Presentation (CTI)

OBJECTIVES: Unlike pharmaceuticals, medical devices in Europe face highly fragmented and nationally governed reimbursement systems. In the DACH region, Germany, Austria, and Switzerland offer distinct pathways for device market access, particularly in the inpatient setting. Understanding these national processes is critical for manufacturers seeking coordinated regional launches.
METHODS: A comparative policy analysis was conducted based on health system reports, payer guidelines, and expert interviews. The focus was on inpatient reimbursement mechanisms, evaluation criteria, transparency, and the use of evidence in decision-making. Germany’s NUB application process, Austria’s DRG adaptation via LKF system, and Switzerland’s individual benefit application and SL/NHI processes were analyzed in depth.
RESULTS:

Germany uses the NUB (Neue Untersuchungs- und Behandlungsmethoden) pathway for hospital innovations not covered in existing DRGs. In outpatient settings various pathways are available through method evaluation, Hilfsmittelverzeichnis and selective contracting.

Austria integrates devices via LKF catalog adaptations, guided by clinical societies and internal payer assessment. No public HTA body for devices exists; decision-making is opaque, slow, and heavily expert-driven.

Switzerland requires either SL inclusion (for outpatient products) or individual benefit approval by insurers (inpatient). There is no structured HTA for most devices, and reimbursement decisions vary widely across cantons and insurers.

CONCLUSIONS: Medical device reimbursement in the DACH region is highly heterogeneous. Germany offers the most structured—though decentralized—inpatient innovation pathway, while Austria and Switzerland remain comparatively fragmented. Manufacturers must adopt country-specific launch and evidence strategies, with early engagement and robust clinical and economic dossiers increasingly important even in the absence of formal HTA requirements.