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EU Authorized Representative for Kuwait: Which Role Your Company Holds Under MDR

A Kuwaiti company that puts its name on a medical device or an in vitro diagnostic sold in the European Union is the manufacturer under Regulation (EU) 2017/745, whether or not it owns the factory. From that follows Article 11(1): a sole authorized representative established in the Union must be designated before the first unit is placed on the market. This page walks through the roles the Regulation recognises, the identical rule in the IVD regulation, the one-representative-per-generic-device-group principle, the position of Kuwaiti documents abroad (Kuwait is not a party to the Apostille Convention) and the way one mandate with Medex in Türkiye covers the Union and Türkiye.

The question a Kuwaiti company has to answer before anything else

A device company in Kuwait may own a brand, import finished devices, run a factory, or do all three. For the home market it deals with the Ministry of Health. For the Union market the first question is not which authority to approach but which role the company holds, because Regulation (EU) 2017/745 assigns its obligations by role: manufacturer, authorized representative, importer, distributor.

Role under MDRDefinition in Article 2Does a Kuwaiti company fit?
Manufacturer"‘manufacturer’ means 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;" (Article 2(30))Yes, if the device is sold in the Union under the Kuwaiti company's name or trademark, wherever it is made.
Authorized representative"‘authorised representative’ means 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;" (Article 2(32))No. The representative must be established within the Union.
Importer"‘importer’ means any natural or legal person established within the Union that places a device from a third country on the Union market;" (Article 2(33))No. The importer must be established within the Union.

The conclusion is simple. A Kuwaiti company cannot be the representative or the importer of its own devices in Europe. If its name is on the device, it is the manufacturer, and the manufacturer established outside the Union must designate a representative inside it. The roles are compared in authorized representative vs importer vs PRRC.

Article 11(1), for devices and for in vitro diagnostics

"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) 2017/745, Article 11(1).

The in vitro diagnostics regulation carries the same sentence, so a Kuwaiti company that sells test kits as well as devices faces the same condition under both instruments:

"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, Article 11(1).

One representative per generic device group, and where Türkiye fits

"However, for one specific generic device group, the manufacturer should designate only one authorised representative (i.e. a ‘sole’ authorised representative’)."

MDCG 2022-16, section 4.

A Kuwaiti portfolio that mixes, say, surgical consumables and diagnostic kits may therefore be split across mandates by generic device group, or held under one representative for all groups. What it cannot do is have two representatives for the same group. Medex is established in Türkiye, and the guidance confirms that Türkiye is part of the Union market for this purpose:

"The ’Union market’ refers to the territories of the European Union Member States, and due to the European Economic Area (EEA) is extended to Norway, Lichtenstein and Iceland, and via the Customs Union Agreement to Turkey."

MDCG 2022-16, footnote 1.

A single mandate with Medex therefore covers the Union and Türkiye. Where the devices are also sold in Türkiye, the Turkish importer registers them in ÜTS (Ürün Takip Sistemi), Türkiye's product tracking system; that registration is the importer's obligation and a separate contract with us, not part of the representative fee.

Kuwaiti documents: legalisation, not Apostille

Kuwait does not appear in the HCCH status table of Contracting Parties to the Apostille Convention. A Kuwaiti public document is therefore certified for use abroad by consular legalisation. For the Union mandate this is irrelevant: Article 11(2) makes the designation valid when the representative accepts it in writing, with no legalisation step. It becomes relevant only when a Kuwaiti corporate document is presented to a national authority, for example by a Turkish importer in its ÜTS file, and then the consular route and a sworn Turkish translation apply.

Language is the other practical point. The Ministry of Health in Kuwait works in Arabic; the Union file must be answerable in a Union language:

"in response to a request from a competent authority, provide that competent authority with all the information and documentation necessary to demonstrate the conformity of a device, in an official Union language determined by the Member State concerned;"

Regulation (EU) 2017/745, Article 11(3)(d).

What the Union importer will check about you

"a manufacturer is identified and that an authorised representative in accordance with Article 11 has been designated by the manufacturer;"

Regulation (EU) 2017/745, Article 13(2)(b).

Your European importer, the entity that actually places the consignment on the market, is obliged to verify that a representative has been designated before it does so. The verification is usually made against the label, the declaration of conformity and EUDAMED. The label carries our name and registered place of business under Annex I, Section 23.2(d).

Changing representative later

"The detailed arrangements for a change of authorised representative shall be clearly defined in an agreement between the manufacturer, where practicable the outgoing authorised representative, and the incoming authorised representative."

Regulation (EU) 2017/745, Article 12.

If you already have a representative and want to move the mandate, Article 12 requires a three-way agreement covering the dates, the transfer of documents and the handling of complaints after the handover. Our pricing page lists this as "Change of representative: EUR 150. Article 12 handover." and states: "We draft and run that agreement as part of the EUR 150." The procedure is described under how to change EU authorized representative.

Liability and the check before signature

"where the manufacturer is not established in a Member State and has not complied with the obligations laid down in Article 10, the authorised representative shall be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer."

Regulation (EU) 2017/745, Article 11(5).

Because of that paragraph we verify the declaration of conformity, the technical documentation and, above class I, the notified body certificate before we accept any mandate. A Kuwaiti brand owner whose factory holds the certificate in the factory's name should expect that question early, because a certificate in the wrong name is a file that does not close.

Medex is an authorized representative under Article 11 and nothing else in the chain. We are not a notified body: a notified body is, in the words of Article 2(42), "‘notified body’ means a conformity assessment body designated in accordance with this Regulation;" and only such a body can issue the certificate a class IIa, IIb or III device needs. We are not your importer or distributor either; the importer is the Union entity that physically places your consignment on the market, and that role carries its own duties under Article 13.

Fees are listed on our pricing page: "Fees from EUR 800 a year, no setup fee, one mandate." and "Fees are in euros, exclude VAT, and are fixed for three years from signature."

Gulf pages: Qatar, Saudi Arabia and United Arab Emirates.

Frequently asked questions

Our Kuwaiti company imports devices and resells them. Do we need an EU authorized representative?

Only if your name or trademark is on a device placed on the Union market, which makes you the manufacturer under Article 2(30). If the original factory is named on the label and holds the Article 10 obligations, the factory is the manufacturer and designates the representative.

Does the same rule apply to our IVD test kits?

Yes. Article 11(1) of Regulation (EU) 2017/746 is identical in substance: a manufacturer not established in a Member State may place an IVD on the Union market only after designating a sole authorized representative.

Kuwait is not in the Apostille Convention. What changes?

Nothing for the mandate, which is valid on written acceptance under Article 11(2). Where a Kuwaiti public document is used before a national authority, consular legalisation replaces the Apostille.

We already have a representative in another Member State. Can we switch to Medex?

Yes, through the agreement Article 12 requires between you, the outgoing representative where practicable, and Medex. The pricing page lists the handover at EUR 150.

Can Medex also be our importer in Europe?

No. Medex is an authorized representative. The importer is a separate economic operator under Article 2(33) with its own duties under Article 13, and we do not take that role.

Send us the names on your labels, the certificates you hold and the list of devices and IVDs, and we will tell you which entity is the manufacturer and whether one mandate or several will be needed. Request a proposal.

Sources and further reading

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