MDCG2020-10∕1修订版1 《欧盟法规(EU)2017745》下医疗器械临床研究中的安全性报告
MDCG 2020-10/1 1
EU2017/745
2022 10
2017/745 103 MDCGMDCG
Page 1 of 19
5.1
9.4
5.2.2
10.2.1
4
5
10.2.19 - 20
10.2.15 17
MDCG 2020-10/1 1
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May 2020
MDCG 2020-10 Rev 1
Safety reporting in clinical investigations
of medical devices under the Regulation (EU) 2017/745
1 ............................................................................................................................................................................................................................................................................................................ 3
1.1 EUDAMED ...................................................................................................................................................................................................................................................................3
2 ............................................................................................................................................................................................................................................................................................................ 4
2.1 ............................................................................................................................................................................................................................................................................................................4
2.2 ..................................................................................................................................................................................................................................................................4
3 ............................................................................................................................................................................................................................................................................................................ 5
3.1 ........................................................................................................................................................................................................................................................................................5
3.2 AE ............................................................................................................................................................................................................................................................................ 5
3.3 SAE .................................................................................................................................................................................................................................................................. 5
3.4 ............................................................................................................................................................................................................................................................................................5
4 ..................................................................................................................................................................................................................................................................................................... 6
4.1 EUDAMED .............................................................................................................................................................................................................................................................................6
4.2 NCAS ......................................................................................................................................................................................................................................................................6
4.3 ........................................................................................................................................................................................................................................................................................................6
5 ............................................................................................................................................................................................................................................................................................... 7
5.1 74.1 PMCF ............................................................................................................................................................................................................7
5.2 .............................................................................................................................................................................................................................................................7
5.3 ..........................................................................................................................................................................................................................................7
5.4 PMCF ......................................................................................................................................................................................................................................8
6 ........................................................................................................................................................................................................................................................................................ 8
7 .................................................................................................................................................................................................................................................................................................... 8
8 ............................................................................................................................................................................................................................................................................................... 8
8.1 NCAS .............................................................................................................................................................................................................................................................................................8
8.2 ................................................................................................................................................................................................................................................................................................9
9 ............................................................................................................................................................................................................................................................................................ 9
10 .................................................................................................................................................................................................................................................................................................. 11
10.1 ................................................................................................................................................................................................................................................................................11
10.2 ........................................................................................................................................................................................................................................................................13
11 .................................................................................................................................................................................................................................................................................................. 16
12 ...................................................................................................................................................................................................................................................... 16
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作者：一如既往
分类：法规规范
价格：100质量币
属性：19 页
大小：3.03MB
格式：PDF
时间：2026-03-17
