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翻訳と辞書　辞書検索 [ 開発暫定版 ] スポンサード リンク Medical Devices Directive ： ウィキペディア英語版 Medical Devices Directive The Medical Device Directive (Council Directive 93/42/EEC of 14 June 1993 〔(Text of directive (html) ) 〕 concerning medical devices, OJ No L 169/1 of 1993-07-12) is intended to harmonise the laws relating to medical devices within the European Union. The MD Directive is a 'New Approach' Directive and consequently in order for a manufacturer to legally place a medical device on the European market the requirements of the MD Directive have to be met. Manufacturers' products meeting 'harmonised standards'〔(Harmonised Standards under the MDD )〕 have a presumption of conformity to the Directive. Products conforming with the MD Directive must have a CE mark applied. The Directive was most recently reviewed and amended by the 2007/47/EC and a number of changes were made. Compliance with the revised directive became mandatory on March 21, 2010. == See also == * European Medical Devices Industry Group * ''Journal of Medical Device Regulation'' * Registration of medical devices in Italy 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「Medical Devices Directive」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.