European Authorized Representative

Qserve as your European legal representative for medical devices and IVD companies

EN

European Authorized Representative

When is an EU Authorized Representative (EC REP) required?

The European Union requires any foreign manufacturer who intends to sell their devices in any of the Member States to designate a sole authorized representative (EC REP) with a physical address within one of the Member States.

The European Authorized Representative will represent your company to the national authorities. And shall register your devices in the electronic system before commercialization. It is the liaison between a manufacturer and an national competent authority. The use of name and registerd address is on all product related labelling.

A European Authorized Representative may also be known as a EUAR, EC REP, CE REP, EU REP and also an EAR. All of these mean the same; EU Authorized Representative.

Interested in our European Authorized Representative Services?

Send the request for more information about the EC Rep service.

Information request

Responsibilities of the EU Rep

Access and availability of your most up to date technical file
Act within 24 hours in case of incidents and Field Safety Corrective Action (FSCA) reporting.
First point of contact for the competent authority

Due to the increased liability under the MDR/IVDR, Qserve has updated her processes and systems to meet the requirements underlying article 11. Qserve will review your technical documentation and provide support where necessary. Together we ensure that your documentation complies with the regulations. Once completed, your devices will be registered.

Depending on the classification of the device the type of review may vary. For Class I devices the manufacturer has to self-declare the conformity to the MDR/IVDR. For Class II and III, there is Notified Body involved, and only after approval (CE Certificate) the EAR can register the devices.

The roadmap of Qserve's EU Rep

Qserve EC Rep | EU Rep

EU Authorized Representative Service package

Use of the name and registered address within the EU on all product-related labelling.
A thorough review of your EU declaration of conformity and technical documentation.
Review your Quality Management System documentation.
Preparation and registration of the initial product in the electronic system.
Update the listing of product registration in the electronic system.
Assistance in communication between the competent authority and the manufacturer.
Assistance and coordination of complaint handling and incident reporting to the Competent Authorities.
Updates regarding regulatory changes that might impact devices and registrations.
4 hours of ad-hoc consultancy