EUDAMED resources
Evergreen reference guides to EU medical-device regulation and EUDAMED registration: actor and device records, deadlines, UDI structure, EMDN codes and bulk upload. Maintained against the current schema, not dated like the blog.
EU MDR explained:
What Regulation (EU) 2017/745 changes versus the MDD, the device classes, the 2027 and 2028 transition deadlines, and where EUDAMED fits.
IVDR (EU 2017/746) explained:
Regulation (EU) 2017/746 for IVD manufacturers: Classes A to D, transition deadlines under 2022/112 and 2024/1860, and where EUDAMED fits.
EUDAMED registration deadlines:
What the 28 May 2026 cutoff did, what the 28 November 2026 legacy deadline requires, and the legal text behind both.
EUDAMED legacy device registration:
What Regulation (EU) 2024/1860 changed for legacy device EUDAMED entry, how EUDAMED-DI and EUDAMED-ID are assigned, and the path to registering before 28 November 2026.
UDI explained:
What Basic UDI-DI, UDI-DI, UDI-PI and EUDAMED-DI each mean, who assigns each one, where each appears in EUDAMED, and which you need to assign for your portfolio.
MDR Annex II to EUDAMED:
How MDR Annex II content lands in EUDAMED, clause by clause: device description, IFU, label, GSPR, clinical evaluation and PMS.
Basic UDI-DI assignment:
How to assign a Basic UDI-DI under MDR Article 27: the MDCG 2018-1 Rev. 4 grouping rules, the four EC-designated issuing entities, and the assignment errors EUDAMED catches.
How to pick an EMDN code
Walk the seven-level EMDN tree, handle GMDN-sourced data, use the 99 'Other' code pattern correctly, and stay valid against annual updates.
What the PRRC signs off when preparing a EUDAMED submission
A field-by-field walk of the EUDAMED data inside the PRRC's MDR Article 15(3) sign-off scope, with the audit-trail expectation if that sign-off is later challenged.
How to register devices in EUDAMED:
The two-module walkthrough: Actor module first for the SRN, then UDI/Devices, with EU manufacturer, non-EU and importer flows.
EUDAMED submission methods compared:
Compare the three EUDAMED submission methods, Web UI, XML bulk upload, and M2M, against portfolio size, data readiness, engineering capacity, and deadline pressure.
EUDAMED actor registration:
How the EU manufacturer, non-EU manufacturer + AR, and importer flows work, what documents each uploads, and what the SRN structure means once issued.