Your EU Authorised Representative & PRRC for MDR/IVDR medical devices
We provide narrowly scoped EU representation for medical device and IVD manufacturers under MDR and IVDR.
AFINA s.r.o. is a company registered in the Czech Republic since 1996 and operates getEAR.eu as its EU Authorised Representative and PRRC service for medical device and IVD manufacturers. Genuine establishment in the Union matters for this role: Article 11 requires the Authorised Representative to be established in the EU, not merely to present an EU-facing brand.
We do not market this role as MDR/IVDR certification - conformity assessment and certification are separate processes handled by Notified Bodies. We focus on what Article 11 and Article 15 actually require: mandate clarity, document availability, EUDAMED registration, and a qualified PRRC where your organisation needs one.
Tell us your device type, class and where your company is established. We will qualify the next step before any mandate is signed.