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Trial procedure according to § 137e SGB V

With § 137e SGB V, the possibility was introduced for the first time for medical device manufacturers to submit new examination and treatment methods, which are largely based on the use of a medical device, to the (benefit) assessment by the Federal Joint Committee (G-BA) on their own initiative.

A method can be tested in the form of a study if the G-BA determines, based on the current state of knowledge, that its benefit is not yet sufficiently proven, but it offers the potential of a necessary treatment alternative.

According to the G-BA, the available scientific findings on the treatment alternative must lead to the expectation that this is “less complex, less invasive or has fewer side effects” than the methods used in care to date and can therefore lead to an optimization of the treatment.

We develop applications for you in accordance with § 137e SGB V, ensure competent project management and monitoring of the process and communicate with the official bodies, in particular the G-BA.

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