口罩CE認(rèn)證全套資料DIMDI注冊(cè)申請(qǐng)表+歐代協(xié)議+符合標(biāo)準(zhǔn)聲明+MDR準(zhǔn)備清單

1、DIMDI注冊(cè)申請(qǐng)表注：以下信息都需要英文填寫。標(biāo)注*的為必填項(xiàng)Manufacturer制造商N(yùn)ame制造商名稱*State國家*City城市*Postalcode郵編*Street,houseno.茴道門牌號(hào)*Phone電話*Fax傳真E-mail郵箱地址*Medicaldevice(Firstplacingonthemarket)醫(yī)疔命械產(chǎn)品怎息Class分突（請(qǐng)仕塵別小選擇畫，）*()I類()I類火菌-sterile()I類測(cè)量-withmeasuringfunction()Ism類測(cè)量火菌-sterileandwithmeasuringfunction()IIa()IIb()III()

2、III-manufacturedutilisingtissuesofanimaloriginintermsofDirective2003/32/EC()Activeimplantablemedicaldevice有源植入醫(yī)械Certificatenumber(s)正書編號(hào)非一類產(chǎn)品此處必填Tradenameofthedevice商標(biāo)名稱*此處寫商標(biāo)的英文拼音Nameofdevice器械通用名稱*此處與產(chǎn)品央文名稱Nomenclaturecode系統(tǒng)命名編號(hào)產(chǎn)品中文簡介*此處寫產(chǎn)品中文簡介Englishshortdescription英語簡介*此處寫產(chǎn)品英文簡介“能分類(請(qǐng)?jiān)陬悇e前選擇畫，)*(

3、)有源植入()電器和機(jī)械結(jié)合醫(yī)疔器械()生物來源制品()重復(fù)使用儀器()無源植入()一次性使用()牙科產(chǎn)品()補(bǔ)充治療產(chǎn)品是否為有源器械*(請(qǐng)?jiān)陬悇e前選擇畫M)()有源器械()無源器械Medicaldevices(Reprocessing)有此要求的器械必須填與否則可不用填與Semicriticalmedicaldevices對(duì)再處理過程卜太嚴(yán)格的器械()GroupA()GroupBCriticalmedicaldevices對(duì)再處理過程1格的器械()GruppeA/GroupA()GruppeB/GroupB()GruppeC/GroupCCertificatenumberSterilisa

4、tionprocedures火菌過程()Steamsterilization()Gassterilisation()Radiationsterilisation()othersAppliedprocedure附帶需要提供資料：1歐盟授權(quán)代表協(xié)議簽署版2產(chǎn)品CE技術(shù)文檔3產(chǎn)品CE證書和ISO13485證書(1類產(chǎn)品不適用)4產(chǎn)品自我聲明EURepresentativeAgreementDocumentNumber:Thisagreementwillbevalidfor1yearsfromto.Part_Acouldchoosetorenewtheagreementbythen,otherwise

5、thisagreementwillbeterminatedautomatically.此合同有效期為1年，自年月曰至年月曰。到期后由甲方選擇續(xù)約或合同自動(dòng)失效。PartA（甲方）Name（名稱）:Add（地址）：ZipCode（郵編）：ContactPerson（聯(lián)系人）:Tel/Fax（聯(lián)系電話/傳真）：E-mail（郵箱）:PartyB（乙方）Name（名稱）:LuxusLebensweltGmbHAdd（地址）：Kochstr.1,47877,Willich,GermanyDIMDICode:DE/0000047791TaxNumber:DE305829099ContactPerson:

6、LinSunTel/Fax:0049-1715605732E-mail:Info.mluxuslw.deCompetentauthority（主管當(dāng)局信息）NameBezirksregierungDsseldorf,Dezernat24FederalstateNordrhein-WestfalenCityDusseldorfPostalcode40474Street,houseno.Cecilienallee2Phone/Fax+49-211-4750/+49-211-4752671E-maildez24.mpgbrd.nrw.dePartyAherebyappointsPartyBasthe

7、authorizedEuropeanRepresentativefortheirMedicalDevicewithCEmark,PartyBacceptstheappointmenttobetheauthorizedEuropeanRepresentativeforPartyAinthemarketofEuropeanUnion（E.U）,EEAandSwitzerland,Turkey,Bothpartiesenterthisagreementasfollow,theappointedproductcategoriessetoutinbelowform:甲方任命乙方為CE醫(yī)療產(chǎn)品歐盟授權(quán)代表

