Expanding into the EU market?
Expanding into the EU market as a medical device or IVD manufacturer? For non-EU/EEA companies, appointing a European Authorised Representative (EAR) is not just a formality—it’s a legal requirement under MDR and IVDR .
At Aurevia, we act as your official point of contact with EU competent authorities and support you throughout the entire lifecycle—from initial registration to ongoing compliance.
Our EAR services include:
✔ Representation with EU authorities
✔ EUDAMED and national registration support
✔ Technical documentation review
✔ Vigilance support and lifecycle compliance
✔ Continuous regulatory guidance
With deep regulatory expertise and strong connections across Europe, we help you navigate complexity to make your EU market entry smooth and compliant.
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.
Learn more about our EAR services.
BREAKING