经济发展营运商的界定
1
Economic operator：means a manufacturer, an authorisedrepresentative, an importer, a distributor or the person referredto in Article 22(1) and 22(3);
经济发展营运商：就是指生产商，欧盟国家法定代理人，采购商，代理商和条文22(1) 和22(3)所说的工作人员；
2
Manufacturer：means a natural or legal person who manufactures orfully refurbishes a device or has a device designed, manufacturedor fully refurbished, and markets that device under its name ortrade mark;
生产商：就是指生产制造或彻底翻修器材或有着设计方案，生产制造或彻底翻修的器材并且以其命名或商标logo市场销售该器材的个人或法定代表人。
3
Authorised representative：means any natural or legal personestablished within the Union who has received and accepted awritten mandate from a manufacturer, located outside the Union, toact on the manufacturer's behalf in relation to specified taskswith regard to the latter's obligations under this Regulation;
法定代理人：指创立于欧盟国家地区的一切个人或法定代表人，其已接收并接纳来自于欧盟国家之外的生产商的书面形式受权，意味着该生产商执行本政策法规对该生产商所需求的指定的岗位职责。
4
Importer: means any natural or legal person established withinthe Union that places a device from a third country on the Unionmarket;
采购商：指欧盟国家地区的将第三国的医疗设备推广到欧能销售市场上的一切个人或法定代表人。
5
Distributor: means any natural or legal person in the supplychain, other than the manufacturer or the importer, that makes adevice available on the market, up until the point of putting intoservice;
代理商：指供应链管理中除生产商或采购商外，承担器材投入市场直到交付使用的一切个人或法定代表人。
界定来源：2017/745-Medical Device Regulation
文档网站地址：
二、政策法规中有关经济发展营运商的规定
1.Article 10 General obligations of manufacturers 生产商的责任 P10
Article 11 Authorised representative 法定代理人 P21
Article 12 Change of authorised representative 授权代表的变动 P22
Article 13 General obligations of importers 采购商的一般责任 P23
Article 14 General obligations of importers 代理商的一般责任 P24
6
Article 15 Person responsible for regulatory compliance承担政策法规合乎性的工作人员岗位职责P25
7
Article 16 Cases in which obligations of manufacturers apply toimporters, distributors or other persons生产商的责任适用采购商、代理商和别人的状况P27
8
Article 30 Electronic system for registration of economicoperators 经济发展营运商申请注册电子控制系统 P39
9
Article 31 Registration of manufacturers, authorisedrepresentatives and importers
EUDAMED is structured around 6 interconnected modules and apublic website:
现阶段6大模块中已经有几个版块对外开放了，别的的版块的作用欧盟国家仍在进一步的研发中，直到版块所有开发设计的数据系统便会更便捷。