8、，乙方接受甲方任命，為甲方在歐盟、EEA、瑞士、和土耳其市場(chǎng)的CE醫(yī)療產(chǎn)品授權(quán)代表，雙方簽署下列協(xié)議，委托的產(chǎn)品類別見下表：No.ProductName/產(chǎn)品名稱Models/型號(hào)Classification/分類I.ObligationsandLiabilitiesofPartyA甲方職責(zé)和義務(wù)1. PartyAassurestoprovidetheupdatedtechnicalfilesofeachproductcategorywithCEmarktoPartyB.IfPartyAcannotprovidetherequiredtechnicalfiletoPartyBwithin30d

9、aysafterapprovalofCEcertificationorbeforeusingCEmarkfor“selfdeclaration“products,thisagreementwillbeterminatedautomatically,PartyAshouldtakeonanyaftereffectbyitself.Thetechnicalfilesshouldbetheelectroniccopy(PDF/WORD/JPG/vision),thewrittencopywouldbesubmittedifrequiredbythecompetentauthority.Detailo

10、ftherequirementsofthesubmittedfilesasfollowing:甲方確保在認(rèn)證結(jié)束后向乙方提供每一大類帶CE標(biāo)志產(chǎn)品的、最新的技術(shù)文檔。如果甲方在認(rèn)證結(jié)束取得證書之后的30天內(nèi)，或者自我聲明”產(chǎn)品在使用CE標(biāo)記之前，仍然沒有提供給乙方符合要求的CE技術(shù)文檔的，本協(xié)議自動(dòng)失效，甲方承擔(dān)由此而引起的所有后果。甲方必需提交電子文件，文件可以是PDF/WORD/JPG/格式的任何一種。書面文件只有在歐盟當(dāng)局需要審核時(shí)才提交乙方。所提交文檔內(nèi)容的要求如下：(i) Declarationofconformity,符合性聲明(ii) Copyofthelabel,packagi

11、ngandinstructionsforuse(inalllanguagesrequestedbythecountrieswherethedeviceismarketed),標(biāo)簽、包裝、說明書副本(所有上市國家要求的語言的版本)(iii) NotifiedBodycertification(whererelevant),公告機(jī)構(gòu)證書(適用時(shí))(iv) Postmarketsurveillanceprocessanddata,vigilancereportsandcomplaints,processesanddata,上市后監(jiān)督過程和數(shù)據(jù)、警戒報(bào)告以及投訴、處理和數(shù)據(jù)(v) Technicald

12、ocumentationrelevanttomarketsurveillanceinvestigationbeingundertakenbytheMemberState,與歐盟成員國上市監(jiān)督調(diào)查有關(guān)的技術(shù)文件(vi) Relevantclinicaldata/notification,相關(guān)的臨床數(shù)據(jù)/通知(vii) Detailsofanydistributors/suppliersputtingtheCEmarkeddevicesonthemarket,經(jīng)銷甲方CE標(biāo)志醫(yī)療器械的經(jīng)銷商/供方細(xì)節(jié)(viii) Incidentreportsandcorrectiveactionstaken.事

13、故報(bào)告及采取的糾正措施2. BeforeeachproductlistedinthisagreementisplacedintotheEUmarket,PartyAmustnotifyPartyBandprovidePartyBwithproductlabelingupdatedanddetailsofanydistributors/suppliersinEU,otherwisethisagreementwillbeterminatedautomatically,PartyAshouldtakeonanyaftereffectbyitself.本協(xié)議所涉及的每個(gè)產(chǎn)品在投放到歐盟市場(chǎng)之前，甲方必

14、須通報(bào)給乙方，并且應(yīng)向乙方提供最新的產(chǎn)品標(biāo)簽文件和歐盟經(jīng)銷商/供方的信息，否則本協(xié)議自動(dòng)失效，甲方承擔(dān)由此而引起的所有后果。3. Ifthereareanychangesofproductsandupdateoftechnicalfile,PartyAshallnotifyPartyBwithchangenotificationinelectroniccopyassoonaspossible.PartyAshallsendrelevantinformationtoPartyB'semaillistedasbelowwithinoneweekuponchanginginformation

