What is an EU Authorized Representative (EUAR) and why is it required?

An EU Authorized Representative (EUAR) is the legally mandated local representative for non-EU medical device manufacturers. Under EU MDR 2017/745 and IVDR 2017/746, foreign manufacturers must appoint an EU-based EUAR to act as liaison with Competent Authorities and ensure regulatory compliance across all 27 EU member states.

Should I use an independent EUAR or my distributor as EU Authorized Representative?

Independent EUAR is strongly recommended. Using your distributor as EUAR creates commercial dependency - changing distributors means losing EU market access and re-registering all devices. Independent EUARs like Pure Global maintain neutrality, allowing distributor changes without regulatory disruption across 27 EU countries.

What is the typical cost for EU Authorized Representative services?

EUAR costs vary significantly by device class and scope. Regulatory support ranges €4,000-€50,000+ per device. Class I self-certification: €4K-€10K. Class IIa/IIb with Notified Body: €15K-€35K. Class III high-risk: €30K-€50K+. Costs include EUAR fees, technical documentation, EUDAMED registration, and Notified Body coordination (not certification fees).

How do I evaluate EUAR pricing transparency and hidden costs?

Top EUARs provide clear pricing structures with itemized breakdowns. Red flags include 'contact for quote only' with zero guidance, hidden fees for EUDAMED registration or Competent Authority queries, and hourly billing without caps. Pure Global offers transparent pricing ranges, fixed-fee options for standard devices, and no surprise charges.

What technical expertise and MDR/IVDR knowledge should an EUAR have?

Top EUARs employ regulatory specialists with 5+ years EU MDR/IVDR experience, Notified Body relationships, and multi-device-class expertise. Essential qualifications include technical documentation compilation, EUDAMED proficiency, conformity assessment coordination, and understanding of EU harmonized standards. Pure Global combines European regulatory experts with global market knowledge across 30+ countries.

Why does multi-country EUAR coverage matter for EU market strategy?

Single EUAR covers all 27 EU member states, but EUARs with global reach (30+ countries) provide strategic advantages. Cross-market regulatory intelligence enables efficient submissions, leveraging existing approvals (FDA, Health Canada, TGA) for EU technical documentation. Pure Global's presence in Americas, Europe, Asia-Pacific streamlines worldwide market access from one partner.

Choose an EU Authorized Representative (EUAR) FAQ - Updated October 2025

How To 7 Critical Criteria for Selecting Your EU Authorized Representative. Expert guidance by Pure Global regulatory specialists

EU MDR/IVDR Compliance

EUAR Selection Guide

CE Marking Strategy

Pure Global: Modern EU Authorized Representative

Pure Global meets all 7 critical EUAR selection criteria with transparent pricing, global regulatory expertise, and proven MDR/IVDR compliance across 27 EU countries and 30+ international markets.

As your independent EU Authorized Representative, Pure Global combines local European regulatory expertise with global reach to streamline CE Marking and market access. Our transparent pricing, Notified Body relationships, and multi-language support deliver comprehensive EUAR services for medical device and IVD manufacturers.

✓ Transparent EU Pricing

Published rates: Class I €4K-€10K, Class IIa/IIb €15K-€35K, Class III €30K-€50K+

✓ Global Market Access

One EUAR → 27 EU countries + 30+ international markets from single partner

✓ Independent EUAR Status

Not affiliated with distributors - you control your EU registrations and commercial strategy

✓ MDR/IVDR Expertise

10+ years EU regulatory experience, Notified Body relationships, multi-language support

EU Market Size

$181.6B MD

450 million population across 27 EU countries

Regulatory Support Cost

€4K - €50K+

Varies by device class and Notified Body involvement

Selection Criteria

7 Critical Factors

Key criteria to evaluate and compare EUAR candidates

Market Access Timeline

6 - 36 Months

Depends on device class and application quality

Frequently Asked Questions

On This Page

Understanding EU Authorized Representative (EUAR) Basics

EUAR Pricing & Cost Transparency

EUAR Technical Expertise & Qualifications

Multi-Country Coverage & Global Reach

Quick Resources

How to Choose an EU Authorized Representative EUDAMED Database EU MDR Regulation (2017/745)EU IVDR Regulation (2017/746)Pure Global EU Services

Key Dates & Milestones

Guide UpdatedOctober 2025

EU MDR Effective DateMay 26, 2021

EU IVDR Full ApplicationMay 26, 2022

Pure Global EU ServicesActive Now

Pure Global EUAR Pricing

Class I (Self-Certification)

€4,000 - €10,000

Class IIa/IIb (Notified Body)

€15,000 - €35,000

Class III (High Risk)

€30,000 - €50,000+

Includes:

✓ EUAR appointment & liaison
✓ Technical documentation review
✓ EUDAMED registration
✓ Notified Body coordination
✓ Post-market surveillance

EUAR Selection Checklist

Essential Criteria:

☐ Published pricing transparency
☐ Independent (not distributor)
☐ 5+ years MDR/IVDR experience
☐ EU office with EUDAMED access
☐ Notified Body relationships
☐ Multi-language support (EN/DE/FR)
☐ Global market coverage (30+ countries)
☐ Client references available

✅ Pure Global meets all criteria

Note: This FAQ guide provides general information about regulatory requirements and should not be considered as legal advice. Regulations are subject to change. Always consult with qualified regulatory professionals for specific guidance.

Last updated: October 2025 | Based on Choose an EU Authorized Representative (EUAR) official documentation