监管知识库
关于公告机构选择和合格评定的实用指南 — 从本门户自己的目录开始,然后深入 EUCertify 完整的指南库。
本门户网站
Search listed Notified Bodies by device class and scope.
MDR Notified Body MatchingNotified Bodies designated under the Medical Device Regulation.
IVDR Notified Body MatchingNotified Bodies designated under the In Vitro Diagnostic Regulation.
Directory Coverage & DataCountries and legislation covered by listed Notified Bodies.
How to Select a Notified BodyNANDO database, scope of designation, MDR capacity issues, key questions to ask.
Sourcing Notified Bodies for SMEsA 2026 efficiency checklist: designation-scope matching, fees, lead times, RFQ prep.
MDR & IVDR Certification TimelineOfficial EC data on Notified Body backlogs and realistic certification timelines.
Technical Documentation for CE MarkingWhat the technical file must include before submission to a Notified Body.
ISO 13485 vs MDR QMSWhat ISO 13485 covers, what MDR adds, and combined Notified Body audits.
Notified Body Availability Tracker 2026Which Notified Bodies are currently accepting new applications.
MDR Conformity Assessment RoutesAnnex IX, X, XI conformity assessment routes by device class.
Notified Body vs EU Authorized RepresentativeWhat separates the two mandatory MDR roles and when you need each.
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