MDCG 2025-5 关于欧盟2017-746监管下体外诊断医疗器械性能研究的问答
MDCG 2025-5
Medical Device Coordination Group Document
Medical Devices
MDCG 2025-5
2017/746
2025 6
2017/745 103
MDCG
1
MDCG 2025-5
Medical Device Coordination Group Document
Medical Devices
...............................................................................................................................................................................................6
...................................................................................................................................................................................................7
...................................................................................................................................................................................................8
1. IVDR...................................................................................8
2. ........................................................................................................................................................8
3. .........................................................................................................................................................8
4. .........................................................................................................9
5. IVDR ..................................................................................9
6. IVDIVDR
............................................................................................................................................................................. 12
7. ................................................................................................................. 12
8.
IVD 12
9.
IVDR .................................................. 12
10. RUO ............................................................................................. 13
11. ..................................................................................................................................... 14
12. ............................................................................................................................. 14
13. ................................................................................................................................. 15
14. 98/79/EC
............................................................................................................................ 15
/ .......................................................................................................................................................... 15
15. ................................................................................................................. 15
16.
IVDR .......................................................................................................................................................................................... 15
17. IVDR
16
18. CE
......................................................................................................................................................................... 16
2
MDCG 2025-5
Medical Device Coordination Group Document
Medical Devices
19. /
.................................................................................................................................................................................... 17
20. IVD
IVDR 66
.................................................................................................................................... 17
21. A 3
/ ....................................................................................................................................... 17
22.
IVD ............................................................................................. 18
............................................................................................................................................................ 18
23. 58(1) (a) ...18
24. 58 1 a
................................................................................................................................................................ 19
25. 66 7
............................................................................................................ 19
26. 58 1 b... 20
27. 58 1 c 70 1
............................................................................................................................................................................................. 20
28. 58 2 .20
29.
.................................................................................................................................................................................... 21
30. ................................................................................................................................................. 21
31.
............................................................................................................................................................................................ 21
32. 70 1 burdensome ............................................................................................ 22
33. IVDR 70(1) 70(2) CE
CE ......................................................................................................................... 22
34. 58(1) 58(2) CE
................................................................................................................................................................ 22
/ ............................................................................................................................................................................... 23
35. EUDAMED
...................................................................................................................................................................................... 23
3
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MDCG20255MedicalDeviceCoordinationGroupDocumentMedicalDevicesMDCG20255QsNOSYeSuVhhxzvvTOcnkv2017746Sl2025t6ggeNu1kv2017745Sl103gazvSuVhhSOMDCGS0u1bgbTXVvNhbu1kvYTXOvNTNhbNN0eNvkm2YTXOeNNNSfkm2YTXOvezW0geNNhvNOUpWGNQwglgRSgkm2TvlbYkvlOQQwggRv01MDCG20255MedicalDeviceCoordinationGroupDocumentMedicalDev...
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作者：一如既往
分类：法规规范
价格：100质量币
属性：33 页
大小：4.13MB
格式：PDF
时间：2026-03-17
