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

The revised EBM catalog for the second quarter of 2025 published in Germany

On April 1, 2025, the revised EBM (German Uniform Evaluation Standard) catalog for the second quarter of 2025 came into force. The main changes introduced concern updates of the contents (services legends, preambles of several EBM subchapters) and the introduction of new EBM codes related to follow-up and evaluation of another reimbursable health app and second-opinion consultations.

Digital Law came into force in Germany

On March 26, 2025, the Law to accelerate the digitalization of the healthcare system (Digital Law, DigiG) came into force.

Transformation Fund approved in Germany

On March 21, 2025, the Federal Ministry of Health (BMG) announced that the establishment of the Transformation Fund, one of the key elements of the approved hospital reform, was formally endorsed by the Federal Council (Bundesrat) through a corresponding legal ordinance.

Get in touch

Contact us to discuss your needs and learn about our services