European Union

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

Navigate Germany's GKV procurement and reimbursement system, including G-DRG, NUB, DiGA, Hilfsmittelverzeichnis, tenders, BfArM, and market access.

Benchmark medical device regulatory consulting rates by region and consultant tier, with cost drivers and budgeting guidance for registration projects in major markets.

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.

2026 ranking of the largest medical device companies by revenue, with market share context, strategic shifts, and growth drivers across global medtech.

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.

Guide to medical device change control for design, process, and regulatory changes, including FDA QMSR, EU MDR significant changes, Notified Body notification, and best practices.

Plan shelf life and stability testing for medical devices, including ASTM F1980 accelerated aging, real-time studies, sterile barrier testing, packaging validation, and expiration dating.

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.

Understand FDA IDE requirements, 21 CFR 812 risk categories, study design, ISO 14155 alignment, submission steps, costs, and clinical trial timelines.

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

Guide to companion diagnostic regulation, including FDA approval pathways, EU IVDR requirements, therapeutic co-development, PMA and De Novo strategy, and market access evidence.

Understand FDA and EU MDR labeling requirements, UDI system setup, GUDID submissions, global UDI harmonization, compliance checklists, and common pitfalls.

Track medical device policy in 2026, from MDUFA V and VALID Act debates to EU MDR implementation, AI regulation, and global trends affecting market access.

Guide to point-of-care testing regulation, including CLIA waivers, FDA pathways, EU IVDR classification, quality management, and near-patient market trends.

How sustainability, ESG reporting, and circular economy reshape medical device design, manufacturing, EU CSRD compliance, and lifecycle strategy.