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 RepS BV 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 outside the EU/EEA, appointing an EU-based Authorised Representative is a legal requirement to ensure compliance with MDR (Regulation (EU) 2017/745) and IVDR (Regulation (EU) 2017/746).

QbD RepS BV 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.

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 your technical documentation has been drawn up
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
Verify manufacturer has complied with registration obligations in accordance with MDR/IVDR
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

Our 3-step onboarding process

Need assistance? Get in touch.

1. Kickoff & agreement

We sign a clear mandate and define your regulatory roadmap.

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2. Documentation review

We audit your files and ensure regulatory readiness.

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3. Official representation

We act on your behalf and support compliance continuously.

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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

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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, Complete Annex II and III Technical Documentation, and contact details.

How fast can we start?

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

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.

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:

UKRP

If you are a manufacturer that wants to enter the United Kingdom.

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CH-REP

For manufacturers that want to enter Switzerland.

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Related resource

Your Gateway to the EU Market: The Crucial Role of the Authorised Representative

Learn why an EU Authorised Representative is essential for MDR and IVDR compliance — and how QbD RepS BV helps non-EU manufacturers enter the EU market with confidence.

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