15、:info.mluxuslw.de.產(chǎn)品如有改變，技術(shù)文件如有更新，甲方需要在更新信息產(chǎn)生后一周之內(nèi)以電子郵件的形式將相關(guān)信息發(fā)送到乙方以下電子郵箱：info.mluxuslw.de。4. Ifanyaccident/nearaccidentofproducts(includinganyseriousadverseeventduringclinicalinvestigationinpremarketstage)(seeclauseA1.5eof“GuidelineforAuthorizedRepresentatives(MEDDEV2.5/10)(January2012)”)happenswi

16、thinboundaryofE.U.,EEAandSwitzerland,Turkey,PartyAshallhelpPartyBtoinvestigatethereasonintime,andcompletetheinitialreporttogetherwithPartyB.PartyAshallpresenttheinvestigationresultandfinalreporttoPartyBaccordingtoMDD93/42/EEC(MDDproducts),IVDD98/79/EC(IVDDproducts)andtheGuidanceofvigilancesystem.Ift

17、heaccidentoftheproducthappensoutofE.U.,PartyAshallnotifyPartyBassoonaspossible,andPartBshouldmakedecisionwhethertoreporttocompetentauthorityornot.Iftheabovementionedaccident/nearaccidentofproductswasknownbyPartyAatfirst,PartyAmustsendnotificationtotheemailofPartyBasstipulatedinArticle2hereofintwocal

18、endardaysandprovidethecompletereportoftheinvestigation,analysisanddisposalresultoftheaccident/nearaccidenttoPartyBbyE-mailorothereffectivemeansinwritingwithinoneweekafterrelevantaccidenthappened.如果產(chǎn)品在歐盟境內(nèi)及EEA和瑞士、土耳其之發(fā)生事故或者準(zhǔn)事故(包括在上市前的臨床調(diào)查階段發(fā)生的嚴(yán)重不良事故(詳見"GuidelineforAuthorizedRepresentatives(MEDDE

19、V2.5/10)(2012年1月)')，甲方應(yīng)及時(shí)配合乙方調(diào)查原因，并同乙方一起負(fù)責(zé)完成初始報(bào)告。甲方應(yīng)在歐洲共同體理事會(huì)法令按MDD93/42/EEC(MDD產(chǎn)品)或IVDD98/79/EC(IVDD產(chǎn)品)和警戒系統(tǒng)指南規(guī)定的時(shí)間內(nèi)向乙方報(bào)告調(diào)查結(jié)果和最終報(bào)告。如帶CE標(biāo)志的產(chǎn)品，其事故、準(zhǔn)事故發(fā)生在歐盟境外，甲方應(yīng)盡快告知乙方，并由乙方?jīng)Q定是否向主管當(dāng)局報(bào)告。如果上述事故、準(zhǔn)事故是通過甲方渠道先期獲得的，甲方須立即在兩個(gè)自然日內(nèi)以電子郵件形式發(fā)送至上述第2條中的電子郵箱中；并需要對(duì)事故、準(zhǔn)事故的調(diào)查、分析和處理結(jié)果的報(bào)告，用電子郵件或書面方式在相關(guān)事件廣生后一周內(nèi)通知乙方。5. P

20、artyAshallberesponsibleforanybusinessdisputerelatedtotheirproductproblems,suchasmedicalaccidentsorclaimsforcompensationconcerningqualitythatariseaftersale.PartyBshallassistPartyAtohandlethedisputeinaccordancewiththeauthorizationofPartyA.AlltheexpensesoccurredoutsidethechinamainlandduringPartyB's

21、handlingoftheaccidentshallbebornebyPartyA.PartyAshouldpayallofthecostofthetrafficandotherallowanceforPARTB'semployeeoradvisorinthechinamainlandfortheneedofinvestigation,analysisanddisposaloftheaccident.PartyBisentitledtorequirePartyAtopayinadvance.BeforePartyBreceivessuchpaymentPartyBisentitledt

22、orefusetopayonbehalfofPartyAortakerelevantmeasures.甲方應(yīng)對(duì)銷售后發(fā)生的與其產(chǎn)品相關(guān)的醫(yī)療事故或質(zhì)量索賠等業(yè)務(wù)糾紛負(fù)責(zé)。乙方根據(jù)甲方的授權(quán)，協(xié)助甲方聯(lián)絡(luò)處理。在事故處理中，乙方需要在境外支付的相關(guān)費(fèi)用，須甲方確認(rèn)后由甲方承擔(dān)。如果由于調(diào)查、取證質(zhì)量投訴、事故和索賠的需要，乙方雇員或顧問在赴中國內(nèi)地企業(yè)工作的食宿、交通等實(shí)際支出的費(fèi)用，由甲方承擔(dān)，乙方可以要求甲方支付相應(yīng)的預(yù)付款，在該預(yù)付款到賬到達(dá)乙方指定賬戶之前，乙方有權(quán)利拒絕代為支付或者采取相關(guān)措施。6. PartyAshouldkeepthecompletesaleslistofallof

