Regulatory notes

If your company is established outside the European Union and you place medical devices or in vitro diagnostics on the EU market, yes. Article 11(1) of the MDR and IVDR makes it a condition of market access. The appointment must be in writing and in place before the device enters the market.

No. You must appoint a sole authorised representative for a given device or device family. You may use different representatives for different device families, but not two for the same one.

Yes. Under the EU–Türkiye Customs Union and Association Council Decision No 1/2006, devices lawfully placed on the Turkish market circulate freely in the EU. Our actor registration is publicly verifiable in EUDAMED.

A Single Registration Number identifies you as an actor in EUDAMED. Manufacturers, authorised representatives and importers each need one. We handle actor registration as part of the mandate.

Under Article 11(4), device design, your quality management system and the drafting of technical documentation remain with you. No authorised representative can take these over.

Article 12 requires an agreement between you, the outgoing representative and the incoming one, recording when each mandate starts and ends and how documentation transfers.

We acknowledge competent authority requests within one business day. This is our service commitment — the regulations do not set a fixed deadline.