MDCG 2024-10 孤儿医疗器械的临床评估
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MDCG 2024-10
Medical Device Coordination Group Document
Medical Devices
MDCG 2024-10
2024 6
2017/745 103
MDCGMDCG
1
MDCG 2024-10
Medical Device Coordination Group Document
Medical Devices
1. ................................................................................................................................................................. 3
2. .................................................................................................................................................................................4
3. ................................................................................................................................................................................. 5
4. .............................................................................................................................................6
A - ....................................................................................................................................................9
5. .....................................................................................................................9
6. ...................................................................................................................................................... 10
7. ............................................................................................................................................................... 11
8. .............................................................................................................................. 13
9. .............................................................................................................. 14
B - ......................................................................................................................................................17
10. ...................................................................................................................................................17
11. ...........................................................................................18
.........................................................................................................................................................................................22
A.1. .................................................................................................................................................................22
A.2. .........................................................................................................................24
A.3. ..................................................................................................................................29
2
MDCG 2024-10
Medical Device Coordination Group Document
Medical Devices
1.
CEP
CER
IVDR
PMS
GSPR
PMCF
MDCG
AIMDD
2(3)
2 52
2 44
2 22
212
2 24
223
2 48
2 45
2 51
OD
4.3
- 260
4.2.1
4.2.1
4.1
93/42/EEC
-
MDR XIVB 5
2 53 MDCG 2020-6
I
2017/745
2017/746
90/385/EEC
MDRIVDR 5(5)
MDCG 2023-1
MDR 120
93/42/EEC MDD 90/385/EEC AIMDD
CE MDCG 2021-25
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2(7)
3
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作者：一如既往
分类：法规规范
价格：120质量币
属性：33 页
大小：3.58MB
格式：PDF
时间：2026-03-17
