欧盟成员国中标签的语言使用要求.pdf

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1、Language Requirement for Labeling in the EU Member states欧盟成员国中标签的语言使用要求EU Countries in BlueEFTA Countries in RedAUSTRIABELGIUMInstructions For Use(IFU)+LabelLanguage RequirementsGermanDutch+German+French(All three must be used forPatient instructions)BULGARIAEnglishBulgarian for self-test devicesOn

2、ly.CROATIA(Pending EN State)CYPRUSCroatianNon-professional use devicesIn Greek.Professional UseDevices in Greek or EnglishOld regulationsPackaging must show:Sterile devicesLOTCustom made devices-MDDCustom made devices-AIMDDevices intended for performanceEvaluation IN GREEK CHARACTERSAmendment to acc

3、ept English for theseExceptions in pendingCZECH REPUBLICDENMARKESTONIACzechDanishEstonianNoneNoneIVDDRegulation54/1999forProfessionalusers:LabelsandAccompanying documentation must be inEstonian.IVDD Regulation 41/2000 forManufacturersandsuppliers:OnlyInformation necessary for safe use ofthe device m

4、ust be provided in Estonian.FINLANDFRANCEFinnish+SwedishFrenchMDD:Estonian OnlyNoneMaywanttochecktechnicaldocumentation/clinical trial information inFrenchNoneNoneNoneNational requirements in Addition todirectivesNoneNoneGERMANYGREECEGermanGreekHUNGARYMDD+AIMD:HungarianIVDD Instructions For Use MUST

5、 bein HungarianICELANDIRELANDITAL YLATVIAIcelandicEnglishItalianNoneNoneNoneLatvian-For professional use EnglishorGermanisaccepted(MDDandIVDD)GermanLithuanianAll product labels+instructions For UseNoneNoneLIECHTENSTEINLITHUANIALUXEMBOURGFrenchNoneIVDD:Label+IUFcanbeprovidedinMaltese or English.MDD:D

6、utch language waiver possible uponspecialapplication toDutchCompetentAuthorities.IVDD:Englishlanguagepossibleifaccompaniedbycontinuousverificationprocess by manufacturer.NoneIVDD+MDD:Fordevicesusedbyprofessionals only and upon users writtenconsent,IFU can provided in language otherthan Polish.NoneMD

7、D Labels may be in English IUF+CECertificates must be in Romanian by acertified translator.MACEDONIA(pendingEUState)MALTANETHERLANDSMaltese or EnglishDutchNORWAYPOLANDNorwegianPolishPORTUGALROMANIAPortugueseRomanianSERBIA(Pending EU State)SLOVAKIASLOVENIASerbianSlovakSome Czech accepted.be sure toCl

8、arify first.SlovenianLabelsandIFUmustbeinSlovenian.Slovenian IFU for self-testingIVDdevicesismandatoryProfessionalmedicalstaffdevicesIFUmaybeinSlovenian or English.SPAINSpanishRequires submittance of labeling test toCompetent Authorities.Accident report may be filed English.SWEDENSWITZERLANDTURKEY(Pending EU State)UNITED KINGDOMSwedishFrench,German,ItalianTurkishEnglishNoneNoneHas adopted all EU Medical Directives.Manufacturers name onlabel must be moreprominent than any other name.