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EU-REP - Regulatory Affairs - QbD Group (1)

EU Authorised Representative (EU-REP) Services

Need an EU Authorised Representative for Your Medical Device or IVD? QbD Group ensures your compliance with MDR and IVDR as your trusted EU-REP partner. 
 
If you're a medical device or in vitro diagnostic (IVD) manufacturer based outside the EU/EEA, you are legally required to appoint an EU Authorised Representative based within the EU to ensure and maintain compliance with the MDR and IVDR. This is a crucial step in complying with Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR).
 
QbD Group offers professional EU-REP services, supporting you with local representation and ensuring compliance with all regulatory obligations. We are a proud member of the European Association of Authorised Representatives (EAAR) and operate in strict accordance with its Code of Conduct.
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What is an EU-REP and who needs one?

An EU-REP is a natural or legal person established within the European Union who has received and accepted a written mandate from a manufacturer located outside the EU. This mandate authorises the EU-REP to act on the manufacturer's behalf in relation to specific tasks under MDR or IVDR. Who needs an EU-REP?

Manufacturers based outside the European Economic Area (EEA)

Companies placing devices on the EU market under their own name

Startups and SMEs expanding from the US, UK, or Asia into Europe

 

EU Authorised Representative (EU-REP) Services

How can we help you as an EU-REP?

Based in Belgium and with offices across the EU, QbD Group serves as a central hub for regulatory communications with European Competent Authorities. Our experienced team ensures fast, professional handling of all regulatory responsibilities. As your EU-REP, QbD Group will:

  • Represent you to EU Competent Authorities

  • Verify your EU Declaration of Conformity and ensure your technical documentation is prepared and up to date

  • Store copies of technical documentation, Declarations of Conformity, and applicable Notified Body certificates for at least 10 years after your last product is placed on the market

  • Ensure product registration in accordance with MDR/IVDR Articles 24, 26, and 28

  • Provide documentation and product information to EU authorities upon request

  • Forward and manage requests from EU authorities for samples, access, or further clarification

  • Support with post-market surveillance, complaints, incident reports, and Field Safety Corrective Actions (FSCAs)

  • Ensure your product labelling includes correct EU-REP details

Request your free, no-obligation proposal
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Our 3-step onboarding process

Need assistance? Get in touch.
EU Authorised Representative (EU-REP) Services

1. Kickoff & agreement

We sign a clear mandate and define your regulatory roadmap.

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EU Authorised Representative (EU-REP) Services

2. Documentation review

We audit your files and ensure regulatory readiness.

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EU Authorised Representative (EU-REP) Services

3. Official representation

We act on your behalf and support compliance continuously.

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Offering_Regulatory 1
EU Authorised Representative (EU-REP) Services

Why partner with QbD Group?

Our experts have been active for many years as a European Authorized Representative for over one hundred different companies, and build on the regulatory and technical competence of the team. We can fulfil your need for representative services.

 

  • Trusted by 100+ non-EU manufacturers

  • Over 15 years of regulatory expertise

  • Full compliance: We work in line with the latest MDR and IVDR requirements

  • Regulatory credibility: EAAR member following the official Code of Conduct

  • Local presence: Offices in Belgium (EU), with support also available in UK and Switzerland

  • Confidential and secure: Strict document handling procedures

  • Integrated expertise: Access to QbD’s broader regulatory, quality, and CE marking services

Get in touch

EU-REP Frequently Asked Questions

Can QbD also help us with MDR or IVDR compliance beyond EU-REP services?

Yes. Our team can guide you through every step of the CE marking process, including QMS setup, gap assessments, and technical file compilation.

What documents do we need to provide?

Typically: Declaration of Conformity, Technical Documentation, labeling info, PMS/PMCF plan, and contact details.

How fast can we start?

We can usually begin within 1 to 2 weeks, depending on your readiness and documentation status.

 

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Get in touch with our EU-REP experts

Looking for a reliable, experienced EU Authorised Representative? QbD Group is ready to support your market access journey. Contact us for more information or request a free, no-obligation proposal.

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Authorized Representative Services for the UK and Switzerland

Do you want to appoint an Authorised Representative to sell your products in the UK or Switzerland? 

Find out more about our Swiss and UK representative services:

UK-Responsible-Person-UKRP-QbD-Group

UKRP

If you are a manufacturer that wants to enter the United Kingdom.
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Swiss-Authorized-Representative-CH-REP-Services-QbD

CH-REP

For manufacturers that want to enter Switzerland.
Learn more

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