A change to the German legislation regarding the introduction of new innovative medical devices have just been implemented as of May 1st. The new law will be applicable as of 2020.
It is not clear how all aspects of the legislation should be interpreted and what the practical implementation will be like.
From the review of the changed legislation, a key message is that the previous risk to be excluded from the healthcare system is not there. For companies who have been hesitant to apply due to this, the situation has completely changed.
Don’t miss our upcoming webinar (May 7th) where we will discuss the implications of this new change based on the available information.
A few high-lights from the changes:
- There is no evaluation of the potential benefit.
- If there is insufficient evidence to demonstrate the benefit, GBA will initiate a government sponsored trial.
The most important things to consider (given the current knowledge):
- Evaluate the likelihood of a successful outcome. If you are likely to get status 2 (denied), you risk starting a process with a clinical trial that will take quite some resources.
- Initiate the NUB process ASAP. Given this change, we expect that a very intense work schedule for Dr Braun.
- Develop a robust plan for how you would like to have your study carried in order to ensure optimize the opportunity