Inside the Customs Union, Outside the Union: EU Authorized Representative and Türkiye
Türkiye is the only country in this set whose medical device law is MDR itself, published in Turkish in the Resmî Gazete of 2 June 2021 and applied by TİTCK from the same date as the Union. It is also inside the EU-Türkiye Customs Union for medical devices, which changes the authorised representative question in a way no other third country experiences. Almost everything written about Turkish manufacturers and EU representation gets this wrong. This page sets out what the Customs Union settles, what it does not, and where that leaves a manufacturer in Ankara, Gebze or İzmir.
MDR was published in Turkish before most Member States had finished reading it
The Tıbbi Cihaz Yönetmeliği and the İn Vitro Tanı Amaçlı Tıbbi Cihaz Yönetmeliği appeared in the Resmî Gazete of 2 June 2021, issue 31499 (mükerrer). They are not adaptations of MDR and IVDR; they are the two Regulations carried into Turkish law, classification rules, general safety and performance requirements, conformity assessment annexes and economic operator roles intact. The device regulation took effect from 26 May 2021 and the IVD regulation from 26 May 2022, matching the Union dates. TİTCK is the competent authority.
This is the reason a Turkish technical file usually needs less rebuilding than a file from any other country outside the Union. It also creates the single most misunderstood point in the whole of this cluster, which is where an authorised representative may be established.
What the Customs Union settles, and what it leaves entirely to you
Medical devices are inside the EU-Türkiye Customs Union. Following Association Council Decisions 1/95, 2/97 and 1/2006, the Customs Union Joint Committee confirmed in statements of 21 May 2021 and 13 September 2021 that Turkish legislation is aligned with MDR and IVDR, and that where those Regulations and the Turkish provisions giving effect to them refer to the territories of the Parties, those references are, for the purpose of Decision No 1/95, "understood to comprise the territory of the EU-Turkey Customs Union." (European Commission, Notice to stakeholders: EU-Turkey Customs Union Agreement in the field of medical devices, March 2022)
| The question a Turkish exporter arrives with | What the Customs Union settles | What still sits entirely on the manufacturer |
|---|---|---|
| Where may my authorised representative be established? | A manufacturer established in Türkiye has no obligation to designate one on EU territory at all | If you appoint one, the Article 11 mandate and its liability apply in full |
| Is my Turkish notified body certificate accepted in the Union? | Yes — a Turkish notified body has the same rights and obligations as one established in the EU | Getting through the assessment: Annex IX audit, clinical evaluation, unannounced audits |
| Does alignment mean my file is accepted as it stands? | Nothing. Alignment is of the legislation, not of any individual dossier | GSPR conformity, Annexes II and III documentation, PMS and PMCF, UDI assignment |
| Do I still register in EUDAMED? | Nothing — the Customs Union does not replace Union registration duties | Actor registration and an SRN under Article 31, and device and UDI data |
| Am I in the Union for every other purpose? | Nothing. Türkiye is not a Member State | Reading each obligation against its own legal basis rather than assuming membership |
Where a Türkiye-based manufacturer’s representative may sit
The Commission states the position without hedging: "Manufacturers established in the EU have no obligation to designate an authorised representative in Turkey in order to place devices on the Turkish market. Vice versa, manufacturers established in Turkey have no obligation to designate an authorised representative on the EU territory in order to place medical devices on the EU market." (European Commission, March 2022) TİTCK publishes the same conclusion in Turkish.
That is the opposite of what most third-country guidance would lead you to expect, and it is worth stating precisely what it does and does not mean. It means the territorial test in Article 11(1) is read across the Customs Union, so a manufacturer in Ankara or Gebze is not obliged to hold an EU-side mandate merely to place a device on the Union market. It does not mean the manufacturer’s obligations under Article 10 shrink by a single line, and it does not mean an importer, a distributor or a hospital procurement office will not ask you for a representative anyway.
There is a third case, and commercially it is the largest one. Decision No 1/2006 requires an authorised representative to be nominated "in Turkey or in the Community", so, in the Commission’s words, "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." A manufacturer in Seoul, São Paulo or Shenzhen may therefore satisfy the requirement with a mandate held in Türkiye.
