What sets your price
The G-BA / IQWiG added-benefit rating against the chosen comparator therapy — decided on evidence, not on your home-market price.
Plan: comparator & evidence strategy pre-launchGermany is the largest healthcare market in Europe and the natural first stop for a US life-sciences company crossing the Atlantic. But the American playbook — clear a regulator, launch, price freely — does not run here. Approval and price are separate events, run by separate bodies, and the gap between them is where US entrants lose the most time. This is the full map, for both the drug track and the device track.
To sell in Germany, a US company needs an EU legal footing before anything else: for devices, a sole EU Authorised Representative and a PRRC under MDR/IVDR; for medicines, an EEA-based marketing-authorisation holder with an EU QPPV and QP batch release. Then the two tracks split. Devices are CE-marked through a Notified Body under MDR (or IVDR for diagnostics) — but the CE mark only lets you sell, not get paid; reimbursement runs through DRG/NUB in hospitals and G-BA/EBM in outpatient care. Medicines take an EU or national marketing authorisation, then face AMNOG: free pricing for just the first six months since the 2023 reform, then a negotiated price (with clawback) set by what added benefit the G-BA and IQWiG recognise. Digital-health startups have a genuine shortcut — the DiGA fast-track — but a listing still isn't a prescription. The single American reflex to unlearn: authorised is not the same as paid.
US teams arrive fluent in the FDA. That fluency is useful and incomplete: Germany separates the permission to sell from the right to be paid, and puts them in different hands.
In the United States, clearing the FDA and negotiating with payers can feel like one continuous motion. In Germany the two are structurally distinct. A regulator (or a Notified Body, for devices) decides whether your product may be placed on the market. A different set of institutions — the G-BA, IQWiG, the statutory insurers, the DRG system — decides whether, and at what price, the public system pays for it. Roughly 90% of Germans are covered by statutory health insurance, so that second decision is the market.
For a well-funded US scale-up this is a sequencing problem. For an early-stage startup it is an existential one: burn the runway getting authorised, discover that reimbursement is a second project you did not budget, and the German launch stalls at exactly the point it looked finished. The guide below is built to prevent that.
The FDA decision has a German cousin. The payment decision does not — and it is the one that pays salaries.
Which path you are on is set by what you make. Both start from the same EU footing, then diverge — and both end at the same wall: being allowed to sell is not the same as being paid.
Before either track begins, a US company needs a foothold inside the EU legal system. This is where most American entrants underestimate the setup — not the science, the standing.
A US address is not a valid place from which to put a regulated product on the EU market. The regulations require someone established inside the Union to carry legal responsibility. What that role is called, and what it must do, differs by track — but you cannot skip it, and you should decide who plays it before you spend on anything else.
| Requirement | Devices & diagnostics | Medicines |
|---|---|---|
| EU legal standing | A sole EU Authorised Representative (MDR/IVDR Art. 11) established in the EEA, named on the label. | An EEA-established marketing-authorisation holder holds the authorisation and the liability. |
| Responsible person | A PRRC (person responsible for regulatory compliance); the Authorised Rep needs its own PRRC too. | An EU-resident QPPV for pharmacovigilance, plus a Qualified Person (QP) for batch release. |
| Data protection | GDPR applies to any patient or user data — not optional, and stricter than US norms. For connected or digital devices, add BfArM data-security expectations. | |
| The reflex to drop | Authorisation / CE marking makes you eligible. It does not set a price or guarantee a payer. Reimbursement is a separate project on both tracks. | |
Whether you appoint an external service provider for these roles or build your own German entity is a real strategic choice — cheaper and faster to outsource early, more control to insource once volume justifies it. We walk through the trade-off in local representation in Germany, and the broader operating differences (entity, the permanent-establishment tax trap, employment, GDPR) in US companies entering Germany.
For US medtech, the hard news is usually the calendar. MDR is more demanding than the FDA route many founders assume it mirrors, and Notified Body capacity is finite.
Your product's risk class sets everything downstream. Devices run under the MDR; in-vitro diagnostics run under the separate IVDR, which reclassified a large share of tests into higher, Notified-Body-reviewed classes. Confirming which regulation and which class you are in is the cheapest and most decisive early step — it determines your evidence burden, your timeline and your cost. We map that fork in MDR vs IVDR.
A US 510(k) or PMA does not transfer. You will build a technical file to EU requirements, appoint a Notified Body for anything above the lowest class, and demonstrate clinical evidence under MDR’s stricter expectations. Only then do you earn the CE mark — and only then does the real German question begin.
