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EU Authorized Representative for Peruvian Medical Device Manufacturers

In Peru the Dirección General de Medicamentos, Insumos y Drogas, a line body of the Ministerio de Salud, issues the registro sanitario that a dispositivo médico needs before it is sold. A Peruvian manufacturer with that registration has satisfied Lima, not Brussels. Regulation (EU) 2017/745 asks for its own declaration of conformity, its own registration database and a sole representative established in the Union. This page explains how the two systems differ and how Medex fills the Union role.

DIGEMID and the registro sanitario

The Dirección General de Medicamentos, Insumos y Drogas (DIGEMID) describes itself as a line body of the Ministerio de Salud created by Decreto Legislativo N° 584 of 18 April 1990. Its remit covers pharmaceutical products, dispositivos médicos and sanitary products, and its portal carries a dedicated registro sanitario search for dispositivos médicos alongside the registers for medicines. A Peruvian manufacturer therefore holds a product-level registration issued by a ministry directorate, with a registration number that appears on the product.

That structure, one national authority issuing one registration per product, is the structure most of Latin America shares. The Union does not have it. There is no EU product registration decision, and no Union authority issues a number that a manufacturer prints on the box.

What replaces the registro sanitario in the Union

Conformity in the Union is declared by the manufacturer after it has carried out the assessment the Regulation prescribes:

"Prior to placing a device on the market, manufacturers shall undertake an assessment of the conformity of that device, in accordance with the applicable conformity assessment procedures set out in Annexes IX to XI."

Regulation (EU) 2017/745, Article 52(1)

The output is the EU declaration of conformity under Article 19, backed by Annex II technical documentation and, for Class IIa and above, a certificate issued by a notified body under Article 56. The device is then registered in EUDAMED with a Basic UDI-DI under Articles 27 and 29. None of these steps references a Peruvian registration, and none can be replaced by one. The DIGEMID file is useful as a source of test reports and risk management evidence, nothing more.

The representative requirement and the three EU roles

"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 Regulation divides the Union side into three economic operators that Peruvian practice tends to merge. The manufacturer is the person that markets the device under its own name. The representative is defined in Article 2(32) as a person established within the Union acting under a written mandate. The importer is:

"‘importer’ means any natural or legal person established within the Union that places a device from a third country on the Union market;"

Regulation (EU) 2017/745, Article 2(33)

A Peruvian manufacturer therefore needs an importer in the Member State where the goods arrive and a representative somewhere in the Union; the two can be the same company, but they are different roles with different duties, and Medex holds only the representative role. The comparison of representative, importer and PRRC sets out the three.

The Customs Union and the one-mandate rule

Medex is established in Türkiye and acts under EUDAMED SRN TR-AR-000057550. The Union market for medical devices extends to Türkiye through the EU-Türkiye Customs Union, which MDCG 2022-16 records:

"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

The European Commission's Notice to Stakeholders of March 2022 concludes:

"manufacturers established outside the territory of the EU or Turkey only need to designate one authorised representative, either in the EU or in Turkey, in order to place medical devices on the market in the EU or in Turkey."

European Commission, Notice to Stakeholders: EU-Türkiye Customs Union Agreement in the field of medical devices (March 2022), Section I.2

A Peruvian manufacturer thus covers the Member States and Türkiye with one mandate. If it also sells in Türkiye, device registration in ÜTS (Ürün Takip Sistemi), Türkiye's product tracking system, follows as a separate service.

Spanish files, translation and the apostille from Lima

Peruvian technical files are in Spanish, an official Union language, so an authority that determines Spanish can be answered in the original. Medex asks Peruvian clients for the EU declaration of conformity and the main technical documents in English as well, so that a request from another Member State can be answered in the language that authority determines under Article 11(3)(d). The EU declaration must in any event be translated into the language each Member State requires:

"The EU declaration of conformity shall, as a minimum, contain the information set out in Annex IV and shall be translated into an official Union language or languages required by the Member State(s) in which the device is made available."

Regulation (EU) 2017/745, Article 19(1)

Peru is a Contracting Party to the Hague Apostille Convention; the HCCH status table records entry into force on 30 September 2010. The Regulation does not ask for an apostille on the mandate. For ÜTS registration in Türkiye, TİTCK's guide TCKKD-KLVZ-03, Article 8, requires an apostilled original of foreign certificates, with the apostille from the manufacturer's country or from the country of the EU Authorized Representative, or a Turkish consular attestation, or a verifiable e-signed original, together with a sworn Turkish translation.

Peruvian and Union instruments side by side

PeruUnionCarries across?
Registro sanitario issued by DIGEMIDEU declaration of conformity drawn up by the manufacturer (Article 19)No
Registration number on the productCE marking, UDI carrier and Basic UDI-DI in EUDAMED (Articles 20, 27, 29)No
Single national authorityCompetent authority of the Member State where the representative is established (Article 11(7)) plus the authority of each marketStructure differs
Local titular of the registrationManufacturer, representative and importer as separate actors (Articles 10, 11, 13)Roles are split
Spanish documentsTechnical file in a language the authority determines; label and IFU per Member State (Article 10(11))Translation needed outside Spain

Mandate and EUDAMED

Medex drafts the mandate to the tasks in Article 11(3), accepts it in writing and records it in EUDAMED. Each actor registers under Article 31 and obtains a single registration number. Medex verifies that the Peruvian manufacturer has registered itself and its devices under Articles 27 and 29 before devices are placed on the market, and keeps the technical documentation and EU declaration of conformity at the disposal of competent authorities for the period in Article 10(8). Medex is not a notified body and does not issue certificates or carry out conformity assessment. Medex is not an importer or a distributor and does not buy, hold or sell devices. The representative, importer and PRRC roles are separate under the Regulation and stay separate in practice. Fees are published on the pricing page: between EUR 800 and EUR 2,000 per year depending on the MDR or IVDR class, with no setup fee, and fixed for three years from signature.

Frequently asked questions

Our product carries a DIGEMID registro sanitario number. Can we print that on the EU label?

It may remain as part of the manufacturer's own information, but it has no meaning in the Union. The EU label must carry the particulars in Annex I, Section 23.2, including the manufacturer's name and address, the representative's name and address under 23.2(d), the CE marking and the UDI carrier.

Is a Peruvian registration useful at all for the EU process?

As evidence, yes. Test reports, biocompatibility data, sterilisation validation and clinical data assembled for DIGEMID can be reused in the Annex II technical documentation. The registration decision itself is not recognised.

Does Medex register the devices in EUDAMED for us?

The manufacturer registers its own devices; Article 11(4) prevents the mandate from delegating that duty. Medex registers itself as representative, links the mandate and verifies under Article 11(3)(c) that the manufacturer has registered. Medex can guide the manufacturer through the entries.

What language must the mandate be in?

The Regulation sets no language for the mandate itself. Medex drafts it in English, and a Spanish version can be attached for the manufacturer's records. Authority requests are answered in the language the authority determines under Article 11(3)(d).

Do we need an apostille for the Union?

Not for the mandate or the EU declaration. For ÜTS filings in Türkiye, TİTCK requires apostilled or consular-attested originals; Peru has issued apostilles under the Hague Convention since 30 September 2010.

Sources and further reading

To appoint an EU Authorized Representative for devices made in Peru, send your device list and current documents through the proposal form. Medex replies with the mandate scope, the EUDAMED steps and the published fee band for your device class.

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