Do You Need an EU Authorised Representative? A 2-Minute Answer

Most of the confusion around this question comes from people answering a harder question than the one the regulation asks. The MDR does not ask about your revenue, your device class, whether you have a distributor, or whether you have staff in Europe. It asks one thing, and the answer is a yes or a no.

The test, in the regulation's own words

Article 11(1) of Regulation (EU) 2017/745:

"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."

Regulation (EU) 2017/746 says the same thing for in vitro diagnostics, in the same place, in the same words.

So the test is: is the legal manufacturer established in a Member State? If yes, no authorised representative is required. If no, one is required before the first device is placed on the Union market — for every class, from a class I bandage to a class III implant, with no threshold, no grace period and no minimum quantity.

Two definitions do the work.

Article 2(30) defines the manufacturer as "a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark." Note what it does not say: it says nothing about who owns the factory. If you contract out production and sell under your own brand, you are the manufacturer.

Article 2(32) defines the authorised representative as "any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under this Regulation."

Established within the Union. Received and accepted. In writing. Three conditions, and each of them is checked at some point by somebody.

Four cases that catch new manufacturers out

The single-sentence test is easy. These are the situations where manufacturers answer it wrongly.

You have a European subsidiary, but it is not the manufacturer

This is the most common one. A US or Asian company opens a sales office in the Netherlands or Ireland, and concludes that Article 11 no longer applies. It applies unless the subsidiary is the legal manufacturer — meaning the device is designed or made for it, and marketed under its name or trademark, with its name on the label and on the declaration of conformity.

If the label says the parent company and the subsidiary sells, the parent is the manufacturer under Article 2(30) and the parent is not established in a Member State. An authorised representative is still required. The subsidiary can be that representative — a Union-established legal person may hold the mandate — but the mandate has to exist, be accepted in writing, and be registered.

Your distributor says they will "handle the registration"

A distributor is not an authorised representative, and no amount of goodwill makes it one. Article 11(2) requires a written mandate accepted in writing, effective at least for all devices of the same generic device group. Article 11(1) requires a sole representative. An informal arrangement in which a commercial partner registers your devices in their own name is not an appointment; and if that partner puts your device on the market under their own name or trademark, Article 16(1) turns them into the manufacturer, with every manufacturer obligation attached — which is very rarely what either party intended when they signed the distribution agreement.

You only sell to one country

The MDR is a Union regulation. Placing a device on the market in a single Member State is placing it on the Union market. There is no small-market carve-out and no pilot-project exemption. One customer in Portugal triggers the same obligation as a pan-European launch.

You believe you have time because you have not shipped yet

Article 11(1) attaches to placing on the market, and the appointment has to be in place before that moment, not registered afterwards. In practice the appointment also has to precede two things that happen earlier than most manufacturers expect: the representative's name and address must appear on the label or packaging, and the actor registration that produces the manufacturer's and representative's Single Registration Numbers must exist before device registration. Printing packaging before appointing a representative is the most expensive avoidable mistake in this whole sequence, because the fix is a relabelling operation in a customs warehouse.

Who genuinely does not need one

Manufacturers established in a Member State. The plain reading of Article 11(1).

Manufacturers established in an EEA state. The MDR and the IVDR have been incorporated into the EEA Agreement, so Norway, Iceland and Liechtenstein are inside the regime rather than third countries for this purpose.

Manufacturers established in Türkiye. This is a real exception and it is narrow. Under the EU–Türkiye Customs Union, the European Commission's own notice on medical devices states that manufacturers established in Türkiye have no obligation to designate an authorised representative in the EU, and that a third-country manufacturer needs only one authorised representative — either in the EU or in Türkiye. The exception rests on the Customs Union instruments as applied by the Commission and confirmed by TİTCK, not on an amendment to Article 11, whose text still says "Member State".

Anyone not placing devices on the Union market. Manufacturing in Europe purely for export, or supplying devices for a clinical investigation under Article 62 rather than placing them on the market, sit outside Article 11. Devices for clinical investigation do not carry the CE mark and are not "placed on the market" within the meaning of the Regulation.

Health institutions manufacturing for their own use, within the conditions of Article 5(5) — devices manufactured and used only within the institution, not transferred to another legal entity, with the conditions of that paragraph met in full.

Custom-made devices are worth separating out. They are not exempt from Article 11: a non-EU manufacturer of custom-made devices still needs a representative. What differs is the conformity route and the Annex XIII statement, not the representation requirement.

What "established" actually means

It means a registered place of business in the territory, not a mailbox, not a service address, and not a director who happens to live there. The representative is a real legal person that competent authorities can write to in an official Union language, that holds a copy of your technical documentation, and that appears on the label of every device it represents.

It matters because of Article 11(5): where the manufacturer is not established in a Member State and has not complied with its Article 10 obligations, the authorised representative is legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer. That clause is the reason a serious representative reads a technical file before signing a mandate — and the reason one that does not read it should worry you rather than reassure you.

If the answer is yes

The order that works is: confirm your device qualifies and its class, get the technical documentation and declaration of conformity in order, appoint the representative in writing, register both actors in EUDAMED to obtain Single Registration Numbers, register the device, and only then print labelling that carries the representative's name and address. Our note on MDR Article 11 sets out what the representative then owes you, and what to look for when choosing one covers the questions worth asking before you sign.

Medex acts as EU authorised representative for manufacturers outside the Union, with EUDAMED actor and device registration included in the mandate. Our class-based rates are published, because a manufacturer budgeting EU entry should not have to book a call to see a number.

Sources (official)

Regulation (EU) 2017/745, Articles 2(30), 2(32), 5(5), 11, 16 and 62

Regulation (EU) 2017/746, Articles 2, 11 and 16

European Commission — EU–Turkey Customs Union Agreement in the field of medical devices

MDCG 2021-13 — Questions and answers on obligations and related rules for the registration in EUDAMED of actors

Who wrote this

Medex is a medical device manufacturer established in Ankara and a registered authorised representative in EUDAMED under SRN TR-AR-000057550, verifiable in the EUDAMED public actor database. We are not a law firm and do not provide legal advice.