《通用产品安全指令》(GPSD)与专门产品安全指令之间关系的指导文件(二)：

GUIDANCEDOCUMENTONTHERELATIONSHIPBETWEENTHEGENERALPRODUCTSAFETYDIRECTIVE(GPSD)ANDCERTAINSECTORDIRECTIVESWITHPROVISIONSONPRODUCTSAFETY(DirectivesonMedicalDevices,ConstructionProducts,Machinery,MedicinalProductsandMotorVehicles)SECONDCHAPTERDirectorateGeneralHealthandConsumerProtection(DGSANCO)November200521.INTRODUCTION................................................................................................................32.MEDICALDEVICES..........................................................................................................42.1.Producers’obligations..................................................................................................42.2.Distributors’obligations...............................................................................................52.3.ObligationsandpowersofMemberStates.................................................................52.4.Notification,rapidinterventionandadministrativeprovisions................................63.CONSTRUCTIONPRODUCTS........................................................................................63.1.Producers’obligations..................................................................................................63.2.Distributors’obligations...............................................................................................73.3.ObligationsandpowersofMemberStates.................................................................73.4.Notification,rapidinterventionandadministrativeprovisions................................74.MACHINERY......................................................................................................................84.1.Producers’obligations..................................................................................................84.2.Distributors’obligations...............................................................................................84.3.ObligationsandpowersofMemberStates.................................................................84.4.Notification,rapidinterventionandadministrativeprovisions................................95.MEDICINALPRODUCTS.................................................................................................96.MOTORVEHICLES...........................................................................................................96.1.Producers’obligations..................................................................................................96.2.Distributors’obligations.............................................................................................106.3.ObligationsandpowersofMemberStates...............................................................106.4.Notification,rapidinterventionandadministrativeprovisions..............................11Annex1:TableoverviewofrelationshipbetweentheGPSDandsectoralDirectives31.INTRODUCTIONTheCommission’sDirectorateGeneralHealthandConsumerProtection(DGSANCO)intheautumn2003publishedafirstchapterofaninformalguidancedocument1(TheGuideline),clarifyingtherelationshipbetweentheGeneralProductSafetyDirective2001/95/EC(GPSD)andfourkeysectoraldirectivesapplyingtocertainconsumergoods(theToysDirective,theDirectiveonLowVoltageEquipment,theDirectiveonPersonalProtectiveEquipmentandtheDirectiveonCosmeticProducts).SeveralMemberStateshadrequestedanextensionoftheanalysistoseveraladditionalsectoraldirectivesthatmaycoverconsumergoods:theDirectivesonmedicaldevices,theConstructionProductsDirective(CPD),theMachineryDirective(MD),theMedicinalProductsDirective(MPD)andtheMotorVehiclesDirective(MVD).Sincethegeneralprinciplesontherelationshiparealreadyexplainedinthefirstguidancedocument,thesearenotrepeatedinthisdocument.InsteadtheanalysisinthefollowingissummarisedandfocusesonthosearticlesoftheGPSDthatapplytoconsumerproductsfallingundersectordirectives.ThisdocumenthasbeendraftedinclosecontactwithDGEnterprise,MemberStates’expertsandstakeholders.ItisrecalledthatthegeneralscopeoftheGPSDislimitedto“consumerproducts”,asdefinedinitsarticle2(a).“Consumerproducts”areproductsthatareintendedforconsumersorlikely,underreasonablyforeseeableconditions,tobeusedbyconsumersevenifnotintendedforthem.Whatare“reasonablyforeseeableconditions”mustbejudgedintheindividualcaseandwillchangewithmarketdevelopmentsasconsumersincreasinglyusecomplexproducts,forexamplemedicaldevicesandmachinery.ItshouldbenotedthatforthesectorDirectivescoveredbythissecondchapter,themajorityofproductsarenotconsumerproducts.Forexample,theDirectiveonConstructionProductsistoalargepartfocussedontheprofessionalConstructionsector.StillsomeDo-it-yourselfproductsandotherconstructionproductsmigratetotheconsumermarketandarethereforerelevantinthiscontext.AsregardstheMedicalDevicesDirective,examplesofproductsthatwouldfallunderthescopeoftheGPSDarebandaids,crutches,condoms,glasses,contactlenses,hearingaidsorinvitrodiagnosticaforself-testing.Medicaldevicessuppliedtohealthcareprofessionalsandintendedtobeusedbythem–evenifusedonaconsumer–general