93-42-EEC-Medical-Devices-Directive-标准

COUNCILDIRECTIVE93/42/EECof14June1993199361493/42/EECconcerningmedicaldevicesTHECOUNCILOFTHEEUROPEANCOMMUNITIES,HavingregardtotheTreatyestablishingtheEuropeanEconomicCommunity,andinparticularArticle100athereof,,100aHavingregardtotheproposalfromtheCommissionIncooperationwiththeEuropeanParliamentHavingregardtotheopinionoftheEconomicandSocialCommittee,Whereasmeasuresshouldbeadoptedinthecontextoftheinternalmarket;whereastheinternalmarketisanareawithoutinternalfrontiersinwhichthefreemovementofgoods,persons,servicesandcapitalisensured;;,,,Whereasthecontentandscopeofthelaws,regulationsandadministrativeprovisionsinforceintheMemberStateswithregardtothesafety,healthprotectionandperformancecharacteristicsofmedicaldevicesaredifferent;whereasthecertificationandinspectionproceduresforsuchdevicesdifferfromoneMemberStatetoanother;whereassuchdisparitiesconstitutebarrierstotradewithintheCommunity;,,;;;Whereasthenationalprovisionsforthesafetyandhealthprotectionofpatients,usersand,whereappropriate,otherpersons,withregardtotheuseofmedicaldevicesshouldbeharmonizedinordertoguaranteethefreemovementofsuchdeviceswithintheinternalmarkert;,,,;WhereastheharmonizedprovisionsmustbedistinguishedfromthemeasuresadoptedbytheMemberStatestomanagethefundingofpublichealthandsicknessinsuranceschemesrelatingdirectlyorindirectlytosuchdevices;whereas,therefore,theprovisionsdonotaffecttheabilityoftheMemberStatestoimplementtheabovementionedmeasuresprovidedCommunitylawiscompliedwith;,,;,;Whereasmedicaldevicesshouldprovidepatients,usersandthirdpartieswithahighlevelofprotectionandattaintheperformancelevelsattributedtothembythemanufacturer;whereas,therefore,themaintenanceorimprovementofthelevelofprotectionattainedintheMemberStatesisoneoftheessentialobjectivesofthisDirective;172,,;;WhereascertainmedicaldevicesareintendedtoadministermedicinalproductswithinthemeaningofCouncilDirective65/65/EECof26January1965ontheapproximationofprovisionslaiddownbylaw,regulationoradministrativeactionrelatingtoproprietarymedicinalproducts;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,qualityandusefulnessofthesubstancesmustbeverifiedbyanalogywiththeappropriatemethodsspecifiedinCouncilDirective75/318/EECof20May1975ontheapproximationofthelawsoftheMemberStatesrelatingtoanalytical,pharmaco-toxicologicalandclinicalstandardsandprotocolsinrespectofthetestingofproprietarymedicinalproducts;196512665/65/EEC,,,,65/65/EEC;,,,65/65/EEC;65/65/EEC;,;197552075/318/EEC[],,;WhereastheessentialrequirementsandotherrequirementssetoutintheAnnexestothisDirective,includinganyreferenceto'minimizing'or'reducing'riskmustbeinterpretedandappliedinsuchawayastotakeaccountoftechnologyandpracticeexistingatthetimeofdesignandoftechnicalandeconomicalconsiderationscompatiblewithahighlevelofprotectionofhealthandsafety;,[][],,;Whereas,inaccordancewiththeprinciplessetoutintheCouncilresolutionof7May1985concerninganewapproachtotechnicalharmonizationandstandardization,rulesregardingthedesignandmanufactureofmedicaldevicesmustbeconfinedtotheprovisionsrequiredtomeettheessentialrequirements;whereas,becausetheyareessential,suchrequirementsshouldreplacethecorrespondingnationalprovisions;198557,;,;whereastheessentialrequirementsshouldbeappliedwithdiscretiontotakeaccountofthetechnologicallevelexistingatthetimeofdesignandoftechnicalandeconomicconsiderationscompatiblewithahighlevelofprotectionofhealthandsafety;,;WhereasCouncilDirective90/385/EECof20June1990ontheapproximationofthelawsoftheMemberStatesrelatingtoactiveimplantablemedicaldevicesisthefirstcaseofapplicationofthenewapproachtothefieldofmedicaldevices;whereasintheinterestofuniformCommunityrulesapplicabletoallmedicaldevices,thisDirective272isbasedlargelyontheprovisionsofDirective90/385/EEC;whereasforthesamereasonsDirective90/385/EECmustbeamendedtoinsertthegeneralprovisionslaiddowninthisDirective;199062090/385/EEC[];,90/385/EEC;90/385/EEC,;Whereastheelectromagneticcompatibilityaspectsformanintegralpartofthesafetyofmedicaldevices;whereasthisDirectiveshouldcontainspecificrulesonthissubjectwithregardtoCouncilDirective89/336/EECof3May1989ontheapproximationofthelawsoftheMemberStatesrelatingtoelectromagneticcompatibility;;19895389/336/EEC[];WhereasthisDirectiveshouldincluderequirements