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一、經(jīng)濟(jì)運(yùn)營(yíng)商的定義

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);

經(jīng)濟(jì)運(yùn)營(yíng)商：是指制造商，歐盟授權(quán)代表，進(jìn)口商，經(jīng)銷商和條款22(1) 和22(3)所指的人員；

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擁有設(shè)計(jì)，制造或完全翻新的器械并以其名稱或商標(biāo)銷售該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;

授權(quán)代表：指成立于歐盟境內(nèi)的任何自然人或法人，其已收到并接受來(lái)自于歐盟以外的制造商的書(shū)面授權(quán)，代表該制造商履行本法規(guī)對(duì)該制造商所要求的特定的職責(zé)。

4.Importer: means any natural or legal person established within the Union that places a device from a third country on the Union market;

進(jìn)口商：指歐盟境內(nèi)的將第三國(guó)的醫(yī)療器械投放到歐能市場(chǎng)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;

經(jīng)銷商：指供應(yīng)鏈中除制造商或進(jìn)口商外，負(fù)責(zé)器械投放市場(chǎng)直至投入使用的任何自然人或法人。

定義出處：2017/745-Medical Device Regulation

文件網(wǎng)址： https://eur-lex.europa.eu/eli/reg/2017/745/oj/engeur-lex.europa.eu

二、法規(guī)中關(guān)于經(jīng)濟(jì)運(yùn)營(yíng)商的要求

1 1.Article 10 General obligations of manufacturers 制造商的義務(wù) P10

2 Article 11 Authorised representative 授權(quán)代表 P21

3 Article 12 Change of authorised representative 授權(quán)代表的變更 P22

4 Article 13 General obligations of importers 進(jìn)口商的一般義務(wù) P23

5 Article 14 General obligations of importers 經(jīng)銷商的一般義務(wù) P24

6 Article 15 Person responsible for regulatory compliance 負(fù)責(zé)法規(guī)符合性的人員職責(zé)P25

7 Article 16 Cases in which obligations of manufacturers apply to importers, distributors or other persons 制造商的義務(wù)適用于進(jìn)口商、經(jīng)銷商和其他人的情況P27

8 Article 30 Electronic system for registration of economic operators 經(jīng)濟(jì)運(yùn)營(yíng)商注冊(cè)電子系統(tǒng) 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大板塊中已經(jīng)有幾個(gè)板塊開(kāi)放了，其他的板塊的功能歐盟還在進(jìn)一步的開(kāi)發(fā)中，等到板塊全部開(kāi)發(fā)的數(shù)據(jù)系統(tǒng)就會(huì)更方便。