MDCG 2025-9 关于突破性设备(BtX)在法规2017745和2017746下的指南(中文版)
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Medical Device Coordination Group Document
Medical Device
MDCG 2025-9
2017/745 2017/746
BtX
2025 12
2017/745 103
MDCGMDCG
1
MDCG 2025-9
MDCG 2025-9
Medical Device Coordination Group Document
Medical Device
1. .................................................................................................................................... 4
2. .................................................................................................................................................... 5
3. ................................................................................................................................................... 6
4. ............................................................................................................................... 7
4.1 ......................................................................................................................................7
4.2 ..........................................................................................................7
....................................................................................................................................8
4.2.2 ..................................................................9
4.2.3 ....................................................................11
4.2.4 ....................................................................................11
A ............................................................................................. 13
5. ................................................................................................................................. 13
6. ........................................................................................ 16
7. ........................................................................................................ 18
7.1 ....................................................................................................................18
7.2 / .........................................................................................................19
8. PMCF/PMPF ......................................................................................................... 20
8.1 PMCF / PMPF ........................................................................................................20.
8.2 / .........................................................................21
8.3 ................................................................................................................................21
8.4 PMCF/PMPF ..................................................................................................22
9. /CER/PER ............................................................................................... 22
B - ..................................................................................................................... 23
10. ............................................................................................................................... 23
10.1 / .......................................................................................................24
10.2 BtX b
/24
10.3 BtX .......................................................................25
10.4 CECP .........................................................................................25
10.5
HTA ..................................................................................................26
11. .................................................................................................................... 26
11.1 BtX ...................................................................26
11.2 MDRNBs B BtMDs
............................................................................................................27
2
MDCG 2025-9
Medical Device
11.3 BtX .......................................................................................27
11.4 ............................................................................................27
11.5 ........................................................................................................28
12. ........................................................................................................................ 28
13. ................................................................................................................................ 29
13.1 ...................................................................................................................29
13.2 ................................................................................................................29
14. BtX .................................................................................................................................... 30
A.1 BtX ........................................................................................................ 31
A.2
BtX ........................................................................................................................................................... 32
3
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作者：qwe1231...
分类：法规规范
价格：100质量币
属性：36 页
大小：5.8MB
格式：PDF
时间：2026-03-09
