问1、生物学对比是必须要求材料一致吗？即使是二A类产品？

答：是的。根据MDR的要求，申报器械和对比器械的材料应相同。

问2、临床评价时选择几个等同器械比较合适？ 

答：法规没有对等同器械的选择有明确数量的规定。但是要求等价只能基于单一的器械。（Equivalence can only be based on a single device。Evaluators may wish to refer to several devices that are equivalent. In such a situation, equivalence of every single device to the device under evaluation should be fully investigated, demonstrated, and described in the clinical evaluation report。）

问3、国内和国外同产品可以对比吗？

答：应选择在欧盟上市的医疗器械作为对比器械。（the only clinical data that are considered as relevant are the data obtained when the equivalent device is a CE-marked medical device used in accordance with its intended purpose as documented in the IFU）

问4、香港上市和台湾上市，可以用于国内同产品做对比吗？

答：不可以，国内医疗器械临床评价应选择在境内上市的医疗器械作为对比器械。

问5、IIa类产品需要有临床开发计划吗，是不是要做临床试验的才写临床开发计划？

答： 是的，临床研究的设计应遵循临床开发计划。