Challenges of HTA and Reimbursement Submissions for Medical Devices

Securing reimbursement and obtaining HTA approval for medical technologies in Europe is a complex and highly variable process. Differences in submission requirements, evidence standards, and national regulations create significant challenges for MedTech companies, often leading to delays in market entry. Navigating these complexities requires a deep understanding of country-specific processes and a strategic approach to evidence generation.

Our latest White Paper provides a comprehensive analysis of these hurdles and offers practical, actionable solutions to streamline submissions and improve approval success rates. It examines critical pain points - including inconsistencies in evidence expectations, language barriers, and challenges in aligning with local clinical practices - and presents proven strategies to overcome them. Drawing on MTRC’s extensive experience in supporting the development of reimbursement and HTA applications across multiple European countries, this resource equips market access professionals with actionable insights to navigate diverse regulatory frameworks effectively.