Introduction

If you are a non-European manufacturer planning to sell medical devices in Europe, appointing
an EU Authorized Representative is mandatory under MDR and IVDR.
Nexus Global acts as your professional EU Representative and supports your compliance
journey within the European market.

What is an EU Authorized Representative?

An EU Authorized Representative (EU REP) is a legal entity established within the European
Union that acts on behalf of non-EU manufacturers regarding specific obligations under MDR
and IVDR.
The EU Representative communicates with European authorities and ensures regulatory
documentation remains properly maintained and available.

Who Needs an EU Representative?

Manufacturers outside the European Union who want to place medical devices in Europe
require an EU Representative.
Examples of Devices:
• Surgical Instruments
• Dental Instruments
• Diagnostic Devices
• Disposable Medical Devices
• Orthopedic Devices
• Hospital Equipment
• Laboratory Devices

Responsibilities of an EU Representative

• Verify compliance documentation
• Maintain technical documentation
• Support EUDAMED registration
• Assist with regulatory communication
• Support post-market surveillance
• Verify CE compliance and labeling