9879EC指令英文版.docx
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9879EC指令英文版.docx
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9879EC指令英文版
Directive98/79/ECoftheEuropeanParliamentandoftheCouncilof27October1998oninvitrodiagnosticmedicaldevices
OJL331,7.12.1998,p.1–37(ES,DA,DE,EL,EN,FR,IT,NL,PT,FI,SV)
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DIRECTIVE98/79/ECOFTHEEUROPEANPARLIAMENTANDOFTHECOUNCILof27October1998oninvitrodiagnosticmedicaldevices.
THEEUROPEANPARLIAMENTANDTHECOUNCILOFTHEEUROPEANUNION,HavingregardtotheTreatyestablishingtheEuropeanCommunity,andinparticularArticle100athereof,HavingregardtotheproposalfromtheCommission
(1),HavingregardtotheopinionoftheEconomicandSocialCommittee
(2),ActinginaccordancewiththeprocedurelaiddowninArticle189boftheTreaty(3),
(1)Whereasmeasuresshouldbeadoptedforthesmoothoperationoftheinternalmarket;whereastheinternalmarketisanareawithoutinternalfrontiersinwhichthefreemovementofgoods,persons,servicesandcapitalisensured;
(2)Whereasthecontentandscopeofthelaws,regulationsandadministrativeprovisionsinforceintheMemberStateswithregardtothesafety,healthprotectionandperformance,characteristicsandauthorisationproceduresforinvitrodiagnosticmedicaldevicesaredifferent;whereastheexistenceofsuchdisparitiescreatesbarriersto,trade,andwhereastheneedtoestablishharmonisedruleshasbeenconfirmedbyacomparativesurveyofnationallegislationscarriedoutonbehalfoftheCommission;
(3)Whereastheharmonisationofnationallegislationistheonlymeansofremovingsuchbarrierstofreetradeandofpreventingnewbarriersfromarising;whereasthisobjectivecannotbeachievedinasatisfactorymannerbyothermeansbytheindividualMemberStates;whereasthisDirectivelaysdownonlysuchrequirementsasarenecessaryandsufficienttoensure,underthebestsafetyconditions,freemovementoftheinvitrodiagnosticmedicaldevicestowhichitapplies;
(4)WhereastheharmonisedprovisionsmustbedistinguishedfrommeasuresadoptedbytheMemberStatestomanagethefundingofpublichealthandsicknessinsuranceschemesrelatingdirectlyorindirectlytosuchdevices;whereas,therefore,theharmonisedprovisionsdonotaffecttheabilityoftheMemberStatestoimplementsuchmeasuresprovidedthattheycomplywithCommunitylaw;
(5)Whereasinvitrodiagnosticmedicaldevicesshouldprovidepatients,usersandthirdpartieswithahighlevelofhealthprotectionandattaintheperformancelevelsoriginallyattributedtothembythemanufacturer;whereas,therefore,maintenanceorimprovementofthelevelofhealthprotectionattainedintheMemberStatesisoneofthemainobjectivesofthisDirective;
(6)Whereas,inaccordancewiththeprinciplessetoutintheCouncilresolutionof7May1985onanewapproachtotechnicalharmonisationandstandards(4),rulesregardingthedesign,manufactureandpackagingofrelevantproductsmustbeconfinedtotheprovisionsrequiredtomeettheessentialrequirements;whereas,becausetheyareessential,suchrequirementsshouldreplacethecorrespondingnationalprovisions;whereastheessentialrequirements,includingrequirementstominimiseandreducerisks,shouldbeappliedwithdiscretion,takingintoaccountthetechnologyandpracticeatthetimeofdesignandtechnicalandeconomicconsiderationscompatiblewithahighlevelofprotectionofhealthandsafety;
(7)WhereasthemajorpartofmedicaldevicesarecoveredbyCouncilDirective90/385/EECof20June1990ontheapproximationoflawsrelatingtoactiveimplantablemedicaldevices(5)andCouncilDirective93/42/EECof14June1993concerningmedicaldevices(6)withtheexclusionofinvitrodiagnosticmedicaldevices;whereasthisDirectiveseekstoextendtheharmonisationtoinvitrodiagnosticmedicaldevicesandwhereas,intheinterestofuniformCommunityrules,thisDirectiveisbasedlargelyontheprovisionsofthesaidtwoDirectives;
(8)Whereasinstruments,apparatus,appliances,materialsorotherarticles,includingsoftware,whichareintendedtobeusedforresearchpurposes,withoutanymedicalobjective,arenotregardedasdevicesforperformanceevaluation;
(9)Whereas,althoughinternationallycertifiedreferencematerialsandmaterialsusedforexternalqualityassessmentschemesarenotcoveredbythisDirective,calibratorsandcontrolmaterialsneededbytheusertoestablishorverifyperformancesofdevicesareinvitrodiagnosticmedicaldevices;
