From Israeli scale-up to a German reference hospital.
Many Israeli MedTech manufacturers have strong technology, often a CE marking already and a clear US strategy. What is missing is a presence in Germany that convinces hospitals — without overloading a small team with a subsidiary of its own.
- Typical starting point
- CE marking in place or in progress, focus on the US
- Mandatory role
- EU authorized representative under Art. 11 MDR — Israel is outside the EU
- Bottleneck
- A German reference hospital and German-speaking sales
- Reference
- NanoVibronix (US/Israel) — hospital studies and German marketing plan
The typical starting point
Israeli MedTech manufacturers usually arrive with a different profile from US corporations. The product is technologically strong and often grew out of clinical practice. The team is small and focused on development, regulatory approval and investors. Sales often target the US first, because that is where the valuation for a funding round or an exit is built.
Europe then runs on the side: a distributor here, a representative there, the odd hospital trial. The result is a CE marking without market penetration.
Why Germany is the right first market in Europe
Germany is Europe’s largest healthcare market, and German university hospitals carry weight in the European clinical community. A reference from a German university hospital counts in conversations in Austria, Switzerland and Central and Eastern Europe — and with investors.
Our Zassi case shows the logic: after the clinical test at Göttingen University Hospital, Germany became the strongest market in Europe. The acquisition by Hollister followed in 2008. For manufacturers planning an exit, a working German market is a building block of value.
What the CE marking does not take care of
With a CE marking, your product may be placed on the market. That does not mean it gets bought. Usually four things are missing:
- A German reference hospital. German heads of department and nursing directors ask where the product is in use in Germany — not in Tel Aviv or Boston.
- German-speaking contacts. Under Section 8 MPDG, user information must be in German anyway. Hospitals expect training, advice and complaint handling in German as well.
- A German company. It takes part in tenders, signs agreements with purchasing groups and handles delivery and invoicing.
- A maintained MDR file. Obligations do not end with the certificate. EUDAMED registration, post-market surveillance, vigilance and the person responsible for regulatory compliance (PRRC) continue.
Israel is outside the EU, so you need an EU authorized representative under Art. 11 MDR. Often that representative sits in another EU country. That is legally sufficient, but for German hospital listings it is frequently too far away.
No office of your own — but a company of your own
For a small team, a German subsidiary is a big risk: management, staff, accounting and a lease before the first order comes in. We solve this differently. For each mandate we set up a separate German company and run it as interim management. It acts in your name, carries your brand and works only for your product.
On our Hospital Sales & Listings page we describe how this works in practice, using an anonymised example: an Israeli manufacturer whose German sales operation is organised exactly this way today. Once the market holds, you take over the company.
Our route for Israeli manufacturers
- Check MDR status. Do you hold MDR certification, or are you still operating under an MDD certificate within a transition period? That determines what hospitals will accept today.
- Win a reference hospital. Through our Board of Experts we identify the university hospital that fits your indication and set up a pre-sale test.
- Set up the company. The German GmbH takes on contracts, delivery and, if required, the authorized representative role.
- Build sales. Hospital account management, listings and user training run in German; reports to you in English.
Proven in our mandates
Frequently asked questions
- We already have a CE marking. What do we need MEX for?
- A CE marking allows you to sell; it does not sell anything. In Germany, users, infection control and purchasing in each hospital decide whether a product is listed. That takes a German reference, German-speaking contacts and a company that handles tenders, delivery and complaints.
- Our EU authorized representative is in another EU country. Is that a problem?
- Not legally. For German hospital listings, however, a German address with German contacts is a de facto requirement. In our mandates, the German company can take on this role; a change of representative must be documented properly and updated in EUDAMED.
- Our MDD certificate is still valid. How urgent is the switch to the MDR?
- Regulation (EU) 2023/607 extended the transition periods to the end of 2027 or 2028 — but only if the manufacturer meets the conditions, such as an application lodged with a notified body and a quality system under the MDR. German hospitals now ask specifically about MDR status. We check whether your files meet the conditions.
- How do we coordinate across different working weeks?
- The working weeks overlap from Monday to Thursday. Your team in Germany works German hours and in German; you receive reports and decision papers in English, aligned with your weekly rhythm.