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.
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