Your Trusted EU Authorized Representative for Medical Devices
Fulfilling the legal requirement for non-EU manufacturers to have designated representation within the European Union for medical device regulatory compliance and vigilance reporting.
Industry-Leading EC Rep Medical Device Services
EU regulations require all medical device manufacturers located outside the European Union to designate an EU Authorized Representative within the EU. Veranex brings decades of regulatory expertise as your EU Authorized Representative for medical devices, understanding the complex requirements of MDR 2017/745 and IVDR 2017/746. As your EC rep for medical devices, we manage all aspects of representation—from technical documentation verification to vigilance reporting—ensuring your products meet European regulatory standards while minimizing compliance risks.

Regulatory & Quality Consultants Worldwide

Member States Covered by Our Representation Services + UK + Switzerland

Years of Regulatory Experience in Europe
VERANEX
Expert EU representation isn't just a regulatory checkbox but a critical difference between European market success and costly delays.
Comprehensive EU Representation Services
Non-EU manufacturers often struggle with maintaining continuous compliance while operating from outside the EU, risking market access delays and regulatory enforcement actions. Our comprehensive approach addresses these challenges by combining technical documentation management, regulatory intelligence, and strategic guidance with our formal representation role.
We serve as your eyes and ears on the ground in Europe, anticipating regulatory shifts, coordinating with authorities during compliance inquiries, and ensuring swift action during vigilance situations. This integrated service model goes beyond basic representation to provide the continuous support needed to maintain market access and build trust with European regulators, allowing you to focus on core business operations while we manage the complexities of EU regulatory compliance.
Regulatory Compliance & Documentation
- Review product compliance with:
- EU Medical Device Regulation (MDR) 2017/745
- EU In Vitro Diagnostic Regulation (IVDR) 2017/746
- Swiss Medical Devices Ordinance (MedDO)
- Swiss In Vitro Diagnostic Ordinance (IvDO)
- UK Medical Device Regulations (UK MDR)
- UK In Vitro Diagnostic Medical Devices Regulations (UK IVDR)
- Legacy directives
- Maintain current copies of your Technical Documentation for European Competent Authority inspections
- Protect the confidentiality of your proprietary information
Strategic Partnership
- Develop and implement compliant mandate contracts that establish clear responsibilities and interfaces
- Support insurance requirement clarification with access to leading liability insurance experts in life sciences
- Provide European contact details for device labels, packaging, and Instructions for Use
Market Access & Monitoring
- Register your devices with national Competent Authorities before market placement
- Support implementation of necessary adaptations to packaging, labeling, and IFUs to meet national requirements
- Perform audits of EU-based subcontractors, suppliers, and distributors
Vigilance & Safety Oversight
- Ensure proper communication during vigilance situations
- Coordinate incident resolutions and Field Safety Corrective Actions with Competent Authorities
- Notify EU Authorities of major incidents when necessary
Continuous Regulatory Support
- Monitor applicable regulations across all 27 EU member states and 4 European Free Trade Association (EFTA) states
- Provide timely notifications of regulatory changes that may affect your products
- Ensure ongoing compliance as regulatory landscapes evolve
- Ad hoc tailored support for client requests on regulatory queries
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Meet the Team
European Regulatory Leaders Dedicated to Your Success
Elena Lucano, Ph.D.
Sr Manager, Quality and Regulatory Affairs
Dr. Elena Lucano is a dynamic Regulatory Affairs and Quality Assurance consultant with a proven track record of leadership and collaboration in medical devices and digital health. Adept at managing projects from startups to big corporates and spearheading high-impact initiatives across the EU, US, Switzerland, and UK, ensuring alignment with rigorous regulatory frameworks and industry standards. Her engineering background gives her a robust foundation and understanding of the operation of medical devices, as well as aspects connected to their development and production. Over the years, she also got experience and insights on the aspect linked to the privacy of personal data, supporting with GDPR and HIPAA compliance activities. Elena takes over responsibilities and has a global approach when it comes to support customers. Sharp and methodical, she will structure and deliver services that will match customers’ expectations and policy. Elena is fluent in Italian, English and French.
Cédric Razaname
Director, Quality and Regulatory Affairs
Cédric Razaname brings over eight years of specialized expertise in medical device quality systems and regulatory compliance. His comprehensive approach to quality management and regulatory strategy has proven instrumental in guiding companies through complex certification processes and regulatory inspections. As a skilled leader in the medtech sector, Cédric excels in implementing robust quality management systems, managing regulatory submissions, and fostering continuous improvement initiatives. His core strengths in risk management, stakeholder engagement, and critical thinking, combined with his dedication to coaching and mentoring, make him an invaluable resource for medical device manufacturers navigating the intricate landscape of global regulatory requirements and quality standards.
Case Studies
Comprehensive EC Rep Medical Devices Solutions
EC-REP and CH-REP Services
Situation
A UK-based medical device manufacturer was looking to maintain market access across both EU and Swiss markets. With different representation requirements for the European Economic Area (EEA) and Switzerland, they needed a trusted partner who could provide seamless, coordinated support across both jurisdictions without duplicating efforts
Successes
Building on our existing five-year regulatory consulting relationship, Veranex stepped in as both EC Representative and Swiss Representative. Our integrated approach eliminated the complexity of managing multiple representation relationships while ensuring full compliance with both MDR 2017/745 and Swiss MedDO requirements.
By leveraging our dual expertise, the client achieved:
- Reduced administrative burden through coordinated representation services
- Cost optimization by eliminating duplicate processes and documentation reviews
- Enhanced compliance confidence with tailored support for both regulatory environments
Services by Veranex
- Unified EC and CH representation under one strategic partnership
- Tailored technical documentation reviews optimized for both regulatory frameworks
- Coordinated quality management system assessments
Discover More
Related Services at Veranex
MDR Consulting
Strengthen your EU representation with comprehensive MDR consulting that ensures seamless European market access.

IVDR Consulting
Complement your EC Rep services with specialized IVDR consulting for complete diagnostic device compliance.

Quality Consulting
Enhance your EU representation effectiveness through integrated quality systems that satisfy European requirements.

Secure Your CH, UK or EU Authorized Representative for Medical Devices Today
Partner with Veranex for seamless EC Rep services that ensure compliance while accelerating your path to market.



