European Authorized Representative (EU-REP)
for Medical Device Companies

European Authorised Representative for Medical Devices

Responsibilities of the European Authorized Representative (EU-REP) for Medical Devices

Obligations of the European Authorised Representative (EU-REP) for Medical Devices

The obligations of the European Authorised Representative (EU-REP) for medical devices are set out in Regulation (EU) 2017/745 (MDR).
In addition to the applicable registration requirements, the European Authorised Representative must:
  • Verify that the EU Declaration of Conformity and the technical documentation have been properly drawn up by the manufacturer;
  • Verify, where applicable, that the appropriate conformity assessment procedure has been carried out;
  • Keep copies of all required documentation and make them available to competent authorities upon request, including:
  1. technical documentation,
  2. EU Declarations of Conformity,
  3. certificates, including any amendments or supplements;
  • Verify that the manufacturer has registered the required information in EUDAMED in accordance with the MDR;
  • Cooperate with competent authorities on any preventive or corrective actions, and immediately inform the manufacturer of complaints or requests from authorities for device samples;
  • Share responsibility for defective devices with the manufacturer, where the manufacturer is not established in the European Union and has failed to comply with its obligations under the Regulation.

Specialised European Authorised Representative (EU-REP) for Medical Devices

Why choose a specialised European Authorised Representative instead of a distributor?
Appointing a distributor as your European Authorised Representative may appear to be the simplest solution, but it is not always the most appropriate or strategic choice.
By working with a specialised and independent European Authorised Representative, manufacturers retain full control over regulatory compliance and market access, while maintaining flexibility in how their medical devices are marketed and distributed within the European Union.
A dedicated Authorised Representative acts exclusively in the manufacturer’s regulatory interest, ensuring a clear separation between regulatory responsibilities and commercial activities.

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MDQ’s European Authorized Representative (EU-REP) 


Are Designed to Be:

Tailored

The EU-REP service is provided under an annual service fee, reflecting the regulatory responsibilities associated with the appointment as European Authorised Representative.
Fees are structured according to the number of product families.
All activities are clearly defined and detailed in a transparent and accurate quotation.

Performance driven

We support post-market surveillance and vigilance activities, including performance monitoring, incident management, and regulatory reporting in the European Union.
Our team understands the importance of data-driven oversight and knows how to access, assess, and interpret regulatory and clinical information to ensure ongoing compliance with MDR requirements.

Fully Compliant

One of our qualified regulatory engineers oversees the conformity of your medical devices.
Device compliance is systematically verified in accordance with Regulation (EU) 2017/745 (MDR) and applicable competent authority requirements, ensuring robust and reliable regulatory oversight.

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We take the time to fully understand your specific needs, allowing us to deliver the most appropriate solution.
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