MDCG 2020-13 临床评估报告模板

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MDCG 2020-13

Medical Devices Coordination Group Document

Medical Devices

MDCG 2020-13

󳔵󴖋󷋅󳘱󴦦󳭋󵄢󴺀

2020 󴕵 7 󴸉

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

MDCG 󵰲󴥁󴸊󴤑󳭙󳷾󵶅󳗤󶽩󶗅󴤑󾘍󵰲󵈨󵷠󴃕󳭙󳘛󵶅󳔁󳬎󳗤󶽩󴧆󳗼󳔼󴔮󱜃󴸭󴲈󳗷󴕷󷹟󵈨󵷠󴃕󳭙󳘛󴲈

󳗷󾘍󳔎󶟾󶾬󷃇󳔻󳫎󴴡󵈨󵷠󴃕󳭙󳘛󵶅󴊙󴲺󶇌󳸻󱜃󴸭󴲈󳗷󳔮󶽩󷚿󵶅󳗼󳙖󷃃󵞺󳹈󳔎󳡸󴸊󵏖󴚌󶖧󴹠󳦜󾘍󳫫

󴸊󵈨󵷠󵏖󷵣󶟾󴀠󴋺󵈨󵷠󵏖󴚌󳙝󳣻󳡸󴸊󶖧󴹠󳦜󵶅󷃤󷣋󱜃

MDCG 2020-13

Medical Devices Coordination Group Document

Medical Devices

󵷯󴙖

󶊁󳗌 ...................................................................................................................................................................... 3

󶨄󳷵....................................................................................................................................................................... 3

󵄢󴺀󴲺󵏖............................................................................................................................................................... 4

󵄢󴺀 CEAR .......................................................................................................................................................... 6

A 󷟩󳤇󾘛󶽍󴱀󷋧󴟆󾘉󳡭󳭋󴸻󴺅󱜂󳤷󷜡󳱇󱜂󳖨󳯂󳫋󳔵󴖋󾘊

󷋅󳘱 .................................................................................................................................................................. 6

B 󷟩󳤇󾘛󳫃󳔏󳔵󴖋󷋅󳘱󳡭󳭋󴸻󴺅󷋅󳘱󵶅󷋅󴊢󳖻󳭙 ...................................................................................... 7

C 󷟩󳤇󾘛󷊿󴀈󴫐󷛱󱜂󳤇󶍼󱜂󳔵󴖋󷋅󳗸󷊢󳤓󱜂󳛢󴝰󷑅󴲚

󵰲󳤷󷜡󳱇󴫑󳚜󾘍󷜛󵰩󷃅󴼽󳮍󳩐󷌄󴼈󳣇󷜃󵰩 ,

󶉊󴱉󴜨󳮍󴸁󴲱󴦁󴸰󵌵󴕴 .................................................................................................................................. 8

D 󷟩󳤇󾘛󳔵󴖋󴲈󵨯󶗽󷛱 ............................................................................................................................... 15

E 󷟩󳤇󾘛󳔵󴖋󵼕󶅷󳫋󵷹󳡴󵶅󴲈󳗷󷑅󴲚 ........................................................................................................ 18

F 󷟩󳤇󾘛󳔋󴔃󳬏󵷒󵹤󱜂󳔋󴔃󳬏󳔵󴖋󷶐󷋀󳗦󳫋󴷵󴲱󷊢󳤓 ............................................................................. 20

G 󷟩󳤇󾘛󷶐󷵅󷊿󴀈󴫑󳚜󵶅󳚀󵰩󷋵󴴏󳕧󱜂󴊊󳡩󳮍󴜨󶟾󳿱󴴏󱜂󴼈󶉿󳫋󳡷󳗗󳛢󴝰 ....................................... 21

󴜼󳙔󶗔󷊻󾘛 .................................................................................................................................................... 24

󳡸󳙔󶜄󶵒󳷡󶐡 .................................................................................................................................................... 25

󶈭󳔁󷟩󳤇󾘛󴻑󳖜󳔊󶍼󳮍󳖍󶍼 b 󳺌󳨼󵲘󳵩󴾱󵶅󳔵󴖋󷋅󳘱󳮩󷋣󶄌󴖐

󾘉󶈭 54 󴹢󾘊 .................................................................................................................................................. 25

J 󶦃󾘛󳻻󳖏󳔵󴖋󴱱󴩯󵶅󶈧󳬉󴜨󷋂󴴏󶾬󷊥󳔻󳔎󷜃󴙔󵶅󴟆󳢶

󾘉󶈭 61 󴹢󶈭󾘉10󾘊󵈿󾘊............................................................................................................................... 28

K 󶦃󾘛󳡴󳖏󳔵󴖋󴘁󳫒󶉗󵱦󵶅󶣫󴡀󳔵󴖋󳮩󷋣󾘉󶈭 61 󴹢󶈭 2 󵈿󾘊

......................................................................................................................................................................... 30

MDCG 2020-13

Medical Devices Coordination Group Document

Medical Devices

󶘪󵱦󷋮󳤘󶽩

CIP

IFU

CER

SRN

PMS

󴀛󶩰󶜑󶩰󴜨

SSCP

CECP

󴊛󴸠󴊊󳡩󴜨󴷵󴲱󴦦󳭋

CEAR

TDAR

PMCF

󶗠󳔁󷊿󴀈󴼈󷋇󶈧 - 󷊿󴀈󴼈󷋇󶈧

EUDAMED

󳚀󵰩󷋵󴴏

󳔋󴔃󳬏󵷒󵑌

󳔵󴖋󵼕󶅷󷊢󳤓

󳔵󴖋󷋅󳘱󴦦󳭋

󳩖󳔁󵏩󳢍󳫸

󳔋󴔃󳬏󳔵󴖋󷶐󷋀

󳔵󴖋󷋅󳘱󴦦󳭋

󳔋󴔃󳬏󵷒󵑌󴷵󴲱󴦦󳭋

󵈨󵐳󳨼󵲘󳵩󴾱󴱱󴩯󴖔

󳔵󴖋󷋅󳘱󳮩󷋣󶄌󴖐

󴊊󳡩󴜨󳮍󳔵󴖋󴜨󶟾󵂃󷂂

󴦁󴸰󴲈󴽤󷋅󳘱󴦦󳭋

󳰰󳔁󷊿󴀈󴼈󷋇󶈧 󷊿󴀈󴼈󷋇󶈧

󳨼󵲘󳵩󴾱󵏖󷃅󾘉󾘉󵈨󵷠󾘊2017/745 󳫸󳨼󵲘󳵩󴾱󵏖󷃅󾘊

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标签： #报告 #模板 #评估

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MDCG202013MedicalDevicesCoordinationGroupDocumentMedicalDevicesMDCG202013N4O0bTJjg2020t7ggeNu1kv2017745Sl103gazvSuVhhSOMDCGS0MDCGu1bgbTXVvNhbu1kvYTXOvNTNhbNN0geNvkvYTXOeNNNSfkvYTXOvezW0geNNhvNOUpWGNQwglgRSgkvlbYkvlOQQwggRv00MDCG202013MedicalDevicesCoordinationGroupDocumentMedicalDevicesvUN3V3jgel

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