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 a medical device manufacturer ourselves, registered in EUDAMED 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 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.