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 humanbody: 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