For regulated life-sciences products, a local or EU representative isn't optional — it's a legal requirement, and a load-bearing one. We act as, or set up, the representation that lets you enter Germany and the EU compliantly, and keeps you compliant afterwards.
In life sciences, you often cannot legally place a product on the German or EU market without a named local presence carrying real responsibility.
A foreign company frequently assumes “representation” means a sales agent or a mailing address. Under EU medical, pharma and diagnostics rules it means something far heavier: a legally responsible party that interfaces with the authority, holds documentation, and carries safety and vigilance duties on your behalf. Get it wrong and your product can't be placed, or your compliance sits on sand.
Authorization needs a name and an address that the regulator can hold responsible. That name is your representative — choose it deliberately.
It is also the first link in the “authorized isn't paid” chain: the representative gets you legally on the market, after which distribution, tenders and reimbursement decide revenue. See why authorized isn't paid.
Which roles apply depends on your product. Most regulated entrants need more than one — and each is a named, qualified responsibility.
Mandatory for non-EU manufacturers. Registered in the EU, named on the product, and legally accountable to the authorities for your device.
A qualified named person responsible for conformity, technical documentation and vigilance under MDR/IVDR.
Named officers for pharmacovigilance and the safety of a marketed medicine — a standing duty of the authorization holder.
Non-EU companies processing EU personal data often need an EU representative for data-protection purposes — relevant for connected and software products.
Three different things that foreign companies routinely blur. Each carries different responsibility — and only some satisfy the legal requirement.
| Authorised representative | Distributor | Own entity (GmbH) | |
|---|---|---|---|
| Primary purpose | Legal / regulatory accountability | Selling & logistics | Full local operation |
| Satisfies EU-Rep duty? | Yes | No | If EU-based & designated |
| Carries liability to authority | Yes | Limited | Yes |
| Sells your product | No | Yes | Yes |
| Setup cost | Low–medium | Low | Highest |
A distributor moving your product does not discharge your representation obligation. See how the entry modes compare in how to enter Germany.
We cover the full arc — from working out which roles you need to carrying them or standing up your own.
Which representation your product actually needs under MDR/IVDR, pharma law or GDPR — no more, no less.
Act as your EU/authorised representative and named officers, or recruit and vet qualified people into them.
Documentation, vigilance and liaison with the authority — the ongoing duties, not just the initial designation.
We confirm your product's classification and exactly which representative and officer roles the law requires.
In-house, outsourced, or a mix — the representation model that fits your ambition and budget.
Designation, registration (incl. EUDAMED where relevant) and the paperwork that makes it official.
Ongoing vigilance, documentation and authority liaison — so your presence stays compliant as you sell.
A short session maps the required roles for your specific product and lays out the fastest compliant route onto the German and EU market.
This page is a general overview of local and EU representation requirements and is not legal or regulatory advice. Requirements depend on product classification and change over time; confirm the current position for your product with qualified advisers before acting.