医疗器械CE认证MDR法规IVDR法规经济运营商的是什么？

一、经济运营商的定义

1，Economic operator：means a manufacturer, an authorisedrepresentative, an importer, a distributor or the person referredto in Article 22(1) and 22(3);

经济运营商：是指制造商，欧盟授权代表，进口商，经销商和条款22(1) 和22(3)所指的人员；

2，Manufacturer：means a natural or legal person who manufacturesor fully refurbishes a device or has a device designed,manufactured or fully refurbished, and markets that device underits name or trade mark;

制造商：是指制造或完全翻新器械或拥有设计，制造或完全翻新的器械并以其名称或商标销售该器械的自然人或法人。

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;

授权代表：指成立于欧盟境内的任何自然人或法人，其已收到并接受来自于欧盟以外的制造商的书面授权，代表该制造商履行本法规对该制造商所要求的特定的职责。

4，Importer: means any natural or legal person established withinthe Union that places a device from a third country on the Unionmarket;

进口商：指欧盟境内的将第三国的医疗器械投放到欧能市场上的任何自然人或法人。

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;

经销商：指供应链中除制造商或进口商外，负责器械投放市场直至投入使用的任何自然人或法人。

定义出处：2017/745-Medical Device Regulation

文件网址：

https://eur-lex.europa.eu/eli/reg/2017/745/oj/engeur-lex.europa.eu