Europe is the world’s second-largest MedTech market, offering vast opportunities—but also complex challenges. This e-book is your step-by-step guide to navigating them. You’ll learn how to meet MDR/IVDR requirements, assess market size, and select the right countries for entry. It reveals the strengths of Europe’s dynamic device market, from aging-driven demand to emerging technologies and MedTech hubs. Gain insights on cultural selling differences, distribution partnerships, and avoiding pitfalls that cause 70% of companies to fail internationally. Discover strategies for working with hospitals, reimbursement pathways, hiring, payrolling, VAT and import rules, and building successful local teams. Packed with data, market breakdowns, and practical frameworks, this guide equips MedTech and IVD manufacturers with the clarity, tools, and strategies needed to expand successfully into Europe’s diverse healthcare landscape.
