400-0569-812

CN/EN

欧盟CE常用网站入口


1.欧盟医疗器械信息 

https://ec.europa.eu/health/md_sector/overview_en

 

2.欧盟医疗器械专家委员会 

https://ec.europa.eu/health/md_expertpanels/overview_en

 

3.EUDAMED

https://ec.europa.eu/health/md_eudamed/overview_en

 

4.EUDAMED数据库

https://webgate.ec.europa.eu/eudamed/landing-page#/

 

5.MDCG医疗器械协调小组

(Medical Device Coordination Group Working Groups)

https://ec.europa.eu/health/md_dialogue/mdcg_working_groups_en

 

6.MDCG指南

https://ec.europa.eu/health/md_sector/new_regulations/guidance_en#sec10

 

7.欧盟协调标准 

https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards_en

 

8.Basic UDI-DI生成

https://www.gs1.org/services/gmn-generator

 

9.NB公告机构查询网站

(Nando EUROPA -European Commission - Growth - Regulatory policy - NANDO)

https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notifiedbody.main

 

10.NB-MED 文件

https://www.team-nb.org/nb-med-documents/

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