We verify your documentation, register you in EUDAMED and act as your contact point for competent authorities — for both the EU and Türkiye.
If your company is established outside the European Union, you cannot place a medical device or in vitro diagnostic on the EU market without appointing an authorised representative. Article 11(1) of MDR (EU) 2017/745 and IVDR (EU) 2017/746 makes this a condition of market access, not an administrative formality.
The appointment must be made in writing, before your device enters the market, and you may appoint only one authorised representative per device or device family. Your representative must be established in the Union, and their details appear in EUDAMED alongside yours.
What we do under the mandate
We verify that your EU declaration of conformity and technical documentation have been drawn up and that the appropriate conformity assessment procedure has been carried out. We keep a copy of your technical documentation permanently available for competent authorities, register the mandate in EUDAMED, and act as your contact point in the Union. We forward information requests, cooperate on preventive or corrective action, and pass on complaints and reports concerning your devices. These duties are set out in Article 11(3). Authority requests are acknowledged within one business day — that is our service commitment, not a statutory deadline.
What cannot be delegated
Article 11(4) draws a clear line. Device design, your quality management system and the drafting of technical documentation remain your responsibility as the manufacturer. No authorised representative can take these over, and any provider who offers to is misrepresenting the regulation. We are also not your importer, not your distributor, and not a notified body.
Shared liability
Under Article 11(5), if a manufacturer established outside the Union has not complied with its obligations, the authorised representative is legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer. This is why we review documentation before accepting a mandate rather than after.
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 EU. For a manufacturer outside the EU this normally means two separate appointments — one representative in the European Union and another in Türkiye. Because Medex is established in Türkiye, a single mandate covers both markets: one contract, one point of contact, one invoice.
Regulatory responsibility
Medex is registered in EUDAMED as an authorised representative under SRN TR-AR-000057550, and as a manufacturer under SRN TR-MF-000057496. The people who maintain our own records will maintain yours.
What it costs
Annual representation starts at €1,000 for Class I devices and Class A in vitro diagnostics. Our full rates are published, so you can budget before you contact us.
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To prepare a quote we need device names, intended purpose, risk class if known, and current certification status.