EU Authorised Representative (EU REP)

Essential regulatory representation for non‑EU manufacturers placing medical devices and IVDs on the European market.

Your trusted regulatory representative in Europe

The EU Authorised Representative (EU REP) is a mandatory role under MDR 2017/745 and IVDR 2017/746 for all non‑EU manufacturers intending to distribute medical devices or in vitro diagnostics on the European market.
MediQuasar provides a structured, highly qualified EU Authorised Representative service, ensuring robust regulatory oversight, documentation traceability and operational continuity throughout the device life cycle.
The aim is to ensure that technical documentation is available, consistent and compliant with applicable requirements, reducing the risk of market disruptions, recalls or non‑compliance.

Core responsibilities of the EU Authorised Representative

Regulatory representation

Formal appointment as EU REP and management of relationships with European competent authorities.

Documentation verification

Verification of the availability, completeness and compliance of the required technical documentation.

Registrations and traceability

Verification of correct manufacturer identification, management of EUDAMED registrations and device traceability.

Official communications

GManagement of requests, inspections, notifications and formal exchanges with competent authorities.

Incidents and vigilance

Support with complaint and incident handling, FSN/FSCA and required corrective actions.

Ongoing regulatory oversight

Continuous monitoring of compliance and support to the manufacturer for post-market activities..

HOW IT WORKS

MediQuasar assumes the EU Authorised Representative role for non‑EU manufacturers, providing formal regulatory coverage and hands-on support.
The service is delivered in full compliance with Article 11 of the MDR and Article 11 of the IVDR and includes all responsibilities required by the Regulations, without duplicating the manufacturer’s obligations.

Formal EU REP appointment
Verification and retention of technical documentation
Management of interactions with competent authorities and Notified Bodies
EUDAMED registrations (where applicable)
Support in the event of inspections, requests or notifications
Long-term traceability and ongoing document availability

EU REP — Product verification

Before or during the appointment as EU Authorised Representative, MediQuasar performs a preliminary review of the device and the associated documentation to confirm that minimum requirements for placing on the European market are in place.