EU MDR / IVDR

A complete guide to the European Commission's December 2025 proposal to simplify MDR and IVDR. Covers the new Rule 11 for software, indefinite certificate validity, regulatory sandboxes, breakthrough and orphan device pathways, fixed conformity timelines, SME fee reductions, and the expected legislative timeline through 2027.

A complete guide to Field Safety Corrective Actions under EU MDR — when an FSCA is required, reporting timelines (2/10/15 days), how to prepare a Field Safety Notice (FSN), competent authority notification, EUDAMED integration, and how FSCA differs from FDA recalls.

How to classify four common borderline products — hand sanitizer, mouthwash, personal lubricants, and data recorders — across FDA, EU MDR, Brazil ANVISA, and Mexico COFEPRIS. Includes decision trees, regulation citations, and jurisdiction-by-jurisdiction comparison tables.

The complete guide to drug-device combination product regulation — FDA jurisdiction (OCP, RFD, 21 CFR Part 4), EU MDR Article 117, Notified Body Opinions, QMSR changes, CGMP requirements, market pathways, and post-market obligations.

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.

A strategic map of 25+ countries where CE marking provides regulatory leverage — organized by mechanism: full reliance, abridged review, evidence-only acceptance, and reference-only. Know which markets your CE Mark unlocks and what extra steps remain.

Operational playbook for manufacturers that missed the May 26, 2024 Notified Body written agreement deadline under Regulation (EU) 2023/607 — covering legal status of non-qualifying devices, market withdrawal timelines, fresh MDR application routes, sell-off rules, and specific examples by device class.

Comprehensive guide to the EU AI Act requirements for AI-enabled medical devices — covering high-risk classification, conformity assessment, the dual compliance model with MDR/IVDR, data governance, transparency, human oversight, and the August 2026 enforcement deadline.

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 data-driven breakdown of every cost component for CE marking under EU MDR — notified body fees, clinical evaluation, technical documentation, authorized representative, ISO 13485, and ongoing compliance costs with 2026-specific figures.

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.

A practical guide to evaluating and selecting a medical device regulatory consultant — covering key criteria, questions to ask, red flags to avoid, pricing benchmarks, certifications (RAC, RAPS), and a decision framework for companies at every stage.

A practical walkthrough of all 7 IVDR classification rules in Annex VIII — with real device examples, software classification guidance, the IVDD-to-IVDR shift, and the 2025 EU simplification proposal that may reclassify certain IVDs.

Everything you need to know about EU MDR Notified Bodies and conformity assessment — how to select a Notified Body, assessment routes by device class (Annexes IX–XI), audit process, timeline, costs, and the 2025/2026 regulatory landscape.

Step-by-step guide to EUDAMED registration — Actor Module (SRN), UDI/Device Module, Notified Bodies & Certificates, and Market Surveillance. Covers mandatory deadlines from May 2026, legacy device requirements, and compliance strategies.