【精选】欧盟CE认证网站大集合,找到常用入口从此不再难!

鑫明康医械咨询
2023-10-30

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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