A manufacturer established outside the European Union must designate a sole EU Authorised Representative before placing a medical device or IVD on the Union market. MEDAGENT acts as your mandated EU contact and supports the documentation, registration, authority communication and post-market coordination that come with the role.
Why the role is required?
Article 11 of the MDR and IVDR requires a written mandate between the non-EU manufacturer and an authorised representative established in the Union. The mandate must cover at least all devices in the same generic device group and specify the representative tasks.
The authorised representative is more than a forwarding address. It verifies defined compliance documents, keeps information available for competent authorities, supports registration and cooperates on preventive or corrective action.
