翻訳と辞書 |
European Authorized Representative : ウィキペディア英語版 | European Authorized Representative A European Authorized Representative (E.A.R.) serves as a legal entity designated by non European Union (EU) manufacturers, to represent them in the EU and ensure their compliance with the European Directives. == Overview ==
Regulation of goods produced by manufactures outside of the European Union, especially in the medical devices industry, instigated the need for Authorized Representatives. As clarified in the Medical Devices Directive amendment (93/42/EEC), it is required that alongside the CE mark all products must also have an Authorized Representative. As stated in this amendment, an Authorized Representative should serve as a contact point with the EU member states competent authorities. An E.A.R. holds the responsibility to act as a neutral party between the competent authorities and the non EU manufacturers. They must ensure the manufacturer’s compliance with the conformity assessment procedure set out in the European directives which apply to the manufacture’s product. The EAR must uphold dual accountability with the manufactures if problems or questions arise regarding the product. The E.A.R. must provide their contact information for the manufacturer to place on the products, allowing the E.A.R. to be the primary contact for EU authorities.
抄文引用元・出典: フリー百科事典『 ウィキペディア(Wikipedia)』 ■ウィキペディアで「European Authorized Representative」の詳細全文を読む
スポンサード リンク
翻訳と辞書 : 翻訳のためのインターネットリソース |
Copyright(C) kotoba.ne.jp 1997-2016. All Rights Reserved.
|
|