EU Authorized Representative (EU REP) Services

Your Official Gateway to the European Union Market

Reliable EU Authorized Representative Services, EUDAMED Registration, SRN Support, and Regulatory Compliance for Medical Device Manufacturers.

Secure Your EU Market Access

What is an EU Authorized Representative?

Manufacturers located outside the European Union must appoint an EU Authorized Representative (EU REP) before placing medical devices on the European market under Regulation (EU) 2017/745 (EU MDR).

The EU REP acts as the official regulatory liaison between non-EU manufacturers and European Competent Authorities, ensuring ongoing compliance, communication, and market access.

Our structured EU REP services provide manufacturers with a trusted regulatory partner throughout the entire product lifecycle.

  • EU MDR Compliance

    Full compliance with Regulation (EU) 2017/745

  • European Market Access

    Legally place products in EU countries

  • Regulatory Representation

    Official liaison with Competent Authorities

  • Continuous Support

    Ongoing compliance monitoring and guidance

Our EU REP Services

Comprehensive European Regulatory Representation for Medical Device Manufacturers

Regulatory Representation

• Acting as your legally designated EU Authorized Representative

• Representation before European Competent Authorities

• Regulatory communication management

• Manufacturer compliance oversight

• EU MDR regulatory guidance

• Ongoing regulatory support

EUDAMED & SRN Services

• EUDAMED Registration Support

• Single Registration Number (SRN)

• Economic Operator Registration

• Device Registration Assistance

• UDI-DI & Basic UDI-DI Support

• Regulatory Database Management

Technical Documentation Review

• Verification of Technical Documentation

• EU Declaration of Conformity Review

• Annex II & Annex III Assessment

• Device Compliance Verification

• Regulatory Documentation Management

• Compliance Gap Identification

Authority Communication Support

• Communication with Competent Authorities

• Regulatory Correspondence Handling

• Vigilance Reporting Support

• Post Market Surveillance Assistance

• Inspection Coordination

• Audit Support Services

Additional Compliance Support

SRN Registration

Obtaining and managing your European Single Registration Number.

Country Transfer Support

Competent Authority registration changes between EU Member States.

Document Maintenance

Maintaining regulatory records and compliance documentation.

Audit Assistance

Supporting inspections, audits, and authority reviews.

Why Choose QM Service Global?

EU MDR Expertise

Experienced regulatory professionals with strong EU MDR knowledge.

Reliable Representation

Trusted European regulatory representation for global manufacturers.

Continuous Compliance

Long-term regulatory support throughout the product lifecycle.

Benefits of Our EU REP Services

  • Legal EU Market Access

    Meet mandatory EU MDR requirements for non-EU manufacturers.

  • Regulatory Confidence

    Maintain continuous compliance with European regulations.

  • Reduced Regulatory Risk

    Minimize delays, compliance gaps, and regulatory issues.

  • Dedicated Support

    Expert guidance throughout registration and post-market activities.

Secure Your EU Market Access Today

With our structured compliance approach and regulatory expertise, we ensure your products remain fully compliant and continuously supported within the European market.

✪ Reliable EU REP Services • EUDAMED Registration • SRN Support • Continuous Compliance ✪

Talk to an EU REP Specialist