23、theproductsexportingtoanyareaofE.U,EEAandSwitzerland(includingtheOEMproducts)byelectricaldocumentsinEnglishatleast5years,inordertobeprovidedbyPartyBfortheusingtobetransferredorinspectedtotherelevantcompetentauthoritiesofE.U.,EEAandSwitzerland,TurkeyPartyAassurestheaccuracyandthevalidityofthedata.甲方出

24、口歐盟地區(qū)及EEA和瑞士、土耳其之所有產(chǎn)品的銷售清單(包括OEM的銷售清單)，在產(chǎn)品停產(chǎn)后至少五年期間，必須用英文文字、電子文檔形式保留完整無缺，以備乙方隨時(shí)用于歐盟及EEA和瑞士之官方的調(diào)用、檢查。甲方要對(duì)提供的數(shù)據(jù)其準(zhǔn)確性、真實(shí)性負(fù)責(zé)。7. PartyAmustnoticePartyBthecomplaintrecordandtheresultofdisposalontheaccidentofproductsimmediately,andPartyAshouldsave,transfer,check-upanyoftherecordaccordingtothe5tharticleonthe

25、above.甲方針對(duì)客戶/用戶的事故或者準(zhǔn)事故的投訴、抱怨記錄和處理結(jié)果，除了應(yīng)該及時(shí)通知乙方以外，所有記錄的保存、調(diào)用、檢查，按照上述第“舔條款辦理。8. PartyAshouldappointonepersonsastheprimacylinkmanwhoconnectwithPartyBanddealwiththenormaldailygrindaccordingtothisagreement.InformationofbothParties'linkmanshouldbewritteninPageone.Thinformationdeliveredtotheprimacylin

26、kmanwhoconnectwithPartyAbyPartyBshallbedeemedasdeliverytoPartyAandtheinstructionprovidedbytheprimacylinkmanwhoconnectwithPartyAshallbedeemedastheinstructionfromPartyA.甲方需指定一人，作為甲、乙雙方的第一聯(lián)絡(luò)人，主要職責(zé)是與乙方共同協(xié)調(diào)、處理本協(xié)議條款規(guī)定范圍內(nèi)的日常工作。雙方聯(lián)絡(luò)人的聯(lián)絡(luò)方式記錄在本協(xié)議的第一頁。乙方送達(dá)給甲方聯(lián)絡(luò)人的信息視作送達(dá)給甲方，甲方聯(lián)絡(luò)人給出的相關(guān)指示視作甲方給出的指示。9. PartyAshallfu

27、llyrealizetheriskofsellingitsproductstoEU,EEAandSwiss,TurkeymarketwithoutproductregistrationtorelevantcompetentauthorityofE.C.IfitcausedbyPartyA,suchasdelay,admittanceorconcealoffilessubmission,PartyAshouldtaketheaftereffectssuchaswarning,penaltyoreventheresultsthattheCEcertificatewillbewithdrawn,an

28、dthedistributionofitsproductsinEU,EEA,andSwiss,Turkeymarketwillbeprohibited.甲方需要充分認(rèn)識(shí)到本企業(yè)產(chǎn)品由于遲緩、延誤、疏漏或者隱瞞而造成產(chǎn)品沒有登記備案就銷售歐盟市場(chǎng)及EEA和瑞士、土耳其之必定帶來的風(fēng)險(xiǎn)。如果由于甲方的原因，發(fā)生產(chǎn)品沒有登記備案就進(jìn)入歐盟及EEA和瑞士之市場(chǎng)的，甲方將承擔(dān)罰款、警告，甚至直至吊銷CE產(chǎn)品證書和禁止產(chǎn)品進(jìn)入歐盟市場(chǎng)及EEA和瑞士、土耳其之的后果。10. PartyAshallnotifyoftheintentiontoPartyBtocarryoutaclinicalinvestiga

