(CE认证用)欧盟体外诊断医疗器械指令-IVDD-Directive--98-79-EC-(2009

Thisdocumentismeantpurelyasadocumentationtoolandtheinstitutionsdonotassumeanyliabilityforitscontents►BDIRECTIVE98/79/ECOFTHEEUROPEANPARLIAMENTANDOFTHECOUNCILof27October1998oninvitrodiagnosticmedicaldevices(OJL331,7.12.1998,p.1)Amendedby:OfficialJournalNopagedate►M1Regulation(EC)No1882/2003oftheEuropeanParliamentandoftheCouncilof29September2003L284131.10.2003►M2Regulation(EC)No596/2009oftheEuropeanParliamentandoftheCouncilof18June2009L1881418.7.2009Correctedby:►C1Corrigendum,OJL22,29.1.1999,p.75(98/79/EC)►C2Corrigendum,OJL6,10.1.2002,p.70(98/79/EC)1998L0079—EN—07.08.2009—002.001—1▼BDIRECTIVE98/79/ECOFTHEEUROPEANPARLIAMENTANDOFTHECOUNCILof27October1998oninvitrodiagnosticmedicaldevicesTHEEUROPEANPARLIAMENTANDTHECOUNCILOFTHEEUROPEANUNION,HavingregardtotheTreatyestablishingtheEuropeanCommunity,andinparticularArticle100athereof,HavingregardtotheproposalfromtheCommission(1),HavingregardtotheopinionoftheEconomicandSocialCommittee(2),ActinginaccordancewiththeprocedurelaiddowninArticle189boftheTreaty(3),(1)Whereasmeasuresshouldbeadoptedforthesmoothoperationoftheinternalmarket;whereastheinternalmarketisanareawithoutinternalfrontiersinwhichthefreemovementofgoods,persons,servicesandcapitalisensured;(2)Whereasthecontentandscopeofthelaws,regulationsandadministrativeprovisionsinforceintheMemberStateswithregardtothesafety,healthprotectionandperformance,charac-teristicsandauthorisationproceduresforinvitrodiagnosticmedicaldevicesaredifferent;whereastheexistenceofsuchdisparitiescreatesbarrierstotrade,andwhereastheneedtoestablishharmonisedruleshasbeenconfirmedbyacomparativesurveyofnationallegislationscarriedoutonbehalfoftheCommission;(3)Whereastheharmonisationofnationallegislationistheonlymeansofremovingsuchbarrierstofreetradeandofpreventingnewbarriersfromarising;whereasthisobjectivecannotbeachievedinasatisfactorymannerbyothermeansbytheindi-vidualMemberStates;whereasthisDirectivelaysdownonlysuchrequirementsasarenecessaryandsufficienttoensure,underthebestsafetyconditions,freemovementoftheinvitrodiagnosticmedicaldevicestowhichitapplies;(4)WhereastheharmonisedprovisionsmustbedistinguishedfrommeasuresadoptedbytheMemberStatestomanagethefundingofpublichealthandsicknessinsuranceschemesrelatingdirectlyorindirectlytosuchdevices;whereas,therefore,theharmonisedprovisionsdonotaffecttheabilityoftheMemberStatestoimplementsuchmeasuresprovidedthattheycomplywithCommunitylaw;(5)Whereasinvitrodiagnosticmedicaldevicesshouldprovidepatients,usersandthirdpartieswithahighlevelofhealthprotectionandattaintheperformancelevelsoriginallyattributedtothembythemanufacturer;whereas,therefore,maintenanceorimprovementofthelevelofhealthprotectionattainedintheMemberStatesisoneofthemainobjectivesofthisDirective;(6)Whereas,inaccordancewiththeprinciplessetoutintheCouncilresolutionof7May1985onanewapproachtotechnicalharmo-nisationandstandards(4),rulesregardingthedesign,manufacture1998L0079—EN—07.08.2009—002.001—2(1)OJC172,7.7.1995,p.21andOJC87,18.3.1997,p.9.(2)OJC18,22.1.1996,p.12.(3)OpinionoftheEuropeanParliamentof12March1996(OJC96,1.4.1996,p.31),Councilcommonpositionof23March1998(OJC178,10.6.1998,p.7)andDecisionoftheEuropeanParliamentof18June1998(OJC210,6.7.1998).CouncilDecisionof5October1998.(4)OJC136,4.6.1985,p.1.▼Bandpackagingofrelevantproductsmustbeconfinedtotheprovisionsrequiredtomeettheessentialrequirements;whereas,becausetheyareessential,suchrequirementsshouldreplacethecorrespondingnationalprovisions;whereastheessentialrequirements,includingrequirementstominimiseandreducerisks,shouldbeappliedwithdiscretion,takingintoaccountthetechnologyandpracticeatthetimeofdesignandtechnicalandeconomicconsiderationscompatiblewithahighlevelofprotectionofhealthandsafety;(7)WhereasthemajorpartofmedicaldevicesarecoveredbyCouncilDirective90/385/EECof20June1990ontheapproximationoflawsrelatingtoactiveimplantablemedicaldevices(1)andCouncilDirective93/42/EECof14June1993concerningmedicaldevices(2)withtheexclusionofinvitrodiagnosticmedicaldevices;whereasthisDirectiveseekstoextendtheharmo-nisationtoinvitrodiagnosticmedicaldevicesandwhereas,intheinterestofuniformCommunityrules,thisDirectiveisbasedlargelyontheprovisionsofthesaidtwoDirectives;(8)Whereasinstruments,apparatus,appliances,materialsorotherarticles,includingsoftware,whichareintendedtobeusedforresearchpurposes,withoutanymedicalobjective,arenotregardedasdevicesforperformanceevaluation;(9)Whereas,althoughinternationallycertifiedreferencematerialsandmaterialsusedforexternalqualityassessmentschemesarenotcoveredbythisDirective,calibratorsandcontrolmaterialsneededbytheusertoestablishorverifyperformancesofdevicesareinvitrodiagnosticmedicaldevices;(10)Whereas,havingregardtotheprincipleofsubsidiarity,reagentswhichareproducedwithinhealth-institutionlaboratoriesforuseinthatenvironmentandarenotsubjecttocommercialtransactionsarenotcoveredbythisDirective;(11)Whereas,however,devicesthataremanufacturedandintendedtobeusedinaprofessionalandcommercialcontextforpurposesofmedicalanalysiswithoutbeingmarketedaresubjec