MDR法規(guī)下關(guān)于經(jīng)濟(jì)運(yùn)營(yíng)商的要求

      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(xiāo)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(chēng)或商標(biāo)銷(xiāo)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(xiāo)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.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(xiāo)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(xiāo)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。

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