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Your innovative medical device is better for patients and for their healthcare systems. It will shortly be certified with the CE Mark, but those German payers (aka, sickness funds) require much more ‘evidence’ in order to reimburse it, that it would take a few more years (and a lot of money) to actually commercialize it.
However, there’s a shortcut. Following a recent change in German law, German sickness funds may now be able to provide funding for a ‘controlled study‘, during which the required ‘evidence’ could be gathered, at their expense.
This article, “A Shortcut to Medical Device Reimbursement in Germany - Experimental Coverage in the Physician’s Office”, explains this new option in plain English.