratedandheldbythemanufacturer.................................................................17

8.2.Dataretrievedfromliterature............................................................................................18

9.Appraisalofpertinentdata（Stage2）................................................................................19

9.1.Generalconsiderations.....................................................................................................19

9.2.Theappraisalplan............................................................................................................20

9.3.Conductoftheappraisal...................................................................................................20

9.3.1.Howtoevaluatemethodologicalqualityandscientificvalidity.........................................20

9.3.2.Howtodeterminetherelevanceofadatasetfortheclinicalevaluation..........................24

9.3.3.Howtoweightthecontributionofeachdataset...............................................................26

10.Analysisoftheclinicaldata（Stage3）...............................................................................27

10.1.Generalconsiderations.....................................................................................................27

10.2.Specificconsiderations.....................................................................................................27

10.3.Wheredemonstrationofconformitybasedonclinicaldataisnotdeemedappropriate...29

11.Theclinicalevaluationreport（CER,Stage4）..................................................................29

12.Theroleofthenotifiedbodyintheassessmentofclinicalevaluationreports..................31

Appendices....................................................................................................................................32

A1.Demonstrationofequivalence..........................................................................................32

A2.Whenshouldadditionalclinicalinvestigationsbecarriedout?

.........................................34

A3.Devicedescription-typicalcontents................................................................................35

A4.Sourcesofliterature.........................................................................................................36

A5.Literaturesearchandliteraturereviewprotocol,keyelements........................................37

A5.1.Backgroundtotheliteraturesearchandtheliteraturereview..........................................38

A5.2.Objective.........................................................................................................................38

A5.3.Methods..........................................................................................................................39

A6.Appraisalofclinicaldata-examplesofstudiesthatlackscientificvalidityfordemonstrationofadequateclinicalperformanceand/orclinicalsafety............................39

A7.Analysisoftheclinicaldata-compliancetospecificEssentialRequirements.................41

A7.1.Conformityassessmentwithrequirementonsafety（MDDER1/AIMDDER1）...............41

A7.2.Conformityassessmentwithrequirementonacceptablebenefit/riskprofile

（MDDER1/AIMDDER1）................................................................................................42

A7.3.Conformityassessmentwithrequirementonperformance（MDDER3/AIMDDER2）...46

A7.4.Conformityassessmentwithrequirementonacceptabilityofundesirableside-effects

（MDDER6/AIMDDER5）................................................................................................47

A8.Devicesforunmetmedicalneeds-aspectstoconsider..................................................48

A9.Clinicalevaluationreport-proposedtableofcontents,examplesofcontents.................49

A10.Proposedchecklistforthereleaseoftheclinicalevaluationreport..................................54

A11.Informationondeclarationsofinterests............................................................................56

A12.Activitiesofnotifiedbodies...............................................................................................56

A12.1.Notifiedbodyassessmentofclinicalevaluationbyconformityassessmentroute...........56

A12.2.Examinationofadesigndossier（AnnexII.4;Annex2.4）orofatypeexaminationdossier

（AnnexIII;Annex3）..........................................................................................................57

A12.3.Evaluationaspartofqualitysystemrelatedprocedures..................................................61

A12.4.Notifiedbodyspecificproceduresandexpertise..............................................................62

1.Introduction介绍

Pursuantto依据

-section6aofAnnexItoDirective93/42/EEC（amendedbyDirective2007/47/EC）andto

-section5aofAnnex1toDirective90/385/EEC（amendedbyDirective2007/47/EC）,

thedemonstrationofconformitywithEssentialRequirementsforamedicaldevicemustincludeaclinicalevaluation,whichisconductedinaccordancewithAnnexXtoDirective93/42/EECorwithAnnex7toDirective90/385/EEC.

MDD指令93/42/EEC（amendedbyDirective2007/47/EC）附录I的6a部分和

MDD指令90/385/EEC（amendedbyDirective2007/47/EC）附录I的5a部分

和医疗器械的基本要求一致性的证明必须包含临床评价，根据Directive93/42/EEC的附录10和Directive90/385/EEC的附录7来指导。

Thisdocumentpromotesacommonapproachtoclinicalevaluationformedicaldevicesregulatedbydirectives90/385/EECand93/42/EEC.Itdoesnotconcerninvitrodiagnosticdevices.

Thedepthandextentofclinicalevaluationsshouldbeflexibleandappropriatetothenature,intendedpurpose,andrisksofthedeviceinquestion.Therefore,thisguidanceisnotintendedtoimposedevice-specificrequirements.

这个文件提供了按directives90/385/EECand93/42/EEC规定开展医疗器械临床评价的一般途径，不包含体外诊断试剂。

Thisdocumentusestheterms"must","shall","haveto"wherethesetermsareusedintheDirectives."Should"isusedinotherinstances.

本文档使用了术语“必须”、“应当”、“必须”这些术语使用的指令。

“应该”在其他情况下使用。

2.Scope范围

Thisguideisnotlegallybinding;onlythetextoftheDirectivesisauthenticin