Can an authorised representative be the importer of the same medical device?

Yes. MDCG 2021-27 Rev.1 states that the same natural or legal person may act as both authorised representative and importer for an individual device, and nothing in Regulation (EU) 2017/745 expressly prohibits it. The condition attached in that guidance is that the entity fulfils the obligations of each economic operator under Article 11 and Article 13 separately and can demonstrate compliance with both.

Does the MDR require the authorised representative to be independent of the importer?

No independence test appears in the Regulation. MDCG 2022-16 goes further and accepts that a mandate should be drawn up whether or not the authorised representative sits inside the same larger organisation as the manufacturer. Independence is therefore a practical and commercial question, not a legal condition — but Article 13(2) verification duties still have to be performed and evidenced, even when the verifier and the verified are the same company.

Do I need two SRNs if my authorised representative is also my importer?

Yes. EUDAMED issues one Actor ID or SRN per actor role, and the Commission's guidance states that an economic operator with multiple roles must submit separate registration requests to obtain a different SRN for each role. Annex VI Part A Section 1.1 requires the type of economic operator to be declared at registration, so the authorised representative and importer registrations are two distinct records approved by the competent authority.

Can the same company be the importer and the distributor of a device?

No, not for the same individual device. The Article 2(34) definition describes a distributor as a person in the supply chain other than the manufacturer or the importer, so the two roles are mutually exclusive by definition. MDCG 2021-27 Rev.1 confirms that one person cannot fulfil the role of importer and distributor for an individual device, in contrast to the authorised representative and importer combination.

Whose name goes on the label if one entity holds both roles?

Both entries appear. Annex I Section 23.2(d) requires the name and registered place of business of the authorised representative when the manufacturer is established outside the Union, while Article 13(3) requires the importer's name, registered place of business and contact address on the device, its packaging or an accompanying document. The same address is shown twice, under two different identifications, because the entries serve different purposes.

Is my EU customer automatically the importer?

If that customer is the first person to place the device from a third country on the Union market, then yes — Article 2(33) defines the importer by that act, not by any contract. A buyer cannot decline the role by agreement, and it must register in EUDAMED, add its details to the device entry and meet all Article 13 obligations, including the pre-market verification checks.

What are the practical risks of combining the authorised representative and importer roles?

Three recur in inspections. The Article 13(2) verification becomes self-verification and needs documented internal evidence. The notifications that Article 13(2), 13(7) and 13(8) direct to the manufacturer's authorised representative are sent to yourself and must still be recorded. And the Article 11(3)(h) duty to terminate the mandate for manufacturer default sits directly against the entity's own trading interest.

Can an Authorised Representative Be the Importer Under the MDR?

7 days ago

7 min read

Yes — one legal entity can hold both roles. The Medical Device Coordination Group has answered the point head-on, and Regulation (EU) 2017/745 contains no provision forbidding a company designated as an EU authorised representative from also acting as importer for the same device. So when a non-EU manufacturer asks can an authorised representative be the importer of its devices, the accurate answer is that the MDR does not expressly prohibit the combination, but it does not merge the two sets of duties either. Each role keeps its own definition, its own article, its own label entry and its own EUDAMED registration.

The two definitions the whole question turns on

Article 2 of the MDR 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" (MDR Art. 2(32)). The importer is "any natural or legal person established within the Union that places a device from a third country on the Union market" (MDR Art. 2(33)).

Put them side by side and the overlap becomes obvious. The first definition describes a contractual relationship — a written mandate accepted in advance. The second describes a commercial act: being the person who first places a third-country device on the Union market. Neither excludes the other. Contrast the distributor, defined as "any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service" (MDR Art. 2(34)). That wording carves the importer out expressly, which is why importer and distributor cannot be the same person for one device, while authorised representative and importer can.

Can an authorised representative be the importer? What the MDCG guidance says

MDCG 2021-27 Rev.1, the endorsed question-and-answer document on Articles 13 and 14, added the point in December 2023 in exactly these words: "Can the same natural or legal person assume the role of authorised representative as well as importer for one individual device under the MDR/IVDR?" The answer given is "It is possible for the same natural or legal person to act as both authorised representative and importer for a specific device (i.e., an individual device). The natural or legal person acting as both roles would need to fulfil the obligations of each economic operator outlined in Article 11 and Article 13 of the Regulations respectively and be able to demonstrate compliance to the applicable requirements."

Two qualifications matter. MDCG documents state on their face that they are not legally binding and that only the Court of Justice of the European Union can give binding interpretations of Union law, so this is endorsed practice rather than statutory permission. And the permission is conditional on fulfilling each set of obligations and being able to demonstrate it. Note too that the answer is framed per individual device, so a manufacturer with a broad portfolio should run the assessment device by device rather than treat it as a blanket arrangement. The next question shows the boundary is real: one person "cannot fulfil the role of importer and distributor for an individual device".

