In the recent past, medical devices have increasingly moved into the focus of benefit assessment. The new legal procedures within the scope of trial regulations according to § 137e SGB V and the benefit evaluation of medical devices according to § 137h SGB V present new challenges to manufacturers of medical devices of higher risk classes. The procedures for reimbursement of medical devices are complex and generally of long duration, so that careful planning of the reimbursement process seems indispensable. Medical devices can be remunerated and reimbursed as medical services (e.g. laboratory analysis), as implements, as medical devices similar to drugs or, for example, as part of inpatient treatment. Especially the variety of products in connection with the respective legal framework conditions requires the analysis of the reimbursement process in order to formulate an adequate strategy. Since the requirement of permission proviso applies in the outpatient area, which is equivalent to a fourth hurdle, new examination and treatment methods can only be used in the medical area if the responsible Joint Federal Committee (G-BA) has explicitly permitted them (§ 135 SGB V). We advise you with regard to the content requirements of the procedures for the reimbursement of medical devices in the outpatient or inpatient area. We support the development and implementation of the market access strategy.