29、tionforMDDorAIMDD,andtheintentiontocarryoutaperformanceevaluationforIVDDperformedinEU,EEAandSwiss,Turkey.甲方應(yīng)通知乙方在歐盟、EEA和瑞士及土耳其對(duì)醫(yī)療器械或者有源植入性醫(yī)療器械進(jìn)行臨床試驗(yàn)的計(jì)劃，以及對(duì)體外診斷試劑進(jìn)行性能評(píng)估的計(jì)劃。11. PartyBisreleasedbyPartyAofanyliabilityrelatingtothemedicaldevicesmanufacturedbyPartyA.甲方承諾，乙方不對(duì)甲方生產(chǎn)的醫(yī)療器械的索賠承擔(dān)任何責(zé)任12. PartyAwi

30、llbefullyresponsiblefortheperformanceofitsproductsandwillholdPartyBharmlessagainstanyliabilityclaimarisingfromtheuseoftheproductsmanufacturedbyPartyA.甲方為其產(chǎn)品性能承擔(dān)全部責(zé)任，并將確保乙方不會(huì)因?yàn)榧追缴a(chǎn)的產(chǎn)品在使用過程中產(chǎn)生的任何責(zé)任索賠而承擔(dān)損失。13. AnyliabilitiesfordamagetoanythirdpartyattributedtoservicestipulatedhereinprovidedbyPartyB,Par

31、tyAshallbearallliabilitiesfordamageandundertaketoexemptanyresponsibilitiesofPartyBtoanythirdparty.IfitisrequiredforPartyBtoemployanyexpertandcounsel,especiallytoemploylegalcounseltoprovideconsultationandlegalagency,PartyAshallbearallrelevantfeescausedbytheemploymentandpaysuchfeesinadvanceuponrequest

32、ofPartyB.如果乙方因提供本協(xié)議規(guī)定的服務(wù)而產(chǎn)生對(duì)第三方的賠償責(zé)任，甲方應(yīng)當(dāng)全權(quán)承擔(dān)相關(guān)賠償責(zé)任，并免除乙方對(duì)外的責(zé)任。如果乙方由此需要聘請(qǐng)專家和顧問，特別法律顧問提供咨詢和法務(wù)代理，甲方應(yīng)承擔(dān)乙方因此而產(chǎn)生的相關(guān)合同費(fèi)用，乙方有權(quán)要求甲方預(yù)付相關(guān)費(fèi)用。II.ObligationsandLiabilitiesofPartyB乙方的職責(zé)和義務(wù)1. AbouttheregisterforPartyA'sproductswithCEmarktorelevantcompetentauthorityofE.C.,PartyAshallapplyitinwrittentoPartyBands

33、upplyallthefilesandformsneeded.PartyBshallreviewitwithin7workingdays,andsubmittocompetentauthorityofthecountryinwhichPartyBislocated(Germany)within5days.IfPartyA'sapplicationisreturned/rejectedbyPartyBorthecompetentauthorityforthecontentsofthesubmittedfiles,theaboveschedulewillbeadjustedaccordin

34、gly.Ifitneedsanyexpenditurebythecompetentauthority,onlyaftergettingPartyA'sappravylAtknairntakeonthepayment.IfPartyA'sproductsregisterfailsbyPartyB'sreason,accordingtoGermany/EUrelevlawsPartyBwillbegivenawarning,penaltyandeventhequalificationoftheEuropeanRepresentativewillberevoked.如果甲方已

35、加貼CE標(biāo)志的產(chǎn)品按歐盟相關(guān)規(guī)定必須需要辦理CE產(chǎn)品歐盟登記備案的，需先由甲方提出申請(qǐng)，并提供所有符合規(guī)定的文件并填寫申請(qǐng)表格，經(jīng)乙方初步認(rèn)可后，由乙方負(fù)責(zé)在7個(gè)工作日完成初審，5個(gè)工作日內(nèi)提交乙方所在國德國主管當(dāng)局審核申請(qǐng)登記備案的文件。但是由于甲方提交文件內(nèi)容方面的原因被乙方或者當(dāng)局退回/拒絕的申請(qǐng)，不在此時(shí)間規(guī)定之列。德國主管機(jī)構(gòu)審核上述登記備案如需要收取相關(guān)費(fèi)用的，需經(jīng)甲方同意方可由乙方代為支付。如果由于是乙方的原因，甲方的申請(qǐng)登記備案手續(xù)失敗而影響企業(yè)產(chǎn)品正常進(jìn)入歐盟市場(chǎng)的，根據(jù)德國/歐盟有關(guān)法律法規(guī)，乙方將受到警告、罰款、吊銷擔(dān)任歐盟代表資格的處罰。2. PartyBshallre

