Our services

Article 11 representation and EUDAMED registration under a single mandate. ÜTS registration consultancy is a separate service under a separate contract. We are registered in EUDAMED as an authorised representative under SRN TR-AR-000057550.

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Three services, two contracts. Article 11 representation and EUDAMED registration run under a single mandate and a single annual fee. ÜTS registration consultancy is a separate engagement under a separate contract, because it answers a different question: not who represents you in the Union, but who places your device on the Turkish market.

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If your registered place of business is outside the European Union and you place medical devices or IVDs on the EU market, Article 11(1) of both the MDR and the IVDR makes the appointment of a sole authorised representative a condition of market access: "the device may only be placed on the Union market if the manufacturer designates a sole authorised representative." That is the first service. The mandate covers the tasks Article 11(3) sets out as a minimum, and it does not cover the manufacturer obligations Article 11(4) keeps with you: device design, your quality management system and the drafting of the technical documentation.

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EUDAMED registration is included in that mandate rather than sold alongside it. Actor registration for you and for us, the Single Registration Number, Basic UDI-DI and UDI-DI records, and the mandate record that links your company to ours are all part of the annual fee. One device equals one Basic UDI-DI, unlimited UDI-DI variants under the same Basic UDI-DI are covered, and the first ten UDI-DI entries are included.

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ÜTS registration consultancy is for companies established in Türkiye that hold a medical device sales centre authorisation and are responsible for their own ÜTS records. The registration itself is filed by the Türkiye-established economic operator, the importer or the distributor, from its own account. It is not filed by a foreign manufacturer, and it is not filed by an authorised representative on a manufacturer's behalf.

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What the mandate obliges us to do. Article 11(3) of the MDR and the IVDR fixes the minimum content of every mandate:

"The mandate shall require, and the manufacturer shall enable, the authorised representative to perform at least the following tasks in relation to the devices that it covers:"

In practice that means we verify that your EU declaration of conformity and technical documentation have been drawn up and that the right conformity assessment route was followed; we keep a copy of the technical documentation, the declaration and any certificate at the disposal of competent authorities; we meet our own Article 31 registration obligations and check yours under Articles 27 and 29; we answer competent authority requests, forward requests for samples, cooperate on corrective action, and pass on complaints and incident reports without delay. Point (a) is where the work starts:

"verify that the EU declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;"

Point (h) is the one most manufacturers never read, and it is the reason we examine the file before we sign rather than after:

"terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation."

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EU declaration of conformity check. Class I devices under the MDR and class A IVDs under the IVDR reach the market on the manufacturer's own declaration, with no notified body involved. We check the declaration against the content the Regulation requires before you sign it, and again as part of the point (a) verification when we take on the mandate. The declaration stays yours: it is drawn up and signed by the manufacturer.

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How an engagement runs. You send the device list with the intended class of each device through the proposal form. Within one business day you receive a fixed-price written proposal and a draft mandate. After signature we review the declaration and technical documentation under point (a), link the mandate to your actor record in EUDAMED, and your labels and packaging then carry our name and address as your authorised representative. From that point the tasks above run for as long as the mandate is in force.

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What we do not do matters as much as what we do. We are not a notified body and we do not carry out conformity assessment. We do not write your technical documentation. We do not act as your importer or your distributor, and we do not find you one. We do not provide legal advice. Where something falls outside the mandate we say so before you sign, not after you ask.

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The appointment is valid on both sides of the EU-Türkiye Customs Union, so one mandate covers both territories. Rates are published by device class, with no setup fee.