A Pathway for Expedited Reimbursement in the German Medical Device Market

According to section 92 of the law to strengthen healthcare services under the statutory health insurance (SHI healthcare strengthening act - SHI VSG), enacted by the German Bundestag on June 11, 2015, the Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) indicated its desire to encourage new forms of healthcare that go beyond the current standard of care.

Following a successful pilot phase, the Innovation Fund (Innovationsfonds) was made permanent by the German legislator (Digital Healthcare Act - DVG). For the 2026 cycle, the fund remains a cornerstone of German healthcare evolution. While the standard annual budget is €200 million, a one-time adjustment for 2026 has set the available funding at €100 million, specifically targeting new forms of care and health services research that show clear potential for permanent adoption into the statutory health insurance (SHI) system.

1. The Fund

Established as a permanent fixture of German law, the fund allocates up to €200 million annually (with a specific €100M allocation for 2026) to transition medical innovations into standard care.

The Federal Insurance Office (Bundesversicherungsamt) will collect and manage the Innovation Fund, and allocate funding based on the decisions of the Innovation Committee (Innovationsausschusses), which will be formed by the Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) by January 1st, 2016.

2. Innovation Committee

The Innovation Committee will include the following members:

  • 3 representatives of the association of the statutory health insurance sickness funds (GKV-Spitzenverband).
  • 1 representative of the federal association of statutory health insurance physicians (KBV).
  • 1 representative of the federal association of dentists (KZBV).
  • 1 representative of the German hospital federation (DKG).

An impartial chairman of the Federal Joint Committee (G-BA) as well as two representatives of the Federal Ministry of Health and a representative of the Federal Ministry of Education and Research. Patient organizations, with no voting rights, will be consulted with.

The innovation committee will be assisted by an Expert Advisory Group, consisting of up to 10 representatives of science and healthcare practice appointed by the Federal Ministry of Health. The Expert Advisory Group will:

  • Make recommendations for the issuance of calls for proposals,
  • Carry out short assessments of applications for funding,
  • Provide recommendations to assist the Innovation Committee in its funding decisions.

3. Who may apply?

Although an application for funding should typically involve a health insurance company, applicants for funding can also be independent physicians, approved medical centers, approved hospitals, state hospital associations, physicians' associations, pharmaceutical companies, medical device manufacturers and patient organizations.

A successful project typically requires a partnership between a manufacturer and at least one Statutory Health Insurance (SHI) fund (Krankenkasse). This ensures that the innovation is tested within the actual financial and operational framework of the German healthcare system.

4. Funding criteria

In order to be eligible for funding, suggested projects should be scientifically evaluated and demonstrate in particular:

  • Improvement of the quality and efficiency of providing healthcare services,
  • Elimination of supply shortages,
  • Optimization of the cooperation within and between different areas of care, utilities and professional groups,
  • Interdisciplinary and multidisciplinary care models,
  • Transferability of knowledge, in particular to other regions or indications,
  • Proportionality of implementation costs and benefits,
  • Evaluability.
  • Integration of AI and digital health solutions into existing care structures.

5. Next steps

Medical device manufacturers, who believe their technology could impact the quality and efficiency of healthcare services in the German market, should prepare a dossier, demonstrating their product's benefits and approach relevant German health insurance funds in order to explore potential collaborative projects.

Mediclever can assist by preparing the required dossier and leveraging its contacts in the German healthcare market to introduce you to the appropriate decision makers within the relevant health insurance funds.

Innovation Fund & MedTech Reimbursement FAQs

What is the budget for the Innovation Fund in 2026?

Following its permanent establishment, the fund provides roughly €200M annually for projects that bridge the gap between innovation and standard care.

Is this the same as a NUB application?

No. While NUBs focus on hospital-specific extra costs (read our guide on NUB reimbursement in Germany), the Innovation Fund focuses on cross-sectoral care models and long-term research to change the standard of care nationwide.

Can start-ups apply directly?

Start-ups can be part of a consortium. Success usually requires a partnership with a health insurance fund (Krankenkasse) to demonstrate scalability across the German market.

Medical Device Reimbursement Services by Country

  • Australia
  • Israel

About the Author

Expert in Global Medical Device Reimbursement with over 20 years of experience. Helping MedTech companies navigate coding, coverage, and payment.

Amir Inbar