In-Country Representative Services
EU-REP, UKRP, and CH-REP services
Our regulatory experts serve as EU-REP/UKRP/CH-REP to allow easy access of IVD and MD devices to the European, UK, and Swiss markets.
What is an Authorized Representative?
An Authorized Representative is a legal entity established within a specific jurisdiction that acts on behalf of a non-EU / non-UK / non-Swiss manufacturer. They serve as the main point of contact between the manufacturer and local competent authorities, ensuring compliance with the region's medical device and in vitro diagnostic device regulations and managing post-market responsibilities.
Partner with confidence: why choose QbD Group as your Authorized Representative
We provide experienced, independent, and fully compliant representation across key European markets.
Multi-Market Expertise
We ensure full compliance with EU MDR/IVDR, UK, and Swiss regulations — providing reliable representation in all three key markets.
More Than Just Representation
Beyond meeting legal requirements, we offer end-to-end support including regulatory strategy, technical documentation, and post-market surveillance.
Regulatory Expertise Across Borders
With a vast network of regulatory consultants across the EU, UK, and Switzerland, QbD Group offers local expertise combined with cross-border regulatory consistency.
Direct, Expert Communication
You'll work directly with experienced regulatory professionals — fast, transparent, and personalized.
Trusted Access Partner
As your EU-REP, UKRP, and CH-REP, we serve as the official point of contact for authorities and can provide the required documentation we hold on file upon request.
Authorised Representative Services for All Device Classes
We provide consistent and reliable Authorised Representative services across all device classes and IVD categories, ensuring compliance regardless of your device's risk profile.
What we offer
Our regulatory experts serve as EU-REP/UKRP/CH-REP to allow easy access of IVD and MD devices to the European/UK/Swiss market.
Documentation verification
Ensure Declaration of Conformity & technical documents have been drawn up.
Compliance confirmation
Verify manufacturer has complied with registration obligations.
Labeling & Identification
Confirm devices display the manufacturer's & AR's name/address per regulations.
Incident & Complaint Handling
Serve as the primary contact for EU/UK/Swiss authorities, cooperate on corrective actions & incident reporting.
Communication with Authorities
Provide required documentation & maintain compliance records for up to 10 years.
Market Surveillance Support
Work with authorities on corrective actions, market surveillance, and device withdrawals.
Beyond representation: your full compliance partner
Our Authorized Representative service is part of a fully integrated regulatory and quality framework that keeps your device compliant at every stage.
QbD Group goes further than standard authorised representation. We act as your long-term regulatory partner guiding your market entry and ensuring sustained compliance across the entire device lifecycle.
Regulatory Affairs Support
Strategic regulatory support covering the full spectrum of compliance needs, from representation obligations to technical documentation, submissions, and regulatory lifecycle management.
Quality & Auditing Services
Independent internal, supplier, or mock audits to verify your Quality Management System (QMS), supplier controls, and MDR/IVDR compliance readiness.
Post-Market Surveillance & Vigilance
Support with the monitoring of post-market obligations, assistance in vigilance and FSCA/FSN processes, and guidance in identifying and assessing emerging risks.
Training & Compliance Check-ins
Access to experienced RA and QA professionals for targeted training, strategic advice, and/or quick assessments of regulatory or quality impacts.
Trusted Authorized Representative Services for the EU, UK, and Switzerland
Why QbD Group
Your trusted partner
QbD Group is your trusted partner for Authorized Representative services across Europe.
Global vision, local expertise: with regulatory hubs across Europe and international experience, we provide smart, scalable solutions for MedTech manufacturers.
Regulatory excellence: backed by industry leaders like Qarad, we bring over 20 years of experience in medical device and IVD compliance.
End-to-end support: from CE marking to post-market obligations, QbD Group helps you manage the full lifecycle of your product in key markets.
Personalized, proactive approach: our team works closely with yours to align your regulatory strategy with your business goals.
Let's talk Regulatory Affairs
From regulatory strategy to product approval, our experts are ready to guide you through every step.