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EU Authorized Representative for Albanian Medical Device Manufacturers

Albania is not a Member State of the European Union. Its National Agency for Medicines and Medical Devices registers devices under Law No. 89/2014 "On Medical Devices" and three technical rules on essential requirements, conformity assessment and CE marking that track the former Union Directives. An applicant in Tirana files a copy of the declaration of conformity or CE certificate; a manufacturer in Albania that wants the Union market must first create those documents under Regulation (EU) 2017/745 and then designate a sole representative established in the Union. This page sets out both sides.

AKBPM and Law No. 89/2014

The Agjencia Kombëtare e Barnave dhe Pajisjeve Mjekësore (AKBPM) has a Medical Devices Sector that carries out the administrative and technical evaluation of documentation submitted by applicants for the registration of medical devices in Albania, compiles the national register of medical devices and inspects devices placed on the Albanian market, within the scope of Law No. 89/2014 "Për Pajisjet Mjekësore" and its by-laws. The sector's page lists the instruments it applies: Decision No. 508 of 10 June 2015 approving the technical rule on essential requirements, conformity assessment and CE marking of active implantable medical devices; Decision No. 731 of 2 September 2015 approving the technical rule on essential requirements, conformity assessment, classification and CE marking of medical devices; and Decision No. 189 of 9 March 2016 on in vitro diagnostic medical devices.

Two details of the Albanian procedure matter for an exporter. The applicant for registration is the wholesale trader of medical devices in Albania, which must hold a wholesale trading authorisation. And the file includes a photocopy of the declaration of conformity and/or CE documentation under the three decisions. Albanian registration therefore presupposes conformity documents created elsewhere.

The CE side has to exist before the Union side

For a device made in Albania, the declaration of conformity that AKBPM asks for can only come from conformity assessment under the Regulation:

"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 manufacturer builds Annex II technical documentation, obtains a notified body certificate under Article 56 for Class IIa and above, draws up the EU declaration of conformity under Article 19 and affixes the CE marking under Article 20. An Albanian registration based on Albania's own technical rules is a national act; it is not CE marking under the Regulation and has no effect in a Member State.

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 Albanian applicant, a wholesale trader, is a distribution-side actor. The Union representative is something else:

"‘authorised representative’ means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under this Regulation;"

Regulation (EU) 2017/745, Article 2(32)

An Albanian company cannot hold the Union mandate. The mandate is in writing, accepted in writing and effective for at least every device of the same generic device group (Article 11(2)); MDCG 2022-16 confirms one representative per generic device group.

Why Medex, in Türkiye, can be the representative

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, 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 states that a manufacturer established outside the EU and Türkiye needs to designate only one representative, in either territory, to place devices on the market in both. An Albanian manufacturer with Medex as representative therefore covers the Member States and Türkiye on one mandate. Device registration in ÜTS (Ürün Takip Sistemi), Türkiye's product tracking system, is a separate step for Turkish sales that Medex also carries out.

Albanian documents, translation and the apostille

Albanian regulatory files are in Albanian, which is not an official Union language. Medex asks Albanian manufacturers for the EU declaration of conformity and the core technical documents in English, because the representative must answer competent authorities in the language they determine:

"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 lists Albania as a Contracting Party to the Hague Apostille Convention with entry into force on 9 May 2004. The Regulation does not require the mandate to be apostilled. For ÜTS filings in Türkiye, TİTCK's guide TCKKD-KLVZ-03, Article 8, requires 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.

Albanian and Union instruments compared

Albania (Law No. 89/2014)Union (Regulation (EU) 2017/745)Carries across?
Registration filed by the wholesale traderManufacturer signs the EU declaration and the mandate; importer verifies (Article 13(2))Roles are split differently
Copy of the declaration of conformity and/or CE documentation in the fileThe EU declaration of conformity itself, drawn up by the manufacturer (Article 19)Albania relies on the document; the Union creates it
Technical rules under Decisions 508/2015, 731/2015 and 189/2016Regulation (EU) 2017/745 and Regulation (EU) 2017/746Different legal acts
National register of medical devicesEUDAMED device registration (Article 29)No
Albanian documentationLanguage determined by each Member State's authority; label per Article 10(11)Translation needed

Mandate and EUDAMED

"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 Albanian 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

AKBPM asks for a copy of our declaration of conformity. Can Medex issue it?

No. The EU declaration of conformity is drawn up by the manufacturer under Article 19 after conformity assessment. Medex verifies that it exists and keeps a copy under Article 11(3), and can support its preparation for Class I devices, but the declaration is the manufacturer's own act.

Our wholesale distributor in Tirana registers our devices. Can it also be our EU representative?

No. Article 2(32) requires the representative to be established within the Union, and the Customs Union extends that to Türkiye. An Albanian company cannot hold the mandate; the distributor keeps its Albanian role.

Does an Albanian registration under Decision 731/2015 count as CE marking?

No. The CE marking is affixed under Article 20 of the Regulation after conformity assessment under Article 52, with an EU declaration of conformity and, for Class IIa and above, a notified body certificate. Albania's technical rules are national instruments.

Is an apostille needed on the mandate?

Not under the Regulation. An apostille is needed only for documents uploaded to ÜTS in Türkiye; Albania has issued apostilles under the Hague Convention since 9 May 2004.

Does one mandate cover the EU and 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 Albania, 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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