US teams routinely treat the CE mark as the finish line. In Germany it is the starting line for reimbursement. In hospitals, payment flows through the DRG case-fee system, with the NUB route for genuinely new methods; in outpatient care it runs through the G-BA and the EBM fee schedule. Each has its own evidence and process, and none is automatic.
Getting listed to be bought is a further step again — German hospital procurement is committee-driven, tender-heavy and slow. We cover both the reimbursement mechanics in getting a device reimbursed and the buying reality in hospital & tender access.
For US pharma, the surprise is not getting approved — it is what happens in the year after. Germany lets you launch at your own price, then claws the decision back.
First, the authorisation. Most innovative medicines enter through the EU centralised procedure via the EMA, which yields one authorisation valid across the whole EU — often the reason Germany is chosen as the European beachhead in the first place. National and mutual-recognition routes exist for other cases. We lay out the choice in the four authorisation routes. Behind it sit the continuing duties most US teams under-scope: pharmacovigilance, GMP/GDP and the officers the law requires, covered in pharmacovigilance & GxP.
Then comes AMNOG, and this is the part that rewrites the American mental model. You may set your own price at launch — but since the 2023 GKV-FinStG reform, only for the first six months (down from twelve). In parallel, the G-BA commissions IQWiG to assess your medicine’s added benefit versus an appropriate comparator. That rating — not your US price, not your list price — sets the ceiling for the negotiated reimbursement price that applies from month seven, and you may owe a clawback on the difference for those first months. A weak or unproven added benefit can collapse your price regardless of how the product sells.
The G-BA / IQWiG added-benefit rating against the chosen comparator therapy — decided on evidence, not on your home-market price.
Plan: comparator & evidence strategy pre-launchSix months of free pricing, then a negotiated price from month seven — with a rebate owed on the gap. Model the negotiated price, not the launch price.
Plan: revenue on the negotiated numberThe full mechanism — the dossier, the comparator fight, the negotiation and arbitration — is set out in AMNOG explained. Once priced, supply reaches Germany’s pharmacies through a regulated channel of wholesalers under GDP and EU serialisation, described in pharma distribution. And if you manufacture or import the finished product into the EU, you will need the AMG manufacturing/import authorisation covered in manufacturing & import authorisation.
If you are a US digital-health startup, Germany offers something almost unique in the world: a national route to get an app prescribed and reimbursed. It is real, and it is faster than the tracks above — but it has the same twist.
The DiGA pathway lets a qualifying digital health application go through a BfArM fast-track and become prescribable and reimbursed by statutory insurers — a genuine, structured on-ramp that does not exist in most markets. For a lean software company it can be the most capital-efficient way into German healthcare revenue.
The catch is the familiar one in a new costume: a DiGA listing is not a prescription. Getting into the directory makes you reimbursable; getting doctors to prescribe and patients to use it is the commercial work that follows. And the data bar is high — GDPR plus BfArM’s data-security requirements and, increasingly, a BSI-aligned security posture. We cover the route in DiGA: getting an app prescribed and the data hurdle in data security for digital health.
The two mistakes that burn startup capital are treating reimbursement as a formality, and doing the steps in the wrong order. A little sequencing discipline saves a lot of money.
| Phase | Devices & diagnostics | Medicines |
|---|---|---|
| 1. EU footing | Authorised Rep + PRRC appointed; entity or rep decision made. | MAH / QPPV / QP secured; entity or partner decision made. |
| 2. Permission to sell | MDR/IVDR classification, technical file, Notified Body, CE mark. | Marketing authorisation (usually EU centralised). |
| 3. The real gate | Reimbursement: DRG / NUB or G-BA / EBM — plan evidence early. | AMNOG: comparator + added-benefit evidence — plan pre-launch. |
| 4. Reach the buyer | Hospital tenders, purchasing groups, distributors. | Wholesaler / pharmacy channel; specialist routes by product. |
The through-line for a startup: work step 3 while you are still doing step 2. The evidence that wins reimbursement — the right comparator, the right clinical or health-economic data — has to be planned before launch, not scrambled after it. The specific budget lines a medical-goods company underestimates (QMS, regulatory, access) are laid out in the real cost of entering Germany.
Germany rewards the company that plans to get paid before it is allowed to sell.
Five patterns account for most stalled American entries. All are avoidable with foresight.
Every one of these is a version of the same thesis we apply to every market, inbound and outbound: authorized isn’t the same as paid.
Start with a fixed, written roadmap for your product and track, then plan execution in a working session — the EU footing, the reimbursement evidence and the order to do them in.
A one-off written roadmap for your specific product — which track, which route, and where reimbursement, not approval, is the real work.
A focused session to structure the entity-vs-representative decision, plan the added-benefit or DRG evidence, and set the first year.