公司已取得CE证书的产品按欧盟相关规定，必须需要办理CE产品欧盟登记备案的，需提出申请，并提供所有符合规定的文件并填写申请表格，经乙方初步认可后，由乙方负责在7个工作日完成初审，5个工作日内提交乙方所在国荷兰主管当局审核申请登记备案的文件。但是由于甲方提交文件内容方面的原因被乙方或者当局退回/拒绝的申请，不在此时间规定之列。提交文件的内容、时间等细节，应该在双方协议的附件中明示。（登记备案的费用甲乙方根据实际注册情况另外商议并签订合同）
If it needs any expenditure by the competent authority,only after getting Party A’s approval, then Party A can take on thepayment. If Party A’s products register fails by Party B’s reason,according to EU relevant laws Party B will be given a warning,penalty and even the of the European Representativewill be revoked.
如果需要任何主管机构审核上述登记备案如需要收取相关费用的，需经甲方同意方可由乙方代为支付。如果由于是乙方的原因，甲方的申请登记备案手续失败而影响企业产品正常进入欧盟市场的，根据欧盟有关法律法规，乙方将受到警告、罚款、吊销担任欧盟代表资格的处罚。
2.1 Party B shall reservetechnical files of each category of Party A's products with CEmark, and take up the responsibility of keeping, confidentialityand submission. The technical files shall be reserved at least 5years after the last batch product’s manufacturing. Once competentauthority needs the technical files (including new editiontechnical files which had already registered) of each category ofPart A’s products with CE mark. Party B should send them tocompetent authority within ten working days.
乙方应保留甲方每一大类获得CE标志产品的技术电子版文档，并负保管、保密和提交当局的责任。该文档至少保存至Zui后一批产品停产五年后。一旦欧盟主管当局需要获得CE标识产品的技术文件（含已备案的技术文件的新版本），乙方负责在10个工作日内递交欧盟主管当局。
2.2 Party B would not beresponsible for the file content. All the documents, such as saleslist and complain records are deemed confidential information;Party B have the obligation to send them to competent authority ifnecessary. Part B should maintain and keep them secret.
乙方不对甲方提交的文件内容负责，乙方对甲方提供的销售清单、投诉记录等文件，负责递交欧盟相关机构审阅并负有保管、保密的责任。
2.3 Party B permits PartyA to use part B’s name and address for the purpose ofinclusion/printing on all packaging, labeling and instruction foruse, of products that carry CE Marking and that have beenrepresented by Party B.
乙方允许在被乙方代表的加贴CE标志的甲方产品的包装、标签、说明书、宣传册等上面加印乙方名称地址作为甲方的欧盟授权代表。
2.4 Party B shall keepfollowing files of party A’s products with CE mark at the disposalof the national authorities, at least five years after the lastbatch product’s manufacturing. Minimum documents are:
1) Declaration of conformity,
2) Copy of the label, packaging and instructions for use(in all languages re by the countries where the device ismarketed),
3) Notified Body certificate (where relevant),
4) Post market surveillance process and data, vigilancereports and complaints, processes and data,
5) Technical documentation relevant to market surveillanceinvestigation being undertaken by the Member State,
6) Relevant clinical data / notification,
7) Details of any distributors / suppliers putting the CEmarked devices on the market,
8) Incident reports and corrective actionstaken.
乙方应保留甲方以下与CE标志产品有关的资料供主管当局使用，至少保存至Zui后一批产品出厂后五年。这些资料至少应包括：
1)符合性声明
2)标签、包装、说明书副本（所有上市国家要求的语言的版本）
3)公告机构证书（适用时）
4)上市后监督过程和数据、警戒报告以及投诉、处理和数据
5)与欧盟成员国上市监督调查有关的技术文件
6)相关的临床数据/通知
7)经销甲方CE标志医疗器械的经销商/供方细节
8)事故报告及采取的纠正措施
2.5 Party B must keepParty A informed in all matters that may be connected to thedevices placed on the market in the EU. At the minimum, theexchange of information concerning following shall becovered.
乙方应通知甲方所有有关其在欧盟上市医疗器械的信息，至少包括:
2.6.1SafeguardClause保护条款
“Where a Member State ascertains that a medical devices,when correctly installed, maintained and used for their intendedpurpose may compromise the health and/or safety of patients, usersor, where applicable, other persons, or the safety of property, itshall take all appropriate interim measures to withdraw suchdevices from the market or prohibit or restrict their being placedon the market or put into service.”
