MDCG 2020-6 (欧盟)2017∕745号法规此前根据93∕42∕EEC指令或90∕385∕EEC指令获得CE标志的医疗器械所需临床证据

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MDCG 2020-6

Medical Device Coordination Group Document

Medical Device

MDCG 2020-6

󾘉󵈨󵷠󾘊2017/745 󳫸󵏖󷃅󾘛󵉥󳥎󴼺󴩯 93/42/EEC 󴨈󳗥󴤗 90/

385/EEC 󴨈󳗥󶪸󴚘 CE 󴼈󴛘󵶅󳨼󵲘󳵩󴾱󴥁󷸁󳔵󴖋󷋂󴩯

󳤷󷜡󳱇󳮍󳡭󳭋󴸻󴺅󴨈󳩘

2020 󴕵 4 󴸉

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

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

󴕷󷹟󵈨󵷠󴃕󳭙󳘛󴲈󳗷󾘍󳔎󶟾󶾬󷃇󳔻󳫎󴴡󵈨󵷠󴃕󳭙󳘛󵶅󴊙󴲺󶇌󳸻󱜃󴸭󴲈󳗷󳔮󶽩󷚿󵶅󳗼󳙖

󷃃󵞺󳹈󳔎󳡸󴸊󵏖󴚌󶖧󴹠󳦜󾘍󳫫󴸊󵈨󵷠󵏖󷵣󶟾󴀠󴋺󵈨󵷠󵏖󴚌󳙝󳣻󳡸󴸊󶖧󴹠󳦜󵶅󷃤󷣋󱜃

󾘉󵈨󵷠󾘊2017/745 󳫸󵏖󷃅󾘛󵉥󳥎󴼺󴩯 93/42/EEC 󴨈󳗥󴤗 90/385/EEC 󴨈󳗥󶪸󴚘

CE 󴼈󴛘󵶅󳨼󵲘󳵩󴾱󴥁󷸁󳔵󴖋󷋂󴩯

󳤷󷜡󳱇󳮍󳡭󳭋󴸻󴺅󴨈󳩘

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󵷯󴙖

1. 󴊛󳕊 ................................................................................................................................................4

1.1. 󳸩󱜋󳨼󵲘󳵩󴾱󵏖󷃅󱜌󾘉MDR󾘊󴹢󵈿󳔮󴊛󳕊󵶅󴸰󷋮 2 ........................................................ 4

1.2. MDR 󴹢󴲈󳔮󴸫󴊛󳕊󵶅󳡷󳗗󴸰󷋮 2 ...................................................................................... 4

2. 󳫃󶜄󴲈󳗷 .......................................................................................................................................6

3. 󶨄󳷵 ................................................................................................................................................6

4. 󳗌󶗎󳔏󶟍󴵰 ...................................................................................................................................7

5. 󳔁󶤭󴲺󷹣.........................................................................................................................................8

6. 󳡴󳖏󷝘󵱚󳵩󴾱󳔵󴖋󷋅󳘱󵥺󴊛󴲺󷹣󵶅󴨈󳩘 ............................................................................... 10

6.1. 󷵅󳗷 XIV A 󷟩󳤇 1a 󶦃󾘛󳤷󴊛󴤗󴷵󴲱󳔵󴖋󷋅󳗸󷊢󳤓 ...................................................... 10

6.2. 󷵅󳗷 XIV A 󷟩󳤇 1b 󶦃󾘛󵽯󴊛󳫰󵰩󵶅󳔵󴖋󴱱󴩯 .............................................................. 11

6.2.1. 󳔋󴔃󳥎󳔵󴖋󴱱󴩯󴹦󵖑 ................................................................................................ 12

6.2.2. 󳔋󴔃󳬏󳔵󴖋󴱱󴩯󴹦󵖑.................................................................................................. 12

6.3. 󷵅󳗷 XIV A 󷟩󳤇 1c 󶦃󾘛󳔵󴖋󴱱󴩯󷋅󳘱 ......................................................................... 12

6.4. 󷵅󳗷 XIV A 󷟩󳤇 1d 󶦃󾘛󴲱󳔵󴖋󴱱󴩯󵶅󵰠󴤑 .................................................................. 13

6.5. 󷵅󳗷 XIV A 󷟩󳤇 1e 󶦃󾘛󳔵󴖋󴱱󴩯󳤇󴺑 .......................................................................... 14

󷵅󴙖 I - 󳸩󱜋󳨼󵲘󳵩󴾱󵏖󷃅󱜌󾘉MDR󾘊󳔌󳗎󷜃󵰩󵶅 MEDDEV 2.7/1 rev. 4 󵶅󵷹󳡴󶇡󶦃

󴸭󴨈󳩘󵶅󷜃󵰩󴟆󳢶 ............................................................................................................................. 18

󷵅󴙖󳖍 ....................................................................................................... 19 󴳨󵥉󷊿󴀈󳔵󴖋󷋅󳘱󷊢󳤓

󷵅󴙖󳔊 - 󵰩󳖏󵽯󷊥󶈧󳬉󴜨󵶅󳔵󴖋󷋂󴩯󴗻󷊯󴍃󶖨

󶈧󳬉󱜋󳨼󵲘󳵩󴾱󵏖󷃅󱜌󾘉MDR󾘊󵷹󳡴󷜛󵰩󴊊󳡩󳔏󴜨󶟾󷂂󵍃󾘉GSPR󾘊 ....................................... 20

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标签： #医疗器械 #CE #欧盟

摘要：

MDCG20206MedicalDeviceCoordinationGroupDocumentMedicalDeviceMDCG20206kv2017745SlkdRMh9cn9342EECcNb90385EECcNCEhvSuVhhbN4cnR6UFTQlTJggcSW2020t4ggeNu1kv2017745Sl103gazvSuVhhSOMDCGS0MDCGu1bgbTXVvNhbu1kvYTXOvNTNhbNN0geNvkvYTXOeNNNSfkvYTXOvezW0geNNhvNOUpWGNQwglgRSgkvlbYkvlOQQwggRv0kv2017745SlkdRMh9cn9342...

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MDCG 2020-6 (欧盟)2017∕745号法规此前根据93∕42∕EEC指令或90∕385∕EEC指令获得CE标志的医疗器械所需临床证据.pdf

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MDCG 2020-6 (欧盟)2017∕745号法规此前根据93∕42∕EEC指令或90∕385∕EEC指令获得CE标志的医疗器械所需临床证据

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