--- title: "Authorized Representative (EU-REP) — Regulatory Affairs | QbD Group" description: "If you're a medical device or IVD manufacturer outside the EU/EEA, appointing an EU-based Authorized Representative is a legal requirement to ensure compli" url: https://qbdgroup.com/en/services/regulatory-affairs/authorized-representative-eu-rep type: "Page" language: en publisher: "QbD Group" citation: "QbD Group, \"Authorized Representative (EU-REP) — Regulatory Affairs | QbD Group\", https://qbdgroup.com/en/services/regulatory-affairs/authorized-representative-eu-rep" --- # Authorized Representative (EU-REP) Your EU-based regulatory partner If you're a medical device or IVD manufacturer outside the EU/EEA, appointing an EU-based Authorized Representative is a legal requirement to ensure compliance with MDR and IVDR. ## 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. If you're a medical device or in vitro diagnostic (IVD) manufacturer outside the EU/EEA, **appointing an EU-based Authorized Representative is a legal requirement** to ensure compliance with MDR (Regulation (EU) 2017/745) and IVDR (Regulation (EU) 2017/746). **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 ## 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. ### Trusted by 100+ non-EU manufacturers A proven track record of reliable EU representation across diverse device categories. ### Over 15 years of regulatory expertise Deep, hands-on experience with MDR and IVDR compliance requirements. ### Regulatory credibility EAAR member following the official Code of Conduct for authorized representatives. ### Local presence Offices in Belgium (EU), with support also available in UK and Switzerland. ### Confidential and secure Strict document handling procedures to protect your proprietary information. ### Integrated expertise Access to QbD's broader regulatory, quality, and CE marking 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. As your EU-REP, QbD Group will: ### Represent you to EU Competent Authorities Official representation and communication with all relevant EU regulatory bodies on your behalf. ### Verify documentation Verify your EU Declaration of Conformity and technical documentation has been drawn up. Store copies for at least 10 years after your last product is placed on the market. ### Ensure registration compliance Verify manufacturer has complied with registration obligations in accordance with MDR/IVDR. Provide documentation and product information to EU authorities upon request. ### Post-market support Support with post-market surveillance, complaints, incident reports, and Field Safety Corrective Actions (FSCAs). Ensure your product labelling includes correct EU-REP details. ## Our 3-step onboarding process Getting started with QbD Group as your EU-REP is simple and efficient: ### 1. Kickoff & agreement We sign a clear mandate and define your regulatory roadmap. ### 2. Documentation review We audit your files and ensure regulatory readiness. ### 3. Official representation We act on your behalf and support compliance continuously. ## 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. ## Authorized Representative Services for the UK and Switzerland Do you want to appoint an Authorized Representative to sell your products in the UK or Switzerland? Find out more about our representative services: [UKRP If you are a manufacturer that wants to enter the United Kingdom.](https://qbdgroup.com/en/services/regulatory-affairs/ukrp-uk-responsible-person) [CH-REP For manufacturers that want to enter Switzerland.](https://qbdgroup.com/en/services/regulatory-affairs/swiss-authorized-representative) Why QbD Group ## Your trusted partner We are a proud member of the European Association of Authorized Representatives (EAAR) and operate in strict accordance with its Code of Conduct. Trusted by 100+ non-EU manufacturers worldwide. Over 15 years of regulatory expertise in MD and IVD representation. 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. Integrated expertise: Access to QbD's broader regulatory, quality, and CE marking services. ## Let's talk Regulatory Affairs From regulatory strategy to product approval, our experts are ready to guide you through every step. Contact us --- Source: https://qbdgroup.com/en/services/regulatory-affairs/authorized-representative-eu-rep — © QbD Group. Quote freely with attribution and a link back.