A CE mark lets you place a device on the German market. It does not get you paid. Market access is what happens next — DRG and NUB in hospitals, EBM in outpatient care, tenders, and the clinical evidence that turns a compliant device into a purchased one. This is the map, and how the pieces connect.
A CE mark under the MDR (or IVDR for diagnostics) is permission to sell. Whether the German system pays for your device — and how much — is a separate decision made by hospitals, statutory insurers and, for new methods, the G-BA.
For a foreign manufacturer that is the surprise: conformity and reimbursement run on different tracks. Payment depends on the care setting — inpatient devices are funded inside DRG case fees (with the NUB route for genuinely new methods), outpatient devices through the EBM schedule, and some through the aids-and-appliances (Hilfsmittel) route. Get the access path right and the CE mark earns its keep; get it wrong and an approved device sits unused.
A CE mark is a permission slip. Reimbursement is the purchase order. They are decided separately.
Five stages turn a compliant device into German revenue. The class you are in sets the burden of every one.
Your risk class drives evidence, timeline and cost — and diagnostics run on the separate IVDR. See MDR vs IVDR.
A Notified Body conformity assessment for anything above the lowest class, plus — for non-EU makers — an Authorised Representative and PRRC. See local representation.
DRG / NUB for inpatient, EBM for outpatient, Hilfsmittel for aids — and G-BA methods assessment for certain high-risk new methods.
Clinical and health-economic evidence for the chosen route — planned before launch, not after. See device reimbursement.
Committee-driven procurement, purchasing groups and tenders decide adoption. See hospital & tender access.
Access is not one task. These are the workstreams that decide it — each with a deeper guide.
MDR or IVDR, the risk class, the Notified Body route — the fork that sets your whole evidence and cost burden.
MDR vs IVDR →How devices get paid by care setting — the single biggest determinant of your German revenue.
Device reimbursement →Committee-driven procurement, purchasing groups and tenders — how a device is actually bought.
Hospital & tenders →Authorised Representative, PRRC and post-market surveillance — the standing a non-EU maker needs and must keep.
Local representation →For software-as-a-medical-device, the BfArM fast-track to a prescribable, reimbursed app.
DiGA route →The idea under all of it: a CE mark makes you eligible; reimbursement and the tender decide revenue.
Read the thesis →Foreign medtech with a CE mark (or building one) and no route into German hospitals or reimbursement.
Innovative devices that need a NUB application or a G-BA methods assessment before the money follows.
Software-as-a-medical-device teams weighing the DiGA route against classic device reimbursement.
Bringing medicines as well as devices? See pharma market access in Germany. Entering from a specific country? See the tailored guides for US and Swiss companies, or start with the market-entry strategy overview.
We own the access and commercial layer and coordinate the regulatory and clinical specialists — so the reimbursement case is ready before you launch.
The reimbursement route (DRG/NUB/EBM/DiGA), the evidence it needs, and the pricing case — planned pre-launch.
Authorised Representative, PRRC and the compliance the market requires, stood up and maintained. See local representation.
The distributors, purchasing groups and clinical relationships that turn a reimbursement code into orders. See finding distributors.
Everything between a CE mark and a purchased device: choosing the reimbursement route (DRG/NUB in hospitals, EBM in outpatient care, Hilfsmittel for aids), building the clinical and economic evidence, and winning hospital procurement and tenders. A CE mark makes you eligible; market access determines revenue.
By care setting. Inpatient devices are funded within DRG case fees, with the NUB route for genuinely new methods; outpatient devices run through the EBM schedule; some reach patients via the aids-and-appliances (Hilfsmittel) directory. Certain high-risk new methods also require a G-BA assessment.
It lets you place the device on the market, but it does not set a price or guarantee a buyer. Reimbursement and hospital procurement are separate steps — the ones that actually decide whether the device is used and paid for.
NUB (Neue Untersuchungs- und Behandlungsmethoden) is a route for genuinely new inpatient methods not yet covered by the DRG system to receive temporary additional hospital funding while evidence and permanent reimbursement are established.
Before the CE mark is finished. The reimbursement route and the clinical or health-economic evidence it requires should be planned during development, so the access case is ready at launch rather than scrambled afterwards.
Start with a focused session — we'll map the reimbursement route, the evidence and the hospital access path for your device.