36、servetechnicalfilesofeachcategoryofpartyA'sproductswithCEmark.Thetechnicalfilesshallbereservedforatleasttenyearsaftermanufacturingofthelastbatchofproducts.Oncecompetentauthorityneedsthetechnicalfiles(includingneweditionofthetechnicalfileswhichhadalreadyregistered)ofeachcategoryofpartA'sprodu

37、ctswithCEmark.PaytBshouldsendthemtocompetentauthoritywithintenworkdays.乙方應(yīng)保留甲方每一大類獲得CE標(biāo)志產(chǎn)品的技術(shù)文檔，該文檔至少保存至最后一批產(chǎn)品出廠后十年。一旦歐盟主管當(dāng)局需要獲得CE標(biāo)識(shí)產(chǎn)品的技術(shù)文件(含已備案的技術(shù)文件的新版本)，乙方負(fù)責(zé)在10個(gè)工作日內(nèi)遞交歐盟主管當(dāng)局。3. UponreceivingtheCEtechniquefiles,PartyBshallgaveaelectronicreceipttoPartyAwithin3workingdays.It'stheevidencethatParty

38、Bhavereceivedalltherequiredfiles.PartyBwouldnotberesponsibleforthefilecontent.Allthedocuments,suchassaleslistandcomplainrecordsaredeemedconfidentialinformation;PartyBhavetheobligationtosendthemtocompetentauthorityifnecessary.PartBshouldmaintainandkeepthemsecret.乙方收到甲方提供的CE技術(shù)文檔等文件的3個(gè)工作日內(nèi)，向甲方出具電子回執(zhí)&qu

39、ot;；該回執(zhí)”僅證明乙方收到甲方的文件，而不對(duì)文件的內(nèi)容負(fù)責(zé)。乙方對(duì)甲方提供的銷售清單、投訴記錄等文件，負(fù)責(zé)遞交歐盟相關(guān)機(jī)構(gòu)審閱并負(fù)有保管、保密的責(zé)任。4. PartyBshallnotifyanyinformationabouttheproductswithCEmarkwithintheBoundaryofE.C.,includinganyclaimsofcustomersandthecompetitioncompanythatproducethesameCEmarkedproducts,toPartyA.乙方應(yīng)將有關(guān)CE產(chǎn)品在歐盟境內(nèi)的任何消息(包括客戶投訴和同類競(jìng)爭企業(yè))及時(shí)通知甲方。

40、5. IfanyseriousaccidentofproductshappenwithinboundaryofE.C.,PartyBshallnotifyPartyAwithintwocalendardaysofcomplaintorfeedbackonPartyA'sproductsandassistPartyAtoexecutevigilancesystemofmedicaldeviceproducts,andalsomaketheinitialreporttogetherwithPartyA.PartyBshallthenpresenttheinitialreport,inves

41、tigationresultsandthefinalreporttocompetentauthorityofcountryinwhichtheaccidentshappen.如果帶有CE標(biāo)志的產(chǎn)品在歐盟境內(nèi)發(fā)生嚴(yán)重事故，乙方應(yīng)在收到有關(guān)甲方產(chǎn)品的投訴或反饋信息兩個(gè)自然日內(nèi)通知甲方，并在甲方的協(xié)助之下調(diào)查原因，同甲方一起負(fù)責(zé)完成初始報(bào)告。乙方負(fù)責(zé)把完成的初始報(bào)告、調(diào)查結(jié)果和最終報(bào)告向事故發(fā)生國主管當(dāng)局提供。6. PartyBshallappointonepersonsastheprimacylinkmanwhoseresponsibilityistoconnectwithPartyAanddea

42、lwiththenormaldailygrindaccordingtothisagreement.TheinformationofbothParties'linkmanwaswritteninfirstpageofthiscontract.乙方需指定一人，作為甲、乙雙方的第一聯(lián)絡(luò)人，主要職責(zé)是與甲方共同協(xié)調(diào)、處理本協(xié)議條款規(guī)定范圍內(nèi)的日常工作。雙方聯(lián)絡(luò)人的聯(lián)絡(luò)方式記錄在本協(xié)議的第一頁。7. PartyBshallassistPartyAtocomprehendingtheconditionofthesameproductswithinboundaryofE.U,andsendthere

