For manufacturers located outside the European Union, appointing a European Authorized Representative (EAR / EC REP) is a mandatory requirement for placing medical devices and IVDs on the EU market. Your EC REP acts as your legal representative within the EU, ensuring your products comply with EU MDR (2017/745) and EU IVDR (2017/746), while maintaining seamless communication with regulatory authorities and Notified Bodies.

Masuu Global Solutions provides reliable, fully compliant EC REP services, helping manufacturers navigate European market requirements with confidence. As a trusted regulatory partner, we simplify complex EU obligations, ensure documentation readiness, and support you throughout the entire device lifecycle.

European Authorized Representative (EC REP) Services – Overview

Non EU medical device and IVD manufacturers must designate an EU based representative to act on their behalf in all regulatory matters. The EC REP functions as your primary point of contact for European Competent Authorities and ensures that your product remains compliant after entering the market.

With Masuu Global Solutions serving as your EC REP, you gain a partner who:
  • Understands the evolving regulatory landscape
  • Ensures constant compliance with MDR/IVDR requirements
  • Provides proactive regulatory support and communication
  • Maintains all required technical documentation on your behalf

We work closely with manufacturers to ensure product safety, streamline market entry, and maintain long term EU compliance.

Masuu’s European Authorized Representative (EC REP) Service Offerings

Our EC REP Responsibilities Include:

Device Registration

Managing registration with EU National Competent Authorities before product placement in the EU.

Documentation Verification

Reviewing and verifying the manufacturer’s:
  • Declaration of Conformity (DoC)
  • Technical documentation
  • CE Certificates and associated annexes

Conformity Assessment Oversight

Ensuring the correct MDR/IVDR conformity assessment procedure has been followed.

Technical File & Document Retention

Maintaining copies of Technical Files, DoCs, and CE certificates for:
  • 10 years (general medical devices)
  • 15 years (implantable devices)

Regulatory Communication

Managing all interactions with EU Competent Authorities and responding to information requests.

Incident & FSCA Support

Assisting with Field Safety Corrective Actions (FSCA), vigilance reporting, and incident communication.

Representation on Product Labeling

Displaying Masuu Global’s name and address on labeling, packaging, IFUs, and regulatory documentation.

Masuu’s EC REP Expertise

  • Independent, EU based regulatory representation
  • Continuous liaison with Competent Authorities and Notified Bodies
  • Designated single point of contact for all EU regulatory matters
  • Deep expertise across medical devices and IVD categories
  • Strong understanding of region specific requirements and language expectations

Advantages of Partnering with Masuu Global Solutions

  • Cost effective, annual EC REP service packages
  • Experienced regulatory specialists across all device classes
  • EU wide partner network for efficient and localized support
  • Consistent regulatory oversight to prevent compliance gaps
  • Seamless alignment with MDR/IVDR obligations
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