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Market Access and Reimbursement of Medical Devices in Germany

 

Any medical device intended for the German market must bear a CE mark before it can be sold or put into Service. However, this regulatory step does not ensure that a medical device obtains an adequate reimbursement by German health insurances.  The reimbursement application process as well as the available reimbursement pathways depend on whether a medical device is applied in an inpatient setting (within hospitals) or in an outpatient setting. An overview of the available reimbursement pathways for innovative medical devices in Germany as well as the related time and evidence requirements are shown below.