How does a non-EU manufacturer register in EUDAMED?

If you manufacture outside the EU, you cannot register yourself in EUDAMED directly. The path runs through an authorised representative established in the Union, and the steps happen in a fixed order: appoint the AR, the AR registers and gets its own SRN, then you register as a manufacturer, and only then can you register devices. Skip a step and the next one has nothing to attach to. Here is the sequence, and where teams actually get stuck.

This is the majority case, not the exception

It is worth setting the scale first, because the framing is usually backwards. In MD Atlas's indexed subset of EUDAMED — not the complete database — 16,438 registered manufacturers are established outside the EU, EEA and Switzerland, against 15,311 inside. More than half of the registered manufacturer population is a third-country manufacturer needing a representative.

The origins are concentrated: China (7,302), the United States (2,483), Türkiye (1,081), the United Kingdom (1,048) and South Korea (980) lead the list. You can browse the registered manufacturers yourself and filter by country.

Set against that: only 2,921 authorised representatives are registered, most of them in Germany (765), the Netherlands (387), France (265), Italy (265) and Ireland (222). That ratio — roughly six third-country manufacturers per registered AR — is why AR capacity, and AR quality, is a real procurement problem rather than a formality.

One nuance the figures above understate: Switzerland has been a third country under the MDR since the mutual-recognition agreement lapsed, so Swiss manufacturers also need an EU-established representative. Counting Switzerland on the "inside" side of the bar makes the non-EU figure conservative, not inflated.

Step 1 — Appoint an authorised representative

Under Article 11 of the MDR (Regulation (EU) 2017/745), a manufacturer without a place of business in the Union may place a device on the EU market only if it designates a single authorised representative. Two formal requirements are easy to get wrong:

• The designation is a written mandate, and it is only valid once the AR has accepted it in writing. A signed letter from your side is not a mandate.
• The mandate must cover all devices of the same generic device group. You cannot split one device group across two representatives.

The mandate is not a mailbox arrangement. Article 11(3) gives the AR real verification duties — confirming the EU declaration of conformity and technical documentation have been drawn up and the conformity assessment carried out, keeping a copy available for authorities, and cooperating with competent authorities on preventive or corrective action. And Article 11(5) makes the AR jointly and severally liable with the manufacturer for defective devices, in respect of the obligations under its mandate.

The practical consequence: a competent AR will refuse a mandate whose technical file it cannot see. That refusal is a good sign, not an obstacle.

Step 2 — The AR registers first

Before you can be registered, your representative must be. Under Article 31, economic operators submit their registration data to the electronic system set up under Article 30, and EUDAMED assigns each an SRN. The AR's registration is verified by the competent authority of the Member State where it is established.

This is the ordering that trips people: the manufacturer's registration references the AR, so the AR record must exist first. If you have appointed a representative that is not yet registered, your own registration cannot proceed — you are waiting on them, not on the system.

Step 3 — Register as a manufacturer

Now you register as an actor. The information required is set out in Annex VI, Part A, and it is more than a name and address: it includes the type of economic operator, contact details, the name and details of the person responsible for regulatory compliance, and your representative's information.

The validation step is where third-country registration differs from an EU manufacturer's. Your authorised representative validates your actor data — which is exactly why they need visibility of your file — and it is the competent authority of the AR's Member State that sits in the chain for the AR's own registration. The Commission's guidance on actor registration in EUDAMED (MDCG 2021-13) is the operational reference here and is worth reading before you start rather than after your first rejection.

Once verified, EUDAMED generates your SRN and you become findable — searchable by anyone, without a login. Your registration is public.

Step 4 — Register the devices

Only now can devices go in. Under Article 29, the manufacturer assigns a Basic UDI-DI and enters it with the device data before placing the device on the market. The device record hangs off your SRN, which is why the actor steps have to complete first. You can see the result across the indexed device corpus — every device there traces back to a registered manufacturer.

Where teams actually get stuck

Four recurring failures, none of them technical:

1. Appointing an AR that will not do the verification work. The cheapest mandate is usually the one that leaves you exposed, because the AR's liability under Article 11(5) means a serious AR must look at your file — and one that does not look is one that has not understood its own risk.
2. Registering the device before the actor chain is complete. There is no shortcut; the device record needs an SRN to attach to.
3. Treating the mandate as static. If you change representative, the change has to flow through EUDAMED and through your labelling — the AR's name and address appear on the label and in the IFU.
4. Assuming an importer or distributor covers the requirement. It does not. An importer has its own separate registration obligation, and a distributor does not register as an economic operator at all. Neither can stand in for an authorised representative.

A note on the figures

As always, these counts come from MD Atlas's indexed subset of EUDAMED as of July 2026, not the complete database, and they count registered actors — a third-country manufacturer that has not registered at all does not appear in either bar. Given that registration only became mandatory on 28 May 2026, the non-EU share should be expected to grow, not shrink, as the long tail catches up.