EUDAMED

A data-driven analysis of Swissmedic's swissdamed database. We break down actor types, risk classes, legislations, and leading CH-REPs.

Practical guide to April 2026 MDCG updates on MDR/IVDR classification, EMDN v3/2026 codes, the Borderline Manual, and manufacturer compliance actions.

Playbook for diagnosing EUDAMED bulk upload validation errors, including XSD failures, UDI mismatches, EMDN issues, certificate links, DTX codes, and pre-upload checks.

Track 2026 UDI compliance deadlines across the EU, Switzerland, Australia, China, Brazil, Singapore, and the US, with class rules and data requirements.

Guide to Switzerland swissdamed mandatory registration from July 1, 2026, covering UDI uploads, Product Module, CH REP duties, M2M, grace periods, and triggers.

Learn the 10 most common EUDAMED registration mistakes before the May 28, 2026 mandate, including data, UDI, actor, certificate, and workflow errors, plus fixes.

Role-by-role playbook for the May 28, 2026 EUDAMED deadline, covering actor registration, UDI/device data, certificates, surveillance duties, and final readiness steps.

Register and commercialize medical devices in France with EU MDR, ANSM, EUDAMED, French labeling, LPPR reimbursement, CNEDiMTS, and CEPS requirements.

Market medical devices in Germany with EU MDR, BfArM, PEI, MPDG, EUDAMED, DMIDS, German labeling, clinical investigations, and DiGA strategy.

Guide to Italy medical device market access in 2026, including EU MDR, BD/RDM Repertorio registration, EUDAMED deadlines, Italian labeling, and HTA.

Register and market devices in the Netherlands under EU MDR, including IGJ oversight, CIBG Farmatec, NOTIS, Dutch labeling, EUDAMED, CCMO trials, notified bodies, and PMS.

Guide to marketing medical devices in Spain in 2026, covering EU MDR, AEMPS registration, Royal Decree 192/2023, EUDAMED deadlines, Spanish labeling, and regional notifications.

Guide to EU Authorized Representative requirements under MDR and IVDR, including Article 11 mandates, PRRC duties, EUDAMED registration, costs, and selection.

Guide to EU MDR and IVDR transition deadlines for legacy devices, including Articles 120 and 110, class-specific dates, eligibility conditions, EUDAMED, and market access.