European Union
280 articles
EU MDR and IVDR Transition Timeline: Legacy Device Deadlines (2026-2029)
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.
Top Medical Device Companies in 2026: Revenue Rankings, Market Share, and Industry Trends
2026 ranking of the largest medical device companies by revenue, with market share context, strategic shifts, and growth drivers across global medtech.
EU IVDR Classification Rules: The Complete Guide to IVD Risk Classes A–D
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.
EU MDR Notified Bodies and Conformity Assessment Guide
Guide to EU MDR Notified Bodies and conformity assessment, including NB selection, routes by device class, audits, timelines, costs, and 2025-2026 regulatory context.
EUDAMED Registration Guide for Medical Device and IVD Manufacturers
Step-by-step EUDAMED registration guide covering SRN actor registration, UDI/device data, Notified Body certificates, market surveillance, May 2026 deadlines, and legacy devices.
Medical Device Change Control: FDA and EU MDR Requirements
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.
Medical Device Shelf Life and Stability Testing Guide
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.
Medical Device Technical File: EU MDR Documentation Guide
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.
Medical Device Clinical Trials: FDA IDE Requirements Guide
Understand FDA IDE requirements, 21 CFR 812 risk categories, study design, ISO 14155 alignment, submission steps, costs, and clinical trial timelines.
EU MDR PMCF Guide: Plans, Studies, Reports, and Implementation
Guide to PMCF under EU MDR, including PMCF plans, study design, evaluation reports, PMS integration, clinical evaluation updates, and implementation.
Companion Diagnostics (CDx): Regulatory Pathways, Development, and Market Access
Guide to companion diagnostic regulation, including FDA approval pathways, EU IVDR requirements, therapeutic co-development, PMA and De Novo strategy, and market access evidence.
Medical Device Labeling & UDI System: The Complete Regulatory Guide
Understand FDA and EU MDR labeling requirements, UDI system setup, GUDID submissions, global UDI harmonization, compliance checklists, and common pitfalls.
Medical Device Policy & Legislation: Key Laws Shaping the Industry in 2026
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.
Point-of-Care Testing (POCT): Regulatory Requirements, CLIA Waivers, and Market Trends
Guide to point-of-care testing regulation, including CLIA waivers, FDA pathways, EU IVDR classification, quality management, and near-patient market trends.
Sustainability & ESG in Medical Devices: Regulations and Best Practices
How sustainability, ESG reporting, and circular economy reshape medical device design, manufacturing, EU CSRD compliance, and lifecycle strategy.
CE Marking for Medical Devices: EU MDR Requirements, Process, and Assessment
The complete guide to CE marking medical devices under EU MDR — classification, conformity assessment routes, Notified Body selection, technical documentation, and step-by-step process.
Clinical Evaluation Report (CER) for Medical Devices: The Complete Guide
How to write a Clinical Evaluation Report that meets EU MDR requirements and passes Notified Body review — methodology, structure, literature search strategy, and common pitfalls.
EU MDR and IVDR: The Complete Guide to European Medical Device Regulation
Complete guide to EU MDR and IVDR for medical device and IVD manufacturers, covering classification, conformity assessment, UDI, EUDAMED, timelines, and CE marking.
Medical Device Reimbursement: The Complete Guide to Coding, Coverage, and Payment
How medical devices get reimbursed — coding systems, CMS coverage pathways, private payer strategy, health technology assessment, and building a reimbursement strategy from day one.
IVDR Performance Evaluation: The Complete Guide for IVD Manufacturers
How to conduct performance evaluation under the EU IVDR — scientific validity, analytical performance, clinical performance, classification rules, and what Notified Bodies expect.