Market Access Germany: Two Hurdles, One Strategy

Market Entry with Two Hurdles

Foreign medical technology and software manufacturers rarely fail in Germany due to lack of market potential. They fail because of two structural barriers that must be overcome in sequence: first, regulatory approval under the EU MDR; second, access to the reimbursement system of statutory health insurance. Addressing only one of these levels is not enough.

Regulation: EU MDR as a Market Entry Barrier

The MDR is widely seen as a central growth obstacle: clinical data requirements, technical documentation and the involvement of Notified Bodies significantly delay and increase the cost of market entry. Studies show that many products – especially from SMEs – are no longer brought to the EU market or are withdrawn during the process for cost reasons. For foreign SaMD manufacturers, this means: early MDR classification, close alignment of the software architecture with DIN EN ISO 13485, 14971 and 62304, and sufficient resources for interaction with a Notified Body. Only with the CE mark is market entry possible at all.

Cybersecurity: From Optional to Required

As medical devices become increasingly connected, cybersecurity is moving sharply into focus. In 2025, the BSI published detailed recommendations for connected medical devices, requiring systematic risk analyses, documented development and vulnerability processes, and the integration of international security standards. For software manufacturers, this means in practice: secure-by-design, continuous vulnerability management and robust technical documentation are prerequisites, not only for the MDR audit, but also for acceptance by hospitals and practices.

Reimbursement: The Second Mountain After the CE Mark

Even with MDR certification, access to the regulated reimbursement system remains one of the biggest hurdles. Health insurers and purchasing consortia are cost- and risk-sensitive. For digital solutions, selective contracts, evaluation procedures and requirements for evidence of benefit and care effects come on top, going far beyond mere MDR conformity. Without a clear reimbursement strategy – per prescription (DiGA, DiPA, medical aids), direct contracts, self-pay models for privately insured, cooperation with insurers or hospital chains – many foreign providers remain locked out of the mass market, even though their products are formally approved.

Distribution Channels: Fragmented Access to Care Providers

The German market is highly fragmented: alongside large hospital groups and purchasing consortia, regional structures, degree of digitalisation and existing IT landscapes determine access. For foreign software providers, it is difficult without local partners to reach the right decision-makers in hospitals, medical centres and practices, and to integrate into complex IT environments (HIS, PMS, TI). Companies that succeed typically enter distribution partnerships with established MedTech or IT firms early on, offer local support and training, and adapt their business model to German reimbursement logic and procurement processes.

Conclusion: Market Entry Requires Strategy and Project Plan

The German market is highly attractive, but can only be unlocked with a sound strategy and a good project plan: first, rigorous MDR and cybersecurity compliance; second, localised market access through reimbursement and distribution partners. Those who interlock both levels from the outset making clinical studies, security concepts and care evidence usable simultaneously for MDR, BSI expectations and reimbursement dossiers, significantly increase their chances of gaining a foothold in Germany as a foreign software provider.

Sources: Medizin + Technik / DIHK, MedicalMountains & Spectaris, "MDR Balance After Two Years" (2024) · BSI, "Recommendations for Connected Medical Devices" (2025)