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 󴹢󷊿󶇌󵶅󳨼󵲘󳵩󴾱󳩐󷌄󴌐󶗅

󾘉MDCG󾘊󷊥󳫰󱜃MDCG 󵰲󴥁󴸊󴤑󳭙󳷾󵶅󳗤󶽩󶗅󴤑󾘍󵰲󵈨󵷠󴃕󳭙󳘛󵶅󳔁󳬎󳗤󶽩󴧆

󳗼󳔼󴔮󱜃󴸭󴲈󳗷󴕷󷹟󵈨󵷠󴃕󳭙󳘛󴲈󳗷󾘍󳔎󶟾󶾬󷃇󳔻󳫎󴴡󵈨󵷠󴃕󳭙󳘛󵶅󴊙󴲺󶇌󳸻󱜃

󴸭󴲈󳗷󳔮󶽩󷚿󵶅󳗼󳙖󷃃󵞺󳹈󳔎󳡸󴸊󵏖󴚌󶖧󴹠󳦜󾘍󳫫󴸊󵈨󵷠󵏖󷵣󶟾󴀠󴋺󵈨󵷠󵏖󴚌󳙝

󳣻󳡸󴸊󶖧󴹠󳦜󵶅󷃤󷣋󱜃

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 󴨊󵡨󱜋󴀛󳫒󴜨󵽭󳨗󵳈󷋋󴲮󴼈󳣇󱜌󾘉MDR󾘊󳔻󶁟󶗐󵳆󴉧󳙐󷵣󳨼󴔉󾘉NBs󾘊󳸩󳔵󴖋󷋅󳘱 B 󳺌󴀛󳫒󴜨󵽭󳨗󵳈󾘉BtMDs󾘊󴲺󷹣󴫑󳚜󴰰󴨂

󶈭󳔁󵵿󷷷󳡮󴹢󶈭󾘉󳩂󳔁󾘊󷽺 ............................................................................................................27

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

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标签： #指南 #中文 #MDCG

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MedicalDeviceCoordinationGroupDocumentMedicalDeviceMDCG20259QsN2017745S2017746lNzx4VhhBtXvcSW2025t12ggeNu1kv2017745Sl103gazvSuVhhSOMDCGS0MDCGu1bgbTXVvNhbu1kvYTXOvNTNhbNN0geNvkvYTXOeNNNSfkvYTXOvezW0geNNhvNOUpWGNQwglgRSgkvlbYkvlOQQwggRv01MDCG20259MDCG20259MedicalDeviceCoordinationGroupDocumentMedicalD...

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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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