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[关于“医疗器械”术语解释的评论]

[Comments on the interpretation of the term "medical devices"].

作者信息

Ferge Zsigmond

出版信息

Orv Hetil. 2013 Mar 10;154(10):391-3. doi: 10.1556/OH.2013.29559.

Abstract

The Court of Justice of the European Union made a decision on medical devices as non-medicinal products for intended use in interpreting the concept of free movement of goods, such as operating principles concerning the subject matter of the interpretation of Directive 93/42/ EEC - in preliminary ruling according to article 267 of TFEU - on 22 November 2012. With its decision, given assigned explained the concept of the scope of medical devices. The decision of the Court is binding not only for the national court initiating a request for the preliminary ruling, but also for all courts of the Member States. Official reference: Dated judgement 22 November 2012 of the Court of Justice of the European Union to C-219/ Case no. 11 - in preliminary ruling according to article 267 of TFEU. Interpreted provisions: Directive 2007/47/EC of The European Parliament and of the Council of 5 September 2007 as amended by the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices 1st (2) a) first, second and third indent.

摘要

2012年11月22日,欧洲联盟法院就作为非药品用途的医疗器械在解释货物自由流动概念方面做出了一项决定,例如关于对93/42/EEC号指令解释主题的操作原则——根据《欧洲联盟运作条约》第267条进行的初步裁决。通过其决定,对医疗器械范围的概念进行了规定和解释。法院的这一决定不仅对提出初步裁决请求的国家法院具有约束力,而且对成员国的所有法院都具有约束力。官方参考:欧洲联盟法院2012年11月22日对C-219/11号案件的判决——根据《欧洲联盟运作条约》第267条进行的初步裁决。解释条款:经1993年6月14日关于医疗器械的93/42/EEC号理事会指令修订的2007年9月5日欧洲议会和理事会的2007/47/EC号指令第1(2)a)条第一、第二和第三项。

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