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EU Authorized Representative for Algerian Medical Device Manufacturers

In Algeria medical devices are homologated by the Agence Nationale des Produits Pharmaceutiques, a public body under the Ministère de l'Industrie Pharmaceutique. An Algerian manufacturer that holds a décision d'homologation has satisfied Algiers, not Brussels. Regulation (EU) 2017/745 asks for its own conformity assessment, its own declaration and a sole representative established in the Union. This page explains the Algerian scheme, why it stops at the Union border, and how the Article 11 mandate is put in place.

ANPP and the homologation of dispositifs médicaux

The Agence Nationale des Produits Pharmaceutiques (ANPP) describes itself as a public institution under the supervision of the Ministère de l'Industrie Pharmaceutique, in charge of the registration, homologation and quality control of pharmaceutical products and medical devices in Algeria, with vigilance and regulatory watch as further missions. The ANPP lists "Homologation des Dispositifs Médicaux" as one of its three core missions next to the registration of pharmaceutical products and quality control.

The device side runs on its own forms. The ANPP's download page for the medical device homologation unit carries a Formulaire de demande d'homologation, a Récépissé de dépôt des dossiers soumis à l'homologation, and separate forms for renewal, modification and transfer of a homologation, together with a template for the daily declaration of devices (déclaration journalière DM). The vocabulary matters: Algeria homologates a device, it does not certify it. The decision is a national authorisation to place the device on the Algerian market.

Why a homologation has no effect in the Union

The Union does not homologate devices. It requires the manufacturer to carry out the conformity assessment set out in the Regulation and to declare conformity itself:

"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)

An ANPP décision d'homologation is neither an EU declaration of conformity under Article 19 nor a certificate under Article 56. What transfers is the evidence assembled for the Algerian dossier, which can be reorganised into Annex II technical documentation. The device class is also re-derived from Annex VIII; the Algerian classification is not carried over.

The sole representative for a manufacturer in Algiers, Oran or Constantine

"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 representative must be established within the Union, must accept the mandate in writing and is the only representative for a given generic device group. The MDCG guidance on authorized representatives also notes that an importer or a competent authority can check the designation:

"the designation could be verified using the EUDAMED database, or by contacting the manufacturer or the authorised representative directly to confirm that a designation has taken place."

MDCG 2022-16, Section 4

An Algerian manufacturer should expect its first EU distributor to ask for the representative's name before the first order, because the importer must verify under Article 13(2)(b) that a representative has been designated.

Türkiye as the seat of the representative

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

"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 draws the practical conclusion:

"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

An Algerian exporter therefore covers the Member States and Türkiye on one mandate. Sales in Türkiye additionally require registration of the devices in ÜTS (Ürün Takip Sistemi), Türkiye's product tracking system, which Medex carries out as a separate service.

French and Arabic documents, translation and the apostille

Algerian regulatory files are in French or Arabic. French is an official Union language, so a competent authority that determines French can be answered with the original file. For other Member States Medex asks for the EU declaration of conformity and the core technical documents in English, because the representative must answer in the language the authority determines:

"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)

Labels and instructions for use follow Article 10(11), in the language of each Member State where the device is made available. On legalisation, the HCCH status table lists Algeria as a Contracting Party to the Hague Apostille Convention with entry into force on 9 July 2026, and marks the accession as one to which objections have been raised; whether an Algerian apostille is accepted in a particular state should be read from that table. The Regulation does not require the mandate to be apostilled. For ÜTS filings in Türkiye, TİTCK's guide TCKKD-KLVZ-03, Article 8, accepts an apostilled original of a foreign certificate, 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, with a sworn Turkish translation.

Algerian and Union instruments compared

Algeria (ANPP)Union (Regulation (EU) 2017/745)Carries across?
Décision d'homologation of the deviceEU declaration of conformity (Article 19); certificate under Article 56 for IIa and aboveNo
Renewal, modification and transfer of a homologationEU declaration continuously updated; changes handled with the notified body under the certificateDifferent mechanics
Déclaration journalière DMNo equivalent; EUDAMED device registration under Article 29 and UDINo
ANPP under the Ministère de l'Industrie PharmaceutiqueCompetent authority of the Member State where the representative is established (Article 11(7))Structure differs
French or Arabic fileLanguage determined by each Member State's authority; label per Article 10(11)Translation needed outside French-speaking authorities

Mandate, EUDAMED and the limits of the role

"The mandate referred to in paragraph 3 of this Article shall not delegate the manufacturer's obligations laid down in Article 10(1), (2), (3), (4), (6), (7), (9), (10), (11) and (12)."

Regulation (EU) 2017/745, Article 11(4)

Medex drafts the mandate to the tasks of Article 11(3), accepts it in writing, registers as an actor under Article 31 and verifies the manufacturer's own registrations under Articles 27 and 29. A manufacturer without a single registration number starts with the EUDAMED registration service. 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 device is homologated by the ANPP. Does that shorten the EU process?

No. The Union does not recognise foreign homologations. The notified body, or for Class I the manufacturer, assesses conformity against the Regulation. The test reports and risk management records from the ANPP dossier can be reused as evidence; the décision itself cannot.

Can our French technical file be used as it is?

For an authority that determines French, yes. For others, Medex needs the EU declaration of conformity and the core documents in a language that authority determines, usually English. Labels and instructions for use must be in the language of each Member State where the device is sold.

Is an apostille from Algeria needed for the mandate?

Not under the Regulation. The HCCH table records the Apostille Convention in force for Algeria from 9 July 2026, with objections from some Contracting Parties. An apostille or a Turkish consular attestation becomes relevant only for documents uploaded to ÜTS in Türkiye.

Our EU distributor wants to be named as our representative. Is that possible?

A distributor can be designated, but it then takes on the Article 11 duties, including liability under Article 11(5) if the manufacturer has not met Article 10, and it must be the sole representative for the generic device group. Many prefer a representative that is not also a trading partner.

Does the same mandate cover Türkiye?

Yes. MDCG 2022-16 states that the Union market extends to Türkiye via the Customs Union Agreement, and the Commission's Notice to Stakeholders states that a third-country manufacturer needs one representative, in either territory, for both. ÜTS device registration in Türkiye is a separate step.

Sources and further reading

To appoint an EU Authorized Representative for devices made in Algeria, 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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