SaMD Market Access & Reimbursement in Europe

ByPiotr Wrzosinski

CE Mark ≠ Reimbursement

Each EU country has its own reimbursement process.

Highlights:

– Germany (DiGA): Fast track, 12-month provisional access

– France: Multiple programs (ETAPES, PECAN)

– UK: NICE approval + local commissioning (ICBs)

Evidence needs differ, it can be Randomized Controlled Trials (RCTs) or real-world evidence depending on system.

Learn more on Scaling MedTech: From Product to Market

This post is part of SaMD Europe Launch Guide.

This content has been enhanced by GenAI tools.

Piotr Wrzosinski

Piotr Wrzosinski is a life sciences commercial and digital transformation leader with 20+ years of experience across pharma, medtech, and consulting. He writes about medtech, digital health, commercialization, AI, and regulation in Europe through an operator lens focused on adoption, evidence, and scale.