About Medex
A medical device manufacturer and regulatory consultancy in Ankara, acting as authorised representative for manufacturers outside the European Union.
Medex Kurumsal Danışmanlık Ltd. Şti. is a Turkish company working in two related areas: we manufacture medical devices, and we handle regulatory registration for other manufacturers. Authorised representation under the MDR and IVDR is an extension of that work — we already operate inside EUDAMED for our own products.
Our registrations
TR-MF-000057496
Manufacturer SRN. Active in EUDAMED Production, with Basic UDI-DI and UDI-DI records filed for our own devices.
TR-IM-000056252
Importer SRN. Registered actor in EUDAMED Production.
TR-AR-________
Authorised representative SRN. Actor registration submitted and awaiting approval from the Turkish Medicines and Medical Devices Agency (TİTCK).
EUDAMED
All actor registrations are publicly verifiable in the EUDAMED database. We encourage you to check ours before signing anything.
Regulatory responsibility
Article 15(6) requires an authorised representative to have permanent and continuous access to a person responsible for regulatory compliance. Ours is in-house — a partner of the firm, not a contracted third party. The same person is responsible for regulatory compliance across Medex's own device portfolio, which means the requirement is met continuously rather than on paper. A deputy is in place for continuity. Details of the responsible person are provided during due diligence, before any mandate is signed.
Why a Türkiye-based representative is valid for the EU
01
Customs Union
02
Decision No 1/2006
03
Commission notice, April 2022
04
One mandate, two markets
Under the EU–Türkiye Customs Union and Association Council Decision No 1/2006, medical devices lawfully placed on the Turkish market circulate freely within the European Union. In its April 2022 notice to stakeholders, the European Commission addressed the position of economic operators established in Türkiye under the EU medical device framework.
This is what allows a single mandate to cover both markets. We are not a law firm and do not provide legal advice — the official sources are linked below.
How we work
This is the space to tell people what it's like to work with the business. Describe the team's culture and why people enjoy being a part of it. Encourage qualified viewers to apply for open positions and tell them how to submit their applications.
Request a proposal
To prepare a quote we need device names, intended purpose, risk class if known, and current certification status.