Devices — get paid
DRG case fees and the NUB route in hospitals; G-BA methods assessment and EBM in outpatient care. Plan the evidence before the CE mark, not after.
Separate project from the CE markGermany sits next door, shares a language across the border, and is the largest healthcare market in Europe — the obvious first EU market for a Basel or Zurich life-sciences company. And yet, in regulatory terms, Switzerland is a third country. A Swiss approval buys you nothing across the border, and since 2021 Swiss device makers are treated like any other non-EU manufacturer. This is the full map of the gap — and how to cross it.
Switzerland is not in the EU or the EEA, so a Swiss company entering Germany needs an EU legal footing first. For medicines, remember that Swissmedic is not the EMA: a Swiss authorisation does not extend into the EU, so you take a separate EU or national marketing authorisation and appoint an EEA-based holder with an EU QPPV and QP batch release. For devices, the picture sharpened in 2021: when the EU–Switzerland mutual recognition agreement (MRA) lapsed with the arrival of MDR, Swiss manufacturers became third country — needing an EU Authorised Representative and a PRRC exactly like a US firm. A new MRA was signed in March 2026 but is not yet in force, so today the third-country rules still apply. Then both tracks hit the German wall every entrant meets: a CE mark or authorisation lets you sell, but reimbursement — AMNOG for drugs, DRG/NUB for devices — is a separate project. Proximity is not the same as access.
Swiss companies arrive with an advantage no American entrant has — language, culture and geography. That advantage hides the trap: the border is a regulatory hard edge, not a soft one.
From Basel it is twenty minutes to Germany. The commercial closeness is real, and it makes Germany the natural first EU market for Swiss pharma and medtech. But regulatory closeness does not follow geographic closeness. Switzerland runs its own system through Swissmedic, and it is outside both the EU and the EEA. Nothing Swiss crosses the border automatically.
For medicines this has always been true. For medical devices it became sharply true in 2021, when the long-standing EU–Swiss MRA was not renewed under the new MDR — overnight, Swiss manufacturers were reclassified as third-country and had to appoint EU representation to keep selling into the Union. That is the reality to plan around today, even as a newly signed 2026 agreement promises to soften it.
The Swiss advantage is real on the commercial side and worth nothing on the regulatory one. Plan for both truths.
What you make sets your path. Both start by building an EU footing that your Swiss base cannot provide — then both end at the same wall: allowed to sell is not the same as paid.
Because Switzerland is outside the Union, a Swiss address cannot carry the legal responsibility EU rules demand. Someone established inside the EEA has to. This is the step Swiss teams most often assume the border makes unnecessary — it does not.
| Requirement | Devices & diagnostics | Medicines |
|---|---|---|
| EU legal standing | A sole EU Authorised Representative (MDR/IVDR Art. 11) in the EEA, named on the label. | An EEA-established marketing-authorisation holder carries the authorisation and liability. |
| Responsible person | A PRRC for the manufacturer; 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. Switzerland's own FADP is close but not identical; for the EU market, GDPR governs. Connected and digital products add BfArM data-security expectations. | |
| The reflex to drop | A Swissmedic approval or a CE mark makes you eligible — it does not set a price or secure a payer. Reimbursement is a separate project on both tracks. | |
Whether you appoint an external provider for these roles or stand up your own German entity is a genuine strategic choice — leaner to outsource at first, more control once volume justifies insourcing. We work through it in local representation in Germany. Swiss companies that already look at the US market will recognise the pattern: the footing problem is nearly identical, as we set out in the US pharma & medtech guide.
This is the one area where the ground is genuinely shifting, and where getting the timing wrong is expensive. Here is the honest state of play.
With MDR (2021) and IVDR (2022) in force and no updated agreement, the EU–Swiss MRA for medical devices falls away. Switzerland becomes a third country for devices.
Swiss makers need an EU Authorised Representative to sell into the EU; EU makers need a Swiss rep (CH-REP) and Swissmedic registration to sell into Switzerland. This is today's reality.
In March 2026 the EU and Switzerland signed a bilateral package including an updated device MRA. Once it enters into force, MDR/IVDR-certified devices should again be accepted both ways — but until then, nothing changes.
The practical takeaway is not to wait. Building your German and EU market entry on an agreement that has been signed but not ratified is a bet on a date nobody controls. Plan on the third-country footing you need today; treat the returning MRA as upside that simplifies logistics later, not as a reason to delay entry now.
For Swiss medtech, third-country status has a concrete consequence beyond appointing a rep: your conformity assessment has to run through an EU-recognised route.
Your product's risk class sets the burden. Devices run under the MDR; in-vitro diagnostics run under the separate IVDR, which pushed a large share of tests into higher, Notified-Body-reviewed classes. Confirming which regulation and class you are in is the cheapest decisive step — it drives your evidence, timeline and cost. We map that fork in MDR vs IVDR.
Because the MRA lapsed, new medium- and high-risk Swiss devices must be certified by a conformity-assessment body established in the EU, and carry EU representation. A Swiss certificate or a domestic Swissmedic registration does not open the German door on its own. Only a compliant MDR/IVDR route earns the CE mark — and only then does the German market-access question begin.
Swiss teams, like everyone, tend to 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 schedule. None is automatic.
Being listed to be bought is a further step again — German hospital procurement is committee-driven, tender-heavy and slow. We cover the mechanics in getting a device reimbursed and the buying reality in hospital & tender access.
The single most costly assumption a Swiss pharma company can make is that its Swissmedic dossier is most of the EU job. The systems are separate, independent and not mutually valid.
Switzerland authorises medicines through Swissmedic under its own Therapeutic Products Act. The EU authorises through the EMA and national agencies. Neither recognises the other automatically: a Swissmedic authorisation gives you nothing in Germany, and an EU authorisation gives you nothing in Switzerland. The scientific dossiers overlap, but the procedures, timelines and even accelerated pathways differ — Switzerland's temporary authorisation is not the same instrument as the EU's conditional marketing authorisation.
So a Swiss company entering Germany takes a fresh EU route — most innovative medicines through the EU centralised procedure via the EMA, which yields one authorisation valid across the whole Union (often the reason Germany is chosen as the beachhead). National and mutual-recognition routes exist too. We lay out the choice in the four authorisation routes, and the continuing duties — pharmacovigilance, GMP/GDP, the required officers — in pharmacovigilance & GxP.
Once authorised, 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 against a chosen comparator. That rating — not your Swiss price, not your list price — sets the negotiated reimbursement price that applies from month seven, with a clawback owed on the difference.
Model the negotiated price, not the launch price. The full mechanism is in AMNOG explained; the regulated supply channel to pharmacies is covered in pharma distribution, and the AMG manufacturing/import licence in manufacturing & import authorisation.
Whatever the track, the German market is the payment decision, not the permission one. About 90% of Germans are covered by statutory health insurance, so the public system's yes is the market.
DRG case fees and the NUB route in hospitals; G-BA methods assessment and EBM in outpatient care. Plan the evidence before the CE mark, not after.
Separate project from the CE markAMNOG decides the reimbursed price on recognised added benefit. A weak comparator strategy can collapse the price regardless of sales.
Plan comparator + evidence pre-launchThis is the thesis under all of our work, inbound and outbound: authorized isn't the same as paid. For Swiss entrants the lesson is doubled — the border adds an EU-footing hurdle before you even reach the reimbursement one.
As your EU Authorised Representative, PRRC or the coordinator of your MAH and QPPV, we give a Swiss company the compliant EU presence the border requires — and keep it compliant as you sell.
Five patterns account for most stalled Swiss entries into Germany. All are avoidable with foresight.
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 EU 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.