Consleg系统生产(PDF52)(1)

ENConsolidatedTEXTproducedbytheCONSLEGsystemoftheOfficeforOfficialPublicationsoftheEuropeanCommunitiesCONSLEG:1993L0042—20/11/2003Numberofpages:51OfficeforOfficialPublicationsoftheEuropeanCommunities1993L0042—EN—20.11.2003—004.001—1Thisdocumentismeantpurelyasadocumentationtoolandtheinstitutionsdonotassumeanyliabilityforitscontents►BCOUNCILDIRECTIVE93/42/EECof14June1993concerningmedicaldevices(OJL169,12.7.1993,p.1)Amendedby:OfficialJournalNopagedate►M1Directive98/79/ECoftheEuropeanParliamentandoftheCouncilof27October1998L33117.12.1998►M2Directive2000/70/ECoftheEuropeanParliamentandoftheCouncilof16November2000L3132213.12.2000►M3Directive2001/104/ECoftheEuropeanParliamentandoftheCouncilof7December2001L65010.1.2002►M4Regulation(EC)No1882/2003oftheEuropeanParliamentandoftheCouncilof29September2003L284131.10.2003▼BCOUNCILDIRECTIVE93/42/EECof14June1993concerningmedicaldevicesTHECOUNCILOFTHEEUROPEANCOMMUNITIES,HavingregardtotheTreatyestablishingtheEuropeanEconomicCommunity,andinparticularArticle100athereof,HavingregardtotheproposalfromtheCommission(1),IncooperationwiththeEuropeanParliament(2),HavingregardtotheopinionoftheEconomicandSocialCommittee(3),Whereasmeasuresshouldbeadoptedinthecontextoftheinternalmarket;whereastheinternalmarketisanareawithoutinternalfrontiersinwhichthefreemovementofgoods,persons,servicesandcapitalisensured;Whereasthecontentandscopeofthelaws,regulationsandadministra-tiveprovisionsinforceintheMemberStateswithregardtothesafety,healthprotectionandperformancecharacteristicsofmedicaldevicesaredifferent;whereasthecertificationandinspectionproceduresforsuchdevicesdifferfromoneMemberStatetoanother;whereassuchdisparitiesconstitutebarrierstotradewithintheCommunity;Whereasthenationalprovisionsforthesafetyandhealthprotectionofpatients,usersand,whereappropriate,otherpersons,withregardtotheuseofmedicaldevicesshouldbeharmonizedinordertoguaranteethefreemovementofsuchdeviceswithintheinternalmarket;WhereastheharmonizedprovisionsmustbedistinguishedfromthemeasuresadoptedbytheMemberStatestomanagethefundingofpublichealthandsicknessinsuranceschemesrelatingdirectlyorindir-ectlytosuchdevices;whereas,therefore,theprovisionsdonotaffecttheabilityoftheMemberStatestoimplementtheabovementionedmeasuresprovidedCommunitylawiscompliedwith;Whereasmedicaldevicesshouldprovidepatients,usersandthirdpartieswithahighlevelofprotectionandattaintheperformancelevelsattributedtothembythemanufacturer;whereas,therefore,themainte-nanceorimprovementofthelevelofprotectionattainedintheMemberStatesisoneoftheessentialobjectivesofthisDirective;WhereascertainmedicaldevicesareintendedtoadministermedicinalproductswithinthemeaningofCouncilDirective65/65/EECof26January1965ontheapproximationofprovisionslaiddownbylaw,regulationoradministrativeactionrelatingtoproprietarymedicinalproducts(4);whereas,insuchcases,theplacingonthemarketofthemedicaldeviceasageneralruleisgovernedbythepresentDirectiveandtheplacingonthemarketofthemedicinalproductisgovernedbyDirective65/65/EEC;whereasif,however,suchadeviceisplacedonthemarketinsuchawaythatthedeviceandthemedicinalproductformasingleintegralunitwhichisintendedexclusivelyforuseinthegivencombinationandwhichisnotreusable,thatsingle-unitproductshallbegovernedbyDirective65/65/EEC;whereasadistinctionmustbedrawnbetweentheabovementioneddevicesandmedicaldevicesincorporating,interalia,substanceswhich,ifusedseparately,maybeconsideredtobeamedicinalsubstancewithinthemeaningofDirective65/65/EEC;whereasinsuchcases,ifthesubstancesincorporatedinthemedicaldevicesareliabletoactuponthebodywithactionancillarytothatofthedevice,theplacingofthedevicesonthemarketisgovernedbythisDirective;whereas,inthiscontext,thesafety,qualityand1993L0042—EN—20.11.2003—004.001—2(1)OJNoC237,12.9.1991andOJNoC251,28.9.1992,p.40.(2)OJNoC150,31.5.1993andOJNoC176,28.6.1993.(3)OJNoC79,30.3.1992,p.1.(4)OJNo22,9.6.1965,p.369/65.DirectiveaslastamendedbyDirective92/27/EEC(OJNoL113,30.4.1992,p.8).▼BusefulnessofthesubstancesmustbeverifiedbyanalogywiththeappropriatemethodsspecifiedinCouncilDirective75/318/EECof20May1975ontheapproximationofthelawsoftheMemberStatesrelatingtoanalytical,pharmaco-toxicologicalandclinicalstandardsandprotocolsinrespectofthetestingofproprietarymedicinalproducts(1);WhereastheessentialrequirementsandotherrequirementssetoutintheAnnexestothisDirective,includinganyreferenceto‘minimizing’or‘reducing’riskmustbeinterpretedandappliedinsuchawayastotakeaccountoftechnologyandpracticeexistingatthetimeofdesignandoftechnicalandeconomicalconsiderationscompatiblewithahighlevelofprotectionofhealthandsafety;Whereas,inaccordancewiththeprinciplessetoutintheCouncilreso-lutionof7May1985concerninganewapproachtotechnicalharmonizationandstandardization(2),rulesregardingthedesignandmanufactureofmedicaldevicesmustbeconfinedtotheprovisionsrequiredtomeettheessentialrequirements;whereas,becausetheyareessential,suchrequirementsshouldreplacethecorrespondingnationalprovisions;whereastheessentialrequirementsshouldbeappliedwithdiscretiontotakeaccountofthetechnologicallevelexistinga