MEDDEV271 Rev4最新附中文.docx
- 文档编号:12208290
- 上传时间:2023-04-17
- 格式:DOCX
- 页数:157
- 大小:125.28KB
MEDDEV271 Rev4最新附中文.docx
《MEDDEV271 Rev4最新附中文.docx》由会员分享,可在线阅读,更多相关《MEDDEV271 Rev4最新附中文.docx(157页珍藏版)》请在冰豆网上搜索。
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
- 配套讲稿:
如PPT文件的首页显示word图标,表示该PPT已包含配套word讲稿。双击word图标可打开word文档。
- 特殊限制:
部分文档作品中含有的国旗、国徽等图片,仅作为作品整体效果示例展示,禁止商用。设计者仅对作品中独创性部分享有著作权。
- 关 键 词:
- MEDDEV271 Rev4最新附中文 Rev4 最新 中文