Skip to main content

Market access for medical technologies in Germany

A brief overview of key market access pathways and challenges for medical devices, in-vitro diagnostic tests in Germany

dfv

Key topics

There are three key themes describing market access for medical technologies in Germany:

  • Reimbursement: payment mechanism via DRG system, add-on reimbursement via ZE in hospital settings; payment via EBM catalog in out-patient settings
  • Funding: coverage decisions within statutory health insurance by the Federal Joint Committee (G-BA)
  • Health technology assessment: assessments by IQWiG in relation to the creation of out-patient reimbursement codes

Germany has a number of innovative payment schemes for medical technologies. 

dghj

Reimbursement

Reimbursements for hospital procedures are made solely via a German-diagnosis-related group (G-DRG) system. All cases of hospitalization with at least one overnight stay are reimbursed via DRG. Day cases and out-patient care are completely separate from hospital care provisions and are reimbursed via a fee-for-service model (EBM catalog within the statutory health insurance).

The DRG system has the following components:

Diagnosis-related groups

  • DRGs are determined by the combination of a procedure code (OPS) and a diagnosis code (ICD-10-GM). OPS nomenclature is maintained by the BfArM Cologne Office (ex DIMDI) and released annually
  • Most DRGs have a national tariff, which is determined by the administrator of the DRG system, the Institute for the Hospital Remuneration System (InEK)

Add-on reimbursement (Zusatzentgelt, ZE)

  • Add-on reimbursement is provided for expensive devices, procedures, and drugs
  • ZE might or might not have a national tariff

The G-DRG system is approved annually.

Innovation funding (NUB) is not formally part of the DRG system. NUB is granted by InEK for a period of less than a year based on the review of applications made by hospitals. Approved status (status 1) gives hospitals the opportunity to negotiate additional reimbursement with sickness funds. However, it does not guarantee reimbursement, as sickness funds may question the sufficiency of the evidence provided and decide not to pay for the technology.

In out-patient settings, procedures are reimbursed via a fee-for-service mechanism via the EBM Catalog. There are specifics of reimbursement for surgical procedures in day case settings. 

gfhgjh

Funding

From 2016, the national policy-maker, the Federal Joint Committee (Der Gemeinsame Bundesausschuss, G-BA), may initiate a “benefit assessment” procedure for applications dealing with devices from high-risk classes (IIb and III). This would ensure that the level of evidence is sufficient for the device’s use in the German statutory health insurance system. 

dfghjk

Health technology assessment

HTA is almost exclusively limited to assessments by IQWiG in relation to the creation of out-patient reimbursement codes.

111

Specifics for IVD tests

In-vitro diagnostic tests are reimbursed using a fee-for-service mechanism via the EBM Catalog in out-patient settings.

MTRC has experience with more than 340 projects in Germany

News and insights

Further extension of the Hybrid DRGs catalog in 2026 agreed upon in Germany

On April 30, 2025, the National Association of Statutory Health Insurance Physicians (KBV) announced that it had reached an agreement with the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) on the further expansion of the Hybrid DRG catalog in 2026. The decision was made by the extended Evaluation Committee, as no consensus could be reached with the German Hospital Federation (DKG).

The application period is open to propose new topics for the Innovation Fund in Germany

On April 11, 2025, the Innovation Committee at the Federal Joint Committee (G-BA) announced the opening of the application period for the submission of topics for upcoming funding opportunities in the areas of healthcare research and new forms of care. The deadline for submitting topic proposals is June 20, 2025.

GKV report on the utilization and development of digital health application (DiGA) care in Germany

On April 1, 2025, the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) published its report on the utilization and development of digital health applications (DiGA) covering the period from September 1, 2020, to December 31, 2024. The report presents GKV’s key findings along with recommendations aimed at optimizing the current framework for DiGA reimbursement and regulation.

Get in touch

Contact us to discuss your needs and learn about our services