The Definitive Guide to Medical Device Market Access

A practical guide to reimbursement, HTA, payer approval, pricing, evidence, and market access strategy across Europe

Written by Oleg Borisenko, MD, PhD, Founder and Director of MTRC

Why this book matters

European market access for medical technologies is complex, fragmented, and increasingly evidence-driven.

Regulatory approval is not enough. Without reimbursement, payer approval, or a clear HTA strategy, even valuable technologies may struggle to reach patients.

Gateway to Europe helps MedTech, IVD, and digital health companies understand how European access pathways work - and how to plan for them in practice.

What the book covers

The book explains the key elements of European MedTech market access:

Reimbursement, coding, DRGs, and tariffs
Reimbursement, coding, DRGs, and tariffs
Payer and national decision-maker approval
Payer and national decision-maker approval
Payer and national decision-maker approval
Payer and national decision-maker approval
Evidence requirements
Evidence requirements
Market prioritization
Market prioritization
Market prioritization
Market prioritization
IVD and health app access pathways
IVD and health app access pathways
Country essentials for England, France, Germany, Italy, and Spain
Country essentials for England, France, Germany, Italy, and Spain

Who should read it

This book is written for:

  • Market access and reimbursement professionals 
  • HEOR and HTA teams 
  • Medical affairs and evidence generation teams 
  • Commercial and business development leaders 
  • MedTech, IVD, and digital health companies preparing for European launch 

Testimonials

“This is a reference book that summarizes the key elements of market access for medical devices and diagnostics in Europe. Oleg Borisenko shares his expertise to help us navigate Europe’s Market Access scene in a concise manner. A must-read for all of us in the industry and those who seek to get insights on successful market penetration”
Zenichi Ihara Director, Health Economics and Reimbursement EMEA, Abbott
“This book is your compass for navigating Europe’s complex market access landscape. When the way forward seems uncertain, it empowers you to dig deeper, landing with confidence in every country”
Rachele Busca Director, EU Evidence & Access Strategy, Ion, Intuitive Surgical
“Gateway to Europe” cuts through the complexity of European market access with clarity, pragmatism, and real-world relevance. It distills what truly matters in this fast-evolving, VUCA environment. Instead of attempting the impossible, it offers essential principles that guide market access professionals [and industry decision-makers] toward meaningful, impactful access strategies”
Christine Muzel Market Access Leader, Philips

About the author

About the author

Oleg Borisenko, MD, PhD is the Founder of MTRC, a specialist European market access consultancy focused on medical devices, diagnostics, and digital health technologies.

Over more than 15 years, Oleg and the MTRC team have supported MedTech companies across Europe with reimbursement, HTA, evidence strategy, health economics, and payer engagement.

Interested in receiving a printed copy?

Printed copies of Gateway to Europe are available for professionals working in the MedTech, IVD, and digital health technology industries.

MTRC provides complimentary printed copies to relevant professionals and organizations where the book can support European market access planning, reimbursement strategy, HEOR, HTA, evidence generation, launch preparation, commercial planning, business development, or internal education.

 

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The book is also expected to become available for public purchase, including through Amazon, although the exact timing is not yet confirmed.

Explore European market access with MTRC

Use Gateway to Europe as a practical reference for European market access planning — or invite MTRC to brief your team on reimbursement, HTA, evidence, and launch priorities for 2026.

Request a Sample Chapter
Request a Private Briefing
Request a Printed Copy