For non-EU/EEA companies expanding into the EU market as a medical device or IVD manufacturer, appointing a European Authorised Representative (EAR) is a legal requirement under MDR and IVDR.
But EAR is more than just a regulatory requirement. Our EAR experts work closely with non-EU manufacturers to ensure that every step—from documentation to market surveillance—is aligned with EU expectations.
We don’t just represent you—we partner with you to:
• Strengthen your compliance strategy
• Reduce regulatory risk
• Facilitate smooth communication with authorities
Successful market entry in the EU isn’t just about gaining access—it requires staying compliant as regulations evolve.
As Leena Raunio, Quality & Regulatory Affairs Manager at Aurevia, puts it:
“Being your European Authorised Representative is not just about fulfilling a legal requirement—it’s about ensuring your product is supported by a strong, compliant framework throughout its lifecycle.”
Beyond our EAR role, we can support you with quality and regulatory expertise across your entire compliance journey—from regulatory strategy and QMS to audits and post-market activities.
Discover how our EAR experts can support your journey— from market entry to long-term compliance and lifecycle management.
Learn more about our EAR services.
