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EU Authorized Representative for Lebanese Medical Device Manufacturers

Lebanon's Ministry of Public Health regulates medical devices through Decision No. 455/1 of 16 April 2013, which set rules for the import of devices, the qualification of suppliers, the registration of implantable devices on a national list and post-market surveillance. A Lebanese manufacturer exporting to the European Union meets a system that registers no suppliers and keeps no national list, but requires conformity assessment under Regulation (EU) 2017/745 and a sole representative established in the Union. This page explains the difference and the mandate that bridges it.

What MoPH Decision 455/1 does

The Ministry of Public Health (MoPH) states that, based on Decision No. 455/1 dated 16 April 2013, rules and procedures have been established for the import of medical devices in Lebanon including the qualification of suppliers, for the registration of medical devices in the MoPH, and for the post-market surveillance of devices placed on the market. In summary, a medical device supplier must declare beforehand to the Ministry; before first commissioning, all implantable medical devices must be registered on the National List of Implantable Medical Devices using a harmonised national coding system; and suppliers and users must keep records for post-market monitoring and traceability. The Ministry publishes the list of registered implantable devices and a page of medical device recalls.

The scheme is built around importers and hospitals: it qualifies suppliers and tracks implants. A Lebanese manufacturer selling at home is a supplier under that scheme. Selling into the Union, the same company is a third-country manufacturer with a different set of duties.

No supplier qualification in the Union, but full conformity assessment

The Union does not qualify suppliers and does not keep a national list of implants as a condition of sale. It requires the manufacturer to assess conformity under the Regulation before placing the device on the market:

"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)

For implantable devices the Union adds its own traceability tools: the UDI system under Article 27, registration in EUDAMED under Article 29 and, for implants, the implant card under Article 18. The Lebanese national coding does not replace any of them. Evidence assembled for the MoPH, such as test reports and the manufacturer's quality records, can be reused in the Annex II technical documentation.

The sole representative rule

"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 and accept the mandate in writing. MDCG 2022-16 adds that the designation is unique for a generic device group:

"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

A Lebanese supplier declaration to the MoPH is not a mandate under Article 11, and a Lebanese company cannot hold the Union role.

Why Medex, in Türkiye, can hold the mandate

Medex acts under EUDAMED SRN TR-AR-000057550 from Ankara and İstanbul, with a further office in Gdańsk. The EU-Türkiye Customs Union extends the Union market for medical devices to Türkiye, as 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 Lebanese manufacturer with Medex as representative covers the Member States and Türkiye on one mandate. Sales in Türkiye additionally require device registration in ÜTS (Ürün Takip Sistemi), Türkiye's product tracking system, which Medex carries out as a separate service.

Arabic, French and English files, and legalisation without an apostille

Lebanese regulatory files are commonly in English or French, sometimes in Arabic. French is an official Union language; English is the working language of most technical files Medex holds. The representative must answer a competent authority in the language that 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)

The EU declaration of conformity must be translated into the language each Member State requires (Article 19(1)), and labels and instructions for use follow Article 10(11). On legalisation, the HCCH status table of the Apostille Convention does not list Lebanon. An apostille cannot be obtained in Lebanon, and documents that must be legalised for use abroad go through the consular route. The Regulation does not require the mandate to be legalised. For ÜTS filings in Türkiye, TİTCK's guide TCKKD-KLVZ-03, Article 8, provides for an attestation by the Turkish embassy or consulate in the manufacturer's country, or in the country of the EU Authorized Representative, as an alternative to an apostille, and accepts a verifiable e-signed original from the issuing notified body, with a sworn Turkish translation.

Lebanese and Union positions compared

Lebanon (MoPH Decision 455/1)Union (Regulation (EU) 2017/745)Carries across?
Supplier declaration to the MoPHEconomic operator registration in EUDAMED (Article 31) for manufacturer, representative and importerNo
National List of Implantable Medical Devices with national codingUDI (Article 27), EUDAMED device registration (Article 29), implant card (Article 18)No
Supplier and hospital records for traceabilityEconomic operators identify to whom and from whom devices were supplied (Article 25)Similar aim, separate duty
Medical device recalls published by the MoPHVigilance and field safety corrective actions under Articles 87 and 88Separate systems
No apostille availableNot required by the Regulation; Turkish consular attestation for ÜTSConsular route

Mandate and EUDAMED

"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)

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 Lebanese manufacturer's 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 implants are on the MoPH National List. Does that help with the EU?

Not as such. The Union has its own traceability tools: UDI, EUDAMED device registration and the implant card under Article 18. The technical evidence behind your Lebanese file can be reused in the Annex II documentation; the listing itself has no status in the Union.

We are registered as a supplier with the MoPH. Is that the same as an EU representative?

No. The supplier declaration is a Lebanese market instrument. The EU representative is defined in Article 2(32) as a person established within the Union acting under a written mandate, and it must be the sole representative for the generic device group.

Lebanon has no apostille. Does that block anything?

Not the mandate, which needs no legalisation under the Regulation. For ÜTS filings in Türkiye, TİTCK accepts a Turkish consular attestation or a verifiable electronic signature from the issuing body in place of an apostille.

Our files are in French. Do they need translating?

For an authority that determines French, no. 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.

Who registers our devices in EUDAMED?

The manufacturer registers its own devices with a Basic UDI-DI; Article 11(4) prevents that duty from being delegated. Medex registers as representative, links the mandate and verifies under Article 11(3)(c) that the manufacturer has registered under Articles 27 and 29.

Sources and further reading

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