MDR法規(guī)下關于經濟運營商的要求

      一.   經濟運營商的定義

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);

經濟運營商：是指制造商，歐盟授權代表，進口商，經銷商和條款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計，制造或完全翻新的器械并以其名稱或商標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;

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

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

進口商：指歐盟境內的將第三國的醫(yī)療器械投放到歐能市場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;

經銷商：指供應鏈中除制造商或進口商外，負責器械投放市場直至投入使用的任何自然人或法人。

定義出處：2017/745-Medical Device Regulation

文件網址：

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

二.法規(guī)中關于經濟運營商的要求

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

2.Article 11 Authorised representative 授權代表 P21

3.Article 12 Change of authorised representative 授權代表的變更 P22

4.Article 13 General obligations of importers 進口商的一般義務 P23

5.Article 14 General obligations of importers 經銷商的一般義務 P24

6.Article 15 Person responsible for regulatory compliance 負責法規(guī)符合性的人員職責P25

7.Article 16 Cases in which obligations of manufacturers apply to importers, distributors or other persons 制造商的義務適用于進口商、經銷商和其他人的情況P27

8.Article 30 Electronic system for registration of economic operators 經濟運營商注冊電子系統(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大板塊中已經有幾個板塊開放了，其他的板塊的功能歐盟還在進一步的開發(fā)中，等到板塊全部開發(fā)的數據系統(tǒng)就會更方便。

微珂提供專業(yè)的MDR認證服務，歡迎來電咨詢：

   微珂醫(yī)藥擁有海內外專業(yè)成熟的技術團隊、以及與機構深度的戰(zhàn)略合作，服務于醫(yī)療器械企業(yè)，為企業(yè)提供優(yōu)質的定制化服務，協(xié)助企業(yè)從產品技術要求編寫、產品檢測、臨床評價資料編寫與審核、申報與跟蹤，根據企業(yè)實際情況，進行質量管理體系建立，幫忙企業(yè)從管理到產品各環(huán)節(jié)一站式服務！

微珂集團服務熱線：4001182826！