European Authorized Representative (EUAR) for Medical Devices

Your Gateway to the EU Market—Without Compliance Gaps or Delays

If you are a medical device manufacturer located outside the European Union, appointing a European Authorized Representative (EUAR) is not optional—it is a legal requirement for placing your device on the EU market.

Under the EU Medical Device Regulation (EU MDR 2017/745), a non-EU manufacturer must designate a single authorized representative established within the EU before commercialization can begin.

RQMIS provides trusted EU Authorized Representative services to help you meet regulatory requirements, maintain compliance, and successfully access the European market.

Why the EU Authorized Representative Role Matters

The EUAR acts as your official representative within the European Union, serving as the primary point of contact between your company and European Competent Authorities.

Without an EUAR:

• Your device cannot be legally placed on the EU market
• CE certification cannot be completed
• Regulatory registration requirements cannot be fulfilled

More importantly, the EUAR plays a critical role in ensuring your product remains compliant throughout its lifecycle—not just at the time of approval.

What an EU Authorized Representative Does

The EUAR is responsible for supporting regulatory compliance and facilitating communication with authorities.

Regulatory Representation & Communication

• Acts as your official point of contact with EU Competent Authorities
• Responds to regulatory inquiries and requests
• Ensures timely communication of complaints, incidents, and regulatory actions

Technical Documentation & Compliance Oversight

• Verifies that technical documentation and declarations of conformity are in place
• Maintains documentation for regulatory review
• Provides documentation to authorities upon request in the appropriate language

Registration & EUDAMED Support

• Confirms compliance with device and manufacturer registration requirements
• Supports Unique Device Identification (UDI) implementation
• Ensures proper registration within European systems such as EUDAMED

Post-Market Surveillance & Vigilance Support

• Communicates complaints and incident reports to the manufacturer
• Supports corrective and preventive actions
• Cooperates with authorities to mitigate risks associated with devices

Inspection & Audit Support

• Coordinates requests for product samples or access
• Supports regulatory inspections and audits
• Ensures alignment with EU MDR expectations

A Critical Compliance Partner—Not Just a Formal Requirement

Under EU MDR, the role of the Authorized Representative has expanded significantly.

The EUAR now:

• Shares regulatory responsibility with the manufacturer
• Plays an active role in lifecycle compliance and post-market oversight
• Must ensure ongoing alignment with EU regulatory requirements

Choosing the right EUAR is not just about checking a box—it’s about protecting your ability to operate in the EU market.

How RQMIS Supports You

RQMIS provides end-to-end EU Authorized Representative services designed for speed, clarity, and ongoing compliance.

• Dedicated EU-Based Representation: We serve as your official EUAR, providing a reliable, responsive presence within the European Union.
• Regulatory Coordination & Communication: We manage all interactions with EU Competent Authorities, ensuring timely and accurate communication.
• Documentation Review & Compliance Support: Our team reviews your technical documentation and regulatory framework to ensure alignment with EU MDR requirements.
• Ongoing Regulatory Updates: We keep you informed of evolving EU regulatory requirements so you can stay ahead of changes—not react to them.
• Integrated Global Support: Because RQMIS also supports FDA, UKCA, clinical, and quality services, we ensure your EU strategy aligns with your global regulatory approach.

The Outcome

With RQMIS as your EU Authorized Representative, you can:

• Gain and maintain access to the EU market
• Ensure continuous compliance with EU MDR requirements
• Respond quickly to regulatory inquiries and inspections
• Reduce risk of delays, non-compliance, or enforcement action

Enter the EU Market with Confidence

EU MDR has raised the bar for medical device compliance—and the EU Authorized Representative is now central to that process.