European Authorized Representative

Qserve as your European legal representative

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. Qserve will represent your company to the national authorities and shall register your devices in the electronic system before commercialization.

Qserve acts as an authorized representative under the MDD/MDR and IVDD/IVDR. With the introduction of the MDR and IVDR, the authorized representative is considered an economic operator and shall be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer.


Due to the increased liability under the MDR/IVDR, Qserve has updated her processes and systems to meet the requirements underlying article 11. Like to market your device? After completing the mandate, 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. Why? 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.

A European Authorised 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 Authorised Representative.

Interested in our authorized representative services?

We would like to tell you more about the possibilities that Qserve offers as an authorized representative.

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What is included in Qserve’s EU Authorized Representative Service Package? / Qserve’s EU Authorized Representative  Service Package

Use of name and registered address within the EU on all product related labelling.
Official appointed contact address for European regulatory agencies.

A thorough review of your EU declaration of conformity and technical documentation.

Preparation and registration of the initial product in the electronic system. 

Update 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 which might impact devices and registrations

Advice on registration strategies
4 hours ad-hoc consultancy

Interested in our Authorized Representative Services?

After completing the form, you can download our EU Authorized Representative brochure. We will contact you within 2 business days to help with any questions.

How do you want us to follow up with you?
 
How can we help you? Contact us