医疗器械分类注意事项

①器械分类基于器械的预期使用目的，而非其他任何临时使用目的；

②器械分类基于器械可能出现的zui严苛和zui特殊的使用条件；

③由不同器械组合起来使用的器械，需要分别对各个独立器械进行分类；

④MDR附录XVI中规定的器械附件种类，需要分别对各个附件进行分类；未列出的附件，只需跟随器械本身分类；

⑤和器械一起使用的软件，分类标准等同于该器械；

⑥不和器械一起使用的软件，需要独立进行分类；

⑦如果器械符合多条分类标准规定，则采用zui高等级的分类标准规定。

matters needing attention

① Device classification is based on the intended use purpose of the device, not any other temporary use purpose;

② Device classification is based on the most severe and special use conditions that may occur for the device;

③ Devices used by combination of different devices need to be classified separately;

④ The types of device accessories specified in Appendix XVI of MDR need to be classified separately; Accessories not listed need only be classified according to the device itself;

⑤ For software used with the device, the classification standard is equivalent to the device;

⑥ Software not used with the device shall be classified independently;

⑦ If the device complies with multiple classification standards, the highest classification standard shall be adopted.