About Medex

Medex Kurumsal Danışmanlık Sanayi ve Ticaret Limited Şirketi handles registration and market access for medical device manufacturers.

Authorised representation under Article 11 of the MDR and IVDR is carried out under a written mandate. We are registered as an authorised representative in EUDAMED under SRN TR-AR-000057550.

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Article 15(6) of the MDR sets a condition most manufacturers never think to ask about. Authorised representatives "shall have permanently and continuously at their disposal at least one person responsible for regulatory compliance who possesses the requisite expertise regarding the regulatory requirements for medical devices in the Union." Ours is a partner of the firm, with a named deputy for continuity. Permanently and continuously is not a consultant you call when something has already gone wrong.

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We maintain our own EUDAMED actor registration under the same Article 31 deadlines we manage for clients: updates within one week of a change, and confirmation of accuracy after the first year and every second year after that. When we tell you what a EUDAMED correction request looks like, it is because we have answered our own.

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Why a representative established in Türkiye is valid in the Union. MDCG 2022-16 states that an authorised representative must be established within the Union. Türkiye sits inside that framework through the EU-Türkiye Customs Union: Decision 1/95 of the EC-Turkey Association Council, together with Decisions 2/97 and 1/2006, aligns Turkish medical device legislation with the Union acquis. The European Commission set out the consequence in its Notice to Stakeholders of March 2022: a manufacturer established outside both the EU and Türkiye designates one authorised representative, either in Türkiye or in the Union, not one in each. Our SRN carries the TR-AR prefix for that reason, and it is searchable in the EUDAMED public actor database.

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Why we read the file before we sign. The Regulation puts the authorised representative next to the manufacturer when a device is defective. Article 11(5) states it plainly:

"Without prejudice to paragraph 4 of this Article, where the manufacturer is not established in a Member State and has not complied with the obligations laid down in Article 10, the authorised representative shall be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer."

That is why the declaration of conformity and the technical documentation are examined during due diligence, and why a mandate is a considered decision on both sides rather than a form.

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How to verify us before you sign. Open the EUDAMED public actor search, choose the authorised representative role and search for TR-AR-000057550. The record shows our legal name, our registered address in Ankara and the status of the registration. Run the same check on any representative you are comparing; the SRN in a proposal should match the public record exactly.

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If you are changing representative. A change of authorised representative is arranged by written agreement, and Article 12 sets out who is party to it:

"The detailed arrangements for a change of authorised representative shall be clearly defined in an agreement between the manufacturer, where practicable the outgoing authorised representative, and the incoming authorised representative."

We draft that agreement with you, set the handover date for documentation, labelling and EUDAMED records, and take over the mandate from the date agreed.

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Where we work. Our head office is in Çankaya, Ankara, with an office in Maltepe, İstanbul and a contact office in Gdańsk, Poland. We work in English with manufacturers and, where a competent authority asks, provide documentation in the official Union language that Member State determines.

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What we are not. We are not a notified body, we do not carry out conformity assessment and we do not issue certificates. We do not write technical documentation. We are not your importer or your distributor. We do not give legal advice. Article 11(4) keeps device design, your quality management system and the drafting of the technical documentation with you, and no mandate we sign changes that.