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EU Authorized Representative for Moldovan Medical Device Manufacturers

Moldova is not a Member State of the European Union. Its Agenția Medicamentului și Dispozitivelor Medicale runs two tracks under Law No. 102 of 9 June 2017: a notification route for devices that already carry the CE marking and a registration route for devices that do not. A Moldovan manufacturer therefore already knows that CE marking is the currency of the Union. What it may not know is that the marking comes with a sole representative established in the Union, EUDAMED registration and a declaration that only the manufacturer can sign. This page sets out that side.

AMDM and Law No. 102/2017

The Agenția Medicamentului și Dispozitivelor Medicale (AMDM) describes itself as the administrative authority with regulatory and supervisory competence for medicines, pharmaceutical activity and medical devices. Its device pages rest on Legea nr. 102 din 9 iunie 2017 cu privire la dispozitivele medicale, which defines a medical device in terms that mirror the former Union Directives and classifies devices into Classes I, IIa, IIb and III on the basis of eighteen rules.

The AMDM keeps two procedures side by side: the notification and registration of medical devices that hold the CE marking, run through an online platform, and the registration of medical devices that do not hold the CE marking, approved by Order No. 212 of 21 March 2018 of the Ministry of Health, Labour and Social Protection under Article 8 of Law No. 102/2017. Under the second procedure the manufacturer or its authorized representative must register with the Agency, before placing on the market, the devices that do not carry the CE marking. Registered devices appear in the Registrul de Stat al dispozitivelor medicale.

What the CE marking means on the Union side

For Moldova the CE marking is a reason to use the lighter track. For the Union the CE marking is the end of a process the manufacturer must run 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)

A Moldovan manufacturer that wants the CE marking therefore 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 marking under Article 20. A Moldovan registration under the non-CE procedure has no effect in the Union and does not shorten any of these steps. Once the CE marking exists, the same device can of course be notified to the AMDM under the CE track for the Moldovan market.

The representative requirement

"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)

Moldovan law lets the manufacturer or its authorized representative file with the AMDM. The Union role is defined narrowly and is not transferable:

"‘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)

A Moldovan company is not established within the Union and cannot hold the Union mandate. The mandate must be in writing, accepted in writing and effective for at least every device of the same generic device group (Article 11(2)).

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 states 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 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 Moldovan manufacturer with Medex as representative therefore 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.

Romanian documents, translation and the apostille

Moldovan regulatory files are in Romanian, which is an official Union language. A competent authority that determines Romanian 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 the Republic of Moldova as a Contracting Party to the Hague Apostille Convention with entry into force on 16 March 2007. 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.

Moldovan and Union instruments compared

Moldova (Law No. 102/2017)Union (Regulation (EU) 2017/745)Carries across?
Notification of CE-marked devices to the AMDMThe CE marking itself, obtained under Articles 19, 20, 52 and 56Moldova relies on the Union; the Union does not rely on Moldova
Registration of non-CE devices (Order No. 212/2018)No equivalent; conformity assessment required for every deviceNo
Classes I, IIa, IIb, III under eighteen rulesClasses I, IIa, IIb, III under Annex VIIISame labels; class re-derived under Annex VIII
Registrul de Stat al dispozitivelor medicaleEUDAMED device registration (Article 29)No
Manufacturer or its authorized representative files with the AMDMSole EU Authorized Representative established within the Union (Article 11)Mirror roles, not transferable

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 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 device is registered with the AMDM under the non-CE procedure. Is that a step towards the CE marking?

No. The non-CE registration is a Moldovan market instrument. The CE marking is obtained under the Regulation through conformity assessment, an EU declaration of conformity and, for Class IIa and above, a notified body certificate. Evidence from the Moldovan file can be reused; the registration cannot.

Once we have the CE marking, do we still need an EU representative?

Yes. Article 11(1) applies to every manufacturer not established in a Member State, whatever the class and however the marking was obtained. The representative's name also goes on the label under Annex I, Section 23.2(d).

Can our Romanian technical file be used directly?

For an authority that determines Romanian, yes. For others Medex needs the EU declaration of conformity and the core documents in a language that authority determines, usually English. The EU declaration must be translated into the language each Member State requires.

Does the mandate need an apostille from Chișinău?

Not under the Regulation. An apostille is needed only for documents uploaded to ÜTS in Türkiye; the Republic of Moldova has issued apostilles under the Hague Convention since 16 March 2007.

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 Moldova, 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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