EUDAMED

A practical guide to the April 2026 MDCG updates affecting every EU medical device and IVD manufacturer. Covers MDCG 2021-24 Rev.1 classification guidance changes, EMDN v3/2026 code updates (MDCG 2026-1, 2026-2, 2026-3, MDCG 2021-12 Rev.2), the Borderline and Classification Manual Version 5, and what manufacturers must do to stay compliant.

A systematic playbook for diagnosing and resolving EUDAMED bulk upload validation errors — covering XSD schema failures, Basic UDI-DI/UDI-DI mismatches, EMDN code issues, certificate linkage errors, DTX error codes, NB confirmation bottlenecks, and a pre-upload validation checklist.

2026 is the most consequential year for medical device UDI compliance globally. Mandatory deadlines hit in the EU (May 28), Switzerland (July 1), Australia (July 1), and China. This guide covers every active UDI system, class-by-class deadlines, data requirements, and what happens if you miss them.

Switzerland's swissdamed database becomes mandatory on July 1, 2026, requiring all medical device manufacturers to register products and upload UDI data. This guide covers the Product Module, CH REP requirements, M2M functionality, grace period rules, immediate registration triggers, and the consequences of non-compliance.

With EUDAMED becoming mandatory on May 28, 2026, manufacturers are discovering that registration is far more complex than a simple data upload. Here are the 10 most common mistakes — and exactly how to avoid each one.

Role-by-role action playbook for the May 28, 2026 EUDAMED mandatory deadline — covering actor registration, UDI/device registration, certificate uploads, and market surveillance obligations with a countdown checklist and member-state penalty matrix.

Everything you need to know about marketing medical devices in France in 2026 — including EU MDR requirements, ANSM registration, EUDAMED deadlines, French-language labeling mandates, CNEDiMTS and CEPS reimbursement pathway, LPPR listing, clinical investigation procedures, materiovigilance obligations, and practical market entry guidance for Europe's second-largest medical device market.

Everything you need to know about marketing medical devices in Germany in 2026 — including EU MDR requirements, BfArM and PEI responsibilities, MPDG national law, German-language labeling mandates, DMIDS and EUDAMED registration, clinical investigation procedures, DiGA digital health pathway, and practical market entry guidance for Europe's largest medical device market.

Everything you need to know about marketing medical devices in Italy in 2026 — including EU MDR requirements, Ministry of Health national registration via BD/RDM (Repertorio) database, EUDAMED deadlines, Italian-language labeling mandates, national HTA program (PNHTA-DM), clinical investigation procedures, post-market surveillance, and practical market entry guidance for Europe's fourth-largest medical device market.

Everything you need to know about marketing medical devices in the Netherlands in 2026 — including EU MDR requirements, IGJ oversight, CIBG Farmatec and NOTIS national registration, Dutch-language labeling mandates, EUDAMED deadlines, clinical investigation procedures via CCMO, post-market surveillance, Dutch notified bodies (BSI, DEKRA, Kiwa), and practical market entry guidance for one of Europe's most important medical device hubs.

Everything you need to know about marketing medical devices in Spain in 2026 — including EU MDR requirements, AEMPS national registration database, Royal Decree 192/2023, EUDAMED deadlines, Spanish-language labeling mandates, clinical investigation procedures, post-market surveillance, autonomous region distributor notifications, and practical market entry guidance for one of Europe's largest healthcare markets.

A comprehensive guide to EU Authorized Representative (EC REP) requirements under EU MDR and IVDR. Covers Article 11 obligations, mandate requirements, costs, PRRC obligations, EUDAMED registration, and how to select the right EU AR for your medical device or IVD company.

A complete guide to EU MDR and IVDR transition deadlines for legacy devices. Covers Article 120 MDR and Article 110 IVDR transitional provisions, class-specific deadlines, conditions for eligibility, EUDAMED requirements, and practical steps to maintain EU market access.