EU MDR / IVDR

How to classify hand sanitizer, mouthwash, personal lubricants, and data recorders as medical devices or non-devices across FDA, EU MDR, Brazil ANVISA, and Mexico COFEPRIS.

Guide to FDA and EU regulation of drug-device combination products, covering OCP jurisdiction, RFDs, 21 CFR Part 4, EU MDR Article 117, CGMPs, and post-market duties.

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

See where CE marking supports device approvals across 25+ markets, including full reliance, abridged review, evidence acceptance, and remaining local steps.

What manufacturers should do after missing the 2024 MDR Notified Body deadlines, including legal status, withdrawal timing, fresh MDR applications, and sell-off rules.

Learn how the EU AI Act applies to AI-enabled medical devices, including high-risk classification, MDR/IVDR overlap, conformity assessment, and 2026 deadlines.

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.

Plan a realistic 2026 CE marking budget under EU MDR, including notified body fees, clinical evaluation, technical documentation, ISO 13485, and ongoing compliance.

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.

Evaluate medical device regulatory consultants with selection criteria, interview questions, red flags, pricing benchmarks, RAC/RAPS signals, and a stage-based decision framework.

Practical guide to IVDR Annex VIII classification rules for IVD Classes A-D, with device examples, software guidance, IVDD-to-IVDR changes, and the 2025 EU simplification proposal.

Guide to EU MDR Notified Bodies and conformity assessment, including NB selection, routes by device class, audits, timelines, costs, and 2025-2026 regulatory context.

Step-by-step EUDAMED registration guide covering SRN actor registration, UDI/device data, Notified Body certificates, market surveillance, May 2026 deadlines, and legacy devices.

Prepare EU MDR technical documentation for medical devices, including Annex II and III content, FDA DHF comparisons, STED format, ISO 13485 files, and practical assembly steps.

Guide to PMCF under EU MDR, including PMCF plans, study design, evaluation reports, PMS integration, clinical evaluation updates, and implementation.