(10)Whereas,havingregardtotheprincipleofsubsidiarity,reagentswhichareproducedwithinhealth-institutionlaboratoriesforuseinthatenvironmentandarenotsubjecttocommercialtransactionsarenotcoveredbythisDirective;
(11)Whereas,however,devicesthataremanufacturedandintendedtobeusedinaprofessionalandcommercialcontextforpurposesofmedicalanalysiswithoutbeingmarketedaresubjecttothisDirective;
(12)WhereasmechanicallaboratoryequipmentespeciallydesignedforinvitrodiagnosticexaminationsfallswithinthescopeofthisDirectiveandwhereas,therefore,inordertoharmonisetherelevantdirectives,Directive98/37/ECoftheEuropeanParliamentandoftheCouncilof22June1998ontheapproximationofthelawsoftheMemberStatesrelatingtomachinery(7),shouldbeappropriatelyamendedtobringitintolinewiththisDirective;
(13)WhereasthisDirectiveshouldincluderequirementsregardingthedesignandmanufactureofdevicesemittingionizingradiation;whereasthisDirectivedoesnotaffecttheapplicationofCouncilDirective96/29/Euratomof13May1996layingdownbasicsafetystandardsfortheprotectionofthehealthofworkersandthegeneralpublicagainstthedangersarisingfromionisingradiation(8);
(14)Whereas,sinceelectromagneticcompatibilityaspectsformanintegralpartoftheessentialrequirementsofthisDirective,CouncilDirective89/336/EECof2May1989ontheapproximationofthelawsoftheMemberStatesrelatingtoelectromagneticcompatibility(9)doesnotapply;
(15)Whereas,inordertoeasethetaskofprovingconformitywiththeessentialrequirementsandtoenableconformitytobeverified,itisdesirabletohaveharmonisedstandardsinrespectofthepreventionofrisksassociatedwiththedesign,manufactureandpackagingofmedicaldevices;whereassuchharmonisedstandardsaredrawnupbyprivate-lawbodiesandshouldretaintheirstatusasnon-mandatorytexts;whereas,tothisend,theEuropeanCommitteeforStandardisation(CEN)andtheEuropeanCommitteeforElectrotechnicalStandardisation(Cenelec)arerecognisedasthecompetentbodiesfortheadoptionofharmonisedstandardsinaccordancewiththegeneralguidelinesoncooperationbetweentheCommissionandthosetwobodiessignedon13November1984;
(16)Whereas,forthepurposeofthisDirective,aharmonisedstandardisatechnicalspecification(Europeanstandardofharmonisationdocument)adopted,onamandatefromtheCommission,byCENorCenelecorbybothofthosebodiesinaccordancewithDirective98/34/ECoftheEuropeanParliamentandoftheCouncilof22June1998layingdownaprocedurefortheprovisionofinformationinthefieldoftechnicalstandardsandregulations(10),andpursuanttotheabovementionedgeneralguidelines;
(17)Whereas,bywayofexceptiontothegeneralprinciples,thedrawingupofcommontechnicalspecificationstakesaccountofacurrentpracticeinsomeMemberStateswherebyforselecteddevicesmainlyusedfortheevaluationofthesafetyofbloodsupplyandoforgandonation,suchspecificationsareadoptedbythepublicauthorities;whereasitisappropriatethattheseparticularspecificationsshouldbereplacedbycommontechnicalspecifications;whereasthesecommontechnicalspecificationscanbeusedforperformanceevaluationandreevaluation;
(18)Whereasscientificexpertsfromvariousinterestedpartiescouldbeinvolvedinthedraftingofcommontechnicalspecificationsandintheexaminationofotherspecificorgeneralquestions;
(19)Whereasmanufacturing,ascoveredbythisDirective,alsoincludesthepackagingofthemedicaldevice,insofarassuchpackagingisrelatedtothesafetyandperformanceaspectsofthisdevice;
(20)Whereascertaindeviceshavealimitedlifeowingtothedeclineintheirperformanceovertime,whichisrelated,forexample,tothedeterioriationintheirphysicalorchemicalproperties,includingthesterilityorintegrityofthepackaging;whereasthemanufacturershoulddetermineandindicatetheperiodduringwhichthedevicewillperformasintended;whereasthelabellingshouldindicatethedateuntilwhichthedeviceoroneofitscomponentscanbeusedwithcompletesafety;
(21)Whereas,inDecision93/465/EECof22July1993concerningthemodulesforthevariousphasesoftheconformityassessmentproceduresandtherulesfortheaffixinganduseoftheCEconformitymarking,whichareintendedtobeusedinthetechnicalharmonisationdirectives(11),theCouncillaiddownharmonisedconformityassessm
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