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 ofthe device, not any other temporary use purpose;
② Device classification is based on the most severe and specialuse conditions that may occur for the device;
③ Devices used by combination of different devices need to beclassified separately;
④ The types of device accessories specified in Appendix XVI ofMDR need to be classified separately; Accessories not listed needonly be classified according to the device itself;
⑤ For software used with the device, the classification standardis equivalent to the device;
⑥ Software not used with the device shall be classifiedindependently;
⑦ If the device complies with multiple classification standards,the highest classification standard shall be adopted.
