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.