43、latedinformationtoPartyAintime.乙方協(xié)助甲方了解歐盟市場(chǎng)同類產(chǎn)品的情況，并及時(shí)反饋給甲方。8. PartyBshallkeepalltechnicalfilesandinformationofPartyA'sinconfidentiality.乙方應(yīng)對(duì)甲方技術(shù)文檔和資料保密。III. SERVICEFEE服務(wù)費(fèi)用PartyAshallpaytheservicefeestoPartyBseparatelyaccordingtotheagreementfortherelevantserviceprovidedbyPartyB.就乙方提供本協(xié)議規(guī)定的相關(guān)服務(wù)，應(yīng)

44、當(dāng)按照單獨(dú)約定支付乙方服務(wù)費(fèi)用。ProvidedthatPartyArequiresPartyBtoprovidetheservicebeyondscopestipulatedherein,bothpartiesshallagreerelevantfeesseparatelyinwriting.如果甲方需要乙方提供超出本協(xié)議規(guī)定之外的服務(wù)，甲乙雙方應(yīng)當(dāng)對(duì)此另行書約定相關(guān)費(fèi)用。IV. Others1. WrittenFormClause書面形式AmendmentstothisContractshallonlybevalidwhengiveninwriting.Therequirementoffo

45、rmmayonlybewaivedinwriting.Verbalcollateralagreementsormodificationsarenotvalid.本意向協(xié)議的任何更改與補(bǔ)充均需以書面形式進(jìn)行。這一規(guī)定同樣適用于本條款(關(guān)于書面形式)的修改?？陬^協(xié)議和口頭修改無效。2. ContractLanguage合同語言ThisagreementexistsinEnglishandChineselanguage.TheChineseversionisanexactduplicateoftheEnglishversion.本協(xié)議為中文和英文的對(duì)照版本，中文版本和英文版本內(nèi)容完全一樣。3. Se

46、verabilityclause可分割性條款I(lǐng)fanyprovisionofthisagreementoraprovisionincorporatedhereinatalaterdateisorshallbecomeinvalidinwholeorinpart,orifthisagreementoranymodificationthereofisfoundtohaveagap,thisshallnotaffectthevalidityoftheremainingprovisions.Itis,however,theexpressintentionofthepartiestomaintainth

47、evalidityoftheotherprovisionsoftheagreementunderallcircumstances.Inplaceofanyinvalidprovisionortofillagap,avalidandenforceableprovisionshallbeagreedwhichmostcloselycorrespondslegallyandeconomicallytothatwhichthepartiesintendedorwouldhaveintendedwithinthemeaningandpurposeoftheagreementandanylatermodi

48、fications,iftheyhadconsideredthisissuewhenconcludingtheagreements.Iftheinvalidityofanyprovisionisduetoameasureofperformanceortime(time-limitordate)statedtherein,ameasureofperformancewhichmostcloselycorrespondstotheoriginalmeasureinalegallyadmissiblewaymustbeagreedforthisprovision.如若本協(xié)議中的條款或者其補(bǔ)充于現(xiàn)在或者

49、將來無效，其他部分不受其影響，該規(guī)定同樣也適用于協(xié)議內(nèi)容缺失的情形。但協(xié)議雙方明確表示，上述可分割性條款是為了確實(shí)保證合同其它部分不因合同部分無效而整體無效受到影響。就無效條款和缺失部分，協(xié)議雙方應(yīng)當(dāng)在法律允許的范圍內(nèi)本著最接近原有合同目的，最能達(dá)到共同預(yù)期為標(biāo)準(zhǔn)，達(dá)成有效的補(bǔ)充規(guī)定，以替代該無效條款或者填補(bǔ)協(xié)議內(nèi)容的缺失。Thisagreementissubjecttotherequirementspecifiedinthe<EU93/42/EECDirective1998>,<EU2007/47/EECDirective2007>,<EU98/79/ECDir

50、ective2003>andthe<MEDDEV2.12-1REV.8January2013>.Shouldtherebeanyconflictsbetweenthisagreementand<EU93/42/EECDirective1998>,<EU2007/47/EECDirective2007>,<EU98/79/ECDirective2003>andthe<MEDDEV2.12-1REV.8January2013>shallbefollowedasstandards.Iftheregulationaboveupdateo

