欧盟医疗器械CE认证MDR分类流程

 分类流程

①确定器械于人体组织接触时间：临时（<60分钟）、短期（60分钟~30天）、长期（>30天）。

②确定器械介入人体的程度：介入器械、非介入器械。

③确定对应的法规条目

A. 第1~4条规定：非介入器械

B. 第5~8条规定：介入器械

C. 第9~13条规定：有源器械

D. 第14~22条规定：特殊器械的特殊规定。

④根据法规确定分类

Classification process

① Determine the contact time of the device in human tissues: temporary (<60 minutes), short-term (60 minutes to 30 days), long-term (>30 days).

② Determine the extent of the device's intervention in the human body: interventional device and non interventional device.

③ Determine the corresponding regulatory entries

A. Articles 1 to 4: Non interventional devices

B. Article 5-8: Interventional devices

C. Articles 9-13: Active devices

D. Article 14-22: Special provisions for special devices.

④ Classification according to regulations