欧盟CE认证最新动态.pptVIP

什么是 CE 标志(标记)? CE 标志, 又称 CE标记，英文为 CE Marking 是一个30个欧洲国家强制性地要求医疗器械必须携带的安全标志, 其形如 ， 其放大图型如本页顶部中间所示。字母 “CE” 是法文句子 “Conformité Européene” 的缩写。其意为 “符合欧洲 (标准)”。 如果一种医疗器械要想合法的进入欧洲市场销售和被消费者使用，就必须获得ce认证。 欧洲医疗器械指令更改的分析 1. Clinical data now required for ALL devices, including Class I The 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 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 II Class I Sterile and Measuring devices will have more flexibility to select a route to compliance as they will be given the option to select a full quality assurance conformity assessment module. 4. Outsourced design and manufacturing must be more closely monitored If the design or manufacturing of a device is done by a third party, you must demonstrate that you have adequate controls in place to ensure the continued efficient operation of the suppliers quality system. 3.一类(无菌和测量)设备现可以选择附录II.一类(无菌和测量)设备现可以有更多灵活的合格评定程序供选择. 4.外包的设计和生产活动须更严格的监视.如果设备的设计和生产是由第三方来完成,你则必须证明你有足够的控制以确保供应商质量体系的持续有效性. 5. Closer inspection of design documentationNotified Bodies will be required to perform an inspection of design documentation for a represe