AGREEMENTPARTYA:NAME:ADDRESS:TEL:FAX:PARTYB:NAME:ADDRESS:TEL:FAX:PARTYAherebyappointsPartyBastheauthorizeddelegateofEuropeanCommunityandPartyBacceptstheappointmenttobetheauthorizeddelegateofEuropeanCommunityforPartyAinthemarketofEuropeanCommunities.BothpartiesenterthisAgreementasfollows:PARTYAPartyAassurestoprovidetheupdatedtechnicalfilesofeachcategorytoPartyB.Ifthereareanychangesofproducts,PartyAshallnotifyPartyBatonce.IftheseriousaccidentofproductishappenedwithinboundaryofEC,PartyAshallinvestigatethereasontogetherwithPartyB,andcompletetheinitialreportandfinalreport,PartyAshallpresentthesereporttoPartyB,withinregulartimeandreporttocompetentauthority.IftheaccidentofproductsishappenedoutofE.C.PartyAshallnotifyPartyB,andmakedecisionthatwhetherreporttocompetentauthorityornot.PartyAshallberesponsibleforanybusinessdisputesuchasclaimforcompensationcausedbymedicalaccidentsafterPartinhandingthedisputesinaccordancewiththeauthorizationofPartA.AlltheexpenseshappenedduringPartyBhandingoftheaccidentoccurrenceshallbebornePartyA.PARTYBPartyBshallresponsibleforregisteringPartyA'sproductswithCEmarkwithrelevantcompetentauthorityofthecountrytowhichPartyBislocated.PartyBshallreservetechnicalfilesofeachcategoryofPartyA'sproductswithCEmark.Thetechnicalfilesarereservedatleastfiveyearsaftermanufacturingtheproductsoflastbatch.PartyBshallnotifyanyinformationaboutproductswithCEmarkwithinboundaryofE.C.includingclaimofcustomer.IftheseriousaccidentofproductishappenedwithinboundaryofE.C.,PartyBshallnotifyaimmediatelyandassistPartyAtohandlevigilancesystemofmedicaldeviceproducts,andalsoreportinitialreport,investigationresultandfinalreporttocompetentauthorityofcountryinwhichtheaccidentishappened.ThiscontractwillbeterminatedautomaticallyiftheCEcertificationofPartAbeingwithdrawnbytheNotifiedBodyduringtheimplementationofthecontract.PartyB:SignatureDate:PartyA:Signature:Date:
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