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.

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60

+

Regulatory & Quality Consultants Worldwide

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27

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Member States Covered by Our Representation Services + UK + Switzerland

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20

+

Years of Regulatory Experience in Europe

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

Elena Lucano, Ph.D.

Sr Manager, Quality and Regulatory Affairs

Cédric Razaname

Director, Quality and Regulatory Affairs

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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

MDR Consulting

MDR Consulting

Strengthen your EU representation with comprehensive MDR consulting that ensures seamless European market access.

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IVDR Consulting

IVDR Consulting

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

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Quality Consulting

Quality Consulting

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

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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.

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