Can an EU Authorised Representative in Turkey Cover the EU Market?

Short answer: yes. A manufacturer established outside the European Union may appoint an EU authorised representative in Turkey, and that single appointment covers both the EU and the Turkish market.

This is not an interpretation. It is stated in a notice issued by the European Commission's Directorate-General for Health and Food Safety, and it follows from a chain of instruments worth reading in full if you are making this decision. This article sets out that chain, what it means in practice, and — equally important — what it does not mean.

Why manufacturers ask about an EU authorised representative in Turkey

If your company is established outside the EU, Article 11(1) of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) requires you to appoint a sole authorised representative before your device is placed on the Union market. That much is uncontroversial.

The question we actually get is narrower: if the representative is in Ankara rather than in Munich or Amsterdam, will an EU competent authority accept it?

The concern is reasonable. Turkey is not an EU Member State. It is also not part of the European Economic Area. So the answer has to come from somewhere other than membership — and it does.

The chain of instruments

1995–2006: the Customs Union is established

The Customs Union between the EU and Turkey was built gradually through Decisions Nos 1/95, 2/97 and 1/2006 of the EC–Turkey Association Council.

Decision No 1/2006 is the one that matters here. It provides that an authorised representative has to be nominated "in Turkey or in the Community" — placing the two territories on the same footing for this specific purpose.

2021: alignment with the MDR and IVDR is confirmed

The EU–Turkey Customs Union Joint Committee issued two statements confirming that Turkish legislation is aligned with the current regulations: one on 21 May 2021 concerning Regulation (EU) 2017/745, and one on 13 September 2021 concerning Regulation (EU) 2017/746.

Both statements confirm that where those regulations refer to the territories of the Parties, the references are to be understood as comprising the territory of the EU–Turkey Customs Union.

That sentence does the heavy lifting. When the MDR says "established in the Union," the territorial reference is read across the Customs Union.

2022: the Commission states the conclusion

In March 2022 the Commission's Directorate-General for Health and Food Safety, together with the Directorate-General for Neighbourhood and Enlargement Negotiations, issued a Notice to Stakeholders on the EU–Turkey Customs Union Agreement in the field of medical devices. It draws two conclusions on authorised representatives.

Manufacturers established in the EU have no obligation to designate an authorised representative in Turkey in order to place devices on the Turkish market, and manufacturers established in Turkey have no obligation to designate one in the EU.

Manufacturers established outside the territory of the EU or Turkey need to designate only 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.

The notice also records that the same conclusions had already been drawn under the previous medical device Directives, in an interpretative document of the Commission services dated 11 February 2020. This is not a recent or provisional position.

MDCG guidance says the same thing

MDCG 2022-16, the Medical Device Coordination Group's guidance on authorised representatives, defines the Union market in its first footnote: the territories of the EU Member States, extended through the EEA to Norway, Liechtenstein and Iceland, and via the Customs Union Agreement to Turkey.

So the guidance document that competent authorities and economic operators rely on when interpreting Article 11 already treats Turkey as within scope.

What this means in practice

For a manufacturer in China, the United States, India, Korea or the United Kingdom, the practical consequence is a choice between two structures.

Structure A — representative established in the EU

You appoint an authorised representative in an EU Member State for the Union market. If you also want to sell in Turkey, you appoint a second representative there, under a second contract, with a second point of contact and a second invoice.

Structure B — representative established in Turkey

You appoint one authorised representative in Turkey. The same appointment serves both markets.

Both structures are lawful. The difference is administrative weight, not legal validity.

There is a second consequence that is easy to miss. Turkey is entitled to designate notified bodies under both regulations, and a notified body established in Turkey has the same rights and obligations as one established in the EU. Devices covered by a certificate issued by a Turkish notified body circulate freely in the EU, and the reverse is also true.

What appointing an EU authorised representative in Turkey does not mean

We would rather lose a client than have one discover a limitation after signing. Four things this arrangement does not do.

It does not reduce the representative's obligations

An authorised representative established in Turkey carries exactly the same duties under Article 11(3) as one established in Munich: verifying that the declaration of conformity and technical documentation have been drawn up, keeping a copy of the technical documentation available for competent authorities, registering in EUDAMED, acting as the contact point, forwarding information requests, and cooperating on preventive or corrective action.

It does not reduce your obligations as manufacturer

Article 11(4) keeps device design, your quality management system and the drafting of technical documentation with you. No authorised representative — in any country — can take these over.

It does not remove liability

Under Article 11(5), where a manufacturer established outside the Union has not complied with its obligations, the authorised representative is legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer. Establishment in Turkey changes nothing here.

It is specific to medical devices

This article concerns the Customs Union arrangement as it applies to medical devices and in vitro diagnostics under Regulations 2017/745 and 2017/746. Do not assume the same position applies to other regulated product sectors.

How to verify this yourself

We would encourage you not to take our word for any of it. Three checks, each of which takes minutes.

Read the Commission notice. It is four pages and published on the Commission's health portal. The section on authorised representatives is Section I.

Read MDCG 2022-16. This is the official guidance on authorised representative obligations. The definition of the Union market appears in the first footnote.

Check the representative in EUDAMED. Any authorised representative you are considering should hold a Single Registration Number and appear in the EUDAMED public actor database. If a prospective representative cannot give you an SRN to check, that is the end of the conversation.

Sources

Notice to Stakeholders — EU-Turkey Customs Union Agreement in the field of medical devices, European Commission, DG SANTE and DG NEAR, March 2022

MDCG 2022-16 — Guidance on authorised representatives, Regulation (EU) 2017/745 and Regulation (EU) 2017/746

Regulation (EU) 2017/745 on medical devices — Articles 11 and 12

Regulation (EU) 2017/746 on in vitro diagnostic medical devices — Articles 11 and 12

Decision No 1/2006 of the EC–Turkey Association Council

Statements of the EU–Turkey Customs Union Joint Committee, 21 May 2021 and 13 September 2021

Who wrote this

Medex is a medical device manufacturer established in Ankara and a registered authorised representative in EUDAMED under SRN TR-AR-000057550. We publish our rates rather than quoting after a call.

If you are working out which structure fits your portfolio, send us your device list and we will respond in writing.