MDCG_2024-14 关于隐形眼镜主 UDI-DI解决方案实施的指南(中文)
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MDCG 2024-14
UDI-DI
2017/745 103
MDCGMDCG
MDCG2024-14
Medical Devices
Medical DeviceCoordinationGroupDocument
..................................................................................................................................................................3
1. ......................................................................................................................................................................4
2. UDI -D ...........................................................................................................................................................5
2.1 UDI-DL .................................................................................................................................................6
2.1.1 .............................................................................................................................................6
2.1.2 MtO .............................................................................................................................7
3. UDI-DL
9
4. .......................................................................................................................................................10
4.1 10
4.2 .............................................................................................................................10
5. UDI - DI ..................................................................................................................................1
6. Eudamed ..............................................................................................................................12
Page 2 of 12
MDCG 2024-14
Medical Devices
EU2017/745 27 UDI
UDI-DIUDI-DI UDI-PI
UDI
Eudamed UDI-DI UDI-DI
MDR VI
C 6.6.1 EU2023/2197 UDI-DI
UDI-DI
25
UDI-DI
Eudamed
EU2017/745MDREU2023/2197
MDCG UD4
Page3 of 12
4 https://health.ec.europa.eu/medical-devices-sector/new-requlations/quidance-mdca-endorsed-documents-and-other-guidance
en#sec18
3 Commission Delegated Regulation(EU)2023/2197 of 10 July 2023 amending Regulation(EU)2017/745 of the European
Parliament and of the Council,as regards the assignment of Unique Device Identifiers for contact lenses (OJ L,2023/2197,20.10.
2023,ELI:http://data.europa.eu/eli/reg del/2023/2197/oi)
2 https://health.ec.europa.eu/medical-devices-eudamed en
1Regulation(EU)2017/745 of the European Parliament and of the Councilof 5 April 2017 on medical devices, amending
Directive 2001/83/EC,Regulation(EC)No 178/2002 and Regulation(EC)No 1223/2009 and repealing Council Directives 90/385/
EEC and 93/42/EEC(OJL1175.5.2017,p.1.Current consolidated version ELI: https://eur-lex.europa.eu/eli/reg/2017/745/2024-07-
09)
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作者：冒牌货
分类：专业资料
价格：100质量币
属性：12 页
大小：2.22MB
格式：PDF
时间：2026-01-09
