Reimbursement is a separate process — and in Germany it works differently in the hospital than in the clinic. That gap is where most foreign medtech entries stall, and it's the part we handle.
Germany is the largest medical-technology market in Europe and, for most manufacturers, the entry point to the EU.
But a device can be fully legal to place on the market and still have no reimbursement code — which means no hospital 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.”
In-vitro diagnostics follow a different regime (IVDR, not MDR) with its own classification and reimbursement logic. We treat devices and diagnostics as separate tracks — see the IVD section below — rather than blur them into one.
Not “can we place it on the market,” but which setting pays, under which mechanism, and with what evidence — decided before you build the cost base.
Your exact regime and class is the first decision — it determines the conformity route, evidence burden, timeline and cost downstream.
Risk-based conformity by class. Anything above the lowest class needs a Notified Body conformity assessment.
Reclassification pushed most diagnostics into classes that now require Notified Body involvement — a structural change that caught many manufacturers unprepared.
For anything above the lowest risk class, CE marking requires a conformity assessment by a Notified Body (Benannte Stelle). Capacity is scarce and queues are long.
Under MDR and IVDR, Notified Body capacity is scarce and queues are long. Securing a slot and a realistic timeline is part of the plan, not an afterthought.
We don't act as your Notified Body or write your technical file. We make sure the regulatory path, the EC REP setup and the timeline are aligned to the commercial plan — so the CE work and the launch aren't two disconnected projects.
There is no single “German reimbursement.” It depends on where the device is used — and the two routes are genuinely different campaigns.
Germany pays hospitals through DRGs (InEK). Fit an existing DRG and you're bundled into the case rate — which can work against a premium product. Don't fit, and the route is NUB: an annual application cycle, negotiated hospital by hospital.
Statutory outpatient care runs on “permitted only if approved” (Erlaubnisvorbehalt): a new method is not reimbursable until the G-BA positively assesses it and it enters the benefit catalogue (EBM). Evidence-heavy, slow — the single biggest barrier for outpatient-dependent devices.
Getting NUB status — and getting hospitals to actually apply for it — is a campaign, not a form. Choosing which setting to fight for first is the decision that most shapes a medtech launch.
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 associated therapy.
The post-IVDR Notified Body shortage hits diagnostics especially hard. And the commercial buyers — laboratories, hospital labs, diagnostic chains — purchase differently from device buyers, so the access and distribution plan is genuinely separate.
German hospital procurement is committee-driven and slow. The second meeting is earned by trust, evidence and a credible local presence — not by a cold pitch from abroad.
Purchasing groups (Einkaufsgemeinschaften), clinic chains (university hospitals, Helios, Asklepios, Sana, Vivantes), tenders, and long evaluation cycles where clinical champions, procurement and controlling all have a say.
Access usually runs through specialist distributors or key-account relationships. The right channel differs for a device vs a diagnostic vs an equipment sale.
Hospitals, labs and distributors commit gradually — a pilot or single department first, broader adoption later. Reliability, local contactability and evidence decide who scales.
A “we got them CE-marked” claim without a reimbursement-and-adoption story reads as thin to anyone who knows this market. Owning the access layer, and orchestrating the rest, is what counts.
Executed with specialist partners, kept aligned to the commercial goal and timeline — so nothing falls between the desks.
A focused working session plus a short written output — so you know the realistic reimbursement and access picture before committing budget.
Tell us the device and the setting — we'll come back with the regime, the reimbursement route and the first move.
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