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EU Authorized Representative for Uruguay: MSP Habilitación and the MDR Mandate

Uruguay authorises manufacturers of diagnostic reagents, medical equipment and therapeutic devices through a habilitación issued by the Ministry of Public Health: plant plans, procedures, a technical director, a product list with risk classes. It is an establishment authorisation. Regulation (EU) 2017/745 assesses the device as well as the establishment, and recognises no Uruguayan act as proof of conformity. This page maps the MSP file onto the MDR requirements, quotes the Article 11(1) obligation to designate a sole authorized representative, and explains why one mandate with Medex in Türkiye covers the Union market and Türkiye together.

Habilitación in Montevideo: an establishment authorisation, not a device certificate

In Uruguay a company that manufactures diagnostic reagents, medical equipment or therapeutic devices must obtain an authorisation, the habilitación, from the Ministry of Public Health (gub.uy/ministerio-salud-publica), handled by the Dirección General de la Salud. The ministry's procedure page describes the file: a request signed by the legal representative and the technical director, notarial certificates on the company, plans of the plant, a description of processes, the technical director's qualification, written procedures from receipt of raw materials to recall and distribution, and a list of products with their risk classes.

Read that list again and it is recognisable: it is an establishment and quality-system file. The Union has an equivalent requirement, the quality management system in Article 10(9), but it does not stop there. Regulation (EU) 2017/745 assesses the device as well as the plant. The habilitación says that a Uruguayan plant is authorized to make products of listed classes; it says nothing a European authority can use about any one product's conformity with Annex I.

What the MSP file coversThe nearest MDR elementWhat MDR adds
Plant plans, process description, written proceduresQuality management system, Article 10(9)Audit of that system by a notified body above class I (Annex IX, Chapter I)
Technical directorPerson responsible for regulatory compliance, Article 15Defined qualification and the tasks in Article 15(3)
List of products and risk classesClassification under Annex VIIITwenty-two rules applied per device; the class fixes the conformity assessment route
Procedures for returned, non-conforming and recalled productsPost-market surveillance and vigilance, Articles 83 to 92Reporting to competent authorities through EUDAMED, periodic safety update reports from class IIa
Nothing on a specific device's safety and performanceTechnical documentation, Annex II and IIIThe whole file: Annex I checklist, risk management, clinical evaluation, labelling

Why a Uruguayan manufacturer designates a representative

"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 condition is simply not being established in a Member State. A Uruguayan company that places a device on the Union market under its own name must have designated its representative first. The designation becomes effective on written acceptance:

"The designation shall constitute the authorised representative's mandate, it shall be valid only when accepted in writing by the authorised representative and shall be effective at least for all devices of the same generic device group."

Regulation (EU) 2017/745, Article 11(2).

Türkiye inside the Union market

"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.

Medex is established in Ankara. One mandate with Medex covers the Union and Türkiye for the generic device group it names. Where the devices are also sold in Türkiye, the Turkish importer registers them in ÜTS (Ürün Takip Sistemi), Türkiye's product tracking system; we provide that to importers as a separate contract under Türkiye market access.

Language and public documents

Spanish is an official Union language, so a Spanish file can satisfy Article 11(3)(d) where the Member State concerned determines Spanish. For every other Member State we need English, and we hold the declaration of conformity, the labelling and the core of the technical documentation in English from the outset.

Uruguay is a Contracting Party to the Apostille Convention: the HCCH status table records accession on 9-II-2012 and entry into force on 14-X-2012. The mandate does not need an Apostille, because Article 11(2) requires written acceptance and nothing more. An Apostille from Uruguay is used when a Uruguayan corporate or signatory document is presented to a national authority, for example in Türkiye, with a sworn Turkish translation.

What we hold, and for how long

"keep available a copy of the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, issued in accordance with Article 56, at the disposal of competent authorities for the period referred to in Article 10(8);"

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

"Manufacturers shall keep the technical documentation, the EU declaration of conformity and, if applicable, a copy of any relevant certificate, including any amendments and supplements, issued in accordance with Article 56, available for the competent authorities for a period of at least 10 years after the last device covered by the EU declaration of conformity has been placed on the market."

Regulation (EU) 2017/745, Article 10(8), first sentence.

The pricing page states that the rate signed is fixed for three years; the obligation to hold the file runs for as long as the Regulation says.

Liability

"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).

We verify before we sign. For class I that means reading the declaration of conformity and the technical documentation. For class IIa and above it includes the notified body certificate in the manufacturer's name, not in a distributor's. The three Union roles are compared in authorized representative, importer and PRRC.

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."

Nearby files: Argentina, Brazil and Colombia.

Frequently asked questions

We hold an MSP habilitación as a manufacturer of medical products. Is that recognised in the Union?

No. The habilitación is an authorisation of the Uruguayan establishment by the Ministry of Public Health. The Union assesses the device and the manufacturer's quality management system under Regulation (EU) 2017/745, with a notified body above class I.

Our product list for the MSP gives a risk class for each product. Is that the MDR class?

Not necessarily. The MDR class is determined by the rules in Annex VIII. Each product should be classified again under those rules before the conformity assessment route is chosen.

Does the mandate need an Apostille?

No. Under Article 11(2) the mandate is valid when accepted in writing by the representative. Uruguay is a Contracting Party to the Apostille Convention, so an Apostille is available where a Uruguayan public document is needed before a national authority, for example in Türkiye.

Can one representative cover the European Union and Türkiye?

Yes. MDCG 2022-16 states that the Union market extends to Türkiye via the Customs Union Agreement. One mandate with a representative established in Türkiye covers both for the generic device group it names.

What happens if our documentation is incomplete when a competent authority asks?

Under Article 11(5), where a manufacturer outside the Union has not met Article 10, the representative is legally liable for defective devices jointly and severally with the manufacturer. That is why we verify the declaration of conformity and the technical documentation before accepting a mandate.

Send us the product list you filed with the MSP, with its risk classes, and we will return the MDR class per product and the mandate draft. Request a proposal.

Sources and further reading

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