OBJECTIVES: Medical devices (MDs) differ regarding their risk class and intended use (diagnostic, monitoring, intervention). In Germany new medical devices (MDs) must be evaluated by the Federal Joint Committee (G-BA) before being reimbursed. The underlying analysis highlights MD-specific processes and challenges for the outpatient sector.

METHODS: The main steps required for a successful reimbursement of new MDs were identified by a systematic review of publicly available regulations and a stepwise evaluation of the application pathways.

RESULTS: MDs for the outpatient sector are covered by reimbursement catalogue (EBM/GOÄ) and - except the mode of action is already well established -have to pass an assessment by the G-BA (rapid HTA). Such assessments (2018: 26 pending topics, the earliest submission being 2006) can be initiated only by respective umbrella organizations of service providers (e.g. KBV (National Association of Statutory Health Insurance Physicians)). MDs not being recommended by the G-BA are not reimbursable in the outpatient sector (permission reservation). Methods having the benefit not yet adequately proven, but offer the potential for a treatment alternative, may be temporarily authorized on the basis of initiating respective studies (testing directives § 137e SGB V). Methods can be tested in model projects that are usually limited to a maximum of eight years and must be scientifically monitored and evaluated with regard to the desired goals. The evaluation report has to be prepared by independent experts and has to be published. In addition to the statutory health insurance (SHI) service catalogue, additional coverage can be sought by out of pocket payments, so-called “IGeL”-application (§ 6 Abs. 2 GOÄ). Selective contracts between manufacturer and insurances can be negotiated.

CONCLUSIONS: For a successful reimbursement process of new and innovative MDs intended for an outpatient use, manufacturer have to provide robust and scientifically based evidence that are proving the additional benefit.