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. Micro and small manufacturers represented by another Authorised Representative can also engage us as their external PRRC.
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 represented by another Authorised Representative, we can be the PRRC permanently and continuously at their disposal (Article 15(2)).
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.