A CE mark lets you sell your device. It does not mean anyone will pay for it. German reimbursement is a separate process — and it works differently in the hospital than in the clinic. That gap is where most foreign medtech entries stall.
A device can be fully legal to sell (CE-marked) and still have no way to be paid for. Reimbursement in Germany splits by care setting: in the hospital, payment runs through DRG case rates, and if your device doesn't fit one, through the NUB application process; in the outpatient setting, a new method is not reimbursable until the G-BA approves it and it enters the EBM catalogue. Choosing which setting to fight for first is the decision that most shapes a medtech launch.
Germany is Europe's largest medical-technology market. But market authorization and market access are two different things.
A device can be placed on the market legally and still have no reimbursement code — which means no hospital budget will use it and no statutory insurer will cover it. The strategy that matters is not “how do we get CE-marked.” It's “in which setting do we get paid, under which mechanism, and what evidence does that require.”
A CE mark opens the door. The reimbursement code decides whether anyone walks through it.
It depends entirely on where the device is used — and the two routes are genuinely different campaigns, with different decision-makers, evidence and timelines.
Germany pays hospitals through DRG case rates (administered by InEK). Fit an existing DRG and your device is already “paid” — bundled into the rate, which can work against a premium product. Don't fit, and the route is NUB: an annual application to InEK for a temporary additional payment, negotiated hospital by hospital.
Statutory outpatient care runs on “permitted only if approved” (Erlaubnisvorbehalt): a new examination or treatment method is not reimbursable until the G-BA positively assesses it and it enters the benefit catalogue (EBM). Evidence-heavy and slow — the single biggest barrier for anything that depends on outpatient use.
Getting NUB status — and getting hospitals to actually apply for it — is a campaign, not a form.
Inpatient care is paid by DRG (diagnosis-related groups). The first question is simple and decisive: does your device fit an existing DRG?
Two coding layers sit alongside this: procedure codes (OPS) describe what was done, and additional payments (ZE, Zusatzentgelte) can reimburse specific high-cost items on top of the DRG. Over time, a successful new method may be built into the DRG system itself.
For higher-risk devices (classes IIb and III) that use a new theoretical-scientific method, an evidence assessment (§137h) can be triggered when the first NUB request is filed — so the clinical evidence bar and the payment application are linked, not sequential.
NUB gets you a code. Getting hospitals to apply for it, year after year, is the actual work.
In-vitro diagnostics carry their own version of the same problem. Beyond IVDR conformity, reimbursement for lab and point-of-care tests runs through the outpatient EBM catalogue and, for hospitals, the DRG system — with companion diagnostics tied to the reimbursement status of the therapy they support.
And the buyers differ: laboratories, hospital labs and diagnostic chains purchase unlike device buyers, so the access and distribution plan for a diagnostic is genuinely separate from a device. We keep devices and diagnostics on distinct tracks for exactly this reason.
Reimbursement isn't a step after launch. It's the plan the launch is built around.
In a focused session we map your regime and class, the realistic reimbursement route (hospital DRG / NUB vs outpatient G-BA / EBM), which setting to fight first, and the hospital / distributor access plan behind it.