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MTRC has released a White Paper "Challenges of HTA and Reimbursement Submissions for Medical Devices"
Securing reimbursement and obtaining HTA approval for medical technologies in Europe is a complex and variable process. Differences in submission requirements, evidence standards, and national regulations create significant challenges for MedTech companies, often delaying market entry. Successfully navigating these complexities requires country-specific knowledge and a strategic approach to evidence generation.
Our latest White Paper analyses these hurdles and offers practical solutions to streamline submissions and improve approval success rates. It highlights key challenges - such as inconsistencies in evidence expectations, language barriers, and misalignment with local clinical practices.
Read more and request a White Paper here.