Recent German court case could lead to a ‘stop’ for existing medical devices with insufficient evidence

In the last few years the German market has been gradually reshaped from having relatively easy access for new innovative medical devices, to increasingly clear requirements for evidence. A recent court case involving liposuction concluded that the insurance company is not required to pay for an intervention that does not have a proven benefit. Recently, in a meeting with the German authorities, we discussed the implications of this, they said it is still unclear. A possible worst-case scenario could be that this gives the insurance companies the ability to actively reject payments for technologies which do not have a proven benefit. To ensure an adequate ‘proven benefit’, new devices and products would need to meet this very high evidence requirement, which would mean many new devices would fail.

For companies that have already entered the German market, and can fulfil the requirements for the 137(h) process, there is still a way to enter the market.

Though the effect of the court case is not clear, it is clear that Germany has become a market with very high evidence requirements that can potential discourage innovations in this field.