Resources
Reference material on the EUDAMED deadline, EMDN classification, and the data rules that trip manufacturers up most often.
Who must register by November 27, 2026, what data is required, and what the legacy transition rules actually say.
EvidenceWe ran the same five regulatory skill files against two models from one vendor. The results invert, and half the test cases show no benefit at all.
ClassificationNavigate the EMDN category taxonomy and find the correct terminal code for each device.
MappingWhy there is no official cross-reference and how to bridge the gap systematically.
APIRow counts that are not company counts, silent zero-result name misses, and a 1,000-row cap with no paging, verified live against the endpoint.
UDIThe triggers that require a new Device Identifier and how to structure your UDI hierarchy.
UDIMDCG 2026-5: why only the manufacturer can assign a UDI-DI and register a device in EUDAMED, even under a private-label agreement.
UDIUDI-DI identifies one device model and sits on the label. Basic UDI-DI groups the regulatory record and never appears there. Two MDCG worked examples.
DeadlineThe actual legal mechanism, the Article 94/95 competent authority procedure that follows, and what the May 2026 precedent shows so far.
LegacyNo Basic UDI-DI, no UDI issuing entity: the EUDAMED DI and EUDAMED ID mechanism, field by field, and why the registration deadline is separate from the 2027/2028 sell-off dates.
ValidationEMDN code lifecycle changes and device-data field conflicts, sourced to the official EUDAMED UDI/Devices Business Rules, with the exact rule reference for each cause.
Data ExchangeThe EUDAMED Information Centre's own portfolio-size guidance for choosing between the user interface, bulk upload, and M2M, and what each method requires to set up.
Actor RegistrationA non-EU manufacturer's own registration request cannot be completed until its authorised representative already holds an SRN. The order, sourced to the Commission's own process documentation.
Data PrepThe column headers EUDAMED accepts for Basic UDI-DI and UDI-DI data, by legislation, generated straight from EUDAMate's own field registry.
ClassificationSoftware has no category of its own in EMDN. Three worked examples: imaging software, IVD analyser software, and the standalone catch-all code.
ClassificationMDCG 2021-12 Rev.2's two-step answer: assign extension 99 within the correct type now, then propose a new code through the annual procedure.
DeadlineIVDR Article 110, as amended by Regulation (EU) 2024/1860, gives legacy IVDs market-placement dates by class through 2029, with conditions attached.
Actor RegistrationMDR Article 31's second paragraph conditions SRN issuance on completed verification, with no stated deadline. What the Commission's own FAQ and current user guide say, and do not say, about timing.
RecordThe open format specification of the record EUDAMate produces with every export. It shows how each value was derived, who approved it and what was checked.