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TextA/509Words/Timeforreading:3.5minutes/TheEuropeanCommissionsaidonThursdayitwouldtoughentheregulationofmedicaldevicesasaresultofconcernsraisedbybreastimplantsproducedbythedefunctFrenchcompanyPIP,evenasascientificexpertreviewitorderedconcludedtherewascurrently“insufficientevidence”thatwomenusingitsproductsfacedgreaterhealthrisksthanothers.JohnDalli,healthandconsumerpolicycommissioner,pledgedtoexaminesurveillanceandoperationofthe“notifiedbodies”thatscrutinisemedicaldevicesacrosstheEUinacurrentreviewoflegislation,stressing:“Thecapacitytodetectandminimisetheriskoffraudmustbeincreased.”HiscommentsfollowedanofficialreportreleasedonWednesdayinFrancethatcalledfornationalandEU-wideco-operationincludingrandominspectionsandsamplingofmedicaldevicestopreventarepeatofthefraudulentuseofsubstandardnon-medical-gradesiliconebyPIPinimplantssoldtoupto400,000womenaroundtheworld.XavierBertrand,France’sministerofhealth,calledforenhancedactioninFranceandacrossEuropeinthewakeofthestudy,whichhighlightedthatAfssaps,theFrenchmedicalregulator,didnotinspectPIPfrom2001untilatip-offledofficialstoinspectandclosedownthecompanyin2010.Jean-ClaudeMas,itsfounder,isunderpoliceinvestigationformanslaughter.Mr.BertrandhaspledgedtohiremorehealthinspectorsandundertakerandomchecksonmedicaldevicecompaniesfollowinggrowingconcernsoveritsregulatorysystemhighlightedbythewidespreaduseofPIP’ssubstandardbreastimplants.AFrenchdecisionattheendoflastyeartoofferallwomenfreeremovalofPIPimplantstriggeredsimilarproposalsintheUK,GermanyandtheCzechRepublicandhashelpedsparkafreshdebateovertougherEUregulationofmedicaldevices,whicharesubjecttofarlessscrutinythanpharmaceuticals.However,areviewreleasedonThursdaybytheEU’sownScientificCommitteeonEmergingandNewlyIdentifiedHealthRisksconcluded:“Breastimplantscanfail,regardlessofmanufacturer,andtheprobabilityoffailureincreaseswithtimesinceimplantation.Inmostcases,breastimplantfailureappearstobewithoutidentifiablehealthconsequencesforthepatientwiththeexceptionofpossiblelocalcomplications.”Itstressedthatlimiteddatameantthatwhiletherewasnolinkbetweenbreastimplantsandcancer,therewasaneedforfurtherworktounderstandthespecificrisksfromthePIPproducts.Mr.BertrandhasendorsedcallsforaparliamentaryinquiryinFranceaswellasareportfromthecountry’ssocialaffairsinspectorate,mirroringsimilarmovesthatledtotoughnewrequirementsforthepharmaceuticalindustryintroducedlastyearinthewakeofconcernsaboutServier’sdrugMediator.Medicaldevicemanufacturershavecalledforreformstoensurethatthenational“notifiedbodies”whichauditthequalityoftheirproductsacrossEuropeareofaconsistentlyhighstandard,whilecautioningthattoughnewregulatoryrequirementscouldharmtheEU’scompetitiveadvantage.TheFrenchstudyshowedthatAfssapshadreceivedmultiplewarningsovertherelativelyhighfailurerateofPIPimplantscomparedwiththosemadebyothercompanies,eventhoughtheoverallproportionremainedmodest.FromFinancialTimes,February2,20121._______isthemanufacturerofthebreastimplantsunderscrutiny.A.EuropeanCommissionB.PIPC.Afssaps2.Accordingtothepassage,“notifiedbodies”inParagraph2areresponsiblefor_______.A.proposinglegislation,implementingdecisionsinEuropeanUnionB.producingandmarketingthemedicaldevicesacrosstheEUC.providingsomescientificadvicetotheEuropeanCommissionD.assessingwhetheraproductmeetscertainpreordainedstandards3.WhichofthefollowingstatementsisINCORRECTaccordingtothepassage?A.Womenusingthebreastimplantsfacedgreaterhealthrisks.B.Thecapacitytodetecttheriskoffraudshouldbeincreased.C.AnofficialreportcalledforcooperationinFranceandinotherpartsofEU.D.France’sministerofhealthhaspledgedtohiremorehealthinspectors.4.WhichofthefollowingcountrieshavenotallproposedtoofferwomenfreeremovalofPIPimplants?A.France,Germany,UKB.Germany,UK,CzechC.US,Germany,CzechD.Germany,France,Czech5.Whichofthefollowingstatementsistrueaccordingtothepassage?A.ThereisaconsensusontheEUregulationofmedicaldevicesintheEuropeanUnion.B.Allbreastimplantfailureappearstobewithoutidentifiablehealthconsequences.C.ToughnewregulatoryrequirementscouldharmtheEU’scompetitiveadvantage.D.Theoverallproportionoftheimplantfailureisrelativelyhighcomparedwithothers.答案解析：答案：1.B试题分析：本题为细节题。根据第一段“...breastimplantsproducedbythedefunctFrenchcompanyPIP”可知B正确。答案：2.D试题分析：本题为语义题。根据第二段“...‘notifiedbodies’thatscrutinisemedicaldevices...”和倒数第二段“‘notifiedbodies’whichauditthequalityoftheirproducts...”可知D正确；A是EuropeanCommission的职责；B是制药公司的职责；C是ScientificCommitteeonEmergingandNewlyIdentifiedHealthRisks的职责。答案：3.A试题分析：本题为概括题。根据第一段“therewascurrently‘insufficientevidence’thatwomenusingitsproductsfacedgreaterhealthrisksthanothers”可知A错误；根据第二段“Thecapacitytodetectandminimisetheriskoffraudmustbeincreased”可知B正确；根据第三段“...anofficialreport...thatcalledfornationalandEUwideco-operation...”可知C正确；根据第五段“Mr.Bertrandhaspledgedtohiremorehealthinspectorsand...”可知D正确。答案：4.C试题分析：本题为细节题。根据第六段“AFrenchdecisionattheendoflastyeartoofferGermanyandtheCzechRepublic”可知提出这项建议的国家为France,UK,GermanyandCzech。全文都在讲EU，没有提到US。故C错误。答案：5.C试题分析：本题为概括题。根据第六段“sparkafreshdebateovertougherEUregulationofmedicaldevices”可知A错