For a company selling medical goods and instruments, the company-setup cost is the small part. The bigger budget lines are regulatory: the Authorised Representative, the PRRC, MDR conformity and the notified body — plus the market-access spend that stands between approval and revenue. Here's the full stack.
For a medical-device entrant, entry cost has four layers: company setup (a GmbH needs EUR 25,000 share capital plus notary and registration), regulatory (EU Authorised Representative, a PRRC, MDR technical documentation and notified-body conformity assessment for anything above Class I), quality system (ISO 13485, vigilance, EUDAMED registration), and market access (distribution, tenders, reimbursement). The setup line is the cheapest; the regulatory and access lines are where budgets are really won or lost — because being CE-marked is not the same as being bought.
Most first-time budgets over-focus on incorporation and under-fund the regulatory and access work that actually determines whether the product sells.
A German company is quick and cheap relative to what follows. For a maker of medical goods and instruments, the real spend sits in demonstrating conformity and then getting to revenue: the roles the law requires, the notified body's time, an audited quality system, and the distribution and reimbursement work that turns a CE mark into orders. This article walks the full stack, roughly in the order you'll pay for it, with illustrative ranges — treat them as planning anchors, not quotes.
Incorporating is a week's work. Getting a Class IIb device to its first paid order is a program — budget accordingly.
Four visible layers — plus the dashed one most first budgets forget. Ranges are illustrative and depend heavily on device class and portfolio.
Class I self-certified devices skip the notified body; Class IIa/IIb/III do not — which is why device class swings the total more than anything else.
The predictable, one-time part — and the part first budgets get roughly right.
| Item | Illustrative | Notes |
|---|---|---|
| GmbH share capital | EUR 25,000 | Min. capital; at least half paid in at formation. Not a fee — it stays in the company. |
| Notary & registration | ~EUR 800–2,000 | Notarisation and Handelsregister entry. |
| Legal & advisory | ~EUR 2,000–6,000 | Formation support, articles, initial tax registration. |
| Banking & admin | low hundreds | Corporate account, trade-office registration (Gewerbeamt). |
A lighter UG exists with symbolic capital, but for a medical-device company that needs credibility with hospitals, notified bodies and distributors, a proper GmbH is usually the right call — see choosing your entry mode.
This is the layer that separates medical goods from ordinary products — and the one most non-EU companies underestimate.
| Item | Illustrative | Notes |
|---|---|---|
| EU Authorised Representative | EUR ~5k–15k / yr | Mandatory for non-EU manufacturers under MDR/IVDR; carries legal responsibilities, priced accordingly. |
| PRRC | role cost | Person Responsible for Regulatory Compliance — in-house or contracted; a qualified named role. |
| MDR technical documentation | five figures+ | Clinical evaluation, risk file, GSPR conformity — scales with device class and portfolio. |
| Notified body assessment | five–six figures | Required for Class IIa and above; fees plus audit time. Class I self-certifies. |
| EUDAMED / registration | time & setup | Actor, device (UDI) and certificate registration in the EU database. |
Device class is the single biggest cost driver. A Class I instrument can self-certify; a Class IIb or III device carries notified-body fees, clinical evidence and audit time that dwarf the setup line. See MDR vs IVDR for how classification works.
Not a project cost — a recurring one. These run for as long as you sell.
Approval is a cost you pay once. Compliance is a cost you pay every year — plan it as opex, not capex.
A CE mark lets you sell. It doesn't make anyone buy. This is where the return on all the earlier spend is actually earned.
This layer is precisely the gap this consultancy exists to close: authorized isn't paid. Under-budget it and the entire regulatory investment sits idle.
We help medical-goods and instrument companies build a realistic entry budget — the regulatory roles, the notified-body path for your device class, the quality obligations and the market-access spend — so the plan reflects what it actually takes to reach a paid order in Germany.