Manufacturers based outside the European Union (EU) must appoint a single EU Authorized Representative before placing medical devices or In-Vitro Diagnostics (IVDs) on the European market.
With MEDAGENT as your EU Authorized Representative, you gain a reliable regulatory partner who helps keep your EU market access on track. We review key regulatory documentation, support EUDAMED registration requirements, act as your official contact for competent authorities, and coordinate regulatory inquiries, complaints, and incident-related communication. For you, this means fewer administrative hurdles, clearer responsibilities, and more time to focus on your products and business growth.
Why is an EU Authorized Representative required?
Under Article 11 of the EU MDR 2017/745 and IVDR 2017/746, manufacturers established outside the EU must appoint an EU-based Authorised Representative through a written mandate. The mandate must cover at least all devices within the same generic device group and clearly define the representative’s regulatory responsibilities.
The role extends beyond serving as a point of contact. The Authorised Representative must verify the availability of specified compliance documentation, retain access to required records, fulfil applicable registration obligations, cooperate with competent authorities, and support preventive and corrective actions in accordance with the EU MDR and IVDR.
