医疗器械200747EC指令(9342EEC指令的修订案).docxVIP

DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCILof 5 September 2007amending Council Directive 90/385/EEC on the approximation of the laws of the Member Statesrelating to active implantable medical devices, Council Directive 93/42/EEC concerning medicaldevices and Directive 98/8/EC concerning the placing of biocidal products on the market?医疗器械指令更改的分析(针对2007/47/EC)?September 5, 2007, the European Union issued?a new Directive (2007/47/EC) that will affect all manufacturers selling medical devices in Europe.2007年9月5日，欧盟发布了一个将影响所有在欧洲出售医疗器械的制造商的新指令(2007/47的/EC)。?Essentially, this new Directive is the first significant modification to the Medical Device Directive since 1993 and there are several changes you may need to prepare for WELL BEFORE it becomes mandatory in March 2010. Here is a brief overview of major changes本质上讲，这份新指令是自1993年起,对医疗器械指令的第一个重大的修改，在2010年3月强制执行之前，你们需要好好准备它相应的改变。本文是重要变化的简要概述。?1. Clinical data now required for ALL devices, including Class IThe new Directive imposes more stringent requirements as to what constitutes clinical evidence and mandates stronger enforcement by authorities. The definition of clinical data is included and the Essential Requirements includes a requirement for Clinical Evaluation according to Annex X, which has been significantly amended. We highly recommend you review the changes to Annex X.1.?所有器械都将需要临床数据，包括一类产品新指令强加了形成临床证据更为严格的要求，并要求当局强制实施。新指令包括了临床数据的定义，基本要求根据附件X包括临床评估的要求，有明显变化。我们强烈建议你评审附件X的变化。?2. Records must be retained for 5+ yearsRecords must now be maintained for inspection by the Competent Authorities for the useful life of the product or 5 years from date of manufacture, whichever is greater. For implantable devices, records need to be kept for 15 years from the time the last product was manufactured.2.记录至少要保持五年以上记录保存时间不得小于产品使用周期或自生产之日起五年以备检查，对植入设备记录至少需要保存自最后的产品生产之日起15年。?3. Class I (Sterile and Measuring) devices may now choose Annex IIClass I Sterile and Measuring devices will have more flexibility to s