Is our FDA clearance enough to sell in Germany?

No. A 510(k), De Novo or PMA has no legal effect in the EU. You need a CE marking under the MDR (EU 2017/745). Your US files — clinical data, risk management, verification and validation — are nevertheless a valuable basis for the technical documentation.

Do we need our own subsidiary in Germany?

Not legally. The MDR requires manufacturers outside the EU to appoint an EU authorized representative, who can be based in any member state. For hospital listings, however, a German address and German-speaking contacts are a de facto requirement. In our mandates, a German company that we set up and manage for you takes on this role.

Is there anything comparable to US GPOs in Germany?

Yes — hospital purchasing groups (Einkaufsgemeinschaften). They negotiate framework agreements but rarely decide alone: in many hospitals, users, infection control and purchasing review a new product together before it is listed.

How long does it take to reach the first hospital revenue?

That depends mainly on whether the CE marking is already in place. If it is, we start with a pre-sale test at a suitable university hospital. If it is not, the conformity assessment with the notified body sets the timeline. We give you a reliable estimate once we have reviewed your files in a strategy call.

For US manufacturers

From FDA clearance into German hospitals.

A 510(k) clearance opens no hospital doors in Germany. To enter the market, US manufacturers need a CE marking under the MDR, a regulatory presence in the EU and a sales operation that understands how German hospitals buy. Since 1999, we have taken US manufacturers down exactly this route.

Regulatory route: CE marking under the MDR — FDA clearance is not recognised
Mandatory role: EU authorized representative under Art. 11 MDR
Reimbursement: DRG lump sums; new methods via hospitals' NUB requests
Reference: Zassi — US manufacturer, acquired by Hollister in 2008

Why FDA clearance is not enough

In the US, the route for most products is clear: classification, 510(k) or De Novo, listing, sales through GPOs and IDNs. None of these steps applies in Germany. What counts is the European Medical Device Regulation, MDR (EU 2017/745). For the German market this means:

Separate classification. The MDR classifies devices under 22 rules in Annex VIII. An FDA Class II device may be Class IIa or IIb in the EU. Software and devices with a medicinal component are often classified higher than expected.
Conformity assessment. From Class IIa upwards, a notified body audits your quality management system and technical documentation. This replaces the FDA review but follows its own logic and timelines.
Clinical evaluation. US study data can be used but must meet MDR requirements. Equivalence to a comparator device is defined much more narrowly under the MDR than in the 510(k) pathway.

Since 2 February 2026, the FDA’s Quality Management System Regulation (QMSR) incorporates ISO 13485:2016 by reference. Your quality system is therefore closer to European expectations than it used to be. The MDR, however, adds a set of roles and obligations that do not exist in this form in the US system.

What the MDR additionally requires from non-EU manufacturers

EU authorized representative (Art. 11). Without one, you cannot place a device on the EU market. Under certain conditions the representative is jointly liable with you — and will therefore review your files before accepting the mandate.
Importer (Art. 13). Whoever first brings your device into the EU takes on verification duties of its own.
PRRC (Art. 15). A qualified person responsible for regulatory compliance.
EUDAMED and UDI. Actor registration, device registration and unique device identification. The first EUDAMED modules have been mandatory since 28 May 2026.
Post-market obligations. Post-market surveillance, vigilance and periodic safety reporting continue throughout the device’s lifetime.

Germany adds one specific rule. Under Section 8 of the Medical Devices Implementation Act (MPDG), information intended for users must be provided in German. English is permitted only in justified cases and only for professional users — safety-related information must still be in German.

How German hospitals buy and get reimbursed

Hospitals bill inpatient care through DRG lump sums. As a rule, your device is not reimbursed separately; it is a cost item within the lump sum. A higher price therefore needs a clinical or economic rationale that a head of department, a director of nursing and a purchaser can all follow.

For new diagnostic and treatment methods there is the NUB route (Neue Untersuchungs- und Behandlungsmethoden). The request is filed not by the manufacturer but by the hospital, with the InEK institute, by 31 October each year for the following year. If you need this route, you first need hospitals that know your product and are willing to file.

Purchasing is pooled through hospital purchasing groups — comparable to US GPOs, but with less reach into the individual hospital. A new product is usually listed only once users, infection control and purchasing in that hospital have signed off.

The typical mistakes of US manufacturers

Since 1999 we have seen the same patterns:

The distributor as a shortcut. A traditional distributor carries hundreds of lines. A new product that needs explaining and has no German reference hospital gets no priority there.
The subsidiary as step one. Incorporation, recruiting and leases tie up capital before the market has been validated.
The US price as the benchmark. In Germany, the comparison class decides. Without clinical differentiation, a premium product ends up at the price of the cheapest alternative.
English-language material. German hospital decision-makers expect German documents, training and contacts.

More in our insight The 5 costliest mistakes when entering the German hospital market.

Our route for US manufacturers

We work in the order in which risks arise:

Regulatory assessment. We review classification, existing files and the gap to the MDR. This produces a realistic timeline.
German company. We set up a German GmbH for your product and run it as interim management. It takes on the authorized representative role, the PRRC and registrations.
Pre-sale test. Through our Board of Experts we test the product at a suitable university hospital. This creates the German reference before larger sums are committed.
Hospital sales and listings. Roll-out follows the reference — university hospitals and tertiary care centres first, then larger hospital groups.
Handover. Once the market holds, you take over the company — or it becomes part of a sale.

We absorb the six-to-nine-hour time difference: your contacts in Germany work German hours and in German, while you receive reports and decision papers in English.

Proven in our mandates

Bowel management systems · Intensive care · 2002–2008 Zassi Bowel Management Systems Germany became the top EU market at twenty times the volume of the next-best market — followed by the trade sale to Hollister, Inc. (2008). Read the case → Ultrasound thrombolysis · Cardiology · 1999 Ekos Corporation A clinical study set up at several German university hospitals, a cardiology KOL network established, and FDA data translated into an EU and German setting. Read the case → Urology · Catheter-associated infections · 2024 NanoVibronix (UroShield) A study set-up at 5 KOL sites running alongside an integrated marketing platform — clinical evidence and digital authority in a single mandate. The reference case for Module 7, Digital Authority. Read the case →

Frequently asked questions

Is our FDA clearance enough to sell in Germany?: No. A 510(k), De Novo or PMA has no legal effect in the EU. You need a CE marking under the MDR (EU 2017/745). Your US files — clinical data, risk management, verification and validation — are nevertheless a valuable basis for the technical documentation.
Do we need our own subsidiary in Germany?: Not legally. The MDR requires manufacturers outside the EU to appoint an EU authorized representative, who can be based in any member state. For hospital listings, however, a German address and German-speaking contacts are a de facto requirement. In our mandates, a German company that we set up and manage for you takes on this role.
Is there anything comparable to US GPOs in Germany?: Yes — hospital purchasing groups (Einkaufsgemeinschaften). They negotiate framework agreements but rarely decide alone: in many hospitals, users, infection control and purchasing review a new product together before it is listed.
How long does it take to reach the first hospital revenue?: That depends mainly on whether the CE marking is already in place. If it is, we start with a pre-sale test at a suitable university hospital. If it is not, the conformity assessment with the notified body sets the timeline. We give you a reliable estimate once we have reviewed your files in a strategy call.

Last reviewed: 15 October 2026

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