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

3.0 一如既往 2026-03-17 8 4.13MB 33 页 100质量币

侵权投诉

MDCG 2025-5

Medical Device Coordination Group Document

Medical Devices

MDCG 2025-5

󳡴󳖏󳙔󴀗󷋋󴲮󳨼󵲘󳵩󴾱󴜨󶟾󵼕󶅷󵶅󷳯󶉕

󾘉󳚞󴩯󾘉󵈨󵷠󾘊2017/746 󳫸󵏖󷃅󾘊

2025 󴕵 6 󴸉

󴸭󴲈󳗷󴓳󶪸󵰲󾘉󵈨󵷠󾘊2017/745 󳫸󵏖󷃅󶈭 103 󴹢󷊿󶇌󵶅󳨼󵲘󳵩󴾱󳩐󷌄󴌐󶗅

󾘉MDCG󾘊󷊥󳫰󱜃󷋦󴌐󶗅󵰲󴥁󴸊󴤑󳭙󳷾󵶅󳗤󶽩󶗅󴤑󾘍󵰲󵈨󵷠󴃕󳭙󳘛󵶅󳔁󳬎󳗤󶽩󴧆

󳗼󳔼󴔮󱜃

󷋦󴲈󳗷󴕷󷹟󵈨󵐳󴃕󳭙󳘛󴲈󳗷󾘍󳔎󶟾󶾬󷃇󳔻󳫎󴴡󵈨󵐳󴃕󳭙󳘛󵶅󴊙󴲺󶇌󳸻󱜃󴸭󴲈󳗷󳔮

󶽩󷚿󵶅󳗼󳙖󷃃󵞺󳹈󳔎󳡸󴸊󵏖󴚌󶖧󴹠󳦜󾘍󳫫󴸊󵈨󵐳󶝕󵷠󵏖󷵣󶟾󴀠󴋺󵈨󵷠󵏖󴚌󳙝󳣻󳡸

󴸊󶖧󴹠󳦜󵶅󷃤󷣋󱜃

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. 󳸩󳙖󶃎󷴷󵊶󾘍󳔁󷽺󴿁󵑌󴲺󵏖󳘛󴤑󳔻󳙔󴀗󷋋󴲮󳵩󴾱󾘉IVD󾘊󾘍󳗏󶜍󴛆󷽼󶜄󶵒󱜋󳙔󴀗󷋋󴲮󳨼󵲘󳵩󴾱󵏖󷃅󱜌󾘉IVDR󾘊󵶅󵷹󳡴󷃅󴊛󾘠

󵰩󳖏󴜨󶟾󵼕󶅷󾘠............................................................................................................................................................................. 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󾘊󾘍󳯫󳖜󴜨󶟾󵼕󶅷󷸁󷂂󳬒󳔼󶊢󴙔󴍁󴫑󳖥󷜛󵻦󾘠

18. 󴋺󴔧󴸊 CE 󴼈󴛘󵶅󳙔󴀗󷋋󴲮󳨼󵲘󳵩󴾱󷛜󶽍󵋕󷚄󴴰󳬧󴍟󳖏󷸁󷂂󷜛󵻦󴤗󵰴󷋸󵶅󴜨󶟾󵼕󶅷󾘠

󳬒󳔼󶊢󴙔󴍁󴪉󴹄󾘠 ......................................................................................................................................................................... 16

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

文档加载中……请稍候！
如果长时间未打开，您也可以点击刷新试试。

下载文档到电脑，查找使用更方便

立即下载

标签： #医疗器械 #欧盟 #研究

摘要：

MDCG20255MedicalDeviceCoordinationGroupDocumentMedicalDevicesMDCG20255QsNOSYeSuVhhxzvvTOcnkv2017746Sl2025t6ggeNu1kv2017745Sl103gazvSuVhhSOMDCGS0u1bgbTXVvNhbu1kvYTXOvNTNhbNN0eNvkm2YTXOeNNNSfkm2YTXOvezW0geNNhvNOUpWGNQwglgRSgkm2TvlbYkvlOQQwggRv01MDCG20255MedicalDeviceCoordinationGroupDocumentMedicalDev...

展开>> 收起<<

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.pdf

共33页,预览33页

还剩页未读，继续阅读

声明：如果您的权利被侵害，请联系我们的进行举报。

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

相关推荐

相关内容

热门标签

举报选择: