European Authorised Representative (EAR) services
Supporting non-EU medical device manufacturers entering the European market.
European Authorised Representative (EAR)
Aurevia provides European Authorised Representative (EAR) services to support non-EU/EEA manufacturers in placing medical devices and IVDs on the EU market—ensuring compliance with MDR/IVDR requirements and smooth interaction with competent authorities. We are an active member of the European Association of Authorised Representatives (EAAR). As a member of the EAAR and part of a broad international network, we provide efficient support for market access across Europe.
Access to the European Union (EU)
For manufacturers based outside the EU, appointing a European Authorised Representative (EAR) is a legal requirement under both MDR and IVDR. As your EAR, Aurevia acts under a formal contract to support compliance with relevant regulatory obligations related to EU market access. We serve as your official point of contact with competent authorities and ensure alignment with EU requirements throughout the entire product lifecycle.
EAR services
We provide a comprehensive EAR service package tailored to your needs, including:
- Representation and contact with EU competent authorities
- Registration support (including EUDAMED and national requirements)
- Review of technical documentation prior to registration
- Support with vigilance activities
- Ongoing regulatory guidance throughout the product lifecycle
- Assistance with additional national registrations where applicable
Our approach ensures your documentation is complete, compliant, and ready for market entry.
Why choose us?
- Registered European Authorised Representative
- Strong relationships with national competent authorities
- Extensive experience across medical devices and IVDs
- Multidisciplinary expertise covering regulatory, quality, and clinical research
- Active participation in industry initiatives, standards, and working groups
With strong regulatory know-how and real-world experience, we guide you efficiently toward CE marking and EU market access.
Leena Raunio, Quality & Regulatory Affairs Manager
Meet one of our EAR experts
Our European Authorised Representative (EAR) services are delivered by a team of regulatory specialists with deep expertise in MDR and IVDR requirements.
We support non-EU manufacturers throughout the entire product lifecycle—from initial market access to post-market compliance—ensuring smooth communication with competent authorities and reliable regulatory oversight.
With a strong European presence and international network, our team provides responsive, compliant, and efficient support tailored to your needs.
To reach out to the EAR team, submit the form below or email us directly at ear@aurevia.com.
Get in touch with us
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