EU Authorized Representative for Tunisia: From Import Control to an MDR Mandate

Tunisia regulates devices at the border, not at the factory

The instrument that governs devices entering Tunisia is the contrôle technique à l’importation (CTI), run for medical and parapharmaceutical products by the Direction de la Pharmacie et du Médicament (DPM) of the Ministry of Health. The DPM's published notice to importers (Avis aux importateurs de produits soumis au Contrôle Technique à l’Importation, published 26 October 2018, version 003 of 22 July 2024) lists its legal basis: Law No. 94-41 of 7 March 1994 on foreign trade, Decree No. 94-1744 of 29 August 1994 on technical control at import and export, and the ministerial orders of 30 August 1994 and 15 September 2005 fixing the lists of controlled products.

The notice describes the mechanism in one line: "Le CTI est un contrôle au lot par lot." [CTI is a lot-by-lot control.] The importer first obtains an Autorisation Provisoire d’Enlèvement (APE) to clear customs, then an Autorisation de Mise à la Consommation (AMC) to sell, once the control laboratory has returned a conforming result. Devices that have been imported several times can be registered with the DPM so that later AMCs are issued faster, and implantable devices have their own registration form. Every one of these procedures is filed by the importing company.

That design matters to a Tunisian manufacturer for a simple reason: the system is organised around products coming in, not products going out. Nothing in it produces a document that a European competent authority, notified body or distributor will treat as evidence of conformity.

The DPM's own words: a device-specific regulation is still awaited

The same DPM notice introduces its device registration procedure with an unusually candid sentence: "En attendant la mise en place d’une règlementation spécifique aux dispositifs médicaux" [pending the introduction of a regulation specific to medical devices]. The registration route it then describes exists, in the notice's words, to strengthen and shorten the CTI procedure for imported devices.

Read that as the starting point for any export project. A Tunisian manufacturer usually cannot point to a national device classification decision, a national technical file review or a national registration certificate for its own product. The MDR file is therefore built from the Regulation itself, beginning with classification.

"Devices shall be divided into classes I, IIa, IIb and III, taking into account the intended purpose of the devices and their inherent risks. Classification shall be carried out in accordance with Annex VIII." (MDR Article 51(1))

Annex VIII has twenty-two rules. Running them honestly, with the intended purpose written down first, decides whether the project is a class I self-declaration or a notified body engagement, and it is the step most often skipped.

The CE certificate Tunisia asks importers for is the one you now have to earn

There is a useful irony in the DPM notice. Its technical dossier for imported medical devices, submitted to the control laboratory, lists among other items a free sale certificate from the country of origin issued by a supervising body and less than five years old, conformity to ISO 11607 for terminally sterilised packaging, sterilisation validation to ISO 11135, ISO 11137 or ISO 17665, biological evaluation under the ISO 10993 series, ISO 22442 where animal tissue is used, and "Certificat de marquage CE valide établi par l’organisme notifié" [a valid CE marking certificate issued by the notified body].

In other words, Tunisian regulators already read European conformity evidence every working day, and Tunisian importers already collect it. A Tunisian manufacturer exporting to the Union is on the other side of that same transaction: the European importer will ask for exactly what the DPM asks for, and more.

The difference is between an attestation and the underlying evidence. The DPM accepts a declaration that a standard has been met. Annex II requires the reports themselves.

"Manufacturers of class I devices, other than custom-made or investigational devices, shall declare the conformity of their products by issuing the EU declaration of conformity referred to in Article 19 after drawing up the technical documentation set out in Annexes II and III." (MDR Article 52(7))

Association Agreement origin, and the French-language file

Tunisia's trade with the Union runs under the Euro-Mediterranean Agreement establishing an association between the European Communities and their Member States and the Republic of Tunisia (OJ L 97, 30.3.1998). Its origin rules are the reason a EUR.1 movement certificate appears in the DPM's own list of import documents. Preferential origin reduces duty. It is not evidence of conformity, and no provision of MDR gives credit for it.

Language is the second practical point. Much Tunisian regulatory and commercial documentation is written in French, which is an official Union language. MDR leaves the choice of language for labels and instructions to each Member State where the device is made available:

"Manufacturers shall ensure that the device is accompanied by the information set out in Section 23 of Annex I in an official Union language(s) determined by the Member State in which the device is made available to the user or patient." (MDR Article 10(11))

The same applies to the EU declaration of conformity, which Article 19(1) requires to be translated into the language or languages required by each Member State of sale. A French-only file is therefore a sound base for some markets and incomplete for others. Plan the language set per target country before artwork is frozen.

Manufacturer, importer, authorised representative: three separate roles

Because the Tunisian system is built around the importer, it is easy to assume a European importer can carry the whole regulatory load. MDR does not work that way. The manufacturer is defined by whose name is on the product:

"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 trade mark" (MDR Article 2(30))

If your Tunisian company is that person and is not established in a Member State, Article 11(1) requires a sole authorised representative. The European importer then has its own, separate duty to check that the representative exists:

"a manufacturer is identified and that an authorised representative in accordance with Article 11 has been designated by the manufacturer" (MDR Article 13(2)(b))

An importer that finds no representative cannot lawfully place the device on the market. This is usually the point at which a Tunisian exporter learns that a European buyer's purchase order depends on a mandate the manufacturer has not yet signed.

