EU Authorised Representative appointment
Written mandate, EUDAMED registration, document availability and authority liaison under MDR/IVDR Article 11.
Your EU Authorised Representative & PRRC for MDR/IVDR medical devices
For medical device and IVD manufacturers established outside the EU. We act as your EU Authorised Representative under Article 11 of the MDR/IVDR, and can provide PRRC coverage where your organisation qualifies as a micro or small enterprise.
EUDAMED-registered Economic Operator · one mandate for all 27 Member States · accepted only after a compliance review
Before we accept an appointment, we review your device classification, technical documentation and clinical or performance evidence status against MDR/IVDR requirements. If something is missing, we tell you before you pay for representation you could not use yet.
Article 11 defines specific tasks for the Authorised Representative - verifying declarations of conformity and technical documentation exist, keeping documentation available to authorities, cooperating on corrective action and registering with EUDAMED. Your obligations as manufacturer stay with you. We add an EU-based check that your paperwork is in order.
Written mandate, EUDAMED registration, document availability and authority liaison under MDR/IVDR Article 11.
For micro and small manufacturers, we can make a qualified PRRC permanently and continuously available under Article 15(6).
A first check of whether your device and company structure require one.
Tell us your device type, class and where your company is established. Before you sign a mandate, we tell you what the next step is.
An EU Authorised Representative checks that your documentation exists and is in order. Building that documentation is consulting work: regulatory strategy, technical documentation and conformity assessment are handled on getMDR.eu.