51、rchange,PartyAandPartyBshouldactivelynegotiateandcommunicatetoensurethattherequirementsofthenewregulationaremet.本協(xié)議受歐共體關(guān)于醫(yī)療器械的93/42/EEC指令，歐共體關(guān)于醫(yī)療器械的2007/47/EEC指令，歐共體關(guān)于體外診斷醫(yī)療器械的98/79/EC指令和醫(yī)療器械警戒體系指南約束。如本協(xié)議條款與指令或指南沖突，以指令和指南為準(zhǔn)。如上述法規(guī)發(fā)生更新或變更，甲乙雙方應(yīng)積極協(xié)商和溝通，確保持續(xù)滿足新法規(guī)的要求。Duringtheimplementationoftheagreement

52、,thisagreementwillbeterminatedautomaticallywhen:在協(xié)議執(zhí)行期間內(nèi)，下列日期為本協(xié)議的自動(dòng)終止日期：（a） ThedayuponPartA'sCECertificatebewithdrawntemporarily,beclosedorberecalledbythenotifiedbody.（Whentheabovementionedthingshappen,PartyAisobligatedtoaccomplishthefollowingprocessestoavoidthefurtherconsequences:甲方的CE證書因事故被發(fā)證

53、機(jī)構(gòu)暫時(shí)吊銷/關(guān)閉/收回的。（以上事實(shí)一旦發(fā)生，甲方需主動(dòng)配合乙方做好以下善后工作，否則將承擔(dān)由于不作為或者作為不當(dāng)而產(chǎn)生的所有責(zé)任：- BriefstatementinwrittenaboutthereasonswhyCECertificatebeingwithdrawn,beingclosedorbeingrecalledbythenotifiedbody.書面簡要說明證書被吊銷/關(guān)13!/收回的原因。包括更換公告機(jī)構(gòu)的理由。- Writtenstatementofnon-salesiftherearenoproductsunderthewithdrawn,closedorrecalled

54、CECertificateexportingtoEU,EEAandSwiss,Turkeymarket,orifthereareproductsexporting,awrittenstatementofsaleswouldberequiredwiththesaleslists,riskassessmentsandthemeasuresandtimetabletocovertherisk.）書面確認(rèn)被取消的CE證書所有所列產(chǎn)品是否已經(jīng)有出口歐盟市場(chǎng)以及EEA和瑞士、土耳其之市場(chǎng)。如果沒有，請(qǐng)出具書面聲明，如果有，請(qǐng)附上出口銷售清單，同時(shí)請(qǐng)書面評(píng)估由此可能產(chǎn)生的風(fēng)險(xiǎn)并陳述甲方解決問題的措施和時(shí)間表

55、。）（b） PartyAcannotprovidetherequiredtechnicalfiletoPartyBwithin30daysafterapprovaloftheCEcertificationorbeforeusingCEmarkforselfdeclarationproducts.Duringn60heaystfofthisagreementterminated,PartyAcouldtransacttheroutineaffairsastheauthorizedEuropeanRepresentativewhilePartyAcouldappointnewEuropeanRep

56、resentativeandchangetheCEcertification.PartyBshouldreporttheinvalidagreementtothenotifybodyforrecord.甲方在認(rèn)證結(jié)束取得證書之后的30天內(nèi)，或者自我聲明”產(chǎn)品在使用CE標(biāo)記之前，仍然沒有提供給乙方符合要求的CE技術(shù)文檔的，本協(xié)議自動(dòng)失效。在本失效之日起的60天內(nèi)，為了能夠方便甲方聘請(qǐng)新的歐盟代表及更改CE證書等相關(guān)工作，乙方可以代為繼續(xù)行使歐盟代表日常事務(wù)。乙方應(yīng)該將與甲方失效的協(xié)議信息及時(shí)報(bào)公告機(jī)構(gòu)備案。（c） PartyAdoesn'tpaythfeservicefeeaccordi

57、ngtothisagreementandrefusetoexplainonthedeadline.甲方?jīng)]有按協(xié)議規(guī)定的最后期限內(nèi)付清歐盟代表服務(wù)費(fèi)用，又不作解釋的。NootherrightsorobligationsareappliedtoPartyAorPartyBotherthanspecifiedinthisagreement.PARTA:除本協(xié)議外，甲、乙雙方不賦予其他權(quán)利和義務(wù)。PARTB:LuxusLebensweltGmbHSignature（簽字）：CompanyStamp（公章）：Date（日期）:Signature（簽字）：CompanyStamp（公章）：Date（日期）:ECDeclarationofConformityManufacturer公司名稱公司地址和歐代合同上保持一致要有國家ThepeoplesrepublicofChinaLuxusLebensweltGmbHKochstr.1,47877,Willich,GermanyDIMID:DE/0000047791