How to Sell Medical Devices in Europe Without an EU Office

The question arrives in our inbox in the same words every week: do we need a company in Europe to sell there? No. The MDR was written for exactly your situation — a manufacturer established outside the Union, selling in — and it gives you a defined chain of people who act inside the EU while your company stays where it is. What you cannot do is skip a link in that chain.

What you actually need — four things, not a subsidiary

A CE-marked device with its technical documentation in order. A sole authorised representative established in the Union. An importer who brings the devices into EU territory. Live registrations in EUDAMED. That is the entire legal footprint. No office lease, no local staff, no European legal entity of your own.

The authorised representative is the legal anchor

Article 11(1) of the MDR is one sentence and it decides everything: "Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative." The appointment is made by written mandate, accepted in writing, and must exist before the first device is placed on the market — not after the first order, not when a competent authority asks.

The representative verifies that your declaration of conformity and technical documentation exist, holds a copy for the authorities, acts as the contact point in the Union and carries joint and several liability for defective devices under Article 11(5). That liability clause is why a serious representative reads your file before signing — and why one that does not should worry you. Our note on MDR Article 11 covers what transfers and what never can.

The importer is a different role — and often your distributor can hold it

The importer is the first person established in the Union who places your device on the EU market. Under Article 13 the importer checks that the device is CE marked, that the declaration of conformity exists, that you have a representative, and that the device is labelled correctly. The importer's name goes on the device or its accompanying documents. One company can be both importer and distributor; it cannot be your authorised representative for the same devices without wearing two clearly separate hats. The full checklist is in our guide to importer obligations under Article 13.

EUDAMED stopped being optional in May 2026

Since 28 May 2026, under Commission Decision (EU) 2025/2371, the first four EUDAMED modules are mandatory. The order of operations matters, because each record blocks the next: your representative holds a Single Registration Number, you obtain your own SRN as a non-EU manufacturer, the Article 11 mandate is confirmed by both sides inside the system, and only then can your devices be registered with their UDI data. A manufacturer who starts this chain the week a distributor places the first order has started too late. Details in our note on mandatory EUDAMED registration.

Your label changes too

The name and address of your authorised representative appear on the label or, where the regulation permits, in the instructions for use — alongside the EC REP symbol. Plan this before you print packaging, not after: relabelling stock sitting in a customs warehouse is the most avoidable cost in this entire process.

What this costs and how long the chain takes

Representation is a running annual fee, not a one-off — and it scales with device class, not with your revenue. We publish our class-based rates on the pricing page, because a manufacturer budgeting EU entry should not need a sales call to see a number. We do not publish timelines as promises; the regulation sets no fixed processing clock and anyone guaranteeing one is selling something else.

The common failure pattern

It is almost never the technical file. The pattern we see is a manufacturer with a genuinely CE-markable device who signed a distribution agreement first, printed packaging second, and discovered the Article 11 requirement when a customs broker asked for the representative's name. Everything then happens in reverse order, at speed, at premium prices. The chain is four links; start with the legal ones.

Medex acts as EU authorised representative under Article 11 for manufacturers in the United States, Asia and beyond, with EUDAMED actor and UDI registration included in the mandate. Send us your device list and target launch, and we will reply in writing with the exact sequence for your case.

Sources (official)

Regulation (EU) 2017/745, Articles 11, 13, 27, 29 and 31; Annex I, Chapter III

Commission Decision (EU) 2025/2371 of 26 November 2025 — EUDAMED modules mandatory from 28 May 2026

European Commission — EUDAMED actor registration module

Who wrote this

Medex is a medical device manufacturer established in Ankara and a registered authorised representative in EUDAMED under SRN TR-AR-000057550. We file actor, mandate and UDI records for our own devices before we file them for anyone else. We are not a law firm and do not provide legal advice.