Turkish notified bodies and the certificates they issue
Türkiye is entitled to designate notified bodies under MDR and IVDR, and under Article 2(1) of Decision No 1/2006 it may designate more than one. The Commission is explicit on what their certificates are worth: "A notified body established in Turkey has the same rights and obligations as a notified body established in the EU. Medical devices covered by a certificate duly issued by a Turkish notified body may circulate freely in the EU." The reverse also holds, which is why a Turkish manufacturer certified by a German or Italian notified body is in an unremarkable position at home.
The planning question is therefore capacity and scope rather than jurisdiction: choose the body whose designation actually covers your device codes and your sterilisation or software scope, and confirm that coverage before you lodge.
Why Turkish manufacturers still put a mandate in place
Given all of the above, a fair question is why any manufacturer established in Türkiye would appoint an authorised representative at all. Three reasons come up repeatedly in our own casework, and none of them is regulatory obligation.
- The Union counterparty asks for it. Importers and distributors carry verification duties under Articles 13 and 14 and often want a named representative inside their own regulatory reach before they will take title.
- The function is needed regardless. Vigilance handling, competent authority correspondence in a nominated official Union language, EUDAMED actor and device registration, and a person responsible for regulatory compliance under Article 15 all have to sit somewhere with the expertise to do them.
- The manufacturer is not actually established in Türkiye. Contract manufacturing and own-brand labelling arrangements move the legal manufacturer around more often than the factory address suggests, and once the legal manufacturer sits outside both territories the mandate becomes mandatory again.
Medex is established in Türkiye, with its head office in Ankara and a further office in Gdańsk, and holds EUDAMED authorised representative SRN TR-AR-000057550, alongside registrations as a manufacturer, TR-MF-000057496, and as an importer. A PRRC and a deputy are in-house. That combination lets a mandate be placed on whichever side of the Customs Union the commercial arrangement actually needs. Scope and fees are on the EU Authorized Representative service page and in published pricing.
TİTCK registration is a separate route, not a step in this one
Placing a device on the Turkish market means registering it in ÜTS, the national product tracking system administered under TİTCK, through a registered economic operator. That is a domestic market access obligation and it runs alongside, not inside, your Union file: ÜTS records do not feed EUDAMED, and an SRN does not create a ÜTS record. If Türkiye is a destination market rather than your base, the detail belongs on our Türkiye market access page rather than here.
What Turkish manufacturers actually ask
If we do not need an EU-side representative, what exactly are we buying?
The regulatory function, not the postcode. Article 11(3) tasks — verification that the declaration of conformity and technical documentation exist, keeping them available, Article 31 registration, answering competent authorities, handling complaints and vigilance — have to be performed by someone competent whether or not the territorial test obliges you to appoint anybody. Many manufacturers also want the mandate on paper because their European customers ask to see it.
Our device is CE marked by a Turkish notified body. Will a French hospital accept it?
On the law, yes: devices covered by a certificate duly issued by a Turkish notified body may circulate freely in the EU. In tenders you may still be asked to explain the basis, and the Commission notice of March 2022 with the Joint Committee statements of 21 May 2021 and 13 September 2021 is the document set that answers it.
We are a Chinese manufacturer with a Turkish partner. Can our representative be in Türkiye?
Yes. For a manufacturer established outside both the EU and Türkiye, designating a single authorised representative in either territory is sufficient for placing devices on either market. Which side you choose is a commercial and practical decision about who your importers are and where you want correspondence to land.
Does the Customs Union cover in vitro diagnostics as well?
Yes. The Joint Committee statement of 13 September 2021 covers Regulation (EU) 2017/746, and the İn Vitro Tanı Amaçlı Tıbbi Cihaz Yönetmeliği was published in the same Resmî Gazete of 2 June 2021, applying from 26 May 2022. The classification rules and the notified body involvement that IVDR introduced for class B, C and D apply in identical terms. Send us the device list and we will tell you where each line falls.