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歐盟代表職責

歐盟代表職責

       歐盟授權代表(European Authorised Representative 或European Authorized Representative)是指由位于歐洲經濟區EEA(包括EU與EFTA)境外的制造商明確指定的一家公司,這家公司必須要在歐盟國家按公司法正規注冊。該公司按歐盟相關的指令和法律履行特定的職責。

       一、代表非歐盟制造商與歐盟主管當局打交道。

       二、歐盟授權代表保存最新的,貼上CE標志產品的技術文件(Technical Files),確保能隨時及時地提供給歐盟主管當局審查。

       三、根據非歐盟制造商建立的警戒系統程序,歐盟授權代表協助其進行產品事故報告,召回等。

       四、新方法指令要求歐盟授權代表必須位于歐洲經濟區境內并且具有商業注冊地址(某些國家還要求歐盟授權代表必須有公司注冊號或歐盟增值稅VAT注冊號);

       五、EEA成員國的政府及主管機關可以隨時直接找上歐盟授權代表核查EEA境外的制造商是否履行了歐盟相關的指令和法律所要求的職責;  

       六、雖然歐盟授權代表可代表EEA境外的制造商履行歐盟相關的指令和法律對該制造商所要求的特定的職責,但制造商依然要承擔產品責任;

       七、被2007/47/EC修訂后的93/42/EEC 醫療器械指令的Article 14.2 規定:非歐盟的制造商今后必須明確指定單一的歐盟授權代表。也就意味著:制造商不能將一般商務代表(經銷商,進口商等)與歐盟授權代表混為一談; 

       八、在沒有制造商同意的情況下,歐盟授權代表不可擅自單獨更改EEA境外的制造商所制造的產品,即使是為了使違規產品符合歐盟產品指令的要求。

       九、Lotus國際集團公司是按歐盟和英國、荷蘭法規成立的正規公司,公司分別位于英國倫敦、荷蘭海牙,專業提供歐盟授權代表、自由銷售證書、MHRA注冊、CIBG注冊,證書的公證等服務,可以為客戶減少中間環節,節省時間與費用,使您的產品在符合現行歐洲法規的情況下進入市場的程序簡單化。

       十、同時Lotus國際集團公司能為客戶在歐盟境內銷售產品時出現任何問題給予及時的信息溝通與協助解決。

需要特別注意的是:

       一、沒有正規公司營業執照的個人不可以擔任歐盟授權代表!

       二、避免讓在歐洲留學或打工的親戚朋友兼任歐盟授權代表!

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