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.