Getting the Union side in place from Tunis, Sfax or Sousse

Medex Kurumsal Danışmanlık is established in Türkiye. Under the EU–Türkiye Customs Union, the European Commission's Notice to Stakeholders of March 2022 states that 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." Switzerland, Great Britain and the EEA-EFTA states are outside that arrangement and each requires a locally established representative; Medex does not act for those markets.

The steps on our side are fixed:

1. Written mandate under Article 11(3). It sets out the minimum tasks, including verifying that the declaration of conformity and technical documentation exist and holding copies at the disposal of competent authorities.

2. EUDAMED actor registration. Your company registers as manufacturer and receives its Single Registration Number, linked to our authorised representative SRN TR-AR-000057550.

3. UDI. Basic UDI-DI and UDI-DI data are entered for each device before it is placed on the market.

4. Person responsible for regulatory compliance. Medex has an in-house PRRC, as the Regulation requires of every representative:

"Authorised representatives shall have permanently and continuously at their disposal at least one person responsible for regulatory compliance who possesses the requisite expertise regarding the regulatory requirements for medical devices in the Union." (MDR Article 15(6))

5. Label and IFU address. Annex I, Section 23.2(d) requires our name and registered address on the label of a device whose manufacturer is established outside the Union.

Medex works from Ankara, İstanbul and Gdańsk. We do not write technical documentation, we are not a notified body, and we do not find distributors. Annual fees are published on our pricing page, from €800 for class I to €2,000 for class III, with no setup fee and €150 for a change of representative.

Related country and guidance pages

Manufacturers in neighbouring markets face similar questions; we keep separate pages for Egypt, Türkiye and Saudi Arabia. We also have pages for manufacturers in Morocco. The full list of countries is on the EU authorized representative by country page, and the obligations behind the mandate are set out in our EU authorized representative guide.

Frequently asked questions

Our devices have never been registered by the DPM. Is that a problem for the EU?

No. The DPM procedures described in its notice to importers apply to imported products, and the Union attaches no weight to a Tunisian registration in either direction. What the EU requires is MDR conformity: correct classification under Annex VIII, technical documentation under Annexes II and III, an EU declaration of conformity and, for devices above class I or for class Is, Im and Ir, a notified body certificate.

We already hold ISO 13485 certification. Does that cover the quality system requirement?

It covers much of the ground but not all of it. Article 10(9) lists MDR-specific elements, including regulatory compliance strategy, post-market surveillance, vigilance and UDI, that a standard ISO 13485 system does not always address. For class IIa and above the notified body audits your system against MDR, not only against the standard.

Can our French importer be our authorised representative?

It can accept the mandate if it is established in the Union, but it then becomes jointly and severally liable with you under Article 11(5) where you have not met your Article 10 obligations. It also keeps its separate importer duties under Article 13. Many importers prefer not to combine the two roles, and the combination can make a later change of distributor harder.

Will a Türkiye-based representative be accepted by European buyers and authorities?

The Commission's March 2022 notice on the EU–Türkiye Customs Union states that manufacturers outside the EU and Turkey need only one authorised representative, either in the EU or in Turkey. The representative's name and address appear on your label and in EUDAMED in the usual way. For Switzerland and Great Britain you would need separate local representatives.

Sources

Direction de la Pharmacie et du Médicament — Enregistrement des Dispositifs Médicaux — dpm.tn

Direction de la Pharmacie et du Médicament — Avis aux importateurs de produits soumis au Contrôle Technique à l’Importation (published 26 October 2018, version 003 of 22 July 2024) — dpm.tn

Direction de la Pharmacie et du Médicament — Formulaire de demande d’enregistrement de dispositifs médicaux implantables (Annexe 2) — dpm.tn

Euro-Mediterranean Agreement establishing an association between the European Communities and their Member States and the Republic of Tunisia, OJ L 97, 30.3.1998 — eur-lex.europa.eu

Regulation (EU) 2017/745 on medical devices, consolidated text — eur-lex.europa.eu

European Commission — Notice to Stakeholders: EU-Turkey Customs Union Agreement in the field of medical devices (March 2022) — health.ec.europa.eu

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Related guides

Before you appoint anyone, our EU authorized representative guide explains the role and what a mandate covers, the EU authorized representative cost guide shows what the fee should include, and the buyer's checklist helps you compare providers. The contract itself is covered in our note on the mandate agreement under Article 11(3). When you are ready, you can request a proposal.

Other countries we cover

We act as EU authorized representative for manufacturers in many markets. See the pages for Nigeria, Ghana, Kenya, South Africa, the United States and China, or browse the full list by country and the list by device category.

If your devices still need to be registered in EUDAMED, see our EUDAMED registration proposal.