01 / EU rep
EU authorised representative
The German client GmbH (Module 1) takes on the role under Art. 11 MDR — with a German letterhead, a German phone number and the vigilance chain that German hospitals expect.
Module 2 of the plug-and-play solution
MDR compliance that German hospitals accept as listing-ready.
In Germany, a CE conformity assessment on its own is not enough. Hospital procurement reviews the entire regulatory pipeline before a listing is granted: registration with the BfArM, the German competent authority for medical devices, publication in EUDAMED, vigilance and post-market surveillance processes that are actually practised, German-language documentation, a designated PRRC and an EU authorised representative reachable in Germany. We build that pipeline inside the client GmbH, so the first listing conversation can be held on solid ground.
- MDR 2017/745
- EU authorised rep
- BfArM
- PRRC
- Vigilance
The problem
The CE mark is the minimum. Listing readiness is more.
Most foreign manufacturers treat MDR as a CE-mark question: once the conformity assessment is in place, the product is considered ready for market. In Germany that is not enough.
- Before a listing, hospital procurement reviews the whole pipeline — not just the CE certificate.
- The most common mistakes: appointing the PRRC too late, missing German translations, unclear ownership of vigilance duties.
- Without a documented pipeline, procurement will read your product as organisationally immature — regardless of its clinical quality.
21 articles MDR obligations that non-EU manufacturers must meet directly or through their EU authorised representative
8–16 weeks Time to first listing with a clean MDR pipeline, from the start of the mandate
100% of Germany’s leading Einkaufsgemeinschaften — the hospital group purchasing organisations — require PSUR and PMS documentation before a listing
BfArM The national point of contact for vigilance and market surveillance — EUDAMED alone is not enough
The solution — Module 2
Five disciplines for a listing-ready MDR pipeline.
We build your MDR pipeline inside the German client GmbH, coordinated with hospital sales and DSW logistics, so that vigilance and listing requirements hold up from the very first conversation.
02 / PRRC
Person Responsible for Regulatory Compliance
MEX provides the PRRC function under Art. 15 MDR — qualified, documented and ready for audit.
03 / Tech doc
Technical documentation
Annexes II and III MDR — clinical evaluation, PMS plan, PSUR. We close the gaps against your home-market documentation, translate it into German and keep it current.
04 / EUDAMED
UDI & EUDAMED registration
UDI assignment, EUDAMED master data and the link to the BfArM for German market surveillance.
05 / Vigilance
Vigilance pipeline with sales
A documented chain from the hospital user through the field team and DSW logistics to the BfArM. Annual drills, joint audits.
Where we differ
Why not a pure regulatory consultancy?
A conventional compliance consultancy produces the dossier and hands it over. What happens with it inside the hospital is not their problem.
| Aspect | Conventional regulatory consultancy | MDR compliance at MEX |
|---|---|---|
| Output | An audit dossier | A listing-ready pipeline |
| Vigilance chain | Proposed externally, implemented by the manufacturer | Field team and DSW logistics built in, annual drills |
| EU authorised representative | An address somewhere in the EU | The German client GmbH — the same structure that runs sales |
| Language for hospitals | English documentation, German hospitals ask again | Bilingual EN/DE, audit-ready |
| After the listing | The mandate ends | Ongoing PSUR, annual audits, vigilance readiness |
Heads this module
Jörg Saborowski
Founder and managing director of MEX. 27 years of experience with the regulatory regime that preceded the MDR and with the MDR itself since 2017. He owns the regulatory layer of every client mandate — from classification through the vigilance pipeline to listing readiness with the German Einkaufsgemeinschaften.
In Germany, MDR is a listing question, not merely a compliance question. Miss that and you optimise for the wrong audit.
Where does your MDR pipeline stand today — and where would it have to stand for a German hospital listing?
Within four to six weeks we deliver a structured MDR gap analysis with a concrete roadmap: what is already in place, what is missing, and in which order to close the gaps to reach listing readiness.
Request an MDR gap analysis Frequently asked questions
What clients usually want to clarify.
- Is an EU authorised representative anywhere in the EU enough, or does it have to sit in Germany?
- In strict legal terms, an EU rep in any member state is sufficient. In practice, German hospital listings require a German address with German-speaking contacts. In MEX mandates we combine both in the German client GmbH.
- Who takes on the PRRC responsibility?
- We offer the PRRC function as part of Module 2. Alternatively you appoint someone internally; we coordinate in either arrangement.
- Can we book Module 2 on its own, without Module 1 (the GmbH)?
- As a rule, no — the EU authorised representative function and the PRRC should in practice sit inside a German structure. Exceptions are a matter for the strategy call.
- What does a complete MDR pipeline cost?
- That depends on the device class, the state of your home-market documentation and the number of products to be transferred into MDR. We give you a first estimate in the discovery call.