MDR法规下关于经济运营商的要求

      一.   经济运营商的定义

1.Economic operator： means a manufacturer, an authorised representative, an importer, a distributor or the person referred to 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 manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its 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 person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's behalf in relation to specified tasks with 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 within the Union that places a device from a third country on the Union market;

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 supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service;

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

二.法规中关于经济运营商的要求

1.Article 10 General obligations of manufacturers 制造商的义务 P10

2.Article 11 Authorised representative 授权代表 P21

3.Article 12 Change of authorised representative 授权代表的变更 P22

4.Article 13 General obligations of importers 进口商的一般义务 P23

5.Article 14 General obligations of importers 经销商的一般义务 P24

6.Article 15 Person responsible for regulatory compliance 负责法规符合性的人员职责P25

7.Article 16 Cases in which obligations of manufacturers apply to importers, distributors or other persons 制造商的义务适用于进口商、经销商和其他人的情况P27

8.Article 30 Electronic system for registration of economic operators 经济运营商注册电子系统 P39

9.Article 31 Registration of manufacturers, authorised representatives and importers

EUDAMED is structured around 6 interconnected modules and a public website:

目前6大板块中已经有几个板块开放了，其他的板块的功能欧盟还在进一步的开发中，等到板块全部开发的数据系统就会更方便。

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