The two roles compared

Aspect	Authorised representative	Importer
Legal basis	MDR Art. 2(32), Art. 11, Art. 12; Art. 15(6) for the PRRC	MDR Art. 2(33), Art. 13; Art. 16 if the device is relabelled or repackaged
Who can hold it	Established in the Union, holding an accepted written mandate; sole per generic device group	Whoever in fact places the third-country device on the Union market — assigned by conduct, not appointment
Label consequence	Name and registered place of business are a mandatory label particular under Annex I Section 23.2(d)	Details on the device, its packaging or an accompanying document under Art. 13(3), not obscuring the manufacturer's information
EUDAMED registration	Separate actor registration; own SRN in CC-AR-… form	Separate actor registration; own SRN in CC-IM-… form; details added to the device entry
Key obligation	Perform the Art. 11(3) mandate tasks, hold the technical documentation and terminate the mandate if the manufacturer defaults	Verify conformity before placing on the market and cooperate on corrective action afterwards

What changes on the label if one entity holds both roles

The label consequences are cumulative, not alternative. Annex I Section 23.2(d) requires "if the manufacturer has its registered place of business outside the Union, the name of the authorised representative and address of the registered place of business of the authorised representative". Separately, "Importers shall indicate on the device or on its packaging or in a document accompanying the device their name, registered trade name or registered trade mark, their registered place of business and the address at which they can be contacted, so that their location can be established." (MDR Art. 13(3)).

If the same company holds both roles, its name and address appear twice on the same artwork — once carrying the authorised representative identification, once carrying the importer identification — because the two entries answer different regulatory questions. Artwork that shows the address once under a combined caption is routinely rejected. Both entries, including the symbols that may replace the words, are covered in our guide to medical device labelling requirements.

Two actor registrations and two SRNs in EUDAMED

Can an authorised representative be the importer on one EUDAMED registration? No. Article 31(1) is explicit that, before placing a device on the market, "manufacturers, authorised representatives and importers shall, in order to register, submit to the electronic system referred to in Article 30 the information referred to in Section 1 of Part A of Annex VI". The very first data element in that Section is the "type of economic operator", and Article 31(2) requires the competent authority to "issue it to the manufacturer, the authorised representative or the importer" — a single registration number tied to a declared role.

The Commission's own EUDAMED material puts the consequence plainly: "If the economic operator has multiple roles, separated registration requests are required in order to obtain a different and specific Actor ID/SRN for each actor role." One legal entity wearing both hats therefore holds two approved actor registrations and two SRNs, one prefixed AR and one prefixed IM. Article 13(4) then requires the importer to verify that the device itself is registered under Article 29 and to add its details to that registration, and Article 30(3) repeats the point: "Importers shall add their details to the relevant entry/entries." How the actor registration request is built and validated is set out in our article on EUDAMED actor registration and the SRN.

Conflict of interest and practical independence

Can an authorised representative be the importer and still perform the Article 13 checks credibly? That is what inspectors actually probe. The MDR imposes no independence test between the two roles, and MDCG 2022-16 accepts that a mandate "should be drawn up irrespective of whether the authorised representative is independent/outside of, or is part of the same larger organization as the manufacturer." But the obligations were drafted on the assumption of separate persons, and combining them produces several self-referential loops that an inspector will test.

An importer must verify before placing a device on the market that "a manufacturer is identified and that an authorised representative in accordance with Article 11 has been designated by the manufacturer" — if you are that authorised representative, you are verifying your own designation. Where a device is suspect, the importer "shall inform the manufacturer and the manufacturer's authorised representative", and Articles 13(7) and 13(8) route non-conformity findings and incident complaints to the manufacturer and its authorised representative as well. A single entity satisfies those notifications by writing to itself, so the evidence has to be a documented internal record rather than an outgoing email.

The sharper tension sits in Article 11(3)(h), which obliges the authorised representative to "terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation". Termination ends the mandate fee and, for a combined operator, usually the import business with that manufacturer as well. Recital 35 shows the Regulation expected two different parties to share exposure, stating that "the authorised representative should be jointly and severally liable with the importer and the manufacturer"; concentrating both roles in one balance sheet concentrates that liability too. Note also that only the authorised representative side carries a compliance-person requirement: "Authorised representatives shall have permanently and continuously at their disposal at least one person responsible for regulatory compliance" (MDR Art. 15(6)). The full mandate task list is covered in our explainer on MDR Article 11 authorised representative duties, and the Article 13 checklist in the guide to medical device importer obligations.

The usual alternative: authorised representative in one country, importer downstream

Most non-EU manufacturers never need the combination, because the importer role is assigned by conduct rather than by contract. Whoever first buys the device from the third-country manufacturer and places it on the Union market is the importer by operation of the Article 2(33) definition, whether or not any agreement says so. In the standard arrangement the manufacturer appoints an independent authorised representative in one Member State, and the customer that first receives the goods in the Union — typically its own EU distributor or hospital-supply partner — is the importer and registers as such.

That split keeps the Article 13 verification genuinely external, puts two names and two addresses on the label, and avoids a service provider whose mandate-termination duty collides with its own trading interest. It also matters where devices reach several Member States through different first buyers: each is a separate importer with its own registration, while the manufacturer still designates one sole authorised representative per generic device group, because under Article 11(1) "the device may only be placed on the Union market if the manufacturer designates a sole authorised representative". So can an authorised representative be the importer usefully? Mainly where a manufacturer has no EU trading partner at all and needs one entity both to take title to the goods and to hold the mandate — and then both registrations, both label entries and both evidence trails must exist from day one.

Where Medex fits

Medex Kurumsal Danışmanlık acts as an EU authorised representative under EUDAMED SRN TR-AR-000057550, and holds separate actor registrations as importer (TR-IM-000056252) and manufacturer (TR-MF-000057496) — three roles, three SRNs, exactly as the one-role-one-SRN rule requires. We do not carry out notified-body conformity assessment, we do not write clients' technical documentation and we do not source local distributors; if you want the mandate and registration side handled, our EU authorised representative service sets out what is included.