If the relevant Competent Authority contacts the Party Babout its interim measures to withdraw Party A’s device(s) from themarket or prohibit or restrict their being placed on the market orput into service, Party B should immediately communicate suchmeasures to Party A and advise Party A as to the implications ofthis decision.
When the Commission finds that national measures takenunder the Safeguard Clause “are unjustified, it shall immediatelyso inform the Member State which took the measures and themanufacturer or his authorized representative”.
If the relevant Competent Authority contacts Party B,Party B should immediately communicate such information to Party Aand advise Party A as to the implications of thisdecision.
“当一个成员国确信一个医疗器械在正确安装、维护和按照预期用途使用情况下，可能会危害患者、使用者、（适用时）其他人员或财产的健康和/或安全时，应采取所有适当的临时措施以将医疗器械撤出市场、禁止或限制器上市”。
如果有关主管当局就有关对甲方医疗器械采取撤出市场、禁止或限制上市的临时措施联系乙方，乙方应立即将相关措施与甲方沟通，并向甲方建议此决定的相关影响。
当欧盟委员会认为国家的措施不合理，应立即通知采取措施的成员国、制造商或其欧盟授权代表。
如果有关主管当局联系乙方，乙方应立即将相关措施与甲方沟通，并向甲方建议此决定的相关影响。
2.6.2警戒Vigilance
If the relevant Competent Authority contacts Party B aboutits assessment outcome of an incident of Party A’s medical device,Party B should immediately communicate such information to themanufacturer and advise Party A as to the implications of thisdecision.
如果欧盟主管当局通知了乙方关于甲方产品发生的事故的决定，乙方应立即就此联系甲方并且使甲方知晓主管当局的决定。
Party B shall notify any information about the productswith CE mark within boundary of E.U. to Party A, including anyclaims of customers and the competition company that produce thesame CE marked products.
乙方应将获得的有关CE产品在欧盟境内的任何消息(包括客户投诉和同类竞争企业)及时通知甲方。
2.6.3If any accident/ near accident of products (CE markedproducts, premarket clinical investigation products and performanceevaluation products) happens within boundary of E.U., Party B shallnotify Party A within 3 working days after receiving the claims ofcustomers and feedback about the product, and execute vigilancesystem of medical device products under the assisting of Party A,and also make initial report, investigation result and final reportto competent authority of country in which the accidenthappens.
如果带有CE标志的产品，上市前临床试验的产品以及进行性能评估的产品在欧盟境内发生事故或者准事故，乙方应在收到或得知有关甲方产品的投诉或反馈信息3个工作日内及时通知甲方，并在甲方的协助之下调查原因，同甲方一起负责完成初始报告。乙方负责把完成的初始报告、调查结果和Zui终报告向欧盟主管当局提供。
2.6 Party B shall assistParty A to comprehending the condition of the same products withinboundary of E.U, and send the related information to Party A intime.
乙方协助甲方了解欧盟市场同类产品的情况，并及时反馈给甲方。
2.7 Upon receiving thenotice about the intention to carry out a clinical investigationfor MDD or AIMDD, and the intention to carry out a performanceevaluation for IVDD in EU, Party B shall notify communicate theinformation on the manufacturer and on the device to the CompetentAuthorities of the Member State in which he has his registeredplace of business. If any serious adverse events during clinicalinvestigation, i.e. in the premarket phase, Party B Shall fullyrecord and immediately notify to all Competent Authorities of theMember States in which the clinical investigation is beingperformed.
乙方需要在收到甲方关于在欧盟境内进行医疗器械和有源植入性医疗器械的临床试验计划，和体外诊断试剂的性能评估计划的通知后，需将相关信息通知所在国的主管机构CA。如果在临床调查中发生严重不良事件，乙方应及时对其进行完整记录并立即告知进行临床调查所在地的主管当局。
2.8 Party B shall appointone or two persons as the primacy linkman whose responsibility isto connect with Party A and deal with the normal daily grindaccording to this agreement. The information of both Parties’linkman was written in appendixC.
乙方需指定一至二人，作为甲、乙双方的第一联络人，主要职责是与甲方共同协调、处理本协议条款规定范围内的日常工作。双方联络人的联络方式记录在本协议的附件
