Get Started Today

As a trusted partner for non-EU in vitro diagnostic (IVD) manufacturers, we provide comprehensive European Authorized Representative (EC-REP) services to ensure your seamless entry and compliance in the European market. Our expertise in the In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746 positions us as your ideal gateway to the EU.

Why Choose Us as Your EU Representative?

Strategic Location: Based in Germany, the heart of the European Union, we offer swift communication channels and deep understanding of local regulations.
Regulatory Expertise: Our team of experts guides you through the complex compliance process, ensuring adherence to IVDR requirements.

Our Comprehensive EC-REP Services

Regulatory Compliance

Verification of EU declarations of conformity and technical documentation
Assistance with EUDAMED registration and maintenance
Ensuring compliance with all IVDR obligations

Communication Bridge

Act as the primary point of contact for EU Competent Authorities
Facilitate communication between manufacturers, importers, and distributors
Handle regulatory inquiries and provide timely responses

Vigilance and Post-Market Surveillance

Manage incident reporting and field safety corrective actions (FSCAs)
Cooperate with authorities on preventive or corrective actions
Monitor and relay information about complaints and suspected incidents

Documentation Management

Maintain copies of technical documentation, EU declarations of conformity, and relevant certificates
Provide secure access to documentation for authorized parties