EU Authorized Representative (EAR)

We act as your designated EAR in the European Union (EU), ensuring compliance with EU MDR (2017/745) and IVDR (2017/746). We support technical documentation review, incident reporting, and communication with competent authorities.

• Responsibilities (Article 11 MDR)

• QNET Role & Process

• Required Documentation

• Benefits & Liabilities

• Regulatory References

 

 

Your Trusted Partner for EU Market Compliance

What is an EU Authorized Representative?

An EU Authorized Representative (EAR) is a legal requirement for non-EU manufacturers of medical devices, in vitro diagnostic devices (IVDs), personal protective equipment (PPE), and other regulated products who intend to place their products on the EU market.
According to Article 11 of the EU Medical Device Regulation (MDR 2017/745) and IVDR (2017/746), manufacturers located outside the EU must appoint an EAR to act on their behalf in dealing with European Competent Authorities and fulfilling specific regulatory obligations.

This mandate is not a formality—it is a critical compliance role that requires technical, regulatory, and operational competence.

 

Why Choose QNET as Your EAR?

At QNET, we recognize the growing complexity of EU regulations. We provide more than just a registered address; we deliver professional, fully accountable representation that meets legal requirements and international best practices.

1. In-House Expertise: Registered PRRC on Staff

QNET employs a Person Responsible for Regulatory Compliance (PRRC) in-house, as required under Article 15 of the MDR/IVDR. This ensures your products are represented by a team with verifiable competence, not by intermediaries or administrative offices.

 

2. Multi-Jurisdictional Support

We represent clients not only in the EU but also in the UK (UKRP), Switzerland (CH-REP), and the US (US Agent support). This unified, global approach simplifies compliance for international manufacturers and reduces the risk of fragmented representation across different jurisdictions.

 

3. Direct Regulatory Interaction

QNET maintains active communication lines with EU Competent Authorities, Notified Bodies, and other regulatory stakeholders. This ensures that your regulatory files are in safe hands and that post-market communications are handled swiftly, accurately, and with full accountability.

 

4. Full Compliance and Liability Awareness

The EAR role entails significant regulatory responsibilities, including potential legal liability. At QNET, we take this seriously. Our processes are structured in accordance with:

-         MDR/IVDR Article 11 requirements

-         MDCG 2022-16 guidance on EAR obligations

-         ISO 13485:2016 quality management principles

-         Best practices for risk and liability management

This structure helps minimize exposure for both the manufacturer and the representative.

 

5. End-to-End Regulatory Support

While our role as EAR is defined by law, QNET also offers optional regulatory consultancy services for clients needing broader support, such as:

-         Technical documentation gap assessments

-         Post-market surveillance (PMS) and vigilance reporting assistance

-         Compliance with EU labeling and registration requirements (EUDAMED/UDI)

-         Updates on evolving EU legislation and guidance

By combining representation with advisory services, we help our clients not only enter the market but also remain compliant throughout the product lifecycle.

 

What We Do as Your EU Authorized Representative (EAR)

When you appoint QNET as your EAR, we will:

-         Verify that your Declaration of Conformity (DoC) and technical documentation (TD) are compliant

-         Keep a copy of your technical documentation readily available for authorities

-         Cooperate with Competent Authorities on vigilance and corrective actions

-         Fulfill UDI/EUDAMED registration obligations where required

-         Provide an EU contact address for your labels and instructions for use

-         Proactively monitor regulatory updates and inform you of relevant changes

 

Transparency, Integrity, and Partnership

At QNET, we believe in transparent collaboration. We see the EAR role not merely as a legal checkbox but as a partnership based on trust, technical integrity, and regulatory precision. Our clients have direct access to decision-makers, not call centers or anonymous desks.

 

Contact Us

If you are a manufacturer of medical devices, IVDs, PPE, or other regulated products seeking professional, accountable EU representation, contact QNET today to learn more about how we can support your market access and compliance.

Swiss Authorized Representative (CH-REP)

 

To enter the Swiss market, foreign manufacturers must appoint a CH-REP in accordance with Swiss MedDO/IvDO regulations. We handle interactions with Swissmedic, provide registration support, and coordinate vigilance.
[Learn more about our CH-REP services →]

• Obligations under Swiss MedDO
• Swissmedic Notification
• Unique Swiss Requirements
• QNET CH Office Info

Technical Documentation Support

We help you develop, review, and maintain your Annex II and III MDR/IVDR technical documentation, ensuring full readiness for audits and regulatory reviews.
[Learn more about our Technical Documentation services →]

• MDR/IVDR Compliance Strategy
• GAP Analyses & Roadmaps
• GSPR Checklists
• PRRC Advisory (Article 15 MDR/IVDR)

Technical Documentation Services

• Annex II & III Support
• Device Description & Specification
• Benefit-Risk Analysis
• Performance & Safety Evaluation

Product Classification & Registration

• MDR/IVDR Product Classification
• Borderline Device Support
• EUDAMED Registration (Actor/UDI)
• MHRA/Swissmedic Registration

UK Responsible Person (UKRP)

Post-Brexit, manufacturers outside the UK must appoint a UKRP to access the British market. We manage MHRA registrations, maintain your documentation, and serve as your point of contact in the UK.
[Learn more about our UK Responsible Person services →]

• Role under UK MDR 2002 (as amended)
• MHRA Registration Support
• Product Labelling Requirements
• QNET UK Office Details

US Agent Services

Non-US manufacturers must appoint a US Agent to meet FDA requirements. We facilitate communication with the US Food and Drug Administration (FDA) and support your US market activities.
[Learn more about our US Agent services →]

• Role for FDA Correspondence 
• 21 CFR Part 807 Requirements
• QNET’s US Presence & Support

Implementation Quality Management System

 

Our experts assist in setting up and maintaining a Quality Management System (QMS) aligned with ISO 13485, 21 CFR 820, and related regulatory frameworks.
[Learn more about our QMS services →]

• ISO 13485:2016 Systems
• Internal Audits
• Supplier Evaluation
• ISO 14971 Risk Management

EU Representative – GPSR

A GPSR EU Representative (General Product Safety Regulation EU Representative) is a legal entity or individual based in the European Union who represents non-EU manufacturers to ensure compliance with the EU General Product Safety Regulation (GPSR). This representative is responsible for ensuring product safety compliance, maintaining technical documentation, cooperating with market surveillance authorities, and acting as a contact point for regulatory matters within the EU market.

Post-Market Surveillance (PMS) & Vigilance

We design and support PMS systems, vigilance processes, and incident reporting strategies, helping you stay compliant after product launch.
[Learn more about PMS & Vigilance services →]

·        PMS Plans

·        PSURs / PMCF Support

·        Incident Reporting (MIR)

·        Trending & Vigilance Evaluation

Regulatory Strategy & Compliance Consultancy

 

We provide strategic regulatory advice, gap analyses, compliance audits, and tailored consultancy to help you navigate complex global requirements.