Pharma, medical devices, diagnostics and digital health each follow a different regulatory and reimbursement logic in Germany. We keep them as three distinct tracks under one thesis: an approval is the entry ticket — getting paid is a separate project, and it's the one we run.
Germany is the largest and most regulated healthcare market in the EU — and the reference point the rest of Europe watches. For most companies it's the first serious step into the EU.
But market authorization and market access are two different things. A drug can be approved, a device CE-marked, an app listed — and still have no reimbursement, no channel and no adoption. What decides revenue is the mechanism that pays you, the evidence it demands, and the relationships that payers, hospitals and prescribers expect before they commit.
That mechanism is different for each track. Pretending a single approach covers pharma, devices, diagnostics and digital health is exactly what a generalist would do. We lead with the distinction — and go deepest where it matters.
Across every track: the approval is commodity, the reimbursement-and-adoption layer is the moat. We own that layer — and coordinate the regulatory work around it.
What is the entry ticket, who actually pays, and where do foreign entrants stall — per track.
Marketing authorization (EMA / BfArM)
Reimbursement via the AMNOG benefit assessment — G-BA / IQWiG added-benefit rating sets the negotiated price; otherwise a reference price (Festbetrag).
The benefit dossier and the price negotiation — a weak comparator narrative caps revenue before launch.
CE mark under MDR, via a Notified Body (Benannte Stelle)
Splits by setting: hospital DRG / NUB (InEK) vs outpatient G-BA / EBM. No code, no use.
Choosing the wrong care setting to fight first — and hospital procurement that moves by committee.
Conformity under IVDR — reclassification pushed most IVDs to Notified-Body routes
Outpatient EBM and hospital DRG; companion diagnostics track the therapy's status.
The Notified-Body shortage, and lab / diagnostic-chain buyers who purchase unlike device buyers.
BfArM fast-track listing (~90 days) + BSI data-security bar
Statutory insurance from day one; price set by you in year one, then negotiated with GKV-Spitzenverband.
Listed but not prescribed — physician awareness and uptake is the real battle, not the listing.
Medical devices (MDR) and in-vitro diagnostics (IVDR) are separate regulatory regimes with separate buyers — we keep them on distinct tracks rather than blur them into one.
Each pillar has its own page with the full regulatory and reimbursement route. Start here.
The same reimbursement-and-access discipline works in reverse. We move foreign life-sciences companies into Germany, and take German companies to markets abroad.
Foreign pharma, medtech and digital health through German authorization, reimbursement and distribution. Germany first; the EU from there.
German manufacturers, hospitals and labs to foreign markets — target-market regulation, partners, channels and local representation.
The same division of labour holds for pharma, medtech and digital health. We own the commercial and relationship layer; we orchestrate the specialists around it.
Executed with specialist partners, kept aligned to the commercial goal and your timeline — so nothing falls between the desks.
A focused working session plus a short written output — tailored to your track (pharma, medtech, diagnostics or DiGA), so you know the realistic German picture before committing budget.
Tell us your product and target setting — we'll come back with the track, the mechanism and the first move.
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