Market Access Strategy for Medical Devices in Europe
Strategic recommendations on the topic of market access pathways for medical devices and IVD tests
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MTRC Founder Publishes Gateway to Europe, a Practical Guide to MedTech Market Access
The book provides a clear and structured introduction to European market access for medical technologies, with a particular focus on medical devices, in-vitro diagnostics, and selected digital health technologies.
Market access remains one of the most important and often most misunderstood factors in the commercial success of medical technologies. Even clinically valuable and innovative devices may struggle to reach patients if reimbursement, payer approval, health technology assessment, evidence requirements, or country-specific adoption pathways are not properly understood.
Gateway to Europe was written to help address this challenge.
Drawing on MTRC’s experience from close to 1,000 European market access projects, the book translates complex reimbursement, HTA, payer, evidence, and pricing topics into practical guidance for industry professionals. It is designed as a working reference rather than an academic textbook, with a focus on real-world examples, structured explanations, country comparisons, and actionable principles.
The book covers core topics including:
- The key pillars of market access: reimbursement, payer or decision-maker approval, and HTA
- How European health system structures influence access pathways
- Procedure coding, payment mechanisms, DRGs, tariffs, and add-on reimbursement
- Market prioritization and launch sequencing
- Clinical and health economic evidence requirements
- Value communication for medical technologies
- Specific considerations for IVD tests and health apps
- Country-level market access essentials for England, France, Germany, Italy, and Spain
Oleg Borisenko commented:
“European market access is complex, fragmented, and constantly evolving. But the core principles remain understandable if they are explained clearly. My objective with this book was to create a practical guide that helps medical technology companies, market access professionals, HEOR teams, commercial leaders, and newcomers to the field understand what really matters when bringing medical technologies to patients in Europe”.
The book also reflects MTRC’s broader mission: to support medical technology companies with clear, practical, and high-quality European market access insight. As one of the leading MedTech market access consulting companies in Europe, MTRC works with manufacturers of medical devices, IVD tests, and digital health technologies to support reimbursement analysis, market access strategy, evidence planning, health economics, value communication, and ongoing market access intelligence.
Gateway to Europe is intended for professionals working in market access, reimbursement, HEOR, clinical affairs, regulatory affairs, business development, commercial strategy, and leadership roles across the MedTech industry.
The book will be soon available on Amazon.
A limited number of printed copies are currently available for senior professionals in market access, reimbursement, HEOR, HTA, and MedTech commercialization. Submission of a request does not guarantee availability.