About Medex

Medex Kurumsal Danışmanlık Sanayi ve Ticaret Limited Şirketi works on both sides of the regulation. We manufacture medical devices and hold our own actor registrations in EUDAMED, and we handle registration and market access for other manufacturers.

Authorised representation under Article 11 of the MDR and IVDR is the same work, carried out under a 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, and carries the same responsibility for our own devices as for yours. Permanently and continuously is not a consultant you call when something has already gone wrong.

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Being a manufacturer ourselves is not a marketing line. We hold three actor registrations in EUDAMED and we maintain them 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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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.