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根据医疗产品的其风险大小可以分为4个等级:I级、IIa级、IIb类、III级,德国欧通(微信outong86)就分别针对这4个等级总结出不同的符合性评价程序途径,通过下面的示意图,可以看出,不同类型的产品,其获得CE认证标志的途径(符合性评价程序)不同。

对于IIa、IIb和III类医疗器械的制造商来说,存在着如何选择符合性评价程序途径的问题。主要的区别是选择型式试验的方式,还是选择质量体系的方式,这两种途径各有其特点,制造商应根据自己的实际情况选择最为适合的途径。

 

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