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EU Authorized Representative for Jordan: JFDA Registration and the Article 11 Mandate

The Jordan Food and Drug Administration has run a separate Medical Devices and Supplies Directorate since 2012. A Jordanian manufacturer that has registered there knows what a device file looks like. The Union asks for a different one: technical documentation against Regulation (EU) 2017/745, a declaration of conformity, a notified body above class I, and a sole authorized representative established in the Union before the first unit is placed on the market. Jordan is not a party to the Apostille Convention, which changes how its public documents are certified abroad but not how the mandate is made. This page sets out each point.

Jordan separated devices from drugs in 2012; the Union did so with its own rulebook

The Jordan Food and Drug Administration (jfda.jo) states on its site that the Medical Devices and Supplies Directorate was established as a separate directorate in 2012, having been a division of the registration section of the Drug Directorate since 2006. A Jordanian manufacturer therefore deals with a device-specific directorate at home, and that is an advantage when the time comes to build a European file: the habit of treating devices as devices is already there.

What the JFDA registration cannot do is cross into the Union. Regulation (EU) 2017/745 has no reliance route for a Jordanian registration, and a JFDA decision is not evidence of conformity with the general safety and performance requirements in Annex I. The European file is built from the technical documentation in Annex II and III and, above class I, from a notified body certificate.

The one sentence that decides the matter

"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).

Jordan is not a Member State. A device bearing a Jordanian manufacturer's name may not be placed on the Union market until a sole authorized representative has been designated. The representative must be established within the Union and must have accepted the mandate in writing.

"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).

Why Medex, in Türkiye, is inside 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.

The Customs Union Agreement is what allows a representative established in Ankara to hold the Article 11 mandate. The same guidance explains the word "sole":

"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.

One mandate with Medex covers the Union and Türkiye for the generic device group it names. For a Jordanian manufacturer that also sells in Türkiye, the Turkish importer registers the devices in ÜTS (Ürün Takip Sistemi), Türkiye's product tracking system. We do that work for importers as a separate contract; it is not part of the representative fee.

Documents from Amman: no Apostille, so a legalisation chain

Jordan does not appear in the HCCH status table of Contracting Parties to the Apostille Convention. That has a precise consequence: a Jordanian public document cannot be apostilled, and where a foreign authority wants a certified Jordanian document, the route is consular legalisation rather than an Apostille.

DocumentDoes the Union side need it legalised?
Mandate between you and MedexNo. MDR requires written acceptance by the representative (Article 11(2)); it does not require legalisation.
EU declaration of conformityNo. It is drawn up and signed by the manufacturer under Article 19 and kept by us under Article 11(3)(b). Legalisation adds nothing.
Technical documentationNo. It is evidence, not a public document.
Jordanian corporate document used before a Turkish authority (for example in an importer's ÜTS file)Yes, by consular legalisation, because Jordan is not a party to the Apostille Convention. A sworn Turkish translation is added.

Language follows the same logic. JFDA publishes in Arabic with an English version of its site. 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).

The label: an Amman address and an Ankara address

"if the manufacturer has its registered place of business outside the Union, the name of the authorised representative and address of the registered place of business of the authorised representative;"

Regulation (EU) 2017/745, Annex I, Section 23.2(d).

Your label already carries your own name and registered place of business under point (c). For the Union it also carries ours. That is a change to artwork, and it is one of the first things an importer checks under Article 13(2).

"Importers should verify that the authorised representative in accordance with Article 11 has been designated by the manufacturer (Article 13(2)(b) MDR and IVDR)."

MDCG 2022-16, section 4.

EUDAMED: two actors, one mandate record

  • Medex is registered in EUDAMED as an authorized representative with single registration number TR-AR-000057550 (see EUDAMED registration).
  • You register as a manufacturer; the competent authority verifies the data and issues your SRN (Article 31(2)).
  • The mandate is recorded against both actors, and your devices are registered under their Basic UDI-DIs.
  • The data is confirmed one year after submission and every second year thereafter (Article 31(5)); we run that for our record and remind you of yours.

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."

Other files in the region: Saudi Arabia, Egypt and Israel.

Frequently asked questions

We hold a JFDA registration for the device. Does the EU accept it?

No. JFDA registration authorises the Jordanian market. The Union has no reliance route for it. Conformity with Regulation (EU) 2017/745 is shown through technical documentation and, above class I, a notified body certificate.

Jordan is not in the Apostille Convention. Does that block the mandate?

No. The mandate needs written acceptance by the representative, not an Apostille or legalisation. Legalisation becomes relevant only where a Jordanian public document is presented to a national authority, for example in Türkiye, and then the consular route applies.

Can our mandate with Medex cover Türkiye as well?

Yes. MDCG 2022-16 states that the Union market extends to Türkiye via the Customs Union Agreement, so one representative established in Türkiye covers both for the generic device group named in the mandate.

What does the importer in Europe check about the representative?

Under Article 13(2)(b), that a manufacturer is identified and that an authorized representative has been designated. MDCG 2022-16 says the importer may check the name on the declaration of conformity, the certificate and the label, or verify the designation in EUDAMED.

Does Medex register our devices in ÜTS in Türkiye?

ÜTS registration is an obligation of the Turkish importer, and we provide it as a separate service to importers. It is not included in the representative fee, as the pricing page states.

Send us your JFDA registration references and the current label artwork, and we will return the mandate draft, the label changes under Annex I, Section 23.2(d) and the EUDAMED steps. Request a proposal.

Sources and